Fourth in a five-part series

In the third part of our series on helping early-stage med device companies that are seeking funding, we examined what really happens once a funding agreement is in place and the parties have closed the investment. We looked at how investors often bring in outside experts if they deem things are not moving in the right direction, or as quickly as they want, and some of the issues that can create.

The fact is that outside expertise can be extraordinarily helpful to med device startups seeking funding. Just as an investor-investee relationship is akin to a marriage, working together with the right external experts can expand that relationship to a family. The key is to learn how and when to develop that family.

Start early

In most cases, bringing on external experts early in the development process works far better than waiting until problems arise. It’s already a requirement to include an external expert or specialist as part of the design review process.* Choosing that expert – individual or firm – carefully can offer the opportunity to expand the relationship.

Involving trusted experts from the start ensures that they become familiar with the nuances of the product’s technology, design and path to market. They can recognize challenges before they become real problems, help bypass crises and effectively speed the product to market introduction.

It all sounds great, and it can be – if developers are open to the experiences of those who’ve walked a similar road. Similar to obtaining second opinions, the right external sources can offer sounding boards and alternatives that might otherwise be unfamiliar.

Making the right match

It can take some time to find experts who are experienced in early-stage product development, who’ve walked in your shoes and who know how to get to market quickly and efficiently. They’d ideally be familiar enough with similar technologies to yours that they can relate to your specific product. You’ll also need to be comfortable with trusting and being open with the experts, which can at times be difficult in competitive business environments.

Doing so will allow you to develop a working, functional, effective family, and give you the resources to weather the inevitable storms to come.

Coming up: The importance of real-world testing

Throughout our series, we’ve focused on developing the investor-investee relationship. Once you are marching along, month by month, you’ll need to keep your investor up to date on progress. More often than you might expect, these reports can be aspirational at best and wholly inaccurate at worst. To help, in our last post, we’ll dive into an important tactic that will pave the way for reporting progress to your investors based on solid evidence: the importance of real-world testing.

* The previous FDA Quality System Regulation, which was in effect until this past February, states that “Manufacturers must establish procedures for conducting formal, documented design reviews at appropriate stages. These reviews require cross-functional participation and the inclusion of at least one individual without direct responsibility for the design stage being reviewed.”

As of Feb. 2, this has been changed to reference the provisions of ISO 13485:2016, specifically section 7.3.5: “Participants in such reviews shall include representatives of functions concerned with the design and development stage being reviewed, as well as other specialist personnel.” The reference to “other specialist personnel” can be interpreted as including an “…individual without direct responsibility for the design stage being reviewed.”

Larry Blankenship, Director