Standing Out vs. Fitting In

Innovators are constantly being pulled in different directions on whether they should develop a product that ‘Stands Out’ or one that ‘Fits In’. It’s like middle school all over again! I’ll go through some of the challenges with choosing to develop a new state of the art device versus a device that is an improvement on the current standard of care.

• Intellectual property – Standing Out – When looking into intellectual property, there are two main considerations. The first is patentability – is your invention useful, novel, and unobvious? These three requirements are essential to being granted a patent. The second consideration is freedom to operate – does your invention infringe on the claims of existing patents? You need to make sure you aren’t infringing, this is how lawsuits start (ie. Apple vs. Samsung patent infringement). Finding unoccupied space in the intellectual property landscape almost forces the design of your device to be different than anything else out there.
• Regulatory – Fitting In – As you know the FDA is concerned with having devices that are safe and effective. The 510(k) route of Substantial Equivalence is the mechanism FDA has in place to have a reasonable assurance of safety and effectiveness. In this pathway, you must prove that your device does not significantly differ from predicate devices. So, after convincing the USPTO that your device is one of a kind, you now have to turn around and tell the FDA that it’s not that much different than other devices. Either that or you must go through a more costly (in time, money, and resources) FDA approval process (PMA, or de novo).
• Marketing – Standing Out – After getting the OK from regulatory authorities to sell your product, you now have marketing to conquer. To successfully market your product, it is crucial to differentiate yourself from other products, and to understand the needs of your customers. Does your market favor disruptive technologies that revolutionize care or does your market favor evolutionary changes to products? Disruptive technologies may have a bigger impact and market potential in the long run; however the adoption rate of the technology may be slower compared to devices with more incremental and manageable changes. This is a question companies often ask themselves: do you spend your resources on developing products in your product pipeline, or do you build a new platform technology?
• Reimbursement – Fitting In – Lastly, for reimbursement purposes, it is much easier to fit into an already existing category than to apply for new reimbursement codes. Fitting into pre-existing categories will give you a better chance to have more universal and complete coverage from all insurers. Additionally, providers and hospitals will be more likely to buy a product that has an associated code. This is a case when differentiation doesn’t help out much.

Middle school was a great time…but now I’m happy to be part of the grown-up community of medical devices experts, even though we still have to decide if it’s cool to stand out or fit in.
;-)
Stay tuned in the coming weeks for a deeper dive into each of these 4 areas.

- Sherri