Focus on: Susumu Nozawa

Susumu Nozawa, RAC (US and EU), FRAPS, is the current chair of RAPS’ board of directors. He has more than 15 years of experience in US and international regulatory affairs and compliance, most recently as director of technical and regulatory policy and corporate regulatory affairs at BD in Franklin Lakes, NJ. He also is an active volunteer leader with RAPS as well as other professional organizations, including AdvaMed and the American Medical Devices and Diagnostics Manufacturers Association.

He graciously agreed to answer my questions for the Regulatory Focus series, ‘Focus on…,’ where we talk with regulatory leaders, thinkers and influencers, sharing their diverse perspectives on topics ranging from global trends, to regulatory leadership and their unique personal insights. In this interview we discussed the different approaches to regulation in Japan and the US, the role of leaders and drawing inspiration from the world’s engineering marvels, among other things.

Following is an edited transcript of my interview with Susumu:

What is the most important thing you have learned so far from serving as chairman of the RAPS board of directors, and what advice would you offer your successor?

Enabling robust discussions through collaboration and communication—I have been on the board for nearly a decade, but engagement and collaborations between the board and RAPS staff in recent years have been exceptional. We always share and discuss challenges and new ideas and align ourselves on the strategy to achieve those goals. Continuing such collaboration is critical to build a better RAPS.

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

Regulatory has become a business-enabling function. In the early days of my career in regulatory, the majority of my work was devoted to writing submissions for approvals, and the profession was not well recognized. Over the years, I have seen the regulatory profession grow into a strategic partnership role, informing and supporting successful business decisions, and have often seen the profession being involved in the very early phases of product development. The early involvement is critical to bring increasingly complex technologies into multiple markets in the most efficient ways possible.

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

In addition to the role of strategic business partner, shaping regulatory and technical policies for emerging technologies is becoming an important role for regulatory professionals.

What was your very first job, and what are the most important things you learned from it?

My first job was in R&D at a medical device company, working with physicians to develop new products. It was critical not only to possess the technical knowledge, but also to fully understand the use environment of each product to optimize performance. Also critical was designing a product that is easy to manufacture and service as I learned from seasoned machinists, assemblers and field engineers.

What is the best career decision you ever made?

Relocating to the US from Japan—It has given me a totally different view of global businesses, the regulatory profession and the dynamics of regulatory agencies around the world.

What are the biggest differences between how healthcare products are regulated in Japan compared with how they are regulated in the US? In what ways are they similar?

The regulations in Japan seem to be more prescriptive than the ones in other jurisdictions, and they reflect the culture. A prescriptive regulatory framework works well for established technologies; however, emerging innovative technologies require different approaches, and the product realization processes utilizing global procurement and supply chain practices pose additional challenges for the industry to comply with Japan’s regulatory framework. This is one of the areas where regulatory professionals could collaborate with the regulator to improve the regulatory policies for the benefit of patients, government and the industry.

What personality traits do you look for in the people you hire?

Learning agility and integrity would be the most important traits for regulatory professionals in the current fast-paced business environment.

What traits or skills do you think are most important for regulatory professionals who aspire to become leaders?

Recently, I came across an excellent video by Jack Welch, former CEO of GE, talking about the role of leaders. According to him, a leader needs to be “Chief Meaning Officer,” setting up a clear vision and strategies, and he or she needs to be able to articulate the meaning of the actions for the team. I believe this is very true for regulatory leaders, and it is worthwhile to watch the video if you have not done so.

What makes regulatory a fulfilling field to be in?

The regulatory profession requires not only technical knowledge and writing skills, but also negotiation skills, business acumen and understanding of the dynamic evolution of regulations and standards globally to be fully effective. Not many professions offer this type of exposure to so many critical areas. This, along with the role’s challenges and ability to make meaningful changes to people’s lives, are some of the things I value most.

What has been the most surprising or unexpected thing you have learned in your career?

The current rapid advancements in biotechnologies. For example, gene therapy and next generation sequencing, are mind-boggling and beyond my imagination. Lately, AI has been incorporated into IVD developments. More positive surprises will come for sure. We, regulatory professionals, must be out-of-box thinkers to overcome regulatory hurdles to launch such ground-breaking products.

What piques your curiosity?

Just about anything in technology, such as mega construction projects like Burj Khalifa in Dubai. I was amazed by its magnificent height and beauty when I stood in front of it a few years ago. Who would have thought concrete, a typical construction material, would give engineers major headaches? But they had to pump the material up to a half-mile-high elevation and cure it within certain specifications under unforgiving desert weather. Every engineering marvel has, in addition to its history, fascinating facts and innovations I never would have thought of. Learning about those breakthroughs often triggers my curiosity about other things as well, and gives me opportunities to look at things from different angles.

What is something you are passionate about other than work or family?

Photography—it has been a part of my life since my high school days, and I loved developing film and enlarging photos in a dark room manually. Watching an image emerging from a piece of photo paper as chemical reactions progress was an exciting moment. Now, I do digital photography and am amazed at how much we can do with all the tools available today. The digital technology certainly provides me with ease of taking photos, on-site review and post production editing capabilities, but the fundamentals of photography have never changed: setting a concept before shooting. “There is nothing worse than a sharp image of a fuzzy concept.” This is a quote from Ansel Adams that I keep in my mind when taking photos.

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