As the SARS-CoV-2 pandemic spreads, it is becoming clear that an effective vaccine will be a key milestone in alleviating fear and restarting the economy. Johnson & Johnson announced efforts to produce one billion doses of vaccine for SARS-CoV-2 and Bill Gates announced he will spend billions on factories for several promising vaccines.
In a post-COVID world, supply chains will grow in complexity to reflect a changing global landscape. How can small and medium enterprise compete in a cost-effective manner?
Ximedica and KeborMed announced today that they have entered into a partnership to offer Ximedica customers a new and complete turnkey solution to launching and supporting connected medical devices, in a streamlined, faster and more affordable manner.
“We are excited to partner with KeborMed to enhance our capabilities in the development of connected medical solutions,” said Michael Pereira, President and COO of Ximedica. “We are seeing enormous demand from our clients for the rapid implementation of connected medical devices, particularly as a result of the Covid-19 pandemic dramatically accelerating the development of telehealth and remote patient monitoring solutions. Adding KeborMed’s capabilities to our offering will significantly change how fast we can move from prototype to a fully deployed connected medical solution.”
Read full article: https://rb.gy/ellhhy
Congratulations to Lisa Carmel, VP of Strategy who was named as Ten Women Leaders Breaking the Glass Ceiling. The organization lobbies to enact the legislation in California which mandates that all public companies have female representation on their boards.
Read the full article by Marin Magazine: https://rb.gy/4xxmam
After months of sheltering in place during the COVID-19 pandemic, returning to work will require extra care to prevent new surges of infection. The ‘new normal’ will require updated methods to work and travel safely. Handshakes among other welcoming gestures will have to be avoided for quite a while. Diagnostic technologies are one of the key tools to identify infected patients, becoming the ‘radar’ in the war against pandemics.
At Ximedica, we support inclusivity and condemn all forms of racism and discrimination. We hope for and support positive change that can lead to healing in our communities.
The past weeks have been a reminder that while we are all focused on keeping our loved ones safe and healthy, there continues to be societal inequalities that can only be changed by listening, reflection and ultimately action. There are folks at all levels of Ximedica that have personally expressed support to use this moment to do all three.
We are committed to providing a fair and inclusive environment for you, our greatest assets. To kick-off our efforts, we are establishing a Diversity & Inclusion Council chaired by Michelle Wu, Senior Vice President of Operations and Steve Snow, Vice President of Human Resources. This council will consist of multi-disciplinary peers across all levels of our company and will be tasked with reviewing Ximedica’s inclusion practices throughout the company. The council will bring visibility to Ximedica’s efforts and continue to drive tangible action.
To begin, the council will:
There are no perfect answers and actions because these issues have been generational and deep, but we cannot truly heal our communities unless we move forward in a positive way. The energy coming from our Ximedica family is inspiring. We are a group who thrive on actions and solutions. It will take all of us to move forward together and we all are accountable to do our part so that as an organization we can deliver on these initiatives, and experience positive outcomes we can be proud of both as Ximedicans and as citizens.
Respectfully,
Robert Brown, Chief Executive Officer
Michael Pereira, President & COO
Michelle Wu, Senior Vice President of Operations
Steven Snow, Vice President of Human Resources
Mark Cole, Senior Vice President of Sales & Marketing
PROVIDENCE, RI--Ximedica is delighted to announce the sponsorship of the CoVent-19 Challenge. The CoVent-19 Challenge team is working with private and public sector partners to to expedite U.S. government approvals of a ventilator design to address the ventilator shortage amidst the COVID-19 crisis. The team has made available experts in regulatory assurance and safety testing to ensure all products meet U.S. and international standards.
The scale and magnitude of the fast-moving virus has highlighted the inability to meet demand of key supplies in a pandemic by the current U.S. healthcare system and others around the world. A dozen Boston area anesthesiology residents have launched an eight-week hackathon to design a rapidly deployable, minimum viable mechanical ventilator for patients with COVID-19-related complications in need of a ventilator. Ximedica also saw the need to accelerate innovation in the ventilator space and offered resources and support to the anesthesiologist residents to help define and design a rapidly deployable minimum viable ventilator. Ximedica’s cross-functional medical device development team helped define the requirements for the minimum viable ventilator and is mentoring teams throughout the challenge in order to bring solutions to the market and save patients’ lives as soon as possible.
