Life Science Mentor Network Update
The Life Science Mentor Network includes over 70 industry experts who volunteer their time and knowledge to our companies to fine-tune their business models and enhance their pitch decks for capital investments. Beginning this week, we are going to highlight a new mentor in our newsletter each month to showcase the diversity and knowledge that we are proud to have in our Network!
This month we are featuring former Director of Regulatory Affairs at BMTI/Wright Technology, Gerda Resch. Now retired, Resch’s background mostly consists of medical device regulatory affairs. Throughout her 40-year career, she has mostly worked with startup companies helping them setup their initial regulatory affairs/quality assurance programs before they have the funding to establish departments. See her answers below about why she enjoys the Mentor Network program.
Why did you decide to serve as a mentor?
One can always glean information from the regulations and many startups do not know where to get all the information they need. However, having assistance from someone with real-world experience and advice in the beginning can streamline the process and remove many obstacles, which can later be costly.
What consistent advice do you give to startup companies? What is a common mistake you see companies make?
They aren’t thinking globally enough. Most startups only think what they need to do for their first regulatory approval, not realizing that not planning for other markets initially could incur additional testing, costs and loss of timely market launches. There is a misperception that the FDA is the ultimate regulatory authority, and what is acceptable for them is globally acceptable.
Why do you think Tennessee is a good place to launch a startup in the life science industry?
Tennessee has Oak Ridge, UT, TSU and Vanderbilt, which have excellent resources for these companies, as well as a growing base of regulatory professionals.
