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 witnesses to the agreement, especially good if…   Read more»

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 change, due to the…   Read more»

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 their brand around a secret sauce or…   Read more»

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 management sets the tone for the company culture, in terms of its expressed values. …   Read more»

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 complexity.  I believe that some core administrative…   Read more»

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 Dean/President. In addition, we have a trio of IT employees, certified as PMPs,…   Read more»

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 sustainability, from both a manufacturing and customer relationship standpoint.  In many ways, sustainability is…   Read more»

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 by the European Medical Device Regulation…   Read more»

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 device.  Risk management is an…   Read more»

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 consistently the number one reason for Form 483 inspections for non-compliance or deficiencies. …   Read more»

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 different purpose.  The DID is built around the…   Read more»

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 to both novice and experienced entrepreneur.  The steps involved…   Read more»

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 nor her family have been treated like…   Read more»

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 are supposed to be the gold standard in achieving evidence-based results.  I often wonder…   Read more»

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 clinical studies or trials.  Every study must have a plan for…   Read more»

To make the QA process more efficient for newly developing technologies, my approach would not be different, even though some of the tools I would use might be upgraded.  One of my first steps would be ensuring that I hired…   Read more»

Oh, how I wish an investment in QA/QC infrastructure was a part of this nation’s strategy in addressing and abating the spread of COVID-19.  Having quality systems and professionals in place to mitigate risk and liability to the company, as…   Read more»

Quality Assurance (QA) is more about preventive measures, having the right systems and processes in place, and complying with industry regulations and standards.  Quality Control (QC), however, focuses on performance and outcomes compared to acceptable standards or stated expectations.  Early…   Read more»

I think the FDA heard your complaint, because beginning in 2019, FDA began making significant revisions to its 510(K) process to simplify the procedural steps and acknowledge that with the rapid advancement of technology, it makes more sense for new…   Read more»

Having already lived this experience, while being outside of the academic health setting, there are several things that I know now, but didn’t know then.  One of my first moves would be to gather an advisory board of experts, consisting…   Read more»