Medtech designers have an array of new tools to use for medical device development, enabling better solutions for healthcare.

It is an exciting time to be a medical device design engineer. Development opportunities abound as medical device manufacturers (MDMs) seek to make smaller, more complex, and more functional devices. Industry 4.0, artificial intelligence, data analytics, and additive manufacturing are moving into the spotlight. Applications include digital healthcare, less-invasive procedures, interoperability, cloud computing, software as a service (SaaS), point of care, home healthcare, clinical studies, compliance, robotic surgery, and electronic medical records.

Read the full article: https://www.mpo-mag.com/issues/2020-05-01/view_features/current-state-of-design-mind

Ximedica’s VP of Strategic Development, Melissa Bowley, will be speaking at Device Talks in June 2019 to share best practices in how to rightsize your development strategy.   

What exactly is rightsizing your development strategy? What is a minimally viable product (MVP) and how does it apply when your customer is ultimately a patient? An MVP can be extremely valuable to minimizing risk and gaining a better understanding of your customer and market.   

Start with the goal in mind 

Most companies approach a development firm like Ximedica with an idea or prototype in hand and ask, “Can you develop this into a commercial product in a year?” The answer is often, “possibly, but is that really what you need?” Sometimes moving directly into development of a commercial product is the right strategy, but often we discover there are milestones along the way that may alter your strategy. Typically, we discover these insights by collaborating in a strategy session before we begin a program. As a rule of thumb, you should always start developing your strategy with the goal in mind.  

Enterprise vs. Startup concerns 

There are several fundamental questions worth exploring before investing your time and money. 

If you are a startup, you might be attempting to secure the next round of funding.  What do investors need to feel confident in your technology? These needs may include market data, functional proof of concept, regulatory feedback, or clinical data.   

Perhaps you lead R&D or Product Management for a top 100 medical device company that is looking to beat your competition with a first to market technology. What functionality or features do you truly need in Gen 1 of your device? What additional features can you delay on and build into your multigenerational plan to provide your customers additional value, continued company growth and product launches in the future?

Key questions to ensure success 

Staying hyper-focused on the goal at hand can result in creating tremendous value for investors, shareholders and customers alike. So here are some of the questions that can help define your strategy: 

• What is the major milestone(s) I am pursuing?  (e.g., first to market, first in human, proof of concept, filling a gap in my portfolio) 

• At what points am I creating value and for whom? 

• What need am I addressing for the end user (patient, surgeon, etc.)? 

• What critical features of my product will address the need(s)? Which features can be added in future generations or line extensions? 

• Have I truly tested that this solution will meet that need? How do I get that feedback and iterate quickly? 

• What is my data strategy, and how can I maximize value in the connected ecosystem? 

• Who is financing and are they willing to do so? 

• If applicable, what is my reimbursement strategy? 

• What is my regulatory pathway? 

Join us at Device Talks in Boston on June 5^th as we explore real world product examples of rightsizing your development approach, MVPs (minimally viable products) and some of the tools that will help you address some of these key questions. 

For more information or to register for the event, visit https://boston.devicetalks.com/. We hope to see you there! 

On May 29^th Ximedica partnered with MDO to present a live webinar, “The Future of Telemedicine:The Challenges of Convenience.”

Ximedica’s Director of Digital Products Marco Flavio Marinucci co-presented with EVP of Corporate Development Tracy MacNeal on the landscape and future of telemedicine and remote monitoring. The webinar helps companies understand new ways to successfully go to market in this evolving aspect of the healthcare ecosystem. (more…)

Ximedica recently sponsored the second annual AdvaMed Digital MedTech Conference in San Francisco, April 24 – 25. Additionally, XimedicaDx President Tracy MacNeal moderated a panel, “Building the Health Care Brain Trust: How digital platforms can support breakthrough treatment for chronic disease.” Panelists included Ximedica’s Director of Digital Products Marco Flavio Marinucci, Glooko’s Executive VP Rick Altinger, and Empatica’s CEO Matteo Lai.

During the panel, participants discussed the ways in which a digital platform can give health care professionals deeper insights into chronic conditions like diabetes, epilepsy, and heart disease, and also help patients manage them more effectively. Panelists explored how improving a patient’s outcome can be achieved by pooling data from medical devices, treatment regimens, and patient visits. They also discussed challenges associated with building a platform to support the health care brain trust, and examined how we can aggregate and filter chronic disease data. Attendees were left with a better understanding of how we can leverage what we learn to improve outcomes for all chronic disease patients. (more…)

On March 21, 2018, Ximedica hosted a Digital MedTech Conference Meet-Up along with AdvaMed at our San Francisco office. The event featured a 30 minute panel session and reviewed recent case studies in digital health, and how they do (or don’t) prove their value in the healthcare ecosystem. Panelists included Bridget Hurley, VP of Clinical and Regulatory at Evidation Health; Amy Belt Raimundo, Managing Director at Kaiser Permanente Ventures; and Tracy MacNeal, President of XimedicaDx.

The panel examined the challenges of commercializing valuable digital products from the perspective of payors, providers, and technologists. Attendees were invited to ask questions while enjoying appetizers and drinks. (more…)

Ximedica recently sponsored the 2018 Human Factors and Ergonomics Society Symposium which took place March 26-28 in Boston.

Director of Research & Strategy Elizabeth Roche and Senior Design Assurance Engineer Maria Swenson both presented at the conference. Associate Human Factors Engineer David Powers, User Experience & Design Researcher Meredith Schwarz, Usability & Design Researcher Cynthia Warman, and RA/CA Consultant Ross Lenzing all lent their expertise in the form of poster presentations.

In addition, Ximedica was overjoyed to host a cocktail reception which took place the evening of March 27^th at the conference location, the Boston Marriott Copley Place. Attendees had the chance to network while enjoying delicious appetizers and drinks. (more…)

Ximedica was once again a sponsor of the 23rd Annual Frost & Sullivan Executive MindXChange, “Navigating Healthcare Transformation: Value Based Care, the Patient and the Technology,” which took place March 4-7 in San Diego.

As part of Ximedica’s sponsorship, VP of Innovation Joe Gordon led a hands-on workshop, “From Mind to Matter: A Hands-On approach to Achieving World Class Solutions Through a User Centered Innovation Process” with the help of Director of Business Development David Dingman and VP Business Development Martha Najib. The workshop received top scores and extremely positive feedback from the attendees, who noted the fun activity left them with a strong understanding of user-centered design. (more…)

Ximedica was proud to yet again participate in SLAS 2018, which took place February 3-7 in San Diego.

SLAS welcomed more than 6,600 participants from 40 countries – a new attendance record for the flagship international annual conference and exhibition. This diverse gathering of scientists, academicians, business leaders and students from around the globe participated in an extensive lineup of education, new production information, and opportunities to connect with peers interested in charting the future of life sciences discovery and technology.

SLAS2019 will be held February 2-6 at the Walter E. Washington Convention Center in Washington, DC. Short Courses will take place Saturday-Sunday, Feb. 2-3; the Exhibition and Conference will run Monday-Wednesday, Feb. 4-6. (more…)

On February 11-16, 2018, Ximedica exhibited at the Molecular Medicine Tri-Con event in San Francisco.

Since its debut in 1993, the annual Molecular Medicine Tri-Conference has become one of the world’s leading international events in the field of drug discovery, development and diagnostics. The Tri-Conference unites an ecosystem of 3,700 innovative thinkers and thought leaders throughout biotech, pharma and academia from around the world.

The 2018 meeting included 16 parallel conference tracks, 7 Symposia, and 25 in-depth short courses. New this year were 9 skills-based training programs. (more…)

Join Ximedica’s EVP Corportate Development Tracy MacNeal and VP, Business Development Martha Najib for a webinar as they discuss some key steps for start-ups and investors in the medtech space.

Did you know that only 20% of new businesses survive after their first year? During this webinar, MacNeal and Najib channel their experiences in the medical device industry to guide attendees through the world of technology development for a specific market, and in doing so shared some stories that attendees most likely had not heard before.

The panelists walk attendees through real life cast studies and in doing so, show attendees the difference between a successful investment and one that ultimately fails. Attendees are able to explore ways they can develop a technology for a specific target market that will have a higher survival rate by comparing different stories of success. (more…)

By Tracy MacNeal, EVP Corporate Development

Ximedica sits at the leading edge of many boundaries of new technology, and often our technical teams are frustrated. Deeply and fervently, our team wants to see creativity and human-centric design behind all new technologies and to have patients’ lives genuinely improved by new innovation. Forces of commercialization often make this humanity-based pursuit difficult. In a hurry to get to an early prototype, startup CEO’s skip crucial steps of essential user-focused design. Desperate for the next home run (or even single, double, or triple) investment, venture capitalists seek out proof of concept and data, but often forget to ask whether human factors have been considered. Does the product please the clinician? Does the patient feel comfortable using the product?

Regulatory challenges add pressure. As CEO’s think about how to get new technologies through regulatory hurdles, they forget the essence of a successful launch: that patients and clinicians like using the product. As part of our ongoing dedication to creating and nurturing good design in the medical device and diagnostics industry, Ximedica is pleased to support Senior Industrial Designer Matt Gill as a juror at the Spark awards in San Francisco in November: http://www.sparkawards.com/ (more…)

By Amanda Brantner, Marketing Strategist

Medical product design and development comes with inherent risks that, if not managed appropriately, can hinder market adoption and success. Ximedica practices “human-centered innovation” that reduces risk by focusing on user needs and how they influence the technology’s commercial path. Ximedica’s innovation process helps clients reduce risk in their launch, and creates true value in an increasingly complex healthcare landscape.

