These articles are a work in progress, consisting of insights obtained in over 40 years of professional experience in the medical device industry. This includes eight (8) years as an independent consultant, working with start-ups, small, intermediate and large medical device companies. Much of what you will be reading will consist of things I’ve learned in the trenches. I’ve elected to dispense with much of technical knowledge in these areas,which is readily available in public literature.

I welcome your comments and insights as well.

If you are working in the regulatory space, regardless of whether it is in pharma., food, or medical devices, you must realize two things:

1. You elected to play in this space.

2. There are rules, i.e., regulations, you need to follow. And the purpose of these rules and regulations are to help you market safe and effective devices.

While fear can be a great motivating factor, compliance to regulations, if done in a least burdensome manner, can add value to your business. This post will examine various ways to accomplish this.

Electronic quality management systems (or document management systems) are an essential component of any organization.  In this posting I will share some of my experiences understanding the various features and differences, working with vendors, and providing the best value to clients. Also, I will share with you some of the misconceptions and misunderstandings on the part of the client with respect to what they signed up for.

Yes, MDSAP, while designed to satisfy audting requirements for five nations, can be a great tool to use to check inter-connected processes.  This posting will share some observations with you to, possibly, help you be a more insightful auditor.

If you are a company who has outsourced many of its major development activities, your success in large part depends on the type of relationship established with them.  This posting will look at some of then insights I’ve gathered in industry as well as in eight years consulting with medical device companies and their suppliers.   Topics, including a few selected stories, will include quality agreements, capability analysis, developing relationships, setting and meeting specifications.

Quality Management systems audits, are, as you are aware, a management tool to help the organization understand the degree of compliance to specified criteria.  Getting the auditee to tell you their story often helps you, the auditor, determine what the real issues are.  This posting will share with you some of the observations I have made performing many audits over a period of 30 years.

Working with start-ups can be fun and exciting.  Innovation, invention and creativity at its best.  It can also be very frustrating, depending on the level of knowledge and experience they have playing in the medical device space.  This blog will share with you some of my observations in working with two recent start-up companies.

Yes, the EU MDR is a very complex set of regulations.  All designed with the intention of providing safe and effective medical devices for you and me.  Is it the ultimate elephant?  That is, how do you audit the EU MDR?  One bite at a time?  This posting will provide some insights into how to best make your time (as the auditor, or the auditee, as the case may be) most valuable, to your self and to each other.


Summary:  As an independent consultant in the medical device industry for eight years, there is a great deal that I have been fortunate enough to experience along the way.   In  this posting I will be highlighting a few of my significant learnings during this period.  While some of them appear to be inherently obvious, it is important to reflect on them, anyway.

As this posting is a “work in progress” I have listed, by topic, areas in which I will discuss in the future.  Thougt I would start with what is probably the most important:  Respect the client.

#1: Respect:  It is important to understand how to make a recommendation or a suggestion, or otherwise, a particular direction you feel your client should pursue.  You must put your diplomat hat on when presenting, and always try to relate to a common objective, such as a business or regulatory goal or objective.

#2: They Pay the Bill:

#3: Who is the Real Client?

#4: What is their Problem?

#5: What does Success Look Like?

#6: Understand their Motivating Factors:

#7: How do you Know when you are Done?

#8: Do you Understand their Needs?

#9: How and When to Communicate:

#10: What are the Deliverables (Work Product)?

#11: Are you a Good Fit for the Client?  For the Project?

If you are involved in regulated industries, and are governed by the ISO quality management standards, you are aware of this concept of employing risk-based thinking or risk-based approach.  Having audited and consulted with many medical device companies, it is rare that I have come across many who have effectively grasped this concept.

In  this blog I will explore what I believe should be a reasonable approach to instituting an effective process to manage business risk.