I would not even consider a verbal agreement related to medical device development. I have already been burned going down that track. A verbal agree...

Actually, I do feel like NOT paying for the physician's spouse, if the vendor is taking the physician out for dinner does rank a "petty" in my opinion...

Protection of trade secrets can be nearly as impactful as an actual patent, and much less expensive. Trade secrets create a "mystic" around a product...

Upper management is ultimately responsible for operations, but more important, upper management must create or articulate the company's vision for mid...

By the nature of most medical device companies being small, I think initially my company structure would start out as project-based, then evolve into ...

My current job utilizes a matrix organization. Our non-clinical departments (e.g. Marketing, Public Safety, Marketing, Finance) fit the functional sch...

Besides the already stated benefits of lower complaint costs, better product reliability and higher customer satisfaction, post-market surveillance (P...

Risk management for medical devices is set for by ISO 14971 as the consensus standard of the U.S. Food and Drug Administration (FDA), but is also indi...

Yes, the risk management file is a dynamic and living document. It is also a reminder of the level of detail and diligence that must go into the crea...

From a purely manufacturing or engineering perspective, insufficient design controls can pose dire consequences for medical device development. The F...

In my opinion, to say that the Design Input Document (DID) and Design Specification Document (DSD) both have disadvantages is the wrong way to describ...

The design control regulations implemented by the Food & Drug Administration (FDA) provide a cogent process for the myriad of components that go i...

This example still is a point of outrage to me, because it demonstrates what systemic racism in healthcare looks like. Henrietta Lacks is essentially...

The purpose of blinding and randomization is to eliminate any potential bias and oversampling of a particular subject group, respectively. Theoretica...

The ethical implementation of clinical studies is extremely important me. The prerequisite of pre-clinical research with animal subjects diffuses som...