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  • Writer's pictureStephen Ostertag

Formative Research and Medical Device Startups: Success through Smart Investments

Updated: Aug 9, 2023

Starting a medical device manufacturing company is a courageous endeavor. There’s potential for considerable pay-off, in helping those in need and in generating revenue. However, there are also regulations designed to ensure medical devices are safe and effective that can pose as considerable hurdles to success. The FDA’s Center for Devices and Radiological Health (CDRH) is the primary agency involved with this task, ensuring “that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.”

In December 2022, the CDRH issued a draft guidance titled “Content of Human Factors Information in Medical Device Marketing Submissions” in an effort to seek feedback from industry and FDA staff regarding guidelines intended to complement the FDA’s 2016 “Applying Human Factors and Usability Engineering to Medical Devices.” The 2016 guidance document is designed to assist medical device manufacturers in following human factors and usability engineering best practices, easing the process of FDA pre-market clearance so companies can get their medical devices to market quickly and safely.

The FDA relies on a “Risk-Based Approach” to evaluate proposals and approve medical devices. With this, medical device companies must conduct human factors research in order to demonstrate that their products are safe and effective. The results of said research inform their risk analyses and are used to support their requests for FDA clearance.

The FDA clearance process can be time consuming and may introduce significant delays in marketing devices, especially if medical device companies do not prepare properly. One big mistake that companies make is waiting until their devices are ready to be marketed before conducting research with users. They may think research with users earlier in the development process is unnecessary and not worth the investment, only to get held up later when risk analyses uncover considerable use errors and task failures. The time and cost to fix these errors can sink medical device startups before they get established.

In order to best prepare for FDA clearance, it is wise to seek out research early, as the medical devices are being designed. This research is usually quicker to conduct, less costly, and may be massively helpful in avoiding unnoticed mistakes in device usability and risks. Said research uncovers problems early, when they are still small and less costly to fix with simple design modifications.

At TIMBS Consulting, we can conduct this research for you. In less than a month, we can get you the feedback you need to make sure your devices are intuitive to use, avoid unnecessary frictions, reduce risk and potential harms, setting you up for quick and efficient FDA pre-market clearance later on.

Smart investments early on can increase the likelihood that your device receives FDA clearance the first time you submit.

Contact TIMBS Consulting for a free consultation and to learn how we can save you money, headache, and time.


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