Focus on: Don Boyer

Don Boyer spent more than 30 years at Health Canada, including serving in several senior management positions, before leaving Canada’s regulator to start his own regulatory consulting firm. Earlier this month, he began his term as chairman of the RAPS board of directors. Don is a leader in the global regulatory community, and has been active not only with RAPS, but also with organizations such as the Global Harmonization Task Force and International Medical Device Regulators Forum. He holds the RAC credential and is a RAPS Fellow.

I recently had the opportunity to interview Don for the Regulatory Focus series, ‘Focus on…,’ where we talk with regulatory leaders, thinkers and influencers, sharing their thoughts on a range of topics. In this series, we not only discuss healthcare, regulation and the regulatory profession, we also look for unique personal insights and perspectives. In this interview, Don shared his vision for RAPS’ growth and evolution, talked about the trend toward specialization in the regulatory field and stressed the importance of maintaining a problem-solving mindset.

Following is an edited transcript of my interview with Don Boyer:

As you take over as chairman of RAPS’ board of directors, what is your vision for RAPS in 2019 and beyond?

First, I am committed to the strategic priorities established by RAPS and endorsed by the board of directors. They are critically important and I encourage all members to read them on the RAPS’ website. I consider advancing these priorities to be one of my primary functions as chairman, and a key responsibility for the entire board.

My vision for RAPS includes continuing its evolution as a truly international organization in support of regulatory affairs professionals around the world. To this point, I consider enhancing RAPS’ footprint in Europe to be essential. 2019 will be an important year as we launch the RAPS Regulatory Conference Europe in Brussels in May. It will be important for RAPS, and a priority for the board, to deliver a first-class conference which meets the needs of all regulatory professionals, with a focus on emerging issues in Europe. Needless to say, the content of this conference will be rich and rewarding given the EU’s new Medical Device and IVD Regulations, the situation with Brexit and the impact they have on the regulation of, and market access for, all healthcare products. Additionally, supporting the establishment of chapters and local networks in Europe will be important in expanding the “grass-roots” network among regulatory professionals.

Secondly, my vision for RAPS includes being the premier organization for regulatory education and training. RAPS must remain nimble and flexible in the way it offers these services. It needs to provide up-to-date offerings in response to emerging issues, and do it in the ways members want to receive them. While face-to-face opportunities still have an important role, RAPS needs to continue to explore innovative ways to deliver relevant training and education.

What impact has RAPS had on you?

The biggest impact that RAPS has had on me is giving me the opportunity to meet and interact with so many experienced and knowledgeable regulatory professionals. As a career regulator in an organization with many members from the industry side, the opportunity to get different views on regulatory initiatives and issues has been invaluable. There is no doubt that over the years, conversations I’ve had with fellow RAPS members have influenced my understanding of issues and helped me bring a broader perspective to the development of positions, policies, processes, etc., during my time working at Health Canada.

How has the regulatory profession evolved and changed during the course of your career?

The biggest change that I have witnessed is the opportunity to specialize within the profession. In the early days of my career, regulatory professionals often would cover a wide array of products—drugs, biologics, medical devices, etc.—as well as various aspects of the product lifecycle, including premarket, postmarket, GMP and QMS. Nowadays, regulatory professionals are much more likely to focus on particular products, even within a product category such as medical devices—IVDs versus implants, for example. Additionally, there is more specialization in specific areas of the product lifecycle. With the apparent exponential evolution of technology, I foresee this granularity within the profession continuing.

How do you think the profession will change over the next five years?

With a background primarily in the medical devices sector, I see a few areas, including software as a medical device, cybersecurity, artificial intelligence and personalized medicine as a result of genetic testing, that are having a major impact on how products are regulated. I anticipate that growth in these areas will be exponential and will present significant challenges at the overlap between scientific and technological innovation, and regulation. It will also present opportunities and challenges in the recruitment and training of regulatory professionals with the appropriate skill sets.

How would you characterize the relationship between regulators and regulated industry today, and how has it changed over time?

Generally, the relationship between regulators and regulated industry has improved over the years. I believe the opportunity to build working relationships is encouraging and has gone a long way in collectively resolving or addressing meaningful solutions to challenging issues. Examples of these include FDA’s Digital Health Software Precertification Program; FDA’s building of the National Evaluation System for Health Technology; Health Canada’s Scientific Advisory Panel for Software as a Medical Device; and its Device Advice: Pre-Clinical Meetings pilot project. There continue to be opportunities for improvement in the “customer service” area, but I have noticed a concerted effort to address that as well.

At what point in your career did you begin thinking of yourself as a regulatory professional?

I was fortunate during my career to have exposure at both the domestic and international level. This came relatively early on, and I think at this point it was obvious to me that working in regulatory was a defined career path whether you were working for a regulatory authority or part of the regulated industry.

What are the qualities that make a good regulatory professional?

Knowledge of acts, regulations, guidance, directives, etc., and understanding the purpose of regulation are fundamental to good regulatory professionals and their role in providing safe, effective and high quality products to patients in a timely manner. Additionally, understanding the needs, challenges and responsibilities of each stakeholder—the 360-degree approach—in the delivery of healthcare is paramount. The ability to build and nurture trust and effective working relationships is also extremely important. RAPS’ Regulatory Competency Framework does an admirable job in capturing many of the qualities that make a good regulatory professional.

What has been the most rewarding thing about your career?

I have been fortunate and taken great pleasure throughout my career to engage with people and be involved in a community from all around the globe who are motivated and share a common set of principles and goals.

What do you do outside of work that you are particularly proud of?

At this point in my career, I take pleasure in engaging with young people who seek advice and guidance as they contemplate their career interests and pathways. Their enthusiasm is reassuring and infectious and provides a certain motivation for me as I continue with my own career.

What inspires you?

I continue to be inspired by and attracted to initiatives that take risks and embrace change, creativity and innovation to address problems or challenges. I hope I will always be motivated to explore how to accomplish something instead of languishing on the reasons why it supposedly can’t be done.

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