”As with many other organizations, we felt the need to join in the efforts to make a tangible impact now,” says Michael Pereira, President & COO. “Our team of medical device experts are dedicated to making a difference and we are proud to help.”
The CoVent-19 Challenge provides millions of engineers and designers an opportunity to help with the ventilator crisis. The challenge began April 1st and judges will evaluate the designs based on safety, reliability, speed to market, and manufacturability. Finalist teams will work with medical and technical experts through a four-week invitation-only round to develop and test functional prototypes.
Ximedica is a leading product development company offering end-to-end solutions with deep expertise across a wide range of disciplines with over 30 years of experience and hundreds of satisfied clients in healthcare with the ability to launch products faster with higher market adoption. We use a human-centered, integrated process to create medical products that are thoughtfully designed, approved, manufactured and ultimately delivered to market. Ximedica is headquartered in Providence with additional locations in Minnesota, Hong Kong, Philadelphia and San Francisco
Also published to PR Newswire: https://www.prnewswire.com/news-releases/ximedica-responds-to-the-current-ventilator-shortage-by-sponsoring-the-covent-19-challenge-301042304.html
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
Ventilators have become synonymous with the current COVID-19 outbreak. As hospital demand skyrockets 11-fold due to the exponential increase in COVID-19 patients, supply chain and manufacturers have been stretched beyond capacity. Efforts to project ventilator demand in the U.S. range from 45,000 units to 75,000 units, with 880,000 units projected demand worldwide.
The U.S. recently announced orders for 137,431 new ventilators, worth $2.5 billion, delivered by the end of 2020. In order to meet this demand, a growing list of traditional and non-traditional medtech companies, as well as universities, investors, and entrepreneurs have pledged time and resources to the effort. Tesla is designing ventilators from Model 3 parts along with a partnership with Medtronic. General Motors plans to begin producing 10,000 ventilators per month by mid-April, and Ford hopes to produce 50,000 of the devices in the next 100 days.
As the world begins to understand, SARS-CoV-2 poses several unique challenges. Asymptomatic and infected individuals are highly contagious and present unprecedented viral transmissibility. As countries and markets try to fully understand the economic impact of the pandemic, the value of a rapid diagnostic test for a rapidly spreading virus has never been more clearly demonstrated. The IATA projects that worldwide, the airline industry alone will see 2020 full year passenger revenues plummet by $252 billion, or 44% below 2019’s figure.
In the absence of a vaccine or a treatment for SARS-CoV-2, the only strategy against the spread of the novel coronavirus is to “detect and isolate.” While the number of new cases continues to rise throughout the world, there is a clear escalation of technologies and products to detect SARS-CoV-2. Given the nature and scale of the pandemic, we expect diagnostic trends such as access to point of care, connected systems, and innovative sample collection techniques to accelerate the market landscape.
The COVID-19 pandemic has thrust a number of emerging healthcare trends into the spotlight with a renewed sense of urgency. Memories of the current pandemic and its devastating impact is likely to drive healthcare innovations and investments for the next decade.
The COVID-19 pandemic has exposed gaps in the U.S. healthcare system and worldwide. Gaps not of technology or resource but rather systemic, communication, and information gaps. Addressing these will require a shift from patient-centric to system-centric innovation models built on scalability, connectivity, and usability.
In a series of white papers and interviews to be published over the coming days and weeks, we discuss with our Ximedica diagnostics experts the development and scaling of high throughput and Point-of-Care (POC) diagnostics, globalization vs localization of a product pipeline with our research and strategy experts, and explore the rising need of system integration in a global healthcare economy. Finally, we bring together a panel of our experts to understand what a shift to system-centric innovation could mean for healthcare innovation and improving access.
NEMIC was created because our Founders saw too many medical technologies getting stuck in the "Valley of Death." This was due to a many different reasons, usually on the business side, that marked the technology currently un-fundable. Ximedica, a Rhode Island based FDA registered product developer, would run into the same complications when potentially partnering with startups.