Ximedica’s Joe Gordon, Vice President of Innovation, and Tom Lutzow, Director of Human Factors Industrial Design, recently sat down with Medical Design & Outsourcing for their MDO Webinar Series to discuss methods and tools that can help innovators prepare for, evaluate, and burn down the risk in their programs.

The innovation process is a marriage of concept generation and research that is essential in establishing successful business strategies. This process also provides calibration activities to align goals and metrics both within teams and among development partners. (more…)

By Amanda Brantner, Marketing Strategist

Launching a new IVD technology can involve many hurdles and risks, but investment dollars abound for technologies that can demonstrate significant value in the healthcare market. “Investment and fundraising in the healthcare ecosystem saw a banner first half of 2017, driven in part by advancements in artificial intelligence and machine learning for healthcare applications and a surge in Series A investments,” according to Silicon Valley Banks’ Healthcare Investments and Exits Report 2017. As these new technologies hit the market, the diagnostics industry is seeking innovation models with clear ROls that manage investor risk. (more…)

By Bill Evans, SVP Innovation

Amazon launched another member of the Echo family this week that might well have some interesting healthcare applications. Alexa is getting smarter, and Amazon is making it progressively easier to integrate their artificial intelligence (AI) tools into anyone else’s products. This week’s launch of the Echo Look, which is an Alexa enabled camera, may well raise a smile from those of us used to Saturday Night Live spoof TV commercials, but no, it’s not SNL. This product is for real. Shown in this promo video giving women advice about how they look in their clothing outfits, it uses the AI natural language processing abilities of Alexa to let users vocally self-direct photo and video shoots and then analyses their wardrobe choices to offer advice. Not stated in the video, but of course highly likely, Alexa will make shopping suggestions and, just like any loving husband, will duck the question posed in the title of this blog post. (more…)

On Wednesday, January 18th several Ximedica engineers visited Sophia Academy in Providence, RI, where they led the group of fifth graders in a STEM activity. The goal of the activity was to create a “Secret Treasure Box” by connecting circuits to trigger an alarm when opened. The girls were given several materials and had a limited time to complete the activity. The group had a great time exploring the fundamentals of engineering while interacting with the enthusiastic Ximedica women. Check out some pictures from the activity (more…)

By Jessica Pichs, Principal, Research & Product Strategist

This question is a common one and in Ximedica’s experience, the answer is dependent on several variables.
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On Wednesday, October 5th Ximedica hosted 21 students from the Chariho Career & Technical Center for a Junior Achievement Job Shadow Day at our Providence office.

Junior Achievement of Rhode Island serves to inspire and prepare young people to succeed in a global economy. Junior Achievement is the world’s largest organization dedicated to educating students about workforce readiness, entrepreneurship and financial literacy through experiential, hands-on programs, and their legacy is for all youth to be given access to opportunity and success. (more…)

Ximedica’s User Experience & Design Researcher Meredith Schwartz participated in the Women in Design Panel as part of Design Week RI on Wednesday, September 21st. Design Week RI is the annual showcase and celebration of design in Rhode Island.

Each year, DESIGNxRI presents a multi-day, statewide event to highlight the vast and unique design asset in the state. They partner with dynamic individuals and organizations to bring over 35 events spanning 11 days, including speakers, tours, lunches, panel conversations, parties, awards and more. The Women in Design Panel was organized to celebrate the talent, innovations, breakthroughs and successes that women designers in RI have brought their industries. (more…)

By Bill Booth, Director of Business Development

There’s no argument that technology will continue to become a larger and larger part of our everyday lives. Just look at your personal electronics, car, home automation. Then look at today’s healthcare system. There is no doubt that these advances and our expectations of them will make their way into medical devices. (more…)

Ximedica co-sponsored an evening reception with Dymotek as part of the Design in Plastics Conference taking place at the Rhode Island School of Design (RISD) June 20 - 22, 2016. The tiki-themed party was held at Ximedica’s Providence office on Tuesday, June 21st where attendees gathered for both taco and pizza trucks, refreshing drinks, and rocking entertainment by Ximedica’s own band, the Non Compliants. Attendees were also treated to a private tour of the Ximedica facility. Thanks to everyone who joined us for a great event, and check out some pictures of the fun (more…)

On June 8th the Bridge Design, a Ximedica Company and Ximedica teams welcomed area designers in the newly acquired street level space at the Bridge Office in San Francisco. The party was part of San Francisco Design Week, an event that spans the entire Bay Area from Silicon Valley to the city of San Francisco, offering designers more than 60 studio tours and 75 events throughout the week featuring world-renowned designers, entrepreneurs and innovative thought leaders. (more…)

Visit Design InVitro for a place to find all the great, funny, trendy, poetic, cool, innovative things happening in the world of medical and biotechnology!

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By Hope Hopkins, Director of Communications

The recent media swarm around the British Medical Journal research claiming that Medical Error is the 3rd leading cause of death in US leaves Dr. Don Berwick confounded. In an interview with Boston Public Radio he asserts this isn’t news. “This burden we bear of consequences of errors and injuries in healthcare has now been known for well over 20 years, and carefully documented… actually there’s almost nothing new in this paper, and it’s a little bit perplexing why the public is so unaware of this.” (more…)

On Wednesday, April 27th the Ximedica welcomed fifteen aspiring women engineers to their Providence office for a day of learning and creativity. The girls met with Ximedica’s women engineers, toured the facility, and even got to participate in their own developmental process of engineering a “chair” out of minimal items, including newspapers and duct tape. The group had a great time learning about the fundamentals of engineering. Check out some pictures from the day below and visit our Instagram page for more fun photos! (more…)

Medical device developers look to solve problems in healthcare with a product or service. But for some, that’s where they stop short.

It is critical that medtech developers move beyond a single solution into thinking holistically about the care environment, the various motivations of users and stakeholders, and the opportunities to connect to a larger view of healthcare. If patients have a choice, they are going to favor solutions from companies that offer best overall outcome in cost. Additionally, a high value ecosystem surrounding a physical product can considerably improve a company’s competitiveness.

Understanding the ecosystem opportunity opens the path to successful product development in the digital age. Designers need to understand how their piece of the jigsaw puzzle fits to ensure the products offering is effective and successful. This blog explores the 4 critical areas to consider when designing a new complex ecosystem: (more…)

By Andre LaFreniere, VP Business Development

The title to this post was originally “every company is a technology company”. This borrowed from a phrase that I have heard frequently from individuals that span industries and job functions. The implication is that regardless of what product/service your company offers the intersection with technology is either (a) already a key component of your product/service or (b) it will be very soon. While a part of me laments the things we often lose with technology introduction, namely privacy and simplicity, I must concede that technology acumen is nearly equivalent to literacy and math fluency as a probability measure of success in today’s marketplace. (more…)

By Jessica Pichs, Principal, Research & Product Strategist

In today’s technology-driven world, consumers are often overwhelmed by the volume of choice and information they’re exposed to. Consumers want technologies to simplify their everyday lives; not complicate them. Healthcare providers should keep this ideology in mind when competing for customer loyalty and market share as the design of a medical device is just as important as quality of patient care. This blog explores five best practices for addressing a consumer’s usability expectations for medical devices. (more…)

The healthcare industry is being impacted immensely by developments in the world of robotics that offer solutions for problems ranging from patient healing to physical obstacles in the natural world. Robotics is a trending topic in the Xi Technology Forums, where technologies that go far beyond traditional prosthesis are often discussed. As we celebrate #NationalRoboticsWeek, learn more about how robotics technology is impacting our society, both now and in the future. (more…)

Research and development is the key to creating the next breakthrough in medical progress. With an aging population, people with disabilities living longer, and chronic disease growing at faster rates, now is the time for more—not less—resources to advance cures and treatments that help people live healthier, longer, and more independent lives. (more…)

By Elizabeth Roche, Director, Research & Strategy

If you’ve been in the Human Factors field for even a meager month or two you have likely encountered some degree of terminology muscle-flexing.

It might go something like this—one side insists on using the term ‘Human Factors Validation Testing’ while others argue for ‘Summative Usability Testing’. The first person is citing the FDA Guidance on applying human factors while the second quotes ANSI/AAMI’s HE75. Before long, a third points out that IEC 62366-1:2015 prefers the term ‘Summative Evaluation’. So is it an evaluation or a test? Should we use the descriptor ‘human factors or ‘usability’? While the former aligns with the FDA, the latter is more ubiquitous.

In truth the terminology doesn’t matter as long as those involved agree on the method being employed. In fact, as a discipline do ourselves a disfavor by engaging in such banter. Not only does it decrease efficiency, but it alienates our cross-functional team members by making us look pedantic and our discipline unnecessarily confusing. (more…)

By Jeff Morang, Sr. Human Factors Engineer

So many times I’ve witnessed the same mistake; when nearing the end of a project someone on the Core Team says,“When will we review the Instructions for Use?”. This is usually followed by anawkward silence and frantic gazes in search of reassurance. Surely someone is tucked away in a room diligently typing out a Pulitzer Prize-worthy IFU that will dovetail beautifully into the project’s timeline. Sadly, that’s not usually the case.

