What this Boston Scientific vet learned from a 35-year career in regulatory affairs

How to succeed in RA and other tips and words of wisdom from Boston Scientific retiree and University of Minnesota professor Mac McKeen.

By Mac McKeen

Recently retired from a 35-year career in medtech, I want to share some of my experiences and “pearls of wisdom” with you as you continue your journey.

I have had the good fortune of spending my entire career with big and small companies in Minnesota making cardiac medical devices. Life-saving device development and approval offers exciting challenges and the chance to work at great OEMs like Medtronic, St. Jude Medical (now Abbott) and Guidant (now Boston Scientific).

My journey started as a manufacturing engineer in aerospace and then a supplier development role, cutting my teeth in manufacturing and operations. With experience in a highly regulated industry, I was approached to join the compliance team at Cardiac Pacemakers Inc. to find the problems and fix an FDA consent decree.  This pivot to an entirely different functional area exposed me to virtually every part of the company and process.

Equipped with knowledge of the end-to-end total product life cycle (TPLC) and quality system processes, I joined the regulatory team to work cross functionally, understand the nuances of the process and translate that to the story in submissions. My MBA in contract administration helped me adapt the business process to a highly technical process. The combination of a technical undergraduate degree and an MBA served me well, as I realized my preference was for the business process, not the engineering process.

What is RA? Nothing happens until somebody sells something — and nobody sells medical devices until they are regulatory approved!

Regulatory affairs is one of the few functional areas in a company that is involved from beginning to end of the TPLC. It’s unique in that we get to work directly with most of the other functional areas in the product development process, clinical study and regulatory submission process. Regulatory professionals tell the story of work the team developed to demonstrate and support the product’s safety and performance to meet the intended use and labeling claims.

The 4 Cs for submission success: clear, concise, compelling, and complete

RA is a perfect combination of technical content and business acumen. The ability of the RA professional to understand and apply the technical aspects of the product design and testing and meld this with the technical writing of preparing the submission and telling the story of a product’s development, presenting this information to regulators in a clear, concise, compelling and complete manner is the key to success. RA offers the playbook to the business on how to plan and prepare and win at this process.

Project management and technical writing are fundamental skills that RA professionals need to grow and succeed. Another key is the ability to develop regulatory strategies to address the many challenges of navigating the regulatory process. Effectively communicating these strategies verbally and in writing are essential. To that end I recommend that you take the RAC exam and become RAC certified with RAPS. This is a professional and personal credential that will set you apart from the pack and help fuel your career growth.

The 4 Ps to success: people, process, products and patients

Everything in life is a process. Making medical devices is a process that starts with people using the process to develop products to treat patients.

While the premarket side of RA is more exciting and glamorous, the postmarket role of RA is essential for managing changes to process and products and compliance with regulations and performance of the product (recalls and field actions). I recommend taking on roles and responsibilities in each of these areas.

Post-approval change management is the key difference between medical devices and pharmaceuticals. In the drug industry, they get a product approved and never change the formula.

The device model, on the other hand, is based on launching a product platform — or what I refer to as the “revolution” of the product — and make incremental improvements to expand indications for use and improve performance, which I call the “evolution” of the product as represented in the TPLC model below.

Half the challenge and fun in medtech is postmarket change management and doing it well. Many companies do not invest in this process and consequently run into compliance problems with product recalls and warning letters due to high complaint rates on their products. This is a reflection of a less-than-robust design and manufacturing processes and a lack of discipline to monitor and maintain the quality of the product.

Find your purpose in RA: My definition of quality is: When your customers come back — and your products don’t!

My career in RA guided me to find passion and purpose in the work we do, all related to the patients we serve. RA is a unique role with the opportunity to partner with the quality organization to provide guidance to the team to take the steps necessary to meet the complexities of the regulations around the world, but also to design and manufacture a quality product that fully meets the labeling claims and requirements in the field.

At the risk of overstating the role of RA to the organization, we are a strategic partner and can help build and maintain a high compliance culture at the company. I call that passing the “red face test.” If you can’t explain the approach clearly and completely and you are using a lot of rationalization and leveraging of data, you are putting the process and the product approval at risk — not to mention the patient. The bottom line is that good compliance is good business.

My career ran parallel paths, with simultaneous jobs in industry and education. I invested 25 of those 35 years in educating others about the regulatory process and TPLC to help fill the industry’s talent pipeline. This was well worth the time and effort, providing another outlet for my passion and culminating in the honor of being recognized as a RAPS Fellow in 2020. This was one of my proudest achievements, as it allows me to continue promoting and advancing the RA profession through various committees and board positions.

Thank you for letting me share my experiences with you from my rewarding and fulfilling career. Now it is your opportunity to continue the work we do for patients and achieve your own career dreams.

Mac McKeen was a Boston Scientific regulatory scientist engaged in advancing medical device technology and therapies in both business and academia for the benefit of patients worldwide with experience in all four corners of rapid product development, clinical study, quality system compliance, and regulatory approval of innovative, high-quality Class II and III medical devices. McKeen will continue in education as an adjunct professor at the University of Minnesota College of Science and Engineering’s Medical Device Innovation curriculum.

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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.