Ximedica became one of NEMIC's Founding Partners to help support the startups that they could not partner by suggesting they come to NEMIC and round out their business plans and raise funds. Vice President of Innovation at Ximedica, Joe Gordon, joins us this episode to share Ximedica's capabilities, how they work with clients, and the synergy between Ximedica and NEMIC.
Listen to the podcast, please visit: https://www.nemicenter.com/podcast-1/2020/2/14/med-tech-monday-startups-leveraging-consultants-lh4lp-9jetg-w5bdg
To our clients,
The health and well-being of our clients, vendors, employees, and communities are top concerns for Ximedica, and we are closely monitoring the COVID-19 health situation that is currently impacting our global community.
As we continue to monitor the COVID-19 situation, we are following guidance from local and federal authorities. Many of our Ximedica employees and contractors that can work remotely are working from home. Ximedica has remote access and online collaboration tools (including video conferencing) in place so that meetings and access to electronic files and work are securely and remotely available to our teams. Those that are able to work in the office and have specific work that requires their presence have access to our facilities. Our employees will not be traveling without special internal approval.
Our facilities remain open. Our Facilities’ teams are cleaning/sanitizing our buildings. This includes wiping down commonly touched surfaces, such as light switches and door handles, with alcohol-based solutions multiple times a day.
We request that our clients similarly leverage having remote meetings wherever possible instead of coming to Ximedica’s facilities. If the meeting requires a review of prototypes, testing equipment or other activities that require physical presence, Ximedica will continue to collaborate at our facilities as teams are available. If you have specific questions related to a visit, please contact your Project Manager directly.
Similarly, as we advise our employees, if you have any symptoms or knowingly have been exposed, please cancel any visits. If visiting our facilities, we encourage you to continuously monitor the Center for Disease Control and Prevention (CDC) website for any information related to best practices when in meetings. In addition, we encourage you to take basic preventative measures as outlined by the World Health Organization.
If there is any impact to your programs in the coming weeks and possibly months, our program management and management team will let you know as soon as we know the potential impact.
Ximedica is committed to limiting the spread of this virus and safeguarding the health of the greater community. We ask for your understanding in the event that any of the above causes disruption or inconvenience.
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:
Join us at Device Talks in Boston on June 5th 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!
Join Ximedica for the inaugural Healthcare Robotics Engineering Forum, which focuses on the latest tools, technologies and techniques for healthcare robotics design and development, at the Santa Clara Convention Center in California, December 9th-10th. VP of Strategic Development Michael Neidert will present on a panel, "Robotics-as-a-Service Business Models for Healthcare Solutions," on Monday, December 9th.
DeviceTalks is an educational forum bringing together engineering, product development and commercialization professionals to share the challenges and best practices of getting medical devices to the market. Join us in Santa Clara, December 9 - 10, as we explore the trends and technology that are shaping the future of the medical device industry.
The Program Manager has a Bachelor of Science Degree and a minimum of 5 years of experience in consumer product development, diagnostics, and/or medical equipment and device development or its equivalent experience.
Nature of Role:
Reporting to the Director of Program Management, this individual manages and executes program direction in accordance with the client and development team goals. The following key attributes are required:
Responsibilities:
General:
Medical Specific:
Other experience:
Ximedica is an ISO 13485:2012 certified and FDA registered full-service product development firm with offices in Providence, St. Paul, San Francisco, and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.
We have a close-knit, high-energy culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours. Opportunities are currently available in both our Providence, RI and Minneapolis, MN facilities.
Position:
The experienced Senior Software Engineer supports our rapidly growing domestic and international product development, sourcing, and manufacturing business.
Nature of Role:
Reporting to the Director of Software & Electrical Engineering, the Senior Software Engineer works with the Electrical Engineering team and leads the firmware design effort’s of Ximedica’s product development programs.
Requirements:
A Bachelor’s degree in Computer Science/Engineering, coupled with 5-10 years of experience in embedded systems development within the medical device arena is required along with the following key attributes:
Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:
Responsibilities:
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…)
Michael joined SVLS in 2014 and is focused on healthcare IT and healthcare services investments.
Before joining SVLS, Michael was a General Partner with Edison Ventures, a growth equity investment firm, where he headed the healthcare IT practice. Previously, he was a General Partner at Summit Partners. Michael’s operating experience included roles at IBM Corporation in sales to the healthcare industry, as well as marketing, corporate development and systems engineering.