Instructions for Use, Quick Reference Guides, and labels need to be an integrated part of the design and development effort. It’s no secret that the FDA considers IFU’s and labeling as important as the device itself! (see the FDA’s Guidance on Medical Device Patient Labeling) Moreover, the instructional material should reflect the same quality and design language as the device they are supporting. After all, they are all part of the product experience you are delivering and they all reflect your brand. (more…)

With an abundance of significant medical technology coming through the pipelines, one of the most widespread challenges we face is the lack of committed engagement and understanding of the value models across the continuum of care. Connected devices offer the promise (more…)

Last week, Sr. Human Factors Engineer, Jeff Morang presented at the Medical Device Summit in Boston. His session, part of a collaborative effort with Ed Israelski of Abbvie focused on the increasing expectation that Human Factors Engineering be applied to medical product design throughout the development process. The driving force behind this increasing expectation is not only regulatory bodies and, as Ed noted a host of upcoming edits to already familiar HF guidances (more…)

The Ximedica Technology Forum: A collective enterprise to share, disseminate and discuss new technologies, gadgets and innovations that have recently come into the public domain.

The healthcare industry is being impacted immensely by developments in the world of robotics that offer solutions for problems ranging from patient healing to physical obstacles in the natural world. At September’s Xi Tech Forum, we discussed several robotic technologies that go far beyond traditional prosthesis. For example: the ambulance of the future may look more like a jetpack. Some of these technologies are bound to not only improve lives, but save them. (more…)

Randy Barko, President & CEO recently sat down with RI Public Radio’s Dave Fallon and Mark Murphy, Editor of Providence Business News.

Listen to the full interview here: (more…)

The Ximedica Technology Forum: A collective enterprise to share, disseminate and discuss new technologies, gadgets and innovations that have recently come into the public domain.

Ghost Heart by Texas Heart Institute

Seeking to relieve the shortage of donor organs, THS has developed a heart scaffold that they have been able to grow a working heart from using human stem cells. The scaffold was created from the protein structure of a pig’s heart with the living cells stripped away with a soap solution, and has successfully been implanted into animals. (more…)

The Ximedica Technology Forum: A collective enterprise to share, disseminate and discuss new technologies, gadgets and innovations that have recently come into the public domain.

Disposable EEG Face Mask by University of Eastern Finland

Mask consists of flexible polyester film that has silver ink applied through screen printing. Sixteen hydrogel coated electrodes have direct contact with the face. The mask is MRI and CT compatible and easily applied to the skin, enabling faster EEG to chart brain activity. (more…)

When Industrial Designer Ayan Bhandari set out to compete in the Global Health Track at MIT’s Grand Hack 2015: Hacking Medicine event, he had no idea how much the industrial design experience and user advocacy that he employs daily at Ximedica would assist his efforts.

Ayan joined a small diverse team of health care professionals and engineers, and the team was tasked with generating product concepts targeted at pedestrian safety – a topic of particular interest for the event.

Each teammate shared relevant experiences and narratives during the initial brainstorming activity. One teammate, a native Ugandan, told of how motorbike accidents outnumber and cause more injuries than automobiles in her home country. This is especially true for women, because they are expected to sit sideways holding onto their belongings as the bike weaves through traffic. (more…)

What is an interaction designer? My role is to design digital interactions with technology that fit within people’s lives. The growing trend of mobile and wearable technology means these interactions with users take place more frequently and have more meaningful impacts on relationships with other users, information and their devices. It is very important that the visual and gestural presentation match the user’s personality, location, and even mood. Getting this right can create delightful and potentially life-changing experiences.
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Minnesota is well-known to be a national center for groundbreaking medical technologies, treatment and healthcare initiatives. Ximedica’s Minneapolis office is located in a prime location, allowing us to tap into the resources and opportunities offered by this Midwestern health hub.

Earlier this week, Ximedica’s Vice President of Business Development, Juli Denny attended and exhibited at the MobCon Digital Health Conference in Minneapolis, MN. As the Business Development point person for our Twin Cities office, Juli was interviewed by KSTP Channel 5’s Health Expert, Archelle Georgiou, MDabout the services offered by Ximedica as well as some of the innovative new technologies we’re currently developing in-house. (more…)

By Elizabeth Roche, Director, Research & Strategy

During a week in China conducting in-home interviews to better understand use environments for medical devices I was struck, like others before me, by the contrast between the grime outside the homes and their immaculate interiors.

We spent much of our time in Beijing where smog sits between buildings like silt in a murky river. Construction debris and everyday rubbish was piled up along the streets and in courtyards. The conditions outside each apartment building we visited varied little across income categories. The stairs and walls leading to each apartment were poured concrete covered in spray-paint-stenciled advertisements touting the availability of cleaning ladies, repairmen and the like. However, once we crossed the line into the family living space we encountered nothing but sparkling, shiny apartments. (more…)

Last week, a few Ximedica experts were present at CES 2015 in Las Vegas. Chief Innovation Officer Aidan Petrie also spoke in a panel with the AARP’s Jody Holtzman exploring the needs and strategies for designing products specific to the aging Baby Boomer generation.

As the field matures, new opportunities are emerging specifically to serve the needs of more demanding consumers, better informed patients, and more connected caregivers.

Watch his interview with Tim Reha below. (more…)

The med tech industry is in in a period of massive change driven by several significant forces: the need to cut cost, the rise of a connected and informed patient population, and a significant lag in technology adoption.

A quick look around at the rise of companies in other industries that disrupted the status quo unveils a number of guiding principles that savvy entrepreneurs in the medical field ought to take notice of.

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The Ximedica Technology Forum: A collective enterprise to share, disseminate and discuss new technologies, gadgets and innovations that have recently come into the public domain.

One of the greatest advances in heath care today is inarguably attributed to the advances in sensor technologies. With the innumerable pros, e.g. patient compliance and empowerment towards more proactive care, the ability to monitor effects of say drug therapy there are also the cons, too much data, integration and cost. Therefore success is achieved when the following requirements are satisfied: wearability, reliability, security and interoperability. (more…)

The Ximedica Technology Forum: A collective enterprise to share, disseminate and discuss new technologies, gadgets and innovations that have recently come into the public domain.

As the world of health care continues to evolve, innovations in nonwoven materials are offering major solutions to problems we didn’t even know we had. Ranging from sensor laden-films to liquid battery components, the innovations coming out of colleges and universities around the world are providing endless opportunity for medical devices.

Trending now… (more…)

While the adult healthcare industry continues to grow in size and cost, the world of children’s healthcare remains fragmented and out of focus. More specifically, innovations in pediatrics appeal to smaller markets, due to being broken into numerous developmental phases and categories within the industry. Adult medical product opportunities are versatile and therefore present a greater market need, hence children are often treated using adult-sized equipment (i.e. unnecessary lengths of IV tubing hanging from a child’s mobile unit). The focus on pediatric innovation is so divided that pediatric patients are not being treated with the devices and products they really need. (more…)

By Pamela A. Davol, Clinical and Regulatory Project Manager

Even before the CDRH draft guidance for Human Factors testing was released on June 22, 2011, human factors reviewers at FDA were sending requests for additional information from medical device or pharmaceutical companies who submitted HFE/UE reports that only summarized results from usability validation evaluations of their investigational products to support their marketing submissions. (more…)

By Pamela Davol, Clinical & Regulatory Project Manager

Last year, the Center for Drug Evaluation and Research (CDER) released the draft guidance Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. It was written with the intent to provide guidance on using packaging design and labeling to determine medical dosage strength. The guidance acknowledges that the use of colored labels can be effective in drawing the user’s attention to important information, but emphasizes that the color is more of a supplement to—rather than a replacement for—the information gained by actually reading the label. For this reason, CDER cautions that all labels must be properly evaluated to minimize the occurrence of medication errors. (more…)

Written by Jess Willing-Pichs, with special thanks to contributors, Luke Hagan, Faith David-Hegerich, Ryan Shafer, Dino Kasvikis and Rebecca Huebner.

The collaborative nature of this blog is derivative of Ximedica’s monthly internal Technology Forum, a collective enterprise to share, disseminate and discuss new technologies, gadgets and innovations that have recently come into the public domain. Our engineers, researchers, and designers explore the potential impact of these technologies on future healthcare delivery solutions. In the coming months, we’ll introduce blogs like this one as a result of fruitful Forum discussions. Let us know what you think!

You may remember the buzz in early December about the Sony’s SmartWig patent filing. (more…)

For full whitepaper download, click here.

The US has one of the largest healthcare markets in the world, but the average hospital barely breaks even due to rising costs and shrinking revenue. Day-to-day operations are reigning in supply costs by reprocessing, renting, using generics, and streamlining purchasing in an effort to improve margins. Stricter payment regimens from federal and commercial health plans and a recessionary mindset among patients further complicates these economics creating an emerging value system never before seen. (more…)

By Jeff Wallace, Program Manager

Universities and academic centers are known hotbeds for innovative and disruptive technologies across all industries. While several industries are fertile ground for this type of commercialization, the medical technology space and regulated environment has its own unique challenges that further test the university-born entrepreneur. University entrepreneurs are strongly encouraged to pair up with the right partners, whether it is through their institution’s technology commercialization office or an experienced third-party firm, in order to maximize their chance of realizing market success. Throughout my career managing various medtech development programs, three common challenges continuously bubble up when dealing with academic start-up ventures. While these challenges can be a hindrance, keen entrepreneurs can turn the following into opportunities. (more…)

There are a slew of digital health technologies being developed, but not all are having a profound impact on the healthcare system. How are the most innovative companies developing industry-changing strategies to engage patients and providers across multiple channels? And what master tactics are the most prominent advisors finding most effective in business and helping the world’s healthcare crisis. (more…)

There is no shortage in tech at a show like CES, and this year in particular Digital Health made a number headlines-but ever more the opportunity for health wasn’t just what one might find in that particular hall-the expo floor at-large proved to have ample opportunity and applications for the medical device industry.

