3 Medtech Regulatory Successes (That Started As Failures)

By Bob Marshall, Chief Editor, Med Device Online

Working in the regulated medtech industry is not always ideal for a person who believes in “happily ever after.” The only time I can guarantee that happening is when I sit down and watch a Hallmark movie with my wife. Through all of the plot twists and turns, poor communication, and misunderstandings, somehow everything turns out well in the end.

Having spent 25 years working to bring new medical devices to market, I have more than my fair share of scars from the times that my organizations didn’t meet the expectations of the regulators. However, there also were those times when we got it just right. Below are three examples of companies — with whom I either worked or consulted — that chose good approaches and were rewarded for their efforts. Note: no names are used in these anecdotes, and some details may have been generalized to protect the identities of the companies involved.

When All Else Fails, Get Someone To Change The Law For You

A small company developed a Class 2 device for use with premature infants in the NICU. The problem was that similar devices on the market had contributed to 12 deaths over a 13-year period when used in the home environment. Despite the new device being intended for use in a very different environment than the devices that had been involved in the loss of life, an FDA Safety Bulletin indicated that no 510k clearances would be granted for devices in this product category unless the benefits of using said devices could be shown to outweigh the risk. Market competitors’ workaround was to remove any quality of life claims from their intended use (and labelling), and to market their products under a different category — as Class 1 devices exempt from premarket notification requirements.

The FDA Safety Bulletin’s requirements were particularly challenging since the new device’s benefits addressed quality of life, but were not life-saving. Therefore, how would one show that improving quality of life outweighs the already documented risk of death? It's probably not possible. But, could one show the risk of death could be greatly reduced by limiting the environment of use? Yes.

The company had a pre-submission meeting with the FDA and proposed labeling its device for use only in the highly-monitored NICU environment. After weeks of internal deliberation, the FDA created a new Class 2 product code for such devices — indicated for use only in the highly-monitored NICU environment — and agreed to accept a submission from the company. If you can’t show the benefits outweigh the risks, find a way to control and minimize the risk!

Sometimes The Hardest (But Best) Thing To Do Is Ask For Help

In 2011, a global medical device manufacturer needed to make a change to a component belonging to a Class 3 device that had been on the market for years. The electronic component had become obsolete, and the company made a last-time buy from remaining stock. The company submitted a seemingly routine PMA supplement, including the small design change, which entailed replacing the obsolete component with a new version having the same form, fit, and function. The FDA’s response to the supplement requested the company’s assessment of human factors and usability engineering documentation related to the updated component. Although the component change seemed simple and direct, it was a part that had to be manipulated by the patient on a daily basis, each time the device was used.

Recall that in 2011, the medical device industry was just getting used to the human factors expectations of the third edition of IEC-60601-1 and the 2007 version of IEC-62366. Even the FDA, which had long championed the inclusion of human factors considerations in device development, was just getting ready to release its own draft guidance on applying human factors and usability engineering to medical devices. Thus, it was no surprise that this company had not included human factors/usability information in the PMA supplement, because they didn’t know how to do so.

Fortunately, the company recognized its need for help. Without approval of the PMA supplement, the company would be unable to cut in a change to use the new component in devices shipped within the U.S. Given that the old component was no longer going to be available, this would have been a tremendous loss of revenue. The company got help, but it didn’t just buy a quick fix. Recognizing that human factors were becoming a prominent part of medical device development, the company sought a partner that could fix its PMA supplement today, but also guide the company in building its own competence in usability engineering for tomorrow.

The company chose a consulting partner, which quickly prepared and submitted a new PMA supplement with human factors assessment to keep the device on the market. During the next design change to the device, company employees collaborated with the consulting partner to perform usability engineering and produce human factors documentation for submission. On the third project, for a different product line, company employees performed the usability engineering and produced the human factors documentation, using the consulting partner as a final reviewer only. After this submission was successful, the company was internally competent and self-sufficient in the area of human factors.

Know The Risks And Keep Your Options Open

A startup company developed a software application to collect, track, and share personal health information. The company was unable to attract interest from potential funding sources, primarily due to uncertainty surrounding the regulatory positioning for this type of product. The company developed a detailed regulatory strategy, exploring all of the potential classification options and the associated requirements and risks.

The product could be a Class 2 device, a Class 1 device, a Medical Device Data System, or not a device at all, depending on the functionality offered and the claims that would be made. The company was able to position its product as “not a medical device” by limiting some features, and through careful wording on labeling, marketing literature, and web site claims. The company used the detailed regulatory pathway to obtain necessary funding to commercialize its product. This enabled the company to generate revenue, and left the door open to pursue the other defined pathways in the future.

Don’t Take No For An Answer

The common theme of these experiences is responding to adversity with open-minded persistence. These companies encountered regulatory resistance or uncertainty and responded with creative solutions. In the first case, the company turned the FDA’s Safety Bulletin into a competitive advantage. In the second case, the company used the FDA’s rejection as an opportunity for organizational development. And in the third case, the company engaged the FDA’s own guidance and regulations to convince potential investors to open their wallets. The courage of these companies resulted in three very positive regulatory outcomes.