Michael has served on numerous public and private company boards. HCIT investments at Edison include TrialScope and three successful M&A exits at CambridgeSoft, DiagnosisOne and Octagon Research. Other Edison investments include Andera, VFA and PlumChoice. His investments at Summit, all of which exited at gains through IPO or M&A, include Infor, Unica, OPNET, MCK Communications, Future Three, InstallShield, Microbank, PowerSmart, Staples.com and TrelliSoft.
Michael earned an MBA from Harvard Business School and an AB Degree in Engineering Sciences from Dartmouth College.
Mr. Barko is currently Executive Director, Board of Directors of Ximedica, LLC. Mr. Barko has over 35 years of experience leading medical device and healthcare organizations towards global and financial growth. Mr. Barko has served as the President and Chief Executive Officer of Ximedica, LLC from April 2012 through October 2018. Mr. Barko is a board member of the AdvaMed. Currently, Mr. Barko serves on the Board of Directors of several other privately-owned companies and is involved with several private equity and venture capital groups. In addition, he was named to the AdvaMed Accel and MassMEDIC Board of Directors in 2014.
Prior to these roles, Mr. Barko was Vice President of Corporate Development at Flextronics (NASDAQ:FLEX) and was Corporate Vice President, Marketing & Business Development and member of the Board of Directors at Nypro Inc. During his 25 years with Nypro, he was responsible for the business teams that led to steady growth in annual sales from $40 million to $1 billion. Mr. Barko was also President & CEO of the Nypro Medical Products Group and Chairman of NP Medical Inc. He held senior management positions at Hallmark Plastics in Buffalo, New York and Peninsula Plastics in Erie, Pennsylvania. Mr. Barko graduated from the University of Notre Dame and also completed numerous executive leadership programs including Duke University Fuqua Business School, Dartmouth College Amos Tuck Business School, University of Limerick Ireland, Central European University of Hungary, and The National University of Singapore.
As Chief Strategy and Technology of Ximedica, Michael focuses on developing strategies that help Ximedica’s clients and partners successfully meet their company missions. Michael focuses on supporting clients on how to best manage the right mix of business, technology and portfolio needs understanding budgetary and time constraints, while developing great products.
Michael leads Ximedica’ s design, product development and manufacturing sector leadership teams, ensuring the proper direction of programs and that our client's needs and the program's overall goals are achieved. Michael emphasizes Ximedica’s philosophy of cross-functional collaboration with our clients and being accountable to delivering superior products that make a difference.
Michael has over 25 years of product development and manufacturing experience and has been at Ximedica for over 20 years. During his tenure at Ximedica, he has been involved in the development of hundreds of medical and consumer products in a variety of roles, including Lead Engineer, Program Manager, and Head of Program Management and Engineering.
In addition to his responsibilities within Ximedica, Michael presents at a variety of industry events on how to successfully commercialize great medical products.
Beth Blackburn leads the Ximedica Design and Development team, bringing almost 20 years of proven medical device product development and commercialization experience across all phases of the development lifecycle. Beth spent time at DePuy Mitek as a Design Engineer working on orthopedic implants and RF ablation systems and time at CR Bard integral in launching over 10 products. She holds a BS in Mechanical Engineering from WPI and an MBA from Bryant University
Matt has over twenty years of experience in medical device development with a proven track record across all phases of product development, from early customer research through to manufacturing and market release. Matt came to Ximedica from C.R. Bard where he successfully led the product design, development, and manufacture of a complex, endoscopic surgical device for a multi-center IDE clinical study. Prior to Bard, Matt worked for Covidien where he managed a variety of projects ranging from high-volume, disposable products to electro-mechanical capital equipment.
Matt received his Bachelors Degree in Biomedical Engineering from the University of Miami and his Master’s degree in Business Administration from Bryant University.
As Vice President of Innovation for Ximedica, Joe drives innovation in Ximedica’s core markets of healthcare delivery solutions, medical device development, and consumer healthcare. During his tenure at Ximedica, Joe previously held the position of Director of Technical Innovation.