Trends that will fuel medical product activity (more…)

It is widely understood that the opportunity to revolutionize the way healthcare is delivered is both tremendous and necessary. And yet I was struck having just attended CES that as the heat continues to turn up (think ACA, value-based healthcare models and boomers) the amount of actual change seemed to be slower. There is a call to arms for developing better connections between patient, care providers (docs) and payer systems (insurance) with the ability to analyze and dissect data that will lead to better outcomes, lower costs and healthier lives, one that advances in technology can surely meet.
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By P.A. Davol, Clinical & Regulatory Project Manager, Ximedica, LLC

The regulatory viewpoints and FDA specific recommendations on current human factor usability testing strategies are constantly evolving – and with these changes come the potential to impact product approvals, particularly for combination products. Why is HF usability testing suddenly being turned upside-down for some medical device manufacturers? (more…)

By Aidan Petrie, Chief Innovation Officer

There are a slew of digital health technologies being developed, but not all are having a profound impact on the healthcare system.

How are the most innovative companies developing industry-changing strategies to engage patients and providers? What master tactics are the most prominent advisors finding most effective in business and helping the world’s healthcare crisis?

It’s simple. A successful investment in healthcare today is a product that demonstrates a clear clinical and economic benefit. (more…)

Last week’s post gave you an overview of the FDA’s new Pre-Submission program and all it entails. Today brings a more magnified view – including the exact pieces that make up a Pre-Sub request, and specific examples of what the new guidance doesn’t do.

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By Pamela Davol, Clinical & Regulatory Project Manager

A recent discussion in an online industry group posed the question, Is Usability Research Necessary for your FDA Submission?

The reply was as follows-

There should no longer be a debate or even a question as to whether or not usability studies are required for a regulatory submission of a medical device or product containing a medical device constituent (i.e. combination product with device-delivery system): a manufacturer will not get a new device or combination product with device clearance/approval without usability testing; and even some manufacturers who are making changes to previously cleared/approved devices are being asked to conduct usability testing based on changes to the design-user interface of predicate devices. (more…)

By Pamela Davol, Clinical & Regulatory Project Manager

A Failure Mode is defined as “the manner in which a device (equipment, software, etc.) may fail functionally.” Depending upon the complexity of a device, there may be many conceivable use-errors for every failure mode, not all of which may be observed in usability testing and thus not necessarily required to be identified in a UFMEA. With complex devices where it is essential to prioritize use-steps for evaluation, rather than spending time conceiving of every possible misuse/use-error for a product, identification of primary failure modes associated with use-steps will identify those use-steps that are critical and/or essential for safe and effective product use by end-users (i.e. failure modes resulting in higher severity of harm ratings, independent of probability of occurrence, or impacting on intended product treatment, whether or not diminished/over- treatment may result in harm to the patient). (more…)

If it detects heart rhythm abnormalities, your iPhone is an ECG, says the FDA. With the FDA releasing their final rules for mobile medical app development, a number of self-proclaimed software geeks become the newly anointed medical device developers - having to abide by strict regulatory standards and guidance. (more…)

On August 24th, Ximedica’s CIO and Co-Founder Aidan Petrie argued on behalf of the medical specialist during IDSA’s debate, Designer Faceoff: The Generalist vs. The Specialist, which pitted designers from in and around the industry against one another in a discussion around what it really “takes” to design medical devices for the medical industry. While the audience voted in favor of the generalist we maintain that designing a safe and efficacious product that is fit for its intended use benefits from industry knowledge.
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By Tom Varricchione, VP of Clinical & Regulatory Affairs

Deciphering U.S. FDA and HHS regulations and agency guidance regarding human research protection makes clear the need for protecting the safety and privacy of participants but leaves unclear whether Institutional Review Board (IRB) approval is needed for Human Factors and Usability Studies.[1] Conservative organizations adopt a default position of seeking IRB approval for all human factors and usability research which they perform, but there are categories of such research that remain exempt from the requirement for IRB approval. In addition to interpreting the nuances of the regulations, determining the level of risk a study poses to participants is a determining factor in whether IRB approval is required as well as the type and extent of review and documentation required for the study. For this reason we have developed the following 3-step ‘Quick Start Guide’ for conducting research with human subjects.
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Ximedica’s co-founder and Chief Innovation Officer Aidan Petrie was in sunny San Diego this week to attend and speak at the Digital Health Summer Summit.

His panel - ‘Sensors Uncensored’ - featured three speakers exploring the sensor market from different points of view. As CIO of Ximedica, Aidan regards medical sensors from a product implementation and commercialization perspective. If you weren’t able to attend the Summit, the video clip below gives a well-rounded summary of what was covered.

Enjoy! (more…)

For the past eight weeks, Kiely, a senior from Bay View Academy here in RI has been working side-by-side with a number of our engineering team members to more fully understand engineering as a discipline and future path of study.

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The Tech Collective, Rhode Island’s Bioscience and IT industry association, hosted its first annual RI Bioscience Awards event last week – and among the five award recipients honored that night was our Director of Quality, Michelle Wu.

Read on to learn more about the critical role Michelle plays at Ximedica and why she was selected to receive this honor.

What specific role do you play? How is it critical to the achievement of your company/organization’s goals? In what way are you going above and beyond as a contributor to that success? Please give specific examples. (more…)

The world of consumer health care differs from the medical device sphere in numerous ways – but they both share a common goal: keeping people healthy. ‘People’ can range from the already healthy to the terminally ill, but the objective remains the same.

This week, we’re touching upon trends and innovations in the world of consumer health care products. These include wearable technologies, gender-neutral designs, sustainability, and devices that come with smartphone apps. (more…)

In the context of the consumer space, colors are typically chosen using trend analysis, analogous product research and user preference studies. Though the process is highly subjective (“I like, I feel, I want”), it helps researchers choose a color that will be successful on the market.

But what happens when a product that is used in a clinical, FDA-regulated setting makes its way into the home (as many are doing)? How do we ensure user preferences are met alongside medical industrystandards such as HE-75? Usability guidelines tend to be meticulous about how color is to be used on control interfaces, but are less clear on the color guidelines for at-home products. More and more at Ximedica, we are encountering clients that are looking to launch new product lines that straddle the clinical/consumer space, and have terrific user preference work in place; but they often lack methodology and evidence to support their FDA filing on why they chose a specific color.
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This week, the University of MN hosted the Design of Medical Devices Conference, where our Co-Founder and CIO Aidan Petrie spoke in a panel discussion on collaborative device design.

After his panel, Aidan was interviewed by local Minneapolis news station ABC 5. He answered questions on the next generation of life-saving devices - including one of Ximedica’s past projects, the InfraScanner. Aidan’s interview begins at the 4:35 mark, but the whole video is definitely worth watching, especially if you weren’t able to attend the conference.

Enjoy! (more…)

With robotics on the rise in medtech today, we thought we’d highlight longstanding mentorships between Ximedica’s engineers and aspiring young people in the robotics field.

Ximedicans Paul Bertram and Peter Cameron aren’t developing NurseBots with their teams quite yet, but they are helping local high school students build complex robotic systems that perform intricate mechanical movements. The robots are built for the FIRST Robotics Regional competitions series, which challenges teams to complete an entire functional bot in just six weeks. According to Bertram, “These students are amazing! Every day they come to the lab to test, refine and rebuild the mechanism – completely undaunted by their previous mishaps and upsets.”

Last week, Paul participated with his team, ALARM Robotics, and their robot “InchWorm” at the FIRSTRobotics Regional Competition in Boston. Teams were challenged to build a robot that could successfully compete in either of two required events - throwing a Frisbee or climbing a jagged pyramid. Paul’s team chose the pyramid option because they sensed that building a robot to throw a Frisbee through a 12” wide slot would be “insane.” (more…)

FDA Standard: 62366, Medical devices - Application of usability engineering to medical devices

ISO/IEC 62366 lays out a user-centered standard process that may ultimately help medical device manufacturers avoid user errors and maximize usability. Also included in the standard is a framework for the training of intended users and for the device’s accompanying documentation. It has expanded the scope of its preceding standard, which was solely for electrical medical devices (ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability), to include all medical devices. The 62366 standard is often used when applying for a product’s CE marking. (more…)

Product development organizations have well-established processes in assessing potential hazards for both process and design. However, these processes do not traditionally apply to use error, therefore hazard management teams tend to treat the human component of systems in a superficial, non-formal way.Historically, Human Factors work has taken up the slack by producing formal methods of assessing use error based on sound theory of human performance and problem solving. However, these methods are typically used to assess error after the fact and do not fit well within traditional product development programs.

