#369: Advice to Medical Device Inventors

Global Medical Device Podcast · 23 May 2024 · 43m · Episode 369

What this episode covers

Ron Richard, author of 'Someday is Today' and a medical device expert with 35 years of experience, advises inventors on navigating the path from concept to commercialization. He emphasizes the critical importance of a concise 30-second elevator pitch to secure initial funding from family and friends, validating ideas through stakeholder focus groups, and choosing evolutionary 510(k) pathways over risky revolutionary PMA submissions. Richard also details the financial realities of medical device development, warning that projects often require twice the expected money and four times the time, urging founders to maintain strict burn rates and clear cap tables to survive the 'chasm' to market.

Other shows on the same ground, closest first.

  • 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.

  • Product Startup · 37m

    116: How to Turn an Invention into a Product Business

    Tom Gray, founder of Make48 and former Handy Camel executive, explains how inventors can transition from hobbyist to business owner by choosing between licensing or building a startup. He outlines four critical assets for success: a refined prototype, a concise sales video, a one-page sales sheet, and proper IP protection. Gray advocates for a 'stepping stone' manufacturing strategy, using short runs and aluminum tooling to validate the product with real users before committing to expensive steel tooling. He emphasizes that this iterative approach reduces risk and increases the likelihood of securing licensing deals or investment.

  • Being an Engineer · 50m

    S2E37 Defied the odds: A Physical Product Development Firm That Focuses on Startups & Small Businesses, Mako Design + Invent –Kevin Mako

    Kevin Mako, Founder of Mako Design + Invent, explains how his firm supports hardware startups and small manufacturers by guiding products from initial concept to first production run. He details the financial journey for inventors, emphasizing the use of crowdfunding platforms like Kickstarter and Indiegogo to bridge the gap between prototyping and manufacturing, while advising on the importance of a 'Smart Minimum Viable Product' (SMVP) to manage complexity and cost. Mako also discusses his company's strict ethical policy of never taking equity in client products to avoid conflicts of interest, and highlights the role of his podcast, The Product Startup, in educating the hardware community.

  • 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.

  • Let's Combinate · 59m

    027 - "Become a Historian of the Problem" with Duane Mancini

    Duane Mancini, CEO and Managing Partner of Project Medtech, discusses his transition from medicinal chemistry to medical device regulatory strategy at NAMSA and LabCorp. He explains the critical importance of integrating reimbursement strategy early in the development of combination products to avoid commercialization failures, noting that regulatory choices like 510(k) can negatively impact reimbursement pathways. Mancini details how Project Medtech supports startups through its podcasts, Startup Symposiums, and consulting services, focusing on capital raising, milestone mapping, and navigating the complexities of drug-device combinations like insulin patches.

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