With a passion for applying a human-centered approach to system and device development, Joe has committed himself to advising and leading expert teams of researchers, engineers, and designers in collaboration with a global client base to co-create, implement, and measure solutions that form the leading edge of the industry. Joe has honed his expertise throughout his 20+ career in a wide range of specialized fields including robotics, arthroscopic, audiology, endoscopy, gynecology, orthopedic, urology, and ophthalmology.
Throughout his career, Joe has received several medical design honors and over 50 patents.
In her role as Vice President of Strategy, Lisa is focused on building sustainable growth for the company. She leverages her experience in global product commercialization to help forge long-term collaboration and productive client relationships, with a core focus on Ximedica’s critical, strategic partners.
Lisa has 25+ years of international commercialization of healthcare and consumer products with companies in the US, Europe and China. As co-founder of a healthcare management consulting firm, Lisa led projects involving commercialization strategy, portfolio assessments and due diligence, with special emphasis on medtech innovation. Clients and employers have included Procter & Gamble, MedImmune, Agilent and Emergent Biosolutions. Lisa also gained valuable hands-on startup experience as a founding executive of a commercialized medical device startup. An active member of the medtech startup and investor community, Lisa is as an advisor to many startups and accelerators including CLSI’s FAST program, Medtech Innovator and UCSF Health Hub. She also serves on the board of the California Life Sciences Institute, the innovation arm of California Life Sciences Association, and as an advisor to the Cleveland Clinic Medtech Advisory Board, UCLA’s Technology Ventures Group Advisory Board and Red Crow Angel Investor platform.
As Ximedica’s VP, Organizational and Human Development, Cindy’s passion for maximizing talent in people drives the Human Capital Strategy. Cindy is responsible for creating innovative ways to engage all employees and establishing the culture, systems and training that will develop leaders and empower employees to develop impactful solutions. She connects Ximedica’s purpose and values to the Business Strategy to achieve desired results in performance.
Cindy champions Ximedica’s talent to realize their vision. She works to comprehend people’s personal and professional goals to ensure strong human resources plans are developed that achieve objectives and fulfill short and long-term milestones. Cindy has extensive experience in the non-profit and medical device space developing thriving business relationships by working closely with clients and employees and ensuring program and talent development plans are implemented with quality and on schedule.
Cindy previously held a role as VP, Strategic Development with a focus on Design and Human Factors. Prior to Ximedica, Cindy focused on developing talent as Chief Operating and Strategy Officers and held a national VP role in Health and Membership at YMCA Of the USA focused on innovative business growth and employee development.
Cindy holds bachelor’s degrees in Business and Spanish from Wittenberg University and an MBA, Human Resources, from Bentley University.
She is happiest surrounded by people while at work and prefers some quiet time at home with family and friends, preferably on the water.
In his role as Co-founder and Chief Innovation Officer, Emeritus for Ximedica, Aidan drives innovation in medical device development, consumer healthcare products and human-centered provider systems.
With over 25 years of experience, Aidan’s focus is on building a robust but nimble product development process within a FDA regulated industry with a particular eye to Usability and Human Factors. Aidan teaches Design Leadership at Rhode Island School of Design while also participating on the Commercial Advisory Board of Massachusetts College of Art.
Aidan received his degree from Central St. Martins (UK) in Product Design/Engineering and a Masters in Industrial Design from RISD.
Greg brings over 15 years of healthcare transaction experience to SV, including deep private and public healthcare company investment experience.
He joined SV in 2002 as an Analyst and later transitioned to the role of Portfolio Manager with both portfolio and lead fundraising responsibilities. Greg was promoted to Partner in 2019 and focuses on medical device and healthcare services investments. He is actively engaged in the financing, strategy, operations and acquisitions of portfolio companies.
Prior to SV, Greg worked at Testa, Hurwitz & Thibeault, in the Business Practice, Emerging Technology and Private Equity groups, supporting both venture capital funds and venture backed companies in business formations and financings, mergers and acquisitions, and venture capital fundraising.
Academic credentials
BA, Honors, Colby College; MBA, Honors, Boston University (graduating Beta Gamma Sigma).
Outside of SV
Greg enjoys spending time with his wife and two daughters, and playing golf (they are learning to enjoy it too). He is a Boston native and a graduate of St. Sebastian’s School.
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