Additionally, formal methods tend to be heavy on theory and are not easily used by teams outside of the discipline. (more…)

On February 21st, Ximedica participated in its fourth annual Introduce a Girl to Engineering Day (see last year’s event here). The day is sponspored by the National Engineers Week Foundation, and encourages organizations to promote female participation in engineering and the sciences. We have compiled some photos from Thursday’s event below. Female employees (and some of their male counterparts) gave local high school students a peek into the world of mechanical, software, electrical, and design assurance engineering, as well as industrial design and process management. (more…)

It’s no coincidence that the iPad Mini was made with proportions that fit perfectly into the pocket of a medical professional’s standard lab coat. In fact, one in three physicians surveyed recently by Epocrates said they are planning to purchase an iPad Mini for this reason. But there is more behind the tablet’s popularity with clinicians than its convenient size.

Tablets allow medical professionals to quickly view and share patient data, software, and images; a doctor may connect remotely with patients and colleagues at a moment’s notice. As a result many are jumping at the chance to create slings and hands-free apparatus to cater to the growing presence of iPads in a variety of clinical environments.

Healthcare designers take heed: there are a number of risks associated with greater mobility that need to be considered as we continuously move away from pad and pen. (more…)

As we mentioned in last week’s post, our CIO and Co-Founder Aidan Petrie spoke at the Digital Health Summit earlier this month. His session, entitled ‘It’s All About Me! Designing for the Healthy Consumer,’ and others can now be viewed from the comfort of your desk chair. Enjoy! ​ (more…)

At the Digital Health Summit - a fast growing track in the recent CES show in Vegas - leaders in medicine, entrepreneurs and techies highlighted the opportunities and challenges in the growing fusion of mobile devices and health systems. Mobile devices are creating information trunk roads for data collected realtime from a patient or customer, uploading and rationalizing it in the cloud, and making it available in a simple format to physicians and patients alike. This capability offers the promise of better, cheaper care that is personalized to individual needs, and can provide tracking so that medications and wellness regimes can be fine-tuned to improve outcomes.The primary challenge for this innovation is that the fast, loose and ‘good enough’ tech culture has to join forces with the highly regulated and data driven clinical world - where sensitivity and specificity are required components of a therapeutic device or a diagnostic monitor. On top of that, the patient population of consumers is a very different market to address from the gadget-hungry consumer product market. The motivators for compliance are not the same as for the latest smartphone. (more…)

By Thomas Varricchione, Sr. VP Clinical & Regulatory Affairs

The FDA’s DRAFT Guidance for Industry and Food and Drug Administration Staff was issued for a 90-day comment period on 12/12/12. The guidance is relevant to developers, manufacturers, processors, etc. of medical devices, regardless of whether they are prescription or over-the-counter (OTC) products. The guidance defines home use broadly to mean use anywhere outside of a professional healthcare facility or clinical laboratory, e.g. a home, hotel/motel, office building, airport, train or bus terminal, automobile or any form of public transportation vehicle, etc. In essence, they mean anywhere a healthcare professional is not continually available to use a medical device on you or to assist you in using such a product. (more…)

#1: Holistic evaluation of the healthcare systems to understand its impact on human interaction.

The sum does in fact equal all parts. There is increasing awareness and interest in examining healthcare problems holistically. Be it a study on the impact of interruptions on workflow to the proposal for a HealthcareFMEA, or an engineering initiative at a nearby hospital to examine an integrated network of people, technology, tools and tasks; whole systems need and their impact on human interaction must be considered. (more…)

How can risk be mitigated in the product development process? How can human factors professionals from vastly different industries work together to gain insight into their own processes? These are just two of the hard questions that next week’s MDG Forum, Design and Human Factors Keys to Innovative Medical Device Products: Expert Views on Mitigating Risk in the Development Process aims to answer.

Referencing the FDA’s latest human factors guidance document “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” from June, human factors professionals will draw from their own experiences in exploring the FDA’s latest thinking and expectations. (more…)

By Joni Bouley

According to a new study by Juniper Research and an article by Burrill Report, the wearable device market will be worth over $1.5 billion by 2014. This is nearly double the current value of the market, which is largely dedicated to consumer health and fitness products. Why is there an increasing demand for wearable devices?

Evidently, as smart phones become the source for all of our communications – email, calls, video chat, gaming, social media – more people are feeling like they are ‘slaves’ to their devices. There is always something to respond to, or check on, or browse. Smart phones are tied to 25% of car crashes,and the distracting nature of mobile devices is starting to be seen as a real problem. Physically having to handle our devices while we carry out everyday tasks can be a burden, so the development of hands-free wearables offers a simple solution - and is gaining monumental traction in healthcare. A major benefit of wearable devices (as opposed to devices that you wear) is that they are seamlessly incorporated into your ensemble. (more…)

By Joni Bouley and Tom Varricchione, Senior VP of Clinical & Regulatory Affairs

The FDA’s Pre-IDE (Investigational Device Exemption) program, which originally began in 1995, has recently changed its official title and scope. The program is now referred to as the Pre Submission (Pre-Sub) guidance, and has been adjusted for a broader range of subjects, including devices regulated by the Center for Biologics Evaluation and Research. (more…)

Renowned as one of the most variable healthcare environments, the Trauma Bay was particularly ripe for conceptualization through a human-centered design lens. Recognizing this, the Ximedica Human Factors team got to work creating a fully re-imagined and ergonomic space that allows for expedient care in this critical environment. The result is the ‘Smart Bay’ of the future which Dean Hooper, our Principal Human Factors Scientist will present live at the 56th Annual Human Factors and Ergonomics Society Meeting in Boston next week. (more…)

By Joni Bouley

China’s up-and-coming presence in the medical device industry is more evident than ever with many top device companies bolstering their presence in China’s major cities. Upon returning from the MedTec China show a couple of weeks ago, our team had much to share, among which was a discussion around the reception at the show of our Quality Management System and assumption that because we were U.S. based and have a full QMS in place, our services “must be very expensive.” Recently the lack of quality regulation being displayed in China’s medical device manufacturers has raised some eyebrows, including our own. MedTechInsider.com released an article on China’s regulatory processes (or lack thereof) that quotes a candid appraisal by Lin Xianyong, Director of Medical Device Safety Supervision Division, SFDA Shanghai. (more…)

By Jessica Willing-Pichs, Senior Research and Product Strategist

The shift of healthcare device use from clinical settings to patient homes presents interesting and complex opportunities for medical device manufacturers. Devices now need to be designed for a diverse user group, with a wide range of physical and cognitive abilities, with limited training and installation assistance. Within this varied set of home users, there are parents caring for young children, seniors, recently hospital-discharged, post-surgical patients, individuals suffering from co-morbidities and the terminally ill, as well as clinically trained visiting nurses and case managers.

A device may be prescribed and demonstrated in a clinical setting and then arrive in a box on the new user’s doorstep along with instruction manuals, quick start guides and perhaps a dizzying array of accompanying disposable supplies. Or a caregiver may be assigned to purchase the equipment from an unfamiliar medical supply store and bring it home themselves. (more…)

Ximedica is exhibiting at MedTec 2012 in Shanghai at the moment, and we thought it might be a nice change of pace to share an insider’s look at the conference. Ximedica’s Aidan Petrie and Michael Pereira have set up shop with our Hong Kong Asian operations team, Tony Kung and Morris Chow.

Watching a space go from an open square of concrete floor to a shiny new exhibit is something not many people get to witness! Here’s a look at how the whole thing comes together. (more…)

By Joni Bouley

Last week marked the seventh annual National Health Information Technology Week, which emphasizes the promotion and improvement of technologies used in the healthcare and consumer health industries. At this time last year, President Obama released an official proclamation of the importance of Health IT Week and its message.

According to an article published in MediaPost, the United States spends more per capita than our peer countries, yet ranks lowest in terms of life expectancy and chronic health issues. One way to treat and prevent many of the most common (and treatable) chronic maladies – i.e., hypertension, diabetes, obesity – is to ensure that people are aware of the causes and treatments for these issues. (more…)

By Dean Hooper, Senior Human Factors Engineer

Excerpt taken from Dean’s article on MDDI Online:

The FDA and international standards bodies have long recognized that use error committed during interactions with medical devices negatively influences patient safety. In many cases, these errors are the result of poor design. The regulatory pressures are increasing to demonstrate that products are safe and easy to learn and use. Given the recent addition of the human factors discipline to the Office of Device Evaluation (ODE), the medical device industry is in a state of flux. For some devices, a development program may just be nearing transfer to manufacturing only to be halted by new, user centered design requirements for regulatory submission, i.e., a usability validation study. This article will provide solutions for meeting newer FDA requirements for validation studies without mandating that a client start anew or lose too much development time. (more…)

By Beth Werner, Senior Research & Product Strategist and Lindsey Messervy, Design Researcher and Strategist

What is the role of ethnography in realizing the barriers to change, and how can it be used to reconcile these issues?

As discussed in the first part of this article, the culture of the staff as well as the organization as a whole plays a huge role in carrying through effective changes in practice. Ethnography as a stand-alone practice is particularly well-suited for gaining insight into the current behaviors and practices that are required to jumpstart a change initiative. Not only can ethnography help to uncover behavioral practices and routines, but it can help us, as researchers, understand strategies for realigning expectations across siloed teams as well as strategies for engaging participants with the changes. (more…)

By Beth Werner, Senior Research & Product Strategist and Lindsey Messervy, Design Researcher and Strategist

Hospitals and healthcare organizations, especially in the United States, are beginning to see a major overhaul in terms of healthcare delivery. Healthcare innovation is being touted as a key strategy to refocusing and improving patient care and staff, but it has yet to be truly defined. Innovation does not have to be a full system transformation; it can be as simple as adjusting appropriate staffing levels, increasing communication between staff, patients, and management, or even bringing back the “care” in care giving.

