Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
LTR 26: Seek clinical input early in development to achieve market success later
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LTR 26: Seek clinical input early in development to achieve market success later

Insights from a Let's Talk Risk! conversation with Sara Vazda

Why do many medical devices fail to reach their adoption goal after launch? Or, hit roadblocks during the regulatory review process before launch?

In this episode, Sara Vazda shares that one reason why medical device manufacturers struggle to achieve their business goals is that clinical input is generally not a natural part of the design and development (D&D) process. Medical device D&D is generally driven by Engineering, with clinical aspects considered only during the final phase prior to seeking regulatory approval.

Bottom line - missing clinical input early in the D&D process results in missing key user needs. Often, it later comes back to haunt us in terms of added time and cost of development, and missing launch timeline.

About Sara Vazda

Sara Vazda is an accomplished expert in the medical device industry, with a focus on guiding startups in medical device development and regulatory adherence. Her unwavering commitment to advancing women's health is exemplified through her strategic partnerships with Femtech companies like Ella and Hormona. As a registered biomedical scientist and specialist in laboratory medicine, Sara has accumulated a wealth of experience in various clinical positions, in both private and public hospitals as well as the medical device industry. This extensive background has cultivated a deep understanding of how clinical considerations can significantly influence the adoption of medical devices by both users and patients, resulting in a comprehensive perspective on how design gaps impact user and patient acceptance.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together!