Do you currently support your lead revenue generating, life-enhancing product with a collection of bench studies from 20 years ago? Can you effectively follow the history of the product data from when it was called project Heart to Heart3, then on to Tech4567 and finally PaceMaker Elite Mach 76A with titanium?
We all know that true beauty comes from within and is recognised via the eye of the beholder. In the case of medical device regulatory supporting data, the eyes beholden the beauty are notified bodies, competent authorities, external auditors and health regulators. Adding a pretty new frock or snazzy tie will not improve inadequate inherent beauty or the mandatory quality of your most precious enterprise asset.
Even if, at first glance, the regulatory data may look quite fetching, lulling you into a false sense of security…..remember “beauty is only skin deep, ugly goes clean to the bone”. Now is the time to take that deep dive into the data stores to uncover the ugly hiding underneath which may place your medical device products at a risk of non-compliance.
I am pretty handy with a paint brush, email me at KimYoung@instem.com