What are some of the greatest challenges medical device startups face when bringing their products to market?

This episode features Suzy Engwall, a healthcare innovation consultant with experience mentoring startups and guiding hospitals. She joins Christian Espinosa and Trevor Slattery to discuss the hidden roadblocks medical device innovators face—from funding gaps to internal hospital politics to overlooked cybersecurity. Together they unpack the realities of FDA compliance, AI-driven decision support, and why raising cybersecurity awareness early can mean the difference between market success and failure.

Suzy Engwall is a healthcare innovation leader who’s spent the last 20 years shaking up hospitals and mentoring startups. She runs HealthTech Strategies, where she helps founders, investors, and clinicians bridge the gap between big ideas and practical adoption.

Key points: 

(04:38) Challenges medtech startups face include funding, go-to-market strategy, and regulatory hurdles, with cybersecurity often overlooked.

(05:56) Why 93% of med tech startups fail. 

(08:01) How internal politics within hospitals can derail promising innovations.

(09:32) Hospitals now scrutinize devices for cybersecurity risk beyond FDA approval, raising the bar for manufacturers.

(12:19) Legacy devices often fail modern cybersecurity requirements, forcing redesigns and frustrating manufacturers.

(16:43) AI in diagnostics: who’s responsible when mistakes occur?

(23:24) Why patients rarely question medical devices. 

(31:28) Why cybersecurity is often the last thing innovators ask about—and why that mindset must change.

The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity professionals specializing in providing elite cyber solutions for medical devices. Learn more about securing your product and business from cybercriminals by visiting https://bluegoatcyber.com 

If you’re interested in our services or partnering with us, schedule a Discovery Session: https://meetings.hubspot.com/blue-goat-cyber/discovery-session 

Thanks to Suzy Engwall for being on the show. Connect with Suzy on LinkedIn: https://www.linkedin.com/in/sengwall

Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Chief Technology Officer / Director of MedTech Cybersecurity at Blue Goat Cyber. 

Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/ 

Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9 

Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/ 

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Blue Goat Cyber on YouTube: https://www.youtube.com/@BlueGoatCyber 

Feedback? Questions? Contact: https://bluegoatcyber.com/contact/ 

Learn more about Christian Espinosa, buy his books, or invite him to speak on your stage: https://christianespinosa.com/ 

Christian Espinosa on YouTube: http://www.youtube.com/@ChristianEspinosaOfficial 

The Med Device Cyber Podcast is your essential resource for medical device cybersecurity. Each episode we dive into the latest threats, solutions, and best practices to protect modern healthcare technology. Whether you're a provider, a manufacturer, or a cybersecurity professional, gain the knowledge to safeguard patient safety by subscribing to the Med Device Cyber Podcast. 

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This episode was produced by Story On Media: https://www.storyon.co/