R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.


Medical Device Development: Avoiding Pitfalls in Human Factors / Usability and Design

This article was originally published in Summer of 2016's Made in PA issue, a publication of the Pittsburgh Technology Council.

The competitive landscape of medical devices combined with the advantages of being first to market often tempt manufacturers to move through the product development process at a rapid pace. Deficiencies in the production and process controls subsystem of the Quality System Regulation (QSR) accounted for 32% of the 483 observations cited in 2015.¹

Inadequate Design Controls accounted for 15% of the 483 observations in the same time period. It's no surprise that Warning Letters related to Quality System problems in 2015 often focused on those two areas, along with the Corrective and Preventative Actions (CAPA) subsystem. 

A robust Quality System is certainly the first line of defense that device manufacturers must have in place not only to be compliant with Food and Drug Administration (FDA) regulations, but also to avoid costly mistakes during product development and beyond. Here are a couple of items to consider.

Device Idea to Staying Power in the Market

Have a medical device idea and want to make sure no one steals it? Have a product and are stuck somewhere between clinical trials and clearance? Let's say you have clearance and customers, but you aren't sure you're going to get paid? The start-to-finish product group of experts at this Pittsburgh Technology Council breakfast briefing can help you out! The experts will provide a brief overview of their specialty area and be available following the session for confidential discussions. So, bring your questions and be ready to discuss your product!

Event Details:

Tuesday, August 27, 2013 | 7:30 am - 11:30 am
Venue: K&L Gates, 210 Sixth Ave., Pittsburgh, PA 15222
Cost: $45 Members | $175 Non-Members
RSVP: Online | events@pghtech.org


7:30 am Registration & Continental Breakfast
8:15 am Program
11:30 am Conclusion

Protect your Idea - K&L Gates
Set the Strategy - Maria Fagan, Regulatory and Quality Solutions
Create the Design - Carolynn Johnson, Daedalus
Demonstrate Clinical Utility - Chris Hoyer, CardiacAssist
Obtain Clearance - Speaker TBD
Get Paid - Sharon Kim, Zoll Medical Corporation
Build It - Pat Sims, TMG Electronics
Go to Market and Stay There - Larry Kopyta, Omnyx

The Life Sciences Network (LSN) is sponsored by K&L Gates.
Event Sponsor: Regulatory and Quality Solutions

For more information on the event, or the Pittsburgh Technology Council, contact Jennifer G. Young (jyoung@pghtech.org), Managing Director, Advance Manufacturing & Life Sciences Networks.


Image courtesy of the Pittsburgh Technology Council

Devices Regulations in Europe

On Tuesday, I attended a Pittsburgh Technology Council event downtown titled “Medical Devices and the European Union: What does the Path of Entry Look Like?” which was sponsored by RQS! (We gave out stress balls in the shape of a pill!) I’ve posted a few times before regarding some of the regulatory hurdles of entering the US market, so I was very excited to get more perspective on the European path and share that information with all of you.

Networking Success!

The Networking with Technology event hosted by the Pittsburgh Technology Council and Pittsburgh Social Exchange last Wednesday on September 19th was a success!

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