The healthcare industry is a complex and confusing system. Providing care to one patient can require communication and collaboration between a primary care physician, a specialist, local labs, the pharmacy, hospitals, and rehab facilities. It is critical that every practitioner who is caring for a patient has access to all of the information available about that patient. But critical patient information often sits trapped inside archaic systems, or worse - written on scraps of paper far away from those who need it. (more…)

By Aidan Petrie, Chief Innovation Officer & Co-Founder

Medical technology is getting ever more sophisticated while at the same time the use of medical devices is moving away from the highly trained professional and into the hands of nurses, techs, caregivers and in many cases the patients. This divergence is rapid and its drivers include demographic changes, financial pressures, technology advances, the web, education systems, politics and more. As this shift becomes the norm, what are the implications for the device industry? While all systems will need to move towards a user focus, one major area this change will impact is on the device interface. These interfaces will have to align themselves with the new user, in the user’s environment, and within the user’s personal routines. The interface can no longer be dictated by the provider or programmer as devices make their way out of hospital floors and clinical settings into homes and onto the streets. This does not however mean a call to over simplify or “dumb down” technology but rather to make devices that are culturally appropriate, fit the user and are intuitive to use. The upshot is huge. User-centered design leads to better compliance, cost reduction, and more personalized health. (more…)

By Pam Davol, Clinical & Regulatory Project Manager

What is the FDA’s Unique Device Identification System?

The Unique Device Identification (UDI) System is a new regulation to be imposed by the FDA that requires the labeling of medical devices and medical device constituents (i.e. device components of combination products) to bear a unique identifier, which will adequately identify the device through distribution and use, and may include information on the lot or serial number. (more…)

This week is the official week of Women in Health Care, as celebrated by Rock Health and their ‘XX in Health’ Initiative. Rock Health is a women-led health tech group—referring to themselves as an “incubator of innovation” on their website—that cultivates partnerships with Mayo Clinic, Harvard Medical School, and UCSF. The main objective of ‘XX in Health’ is to improve gender diversity in leadership positions in the health care sector.

Reflecting upon our own personal experiences in hospitals, clinics, and health care-related organizations, you might initially recall interacting mostly with women. According to Rock Health’s Rock Report, females represent 73% of medical and health services managers. So where exactly is the inequality? Well, as you ascend the chain of command (in terms of both power and salary), things begin to change. Only 32% of doctors and surgeons are female. As you make your way to the very top, something astounding happens: the number drops to 4% for health care CEOs.

This drastic negative correlation is the reason why we promote ‘XX in Health Care’ this week. (more…)

By Lisette Miller, Mechanical Engineer

MassDevice held its second annual Big 100 Roundtable East event in Waltham, MA on July 10^th. For being a relatively local affair, there was an impressive turnout of attendees ranging from engineers to marketing folk, regulatory specialists to c-suite execs. My colleague and I were looking forward to hearing discussion of burgeoning trends in the industry and the people behind them. Two major themes mentioned throughout the night resonated strongly with me, and I later shared these insights with my team at Ximedica. (more…)

By Sharon Mulligan, Program Director

What is a warning letter?

The FDA regularly conducts inspections of facilities involved in medical device development and manufacturing to ensure compliance to their regulations. When violations are found, they can result in the issuance of public warning letters (which are posted on the FDA website) or the seizure of product inventory. The FDA can also obtain a court injunction prohibiting further marketing of the product or assessing civil money penalties. What topics monitored by the FDA specifically concern medical device companies? (more…)

By Joe Kralicky, Senior Software Engineer

Continued from last week’s introductory post about cloud computing…

Q: As a professional, how can the cloud change the way my company does business?

A: Since cloud and elastic computing provides the incredible ability to instantly scale, it makes sense for companies that have web sites or services that need to handle intermittent heavy spikes in traffic. Creating an in-house infrastructure that can handle the worst case traffic patterns can be a difficult financial burden. You could spend tens of thousands of dollars on capital equipment, environmental equipment, data services, maintenance, etc., to keep your web site responsive during peak times of the month, even though the peak might end up only being less than one percent of your uptime. Move your public facing operations to the cloud in cases like this. (more…)

By Joe Kralicky, Senior Software Engineer

Q: I am hearing more and more talk about “the cloud” these days, particularly with the advent of Apple’s iCloud. So, what is the cloud?

A: We’ve all seen those high-level network diagrams of systems connecting to each other, with a puffy cloud shape in the middle that everyone magically connects through. The cloud symbol came to represent this nebulous network infrastructure that is the internet.

Nowadays, this “cloud” still represents a somewhat nebulous infrastructure, but more specifically, it represents computing and storage services offered by a wide variety of companies. The big players—i.e., Amazon, Apple, IBM, Google and Microsoft—are in the mix, but there are many small companies that are offering cloud services as well. (more…)

By Joe Arruda, Manufacturing Manager

Here at Ximedica, we research, strategize, brainstorm, design, verify, redesign, test, and validate medical devices…as well as manufacture them on-site.

So why do we manufacture too? Why not skip it altogether? Many design firms hand over the prototype and the plans and send their clients off to find a contract manufacturer, saving everyone the cycle time and grief. The answer: because manufacturing is as critical to the product development process as the initial research that goes into unearthing user needs. Manufacturing on-site has distinct advantages for designers—be it the industrial designers, design engineers, or the design team as a whole. (more…)

By Paul Aceto, Principal Electrical Engineer

Electronic medical devices must provide protection against patient and operator electrical hazards per IEC 60601-1. Electrical isolation for typical voltages (under 1 KV) is easily accomplished using single component optical or transformer based digital isolators. However when a device spec requires a voltage in the order of 10KV isolation becomes an electrical engineering challenge of its own. Recently Ximedica faced this exact challenge and found a solution that surpasses IEC 60601-1 requirements which require protection against a Single Fault Condition and in fact went well beyond the requirements. (more…)

By Jessica Willing-Pichs, Principal, Research & Strategy

We all know that the US healthcare industry is grappling with whole-scale change instigated by the conflicting pressures of declining population health, physician shortage, escalating cost containment efforts, commercial consolidation and legislative reform. It is hoped by many that rapid, creative innovation in the intersection of technology and health will be a significant salve for the industry.

A pivotal cornerstone of our work here at Ximedica focuses on understanding and meeting the changing landscape of patient and clinician needs. Our user-centric philosophy is no different when it comes to the design, development and integration of digital health devices and services – these tools must also be designed with the patient and clinician in mind, considering their use environments, their abilities, their expectations and tolerances. (more…)

By Tiffany Hogan, Director, Research & Strategy

In our Research and Strategy group, we have been working for years to integrate and benefit from the varied backgrounds that we all bring to the table. We are an eclectic mix of designers, social scientists, market researchers and product researchers (to name but a few). As a result of this mix of skill sets, we have been able to combine and build upon our standard methodologies – tweaking things just enough to produce added value with every study we undertake.

One of the techniques we use here at Ximedica to help support design decisions and direction is the practice of “Visual VOC.” Presented with Human Factors design in mind, traditional voice-of-customer data is transformed into a visual format. These huge graphic representations are presented poster-style, and can cover an entire wall in a conference room. While the initial value of these posters lies in being eye-catching, we have also found that documenting user needs in this manner is beneficial both to our clients and to our own designers. (more…)

Last week ABC TV news reporter Joe Mazan and crew visited Ximedica’s midwest offices as part of their ongoing series, Made in Minnesota. Ximedica is just shy of marking its one year anniversary in the area and with a number of medical development efforts (more…)

By Rick Sabourin, Senior Software Engineer

A recent post on the MD&DI DeviceTalk blog is titled, “Understanding the Software Development Process When You’re Not a Software Engineer”. This article focuses on the challenge of managing a medical device project with an embedded software component, and it touches on a number of points which I think deserve highlighting. In my experience, those who are not familiar with medical software development will sometimes suggest merging the design phase into preceding or subsequent phases, in an effort to save time and money. Additionally, some people seem to have the idea that using a well-defined software lifecycle process is pedantic or excessive. At Ximedica we recently underwent a review and subsequent re-architecting of our software SOP to incorporate IEC-62304, HE-75, and FDA draft guidance documents into a streamlined software development process that is now fully integrated into the entire multi-disciplinary medical device development process. (more…)

We are pleased to welcome Jim Szabo to Ximedica and the Healthcare Delivery Solutions team.

Jim brings 22 years of experience developing, implementing, and evaluating behavioral and integrated health programs in Rhode Island. Jim holds an independent clinical social worker license in addition to advance certifications in various evidenced-based clinical practices such as cognitive behavioral therapy, client-directed outcome informed practice, dialectical behavioral therapy, integrated primary care, and motivational interviewing. Jim has been recognized by the Substance Abuse and Mental Health Service Administration for promulgating best practices across a continuum of service agencies and in 2009 Jim was honored with a service award by the College of Problem Drug Dependency. Prior to joining Ximedica, Jim was the Director of Outpatient Services at Gateway Healthcare, a comprehensive behavioral health organization in Rhode Island. (more…)

By Lindsey Messervy, Research & Product Strategist

At Ximedica, we prefer to conduct consumer interviews in people’s homes, rather than in a facility, when we are seeking rich and deep insight into their context and experiences. Crossing the threshold into into a person’s home can be a delicate matter for both you and them. Here are a few tips that will help you navigate through planning, conducting, and following up on in-home research.

