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.

Key Timestamps:

[03:22] – Asha Parekh shares her transition from biomedical engineer to accidental entrepreneur.
[12:35] – Developing the COBRA-OS and the moment Asha realized the life-saving potential of her product.
[22:10] – The role of passion in overcoming challenges as a MedTech entrepreneur.
[35:42] – The importance of securing funding and the challenges of working with quality and regulatory partners.
[52:20] – How to craft a compelling pitch to secure funding for your MedTech device.
[01:04:30] – Asha's milestone moments, including the COBRA-OS being used at Formula One race tracks.

Quotes:

"Passion is what drives you through the tough days. It's what makes the challenges bearable because the impact you're making is worth it." – Asha Parekh
"Pitching is an art form. Telling a compelling story about your product, especially one that saves lives, can make all the difference." – Asha Parekh
"You are the expert on your device. Never forget that, even when you're leaning on regulatory experts. Trust your own knowledge of your product." – Asha Parekh
"The moment I realized that COBRA-OS could save lives, I knew we had to pursue it full-time." – Asha Parekh

Key Takeaways:

Top 3 MedTech Trends:

Growing Impact of Trauma Care Devices – Devices like the COBRA-OS are becoming critical in high-risk environments such as military and emergency settings.
Regulatory Complexity – Expanding into international markets (e.g., achieving CE mark) requires navigating a web of regulatory requirements.
Funding & Innovation – Securing funding is pivotal for early-stage MedTech companies, especially when aiming for large-scale regulatory testing.

Top 3 Practical Tips for MedTech Entrepreneurs:

Find a Mission You’re Passionate About – It will sustain you through difficult phases.
Master the Art of Pitching – A compelling story can unlock funding opportunities.
Be Proactive in Regulatory Knowledge – Don’t rely solely on consultants; know your product’s regulatory pathway inside and out.

References:

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...

#381: MedTech Advice from an Accidental Entrepreneur

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