#005 - The tough journey of building a biotech company, with Federico Bürsgens of GNA-Biosolutions, Germany

The Hardware Entrepreneur · 21 Dec 2016 · 35m

What this episode covers

Federico Bürsgens, Managing Director of Finances, Hardware & Software at GNA-Biosolutions, explains the journey of spinning out a biotech company from the University of Munich to develop ultrafast DNA analysis technology. He details the progression from federal grants and seed funding to a €6 million Series B led by Robert Bosch Venture Capital, highlighting the challenges of validating immature technology for the heavily regulated biomedical market. Bürsgens discusses the strategic decision to hire an external CEO for industry expertise and the choice to outsource manufacturing to manage regulatory burdens while focusing on core R&D.

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 21m

    Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's

    Sara Naab, co-founder and director of quality and marketing at Sandstone Diagnostics, discusses the journey of building Trak, an over-the-counter male fertility monitoring system comprising a mini centrifuge and companion app. She highlights manufacturing, regulatory hurdles with the FDA, and investor relations as the primary challenges, contrasting them with the relative ease of their design control and quality systems. Naab explains how the company leverages agile software methodologies and a culture of humor to navigate the sensitive nature of sperm testing and achieve recognition as one of the Bay Area's most innovative life sciences companies.

  • Let's Combinate · 1h 07m

    017 - "Feet First" with Ahmed Zobi

    Ahmed Zobi, Founder and CEO of Syntr Health Technologies, explains how he bootstrapped his company from a university project to FDA 510(k) clearance for the SyntrFuge System, a device that automates the microsizing of adipose tissue for body contouring and wound care. Zobi details the strategic decision to target aesthetics and orthopedics first to generate revenue while pursuing diabetic foot ulcer indications, and describes the intense personal sacrifices made during the grant submission process and the COVID-19 pandemic. He emphasizes the importance of leveraging mentors, conducting customer discovery through the NSF iCorps program, and building a robust quality management system early to navigate regulatory requirements.

  • Being an Engineer · 39m

    S4E47 Mark Byrne | Startup Engineering, Funding, & Assumptions

    Mark Byrne, founder of PriMedicus Development, discusses his experience leading early-stage life sciences and medical device companies, covering strategies for market validation, securing funding, and managing engineering teams. He emphasizes the importance of direct customer interaction over third-party research, using development contracts with early adopters to de-risk technology before seeking venture capital. Byrne also shares lessons from a failed food safety sensor project and a successful genetic testing product licensed from Mayo Clinic, highlighting the critical role of technical expertise and customer relationships in startup success.

  • The Hardware Story · 1h 22m

    Episode 1 - The Hardware Story of Inito w/ Aayush Rai | Building a B2C medical hardware company

    Aayush Rai, Co-Founder and CEO of Inito, discusses building a B2C medical hardware company from Bangalore, India, targeting the US market with a home fertility monitoring device. He details the journey from prototyping with Arduino to navigating FDA regulations, securing $15M in funding through a unique angel-first strategy, and the critical pivot to focus exclusively on the iOS ecosystem to achieve product-market fit.

  • How I Built This · 42m

    HIBT Lab! Wildtype: Aryé Elfenbein and Justin Kolbeck

    Aryé Elfenbein, a biologist and former cardiologist, and Justin Kolbeck, a former diplomat, co-founded Wildtype to cultivate real salmon from stem cells without killing fish. They discuss their pivot from an initial focus on foie gras to seafood to maximize environmental impact, detailing the technical challenges of growing cells in rented labs and the disappointment of their first tasteless prototype. The founders explain how they overcame sterility issues in custom-built bioreactors and navigated the regulatory path toward FDA approval for commercial sales.

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by The Hardware Entrepreneur. The episode itself belongs to its publisher.