Before the interview… (more…)

By Aidan Petrie, Chief Innovation Officer and Co-Founder

Nine halls and a parking lot full of devices that look a lot like yours…

It is tough to walk the CMEF show and not feel daunted and overwhelmed by the challenges & opportunities Asia presents. As part of the US trade group, Ximedica traveled west to China to participate in this year’s show with a goal to understand how we could continue to support our clients, the SFDA (Chinese version of FDA), build research capabilities on the Pacific Rim and assess the opportunity to develop Asia-specific medical products for those markets. While we have maintained a small office in Hong Kong for over 20 years it has largely supported US-based programs. (more…)

By Beth Werner, Sr. Research & Product Strategist

Before starting any innovation project one of the most important tasks is to understand who the stakeholders are. Understanding the needs, both met and unmet, of the people who will purchase, use, and advocate for your product or service is a critical first step in any development project.

On a typical Healthcare Delivery Systems project we can expect to conduct stakeholder interviews to as many as 50 different people with varying needs and points of view.

There are two types of stakeholders, internal and external. (more…)

With females representing less than 11% of the engineering workforce in our country and the knowledge that gender diversity is often linked to corporate profitability and employee satisfaction, Ximedica is committed to educational outreach opportunities targeting young women.

For that reason last Thursday Ximedica hosted 26 high school juniors and seniors and 4 of their teachers from the Lincoln School and St. Mary’s Bayview Academy at our 3^rd Annual ‘Introduce a Girl to Engineering Day’ event. The event was a half day that consisted of 6 interactive workshops, a guided tour of our facility and most importantly shared wisdom from Ximedica’s female workforce. (more…)

We are pleased to welcome Beth Werner to the Ximedica Research and Strategy team.

Beth joins Ximedica with an arsenal of research tools from design validation to empathetic immersion to understand user needs. In 2011 she was named a recipient of two IDEA awards and a Medical Design Excellence Award for her work in the medical field. Prior to joining Ximedica Beth has managed research projects at both Insight and Continuum.

What brought you to Ximedica? (more…)

Ximedica honors World Usability Day! (more…)

By Kristy Bell, Human Factors Engineer

A risk management plan documents how a project team will identify and evaluate potential risks with a product. The plan outlines the process and the criteria the team will use to determine if mitigation is required for a particular risk. This document becomes part of the complete Design History File (DHF). This activity is an integral part of Ximedica’s product development process to satisfy the requirements of HE-75, 21 CFR 820.30(g), and ISO 14971:2007, (i.e., the guidelines and regulation published by the FDA and the international standard for risk management in the medical device industry). (more…)

By Juris Grauds, Electrical Engineer

As an electrical engineer at Ximedica, I derive much personal satisfaction from solving difficult problems, something we do every day. But “I think, therefore I am” does not fully convey the sense of positive being I find here. Ultimately, I work in the medical field because it contributes to a greater good: helping others. These two important aspects of medical device design recently converged at Ximedica in the form of a wireless dental polishing tool for hygienists.

We were approached to develop a fully portable, wireless, electric polishing device for use everywhere, from a local dentist’s office to a benevolent mission for an indigent or otherwise underserved population center in Honduras. To accomplish this goal, our team was required to solve a myriad issues, beginning with the most obvious − engineering an adequately powerful device with significant size constraints; the handheld portion of the device was not much bigger than an everyday highlighter. As an electrical engineer charged with schematic design and printed circuit board (PCB) layout, every decision made by mechanical engineers affected my component choices and placement, which in turn impacted decisions made by our software engineers and industrial designers. (more…)

By Hope Hopkins, Research & Product Strategist

With the Food & Drug Administration’s (FDA) increased scrutiny on device usability, being able to understand and demonstrate the importance of human factors and intuitive use in device design has become a critical work tool.

Understanding the following 4 principles provides a fundamental knowledge base to be able to successfully design and engineer innovative medical products that incorporate the needs of multiple users and influencers, complex, existing workflows and the challenges of their sensory and physically demanding use environments while remaining FDA compliant.

#1: Understand usability requirements per the FDA (more…)

By Peter Cameron, Research & Development Engineer

In the case of trauma, the focus of course is on getting the patient to medical care as safely and as quickly as possible. This is particularly critical in the case of head trauma, where early care can mean the difference between brain damage and a full recovery — or life and death.

For two years now, I’ve been thinking a lot about this as part of my research role in a new acoustics technology that may one day help doctors better diagnose brain hemorrhages on-site where they occur. The technology measures the vibration of tissue in the cranial cavity using a combination of ultrasound transducers. A force excitation first generates waves in the tissue. The presence of a hematoma causes changes in the physical properties of the medium altering the wave pattern and creating a contrast that can be observed. (more…)

By Kat Darula, Director of Design Research

A recent article in The Wall Street Journal sparked spirited debate on care for emergency department (ED) patients. Reporter Laura Landro’s story, titled “ERs Move to Speed Care; Not Everyone Needs a Bed,” sheds light on a major challenge facing hospitals nationwide: improving hospital care and efficiency takes much more than cost cutting efforts. The article covers lean principles and other efficiency models that hospitals are implementing to recover revenue and enhance the patient experience, including streamlining traditional triage methods, reserving beds for the sickest patients, publishing hospital wait times online, and testing other innovative solutions to provide timely patient care. (more…)

By Thomas Varricchione, Senior Vice President, Clinical & Regulatory Affairs

The FDA recently issued guidance to clarify when modifications to a cleared device require a new application. The guidance, titled 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device, requires that device makers demonstrate how a modified device is similar to the one already on the market.

Medical device manufacturers must file a new 510(k) only when the changes significantly impact a device’s safety and effectiveness or if the revision constitutes a new intended use. Many medical device products undergo incremental changes even after they are introduced into the market, and most of those changes do not require a new 510(k) submission. This is good news for device manufacturers who are concerned about delays in speed to market while striving to improve the use and safety of their products. (more…)

By Thomas Varricchione, Senior Vice President, Clinical & Regulatory Affairs

The FDA’s Center for Devices and Radiological Health recently published their “Analysis of Premarket Review Times under the 510(k) Program” in which they attribute the recent increase in total review time “primarily due to companies taking more time to respond to requests for additional information.” This analysis was prompted by recent industry-sponsored reports, which attribute problems with the 510(k) program to lack of predictability, disruptions, and delays due to staffing turnover and inconsistency in reviews. (more…)

By Christina Vivona, Software Quality Engineer

These days, the medical device industry is developing more devices with software or graphical user interfaces (GUI) than ever before. In my experience, the interface features are often considered too late in the process, rather than early and iteratively throughout the development cycle.

As with all tools, GUIs must meet actual users’ needs in the context of real-time use. And a good tool is transparent to the work it facilitates —it makes the job easier.

The complex nature of many GUIs drives this point home. How many of us have experienced a system that is frustrating, confusing, or takes a long time to learn? (more…)

By Kristy Bell, Human Factors Engineer

Good medical device design begins with good research. As more products are developed for aging baby boomers, our Research and Strategy team has been conducting more usability studies with older participants. While there’s a lot of literature on designing products for older people, there’s little on performing research with them. As part of my research as a Human Factors Engineer, I’ve developed some methods in addressing the unique challenges of performing research with older participants. (more…)

by David C. Robson, VP of Development

In the medical device industry, we all know that revenue projections drive development programs, probably with few contingencies built in. Our client companies face intense pressure to realize development goals on time. And rightly so, they don’t have patience for projects that fall behind schedule. So when they get down the long road past product development, the last thing they want is a hang up at commercialization.

Needless to say, there’s a lot to think about when it comes to new product introduction. But medical device manufacturers striving to quickly introduce new products to the market could take a lesson from a distant cousin: the pharmaceutical industry. Looking for ways to cost-effectively advance candidate molecules from discovery to proven evidence that the drug will work on a human (clinical proof of concept), a number of pharma companies are turning to alternative drug development approaches. These focus exclusively on bringing new compounds to the proof-of-concept stage as efficiently as possible, without the burdens of all the downstream planning that go along with traditional drug development. For example, Eli Lilly’s Chorus initiative has reached decisions about a year earlier and at about half the cost of the current industry model. (more…)

By Peter Cameron, Research & Development Engineer

As a Research and Development (R&D) Engineer, I’m a lot more of the “R” than the “D.” This explains why you’d find me at the 161st meeting of the Acoustical Society of America (ASA) in Seattle this May (For proceedings, see J. Acoust. Soc. Am., Vol. 129, No. 4, Pt. 2, April 2011). Leading researchers in the field from around the world attend the conference. While the scope of the ASA journal covers a wide variety of topics, a significant portion is devoted to biomedical acoustics. Acoustics is a branch of physics dealing with sound and sound waves. In addition to covering the range of audible frequencies, the term “acoustics” covers infrasonic and ultrasonic signals that have frequencies below and above the audible spectrum, respectively.

