So you’ve determined the classification of your medical device or in vitro diagnostic and now it’s time to select a regulatory pathway to market. Pretty straightforward decision, right? If your technology is basically the same as an existing device, you choose 510k. If not, then PMA. End of discussion, right?
Not necessarily. Sure, you can follow in the footsteps of the many device makers who have gone before you. Or better yet, you can evaluate all the potential options available and select the path that gives your product the best chance to succeed in an increasingly competitive and challenging market.
In this workshop, we will explore all pathways to market — including the little-known and little-used ones — and discuss how to decide which to use when.
What are all the pathways to market and the advantages and disadvantages of each?
How do I decide which one to use and when?
If my device is class III, is the PMA my only option? If my device is class II, is the 510k my only option?
How does the Breakthrough Devices Program (BDP) and Safer Technologies Program (STeP) affect pathway options?
Can I market a device without any FDA oversight whatsoever?
If someone else brought a similar device to market using one pathway, must I use the same pathway?
Must I choose only one pathway? Can I use multiple pathways for the same device at the same time?
How can I use label expansions to bring my device to market with less time, money and risk?
How can I get my device on to the market and make it more difficult for my competitors at the same time?
How do I integrate regulatory strategy with reimbursement strategy, product liability strategy, IP strategy, etc.?
Bottom line: not only are there multiple pathways to market but there advantages and disadvantages to each pathway one. You can combine them, mix and match them, do very interesting things with them… All examples of competitive regulatory strategy.
So, unless you understand all of the different possible pathways to market for your device — not just the most common ones – and the advantages and disadvantages to each, how can you decide when to use or not use each one? There are many more possibilities than most people think and learning how best to use them is creative regulatory strategy!
Medical Device Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
R&D Engineers and Management
Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our homepage to learn more.
Michael Drues, Ph.D., is a regulatory strategy consultant specializing in designing novel regulatory strategies to bring new and innovative medical products to market and in developing effective communication strategies between companies and regulatory agencies to minimize time to market and avoid delays.
His consultancy, Vascular Sciences is a consulting and training company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including creative regulatory strategy & competitive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense. If you'd like to learn more click here.