Will Pre-Cert Increase the Advantage of Big Companies? (UPDATE)

The impact of FDA's digital health Pre-Cert program has yet to be fully seen. There is much debate about the relative advantages of big vs small companies on the development side of the device/product equation. The classic view is that big has the resources and experience, but perhaps is over constrained and under motivated. Small has entrepreneurial zeal and fewer rules. I once heard that zeal turned into advice to job candidates that you shouldn’t express interest in any hobbies during your interview because they didn’t want people with distractions.  Small may also have no income, but that is a separate matter. However, design/product development is only part of the challenge in medical devices. Another challenge is regulatory compliance where big might have a great advantage. They probably have their own regulatory department, they have prior experience in FDA compliance generally and filings in particular. And an established company may have a good reputation at the FDA which can lead to smoother sailing, whether or not this is supposed to be the case. (Of course, they might also have a bad reputation leading to resistance and closer scrutiny at the FDA.) But however light or heavy the regulatory burden is, established companies are likely going to find it easier to carry that burden than smaller companies and start-ups. In this regard we might want to remember that the purpose of the burden is to protect the public through the reasonable assurance that the medical ...
Source: Medical Connectivity Consulting - Category: Information Technology Authors: Tags: Mobile Health Standards & Regulatory Source Type: blogs