In the constant endeavor to improve patient safety and comfort, and reduce recovery time, techniques using sound have been sought after for decades now — sound waves propagate in soft tissues and in bone, reaching areas inside the body noninvasively. The pressure oscillations associated with sound can directly affect cells, and the secondary effects of heat and cavitation play significant roles. (more…)

By Aidan Petrie, Chief Innovation Officer & Co-founder

Too often at conferences, I hear that industrial design (ID) is something you do at the end—for aesthetics. However, particularly in medical device development, ID plays a significant role when brought in early and considered throughout development.

The reason most people overlook it is mainly due to uncertainty about how to integrate ID early on and all along. As a result, medical device manufacturers often prescribe single ID activities, usually relating to ergonomics or form factors. (more…)

by David C. Robson, VP of Development

What’s the most important choice a medical device OEM makes once it decides to build a new product? Considering that most OEM’s use third-party resources to augment their staff and help bring new devices to market, I’d say it’s choosing the right development partner. And choosing the right firm starts with establishing a robust and reliable request for proposal (RFP) process.

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By Emilio S. Belavel, MD, FAAEM, Chief Medical Advisor

A recent report by the Journal of the American Medical Association (JAMA) finds that over the last two decades, the number of U.S. hospital emergency departments (ED) in urban areas has declined by about 27 percent: In 1990, the nation had about 2,446 EDs in non-rural areas; today there are 1,779.

Researchers blame the decrease mainly on economics. By law, EDs must treat everyone, regardless of their ability to pay. However, the argument around ED economics is somewhat convoluted. A different report (mentioned in our blog, posted 5/9/11), points to the vast majority of emergency room visitors with health coverage who are referred to EDs by their doctors. Obviously, other factors weigh in, and JAMA study researchers admit that little is known about those factors. (more…)

By Emilio S. Belaval, MD, FAAEM

According to a March 2011 survey [PDF, 236KB] conducted by the American College of Emergency Physicians, many doctors believe emergency rooms will become busier places, despite healthcare reform.

In the survey — an email questionnaire sent to 20,687 U.S. ER physicians to which 1,768 replied — more than 80 percent of emergency room physicians say the number of patients seen in ERs has either increased somewhat or significantly over the last year, a trend they expect to continue. (more…)

By Kristin Simeons, Director of Healthcare Delivery Solutions

Last Wednesday, the United States Department of Health and Human Services (HHS) announced Partnership for Patients, a provision of the Affordable Care Act to help reduce medical errors and improve patient safety in hospitals.

The initiative stems back to concerns over a November 1999 Institute of Medicine report, “To Err Is Human,” which identified significant safety issues within our nations’ hospitals. Sentinel events due to missteps in performing tests and procedures, administering treatments, providing timely care, using equipment, communicating orders — the report cites them all. Since then, there’s been little change: A 2010 DOH report says that 27 percent of hospitalized Medicare patients experience adverse events, 44 percent of which are “clearly or likely” preventable. (more…)

By Margaux Boyaval, Program Director

A recent article in Futurity quotes study findings that three out of four kids and teens with asthma have trouble using inhalers properly and only one in four gets it completely right.

Could inhalers benefit from earlier usability testing? The study’s leader, Betsy Sleath, included 296 patients aged eight to 16 using four different devices, three of which deliver medication, one of which is a need assessment device. The top scoring drug delivery device, Advair’s diskus, had the high score with just 21.9 percent of participants able to perform all steps correctly. (more…)

By Kristin Simeons, Director of Healthcare Delivery Solutions

Wrong site surgery continues to be more prevalent than thought and without any consistent evidence of slowing. Research has repeatedly shown that these adverse events are largely underreported with compliance of physician reporting ranging from 5% to 50% - thus predicting true incidence of wrong site surgery to be hovering around 50 per week or 2600 events per year in the US alone. Costs beyond the obvious cardinal one of patient outcomes are multi-factorial for the healthcare system as well as the patient and reach into the millions. (more…)

By Jessica Willing-Pichs, Senior Research & Product Strategist

In its recent debrief of the Consumer Electronic Show, consumer research website Iconoculture elevated five key tech trends to pay attention to: (more…)

By Derek Hatchett, Director, Emerging Technologies

When the ECRI Institute, an independent organization that evaluates medical devices and procedures, issued its 2011 list of the Top Ten Health Technology Hazards, reprocessed flexible endoscopes made the list for the second year in a row. “At minimum, endoscope reprocessing problems, when discovered, can inconvenience patients and create anxiety; at worst, they can lead to life-threatening infections,” the report says. With tens of thousands of patients undergoing such procedures each year, the issue begs resolution. ECRI said its list was compiled based on “a review of recent recalls; analysis of information found in the literature” and the organization’s “experience in investigating and consulting on device-related incidents.” Most notable was the widespread incidence of contamination of endoscopic equipment at VA hospitals that exposed thousands of veterans to the risk of infection, including HIV. (more…)

By Meredith DeZutter

A few weeks ago I attended a workshop convened by the FDA as they begin the process of drafting a document for the FDA titled “Medical Device Home Initiative.” The purpose of the workshop was for the FDA to gather industry opinion in helping them with future definition of Home Medical Devices. The workshop was well attended by human factors consultants as well as large medical device companies who are concerned about how future regulations will guide them.

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By Tiffany Hogan, Ph.D - Sr. Research & Product Strategist

It seems that each day we are receiving more signals from the FDA that they are increasingly taking medical device usability testing seriously. Very seriously. The agency is asking for usability testing early and often, and is expecting manufacturers to collect sound data in order to support the claims of safety and efficacy that they are making in their device applications. Having sound protocols for such data collection is intended to help speed regulatory approval of new medical devices. Achieving the level of information and data that the FDA is looking for is not easy. (more…)

By Jessica Willing-Pichs, Senior Research & Product Stategist

The infographic below (published in McKinsey Quarterly, January 2011) is a riveting illustration of how much obesity costs American society – at least $450 billion annually. With more than 12.5 million children and 73 million American adults categorized as obese, this is unquestionably a national crisis.

What is equally staggering is that there are so many proven strategies available, whether it as simple as walking our kids to school, watching less TV, getting more sleep, making better personal choices to more complex solutions that involve food access channels and national food & beverage standards. (more…)

A GfK Roper survey conducted for Practice Fusion showed that three in five chronic disease patients in the U.S. believe the use of medical devices designed for home use would improve their conditions. In addition, 62% of the respondents believe communicating with their physicians via the use of home-based technologies would improve their health.

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By Tiffany Hogan, Ph.D., Senior Research & Product Strategist

If you are looking to understand some of the developing trends in the use of technology in healthcare, I recommend PSFK’s impressive and insightful recent report, The Future of Health. Originally prepared for UNICEF, it is a 200+ page report that identifies 15 different trends that have developed or are developing, and speculates on their implication for the future of health care delivery. (more…)

By Francis Diaz, Research & Product Strategist

In an earlier blog entry, I provided a brief overview, based on a number of sources, of the proposed upcoming medical device tax. In this entry, I am going to describe a little more about who is responsible for the tax, and what (could) qualify as taxable. I have used a number of sources for this information and present my assimilated understanding here. (more…)

By Francis Diaz, Research & Product Strategist

I recently took a closer look at the new proposed Device Tax, which is part of the Patient Protection and Affordable Care Act, the major health care reform legislation signed into law by President Obama. This is something that is near and dear to our hearts, here at Ximedica, and I was tasked with writing up a explanation of the issues so that all of our employees could have a basic understanding. As such, we thought we might post it online for others to learn from, as well. (more…)

By Michael Salame, Mechanical Engineer

If you have taken science (or Latin) classes, you can probably infer the meaning of the terms hydrophobic and hydrophilic. Beads of water resting on a plant leaf, for example, exemplify the leaf’s hydrophobic surface - it resists the ingress of water. On the other hand, the makers of Bounty brand paper towels probably take great pride in their product’s hydrophilic quality, in that it will soak up almost anything.

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By Michelle Wu, Director of Quality Services

In my last post, I promised to follow up with an explanation as to why I believe that a design review need not be seen as a moral hazard. I originally began reflecting on this idea after reading a forum post on LinkedIn, where people were debating the potential moral hazards brought on by the design review process. (more…)

By Lynde Kintner

Ximedica recently hosted an event dedicated to the discussion of HE-75, the latest FDA human factors standard for the design of medical devices. It was co-sponsored by the IDSA Rhode Island and IDSA Medical Section. Led by Steve Wilcox, PhD, of Design Science, and Michael Wiklund of Wiklund Research and Design, both members of the committee that developed the standard and contributing authors to the HE-75 content, the review was well attended by a range of product development specialists.

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By Michelle Wu, Director of Quality Services

I recently came across an intriguing discussion thread on the medical device engineers network on LinkedIn. Someone asked whether the design review—a required element in FDA regulations on design control—creates a moral hazard in the device development process. (more…)

By Michelle Wu, Director of Quality Services

I recently attended the Advanced Problem Solving and Root-Cause Analysis Workshop at WPI. Jim Leonard taught a structured root cause methodology for problem solving, which I found very useful. The steps in this comprehensive method include:

• creating the problem statement
• asking a series of problem-specifying questions
• noting distinctions and changes in the information gathered
• brainstorming possible causes
• testing the possible causes against the problem specification, verifying the true cause, and fixing the problem

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