A blog about important topics for medical device and healthcare innovators.
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.
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.
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. 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.
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.
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.
Her favorite experience here was generating and ‘printing’ a 3D vise model using Solidworks and our on-site FDM machines. “They let me keep the vise model once I finished, and it came out really nice,” Kiely shares. According to one mentor, engineer Rick Piatt, “it came out perfectly, with all the components fitting together as they should.”
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.
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.
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.
Wherever you are in your process, Ximedica can help.
More About Our People
Senior VP of Clinical Research & Regulatory Affairs
Principal of Research & Product Strategy
Director of Engineering
Software Engineering Manager
Human Factors Engineer
Design Assurance Engineer
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Providence, RI 02907
1000 Westgate Drive,
St. Paul, MN 55114
Unit 02A, G/F.,
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T: +852 2117 0991
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Ximedica is ISO 13485:2003 Certified and FDA Registered. As a full-service development firm, Ximedica has an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.
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