⭐ Introduction
Welcome to another episode of Career Diaries by elemed, the podcast dedicated to discussing careers in the MedTech industry!
In this episode, Eric Klasen – founder of Waypoint LS Consulting and former VP RA & Quality at Medtronic – joins us for a highly insightful conversation about how regulatory professionals can change the narrative to business with an anything-is-possible approach. Eric shares how to talk business as a regulatory professional, what business leaders really want from their RA team, how to overcome the internal PR challenge RA typically faces, and how to be seen as a partner to the business.
A Unique Path to Regulatory
Eric’s journey into the world of regulatory was unconventional, as he didn’t actively seek out a career in this field. His introduction to regulatory came when he was approached by a troubled company in Italy facing an FDA fraud issue. He agreed to join the company as the Director of Regulatory Compliance, marking his entry into the regulatory domain. This role laid the foundation for a significant change in his career that would span over four decades.
Evolution of Regulatory in the Industry
Eric has had the privilege of working with some of the industry’s leading companies, and his insights into the evolution of the regulatory function are valuable. He highlights key differences between the pharmaceutical and MedTech sectors. In pharma, regulatory is seen as a strategic and technical function, integral to product development and marketing authorisation. In contrast, MedTech companies often struggle to understand the full scope and potential of the regulatory role.
The Role of Regulatory in a Company
Eric defines the primary purpose of regulatory in a company: “Regulatory is the first level access to the market.” Without regulatory approvals, products cannot reach the market legally. This critical function not only ensures compliance with regulations but also facilitates market access. It’s the gateway that every MedTech product must pass through.
Startups and Regulatory Challenges
Startups in the Life Sciences industry face unique challenges. They often lack the resources and experience to navigate the complex regulatory landscape effectively. Eric emphasises the importance of early market research. Startups should use initial funding to understand their market potential thoroughly. This understanding is crucial when seeking further investment and developing a strong business case.
Changing the Regulatory Narrative
One of the key points Eric discusses is changing the narrative around regulatory. He believes that regulatory professionals need to transition from being seen as mere support functions to integral business partners. This shift can be achieved by fostering a deeper understanding of the business side, engaging with colleagues, and actively contributing to strategic discussions.
Eric’s advice for regulatory professionals on changing the narrative is to build relationships with business colleagues. He suggests going beyond the surface level and engaging in one-on-one conversations to understand their challenges, priorities, and concerns. By actively participating in business meetings, regulatory professionals can position themselves as valuable contributors rather than obstacles.
Regulatory as a Business Function
Eric passionately argues that regulatory is not merely a support function but an integral business function. Regulatory professionals should embrace their role in shaping strategy, product development, and market access. This mindset shift fosters collaboration and ensures that regulatory considerations are embedded throughout the product lifecycle.
He stresses that it’s perfectly acceptable to admit when you don’t have all the answers, but it’s crucial to follow up with a commitment to find them. Being honest about uncertainty builds trust with business colleagues.
The Power of Saying ‘Yes'
In the pharma industry, there’s a running joke that regulatory people are like Eskimos, who have numerous words for different shades of white. Regulatory professionals, too, have various ways of saying “maybe.” While it’s essential to remain cautious, overusing “maybe” can hinder progress. Regulatory professionals should shift their mindset from saying “no” by default to saying “yes” with a focus on finding solutions. Rather than listing technical reasons why something can’t be done, they should explore ways to make it happen within the framework of regulations.
By actively engaging in discussions, understanding their challenges, and being open to creative solutions, regulatory experts can position themselves as solution-oriented partners, rather than regulatory hurdles.
Legacy of Effective Communication
Eric’s legacy aspiration is to leave a world where effective communication is the norm in regulatory affairs. He believes in the power of collaboration, honesty, and creativity to bridge the gap between regulatory experts and business professionals. By fostering a culture of clear and solution-oriented communication, regulatory professionals can bring lasting value to their organisations.
Conclusion
By actively engaging with colleagues and embracing regulatory as a business function, regulatory professionals can not only change the narrative but also drive innovation and success in the ever-evolving MedTech landscape.
Regulatory professionals play a vital role in navigating the complex landscape of regulations and compliance. By embracing uncertainty, saying “yes” to opportunities, and effectively communicating with business colleagues, they can become valuable partners in driving their organisations forward. Eric’s insights shed light on the importance of combining technical expertise with a solution-oriented mindset and emphasise the role of leadership in shaping the future of regulatory affairs.
