Myant's claim to fame lies in its development of garments embedded with bio-sensing capabilities. Through the use of conductive yarns, the company has crafted a range of underwear-type garments, tailored for ECG bio-sensing and other clinical measurements. This technology is set to revolutionize the way cardiovascular disease patients are monitored and managed. Unlike conventional periodic sampling methods, Myant's platform provides continuous, real-time data, offering a more comprehensive view of a patient's condition.
Dale's journey into the regulatory realm took a unique trajectory. Armed with a background in biomedical engineering and a license as a professional engineer, he spent a significant portion of his career in academic teaching hospitals. This vantage point offered invaluable insights into the challenges faced by manufacturers and regulatory bodies in delivering safe and effective medical devices. After years of working as a risk management investigator, he became frustrated with medical device safety issues. Fueled by a passion for patient safety, he transitioned into certification bodies, delving into product testing and quality management system audits. Dale's expertise became necessary for companies struggling to navigate the regulatory landscape. With a keen understanding of engineering and risk management, he had a significant impact on regulatory process streamlining:
"My role evolved into regulatory, so I'm an expert in the standards, and I'm an engineer so I understand how software and hardware get built and developed. On the risk side, I've been where all the bad stuff happens, so I was able to look at processes and find more effective ways to shorten regulatory cycles."
His efforts not only expedited market entry but also expanded the company's footprint globally. From Canada to the US, China, and the UK, Dale's influence had an impact on the companies' success.
"My view has been a combination of all those experiences while understanding where you can take risks, where you need diligence, and having a deep understanding of the regulation. Regulations are not only words but also how you interpret and justify them for your product... that seems to make the difference."
One of the most rewarding parts of regulatory affairs for Dale is the satisfaction across the lifecycle, especially being part of a start-up. In addition to being able to go end-to-end in the process, he enjoys teaching, advocating, and helping people understand "why we do what we do." In the dynamic world of startups, Dale faces a unique challenge: instilling a deep understanding of medical device regulations in a team largely unversed in the field: "[...] most devices hit more than one entity: they hit patients, users, and sometimes patients and users are the same person. This is very different for people who come from other industries, so the biggest challenge has been bringing people in with experience to nurture those who have not worked in the industry - the medical device world has unique challenges."
Another challenge with working in the medtech regulatory arena is raising awareness around the value of regulatory affairs: "I think there's a bit of cultural activity needed to raise the awareness that it's really a key part of a multidisciplinary role. It's not one thing - it's not just science, it's not just engineering, it's not just reading regulations [...]." The multidisciplinary nature of this domain, encompassing science, engineering, and clinical applications, underscores its importance.
When asked about future change in the industry, Dale advocated for a harmonized approach to regulations worldwide. The diversity in regulatory requirements across countries poses a significant hurdle for medical device manufacturers. He stressed the need for a unified standard, emphasizing safety and effectiveness, to streamline the approval process and facilitate global market access.
Dale has had a significant impact on the industry, from the bedside of academic hospitals to overseeing quality and regulatory of a startup, he is a true Regulatory Rockstar. He recognizes the need for advocacy of the regulatory affairs community through the Rockstar movement:
"The key is trying to strengthen [the community] so people who are participating in regulatory get access to information, whether it's free or paid. It's so valuable to receive exposure to colleagues who are working in [the industry] and know who [you] can bounce things off of when you get stuck, or have internal or external pushback. Advancing the perception that regulatory is one of the key enablers for a company will translate to its success."
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