I would not even consider a verbal agreement related to medical device development. I have already been burned going down that track. A verbal agreement can only be clearly validated if there are wi...

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. However, I don't believe that the rule will cha...

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. Products that grow in popularity can thus build...

Upper management is ultimately responsible for operations, but more important, upper management must create or articulate the company's vision for middle management and all employees. Upper managemen...

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 a matrix structure as we grew in size and complexi...

My current job utilizes a matrix organization. Our non-clinical departments (e.g. Marketing, Public Safety, Marketing, Finance) fit the functional scheme, and their leadership reports directly to the ...

Besides the already stated benefits of lower complaint costs, better product reliability and higher customer satisfaction, post-market surveillance (PMS) is a process that drives long-term product sus...

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 indirectly bolstered by ISO 13485, which is followed b...

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 creation and eventual commercialization of a medical d...

From a purely manufacturing or engineering perspective, insufficient design controls can pose dire consequences for medical device development. The FDA even cites that poor design controls are consis...

In my opinion, to say that the Design Input Document (DID) and Design Specification Document (DSD) both have disadvantages is the wrong way to describe them, since each intentionally created for a dif...

The design control regulations implemented by the Food & Drug Administration (FDA) provide a cogent process for the myriad of components that go into medical device development. It is a godsend t...

This example still is a point of outrage to me, because it demonstrates what systemic racism in healthcare looks like. Henrietta Lacks is essentially a guinea pig to be profited from. Neither she no...

The purpose of blinding and randomization is to eliminate any potential bias and oversampling of a particular subject group, respectively. Theoretically, the double-blinded and triple-blinded studies...

The ethical implementation of clinical studies is extremely important me. The prerequisite of pre-clinical research with animal subjects diffuses some of my concerns about the safety of human in clin...