In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, about her path from a biomedical engineer to an "accidental entrepreneur."
Dr. Parekh shares how her desire to create impactful medical devices led to the development of the COBRA-OS, a life-saving tool used in trauma care, including military and postpartum hemorrhage situations.
The conversation touches on the challenges and victories of securing funding, navigating regulatory hurdles, and maintaining a mission-driven company focused on patient impact. For those interested in MedTech, this episode provides inspiration, practical insights, and a behind-the-scenes look at innovation in healthcare.
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For new listeners, understanding how regulatory approvals work is essential in MedTech. Devices are classified by risk (Class I, II, III), and each class has specific regulatory pathways. For example, COBRA-OS received Health Canada, FDA, and CE mark approvals, allowing it to enter the market in different regions. The CE mark is required for products sold in Europe, indicating compliance with health, safety, and environmental protection standards.
Frontline Medical Technologies – Learn more about COBRA-OS and its use in trauma care at Frontline MedTech.
Greenlight Guru – For quality and regulatory management solutions, visit Greenlight Guru.
Rook Quality Systems – Learn more about QMS consulting at Rook Quality Systems.
Connect with Etienne Nichols on LinkedIn – LinkedIn Profile.
Connect with Asha Parekh on LinkedIn – LinkedIn Profile.
Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...