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A blog about important topics for medical device and healthcare innovators.


Slides from Jeff Morang's presentation at Medical Device Summit, Boston now available for download.

Three common challenges continuously bubble up in our conversations with academic startup ventures. While these challenges can be a hindrance, keen entrepreneurs can turn the following into opportunities-here's how.

If you missed CES earlier this month you can watch Aidan Petrie and panelists discussing strategies to engage patients and providers across multiple channels online now.

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.

Looking back on CES 2014, while Digital Health was front and center is the size of the opportunity fully understood?

Manufacturers of medication (drug or biologic)-delivery devices (i.e. combination products having a medical device constituent) are now being asked to include risk assessment and usability testing to ensure that the product packaging and labeling is effective in mitigating or reducing incidence of use-errors that could result in patient under-treatment, overdosing or otherwise receiving an incorrect treatment (i.e. dispensing of the wrong medication). The following explains key areas of HF testing impacted by DMEPA draft guidances.

There are a slew of digital health technologies being developed, (last week's CES show a case in point), 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.

By Pamela Davol, Clinical & Regulatory Project Manager

Person holding a device appearing on a monitorA 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.


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).

If it detects heart rhythm abnormalities, your iPhone is an ECG, says the FDA.

Featured Posts

  • Powerful Tech Trends that Will Fuel Activity in Medical Product Development Posted 3 months ago
    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.
  • New HF Regulatory Requirements Impact Usability Validation Studies on Combo Products Posted 3 months ago
    Manufacturers of medication (drug or biologic)-delivery devices (i.e. combination products having a medical device constituent) are now being asked to include risk assessment and usability testing to ensure that the product packaging and labeling is effective in mitigating or reducing incidence of use-errors that could result in patient under-treatment, overdosing or otherwise receiving an incorrect treatment (i.e. dispensing of the wrong medication). The following explains key areas of HF testing impacted by DMEPA draft guidances.
Read More »

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