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Are We in the Golden Age of Medical Devices?

I recently had a chance to take part in a "Friday 5" interview with Medical Design Technology. One of the questions I was asked was "What’s the most exciting aspect of the medical device industry?" My response was that right now, the medical device industry is in a "golden age". Yes, it's true that the high water mark for investment funding for this industry was in 2007. [caption id="attachment_6767" align="alignnone" width="907"]VC deal flow for healthcare sector (source: PitchBook) VC deal flow for healthcare device sector from 2005 - Q1 2014 (source: PitchBook)[/caption] 2014 was the best year for med device investment funding since 2007. Despite an improved funding environment, many medical device startups, inventors, and entrepreneurs feel like there is not enough funding available. Some...

Guide to Medical Device Regulatory Classification

What I am about to share with you is a guide to medical device regulatory classification. In this guide, I will provide you with a step-by-step approach for determining how your medical device will be classifed by U.S. FDA, European Commision, and Health Canada. Getting a basic understanding of regulatory product classification will be invaluable to your efforts to bring new products to market.

Regulatory Classification 101

Basically, every medical device is regulated in some way by regulatory agencies, such as FDA, European Commission, and Health Canada. These regulatory agencies have defined a bunch of rules and regulations (or “laws”) regarding medical devices. The rules that apply to your medical device is dependent on how your product is classified by the regulatory agencies. Each regulatory agency has defined several different classifications...

[podcast] Exciting medical device pilot program with FDA and CMS

David Filmore is the Executive Editor at Informa. In this role, David works with reporters and editors to produce daily for 'The Gray Sheet' – a widely read publication in the medical device and diagnostics arena, published by IBI Pharma. [caption id="attachment_6736" align="alignnone" width="154"]David Filmore - Informa David Filmore - Executive Editor at Informa[/caption] In this podcast, I talk to David Filmore about a joint program between FDA and CMS. The program is in a pilot stage and involves parallel review of medical devices by FDA and CMS.
By reducing the interval between FDA marketing approval and Medical coverage, this process will facilitate the development of innovative products and shorten the time it takes to bring these important products to...

15 Things for Medical Device Startup to Address

As a medical device startup, there are many things you are doing all day, every day to advance your technology and product closer and closer to that next critical milestone. And while doing so, you should implement a bit of infrastructure based on FDA / ISO regulations and requirements. Doing so ensures that your efforts result in the necessary documentation and records to support regulatory submissions and eventual commercialization of your medical device.   To help you, I'm giving you a list of 15 items to address for your medical device startup.  

#1 - Establish Design Controls / Design & Development Procedure(s)

Refer to FDA 21 CFR 820.30. Create a procedure that describes your company’s design and development process.

#2 - Define and document product User Needs

Define and document Intended Use / Indications for Use. User needs describe...