Mac Fortune | The Ideal Role for An Engineer That Loves Entrepreneurialism, Technology, & Business

Being an Engineer · 7 Jul 2023 · 41m · Episode 25

What this episode covers

Mac Fortune, a product manager at OrthoGrid, discusses his career path from mechanical engineering to managing medical device portfolios, emphasizing the importance of bridging R&D and sales. He details OrthoGrid's AI-powered platform for total hip replacement surgery, which uses intraoperative X-rays to improve implant accuracy and leg length alignment. Fortune also shares insights on the challenges of innovation in healthcare, regulatory hurdles, and the value of product managers understanding field realities.

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 43m

    #381: MedTech Advice from an Accidental Entrepreneur

    Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, explains how she transitioned from a biomedical engineering PhD to an accidental entrepreneur with vascular surgeon Dr. Adam Power. They developed the COBRA-OS, a bleeding control device used in trauma care, military settings, and Formula One race tracks. Parekh discusses the critical role of passion in overcoming challenges, the art of pitching to secure millions in funding, and the importance of founders remaining the ultimate experts on their device's regulatory pathway rather than relying blindly on consultants.

  • Global Medical Device Podcast · 30m

    Meet a Guru: Etienne Nichols

    Etienne Nichols, a Medical Device Guru at Greenlight Guru, discusses his transition from mechanical engineering in aerospace and steel to medical device project management, highlighting how a personal injury sparked his interest in biomedical design. He explains that Greenlight Guru was founded to solve the inefficiency of managing dynamic design controls in static Excel spreadsheets, aiming to keep traceability matrices updated in real-time. Nichols emphasizes the value of the 'Guru Edge,' where a team of experienced engineers helps customers navigate complex regulatory workflows, such as UDI implementation and software as a medical device (SaMD), to bring safe products to market faster.

  • Let's Combinate · 1h 06m

    023 - "The Best is Yet to Come" with David Albert

    Dr. David Albert, founder of AliveCor, Lifetone Technologies, and InnovAlaram, recounts his journey from an accidental cardiologist to a serial MedTech entrepreneur. He details the creation of the KardiaMobile personal ECG device, which went viral via a YouTube video, and his earlier work on fire alarm systems for the hearing impaired under Lifetone. Albert emphasizes the importance of balancing scientific innovation with commercial viability, leveraging AI for remote patient monitoring, and navigating FDA regulations to make healthcare more accessible.

  • Global Medical Device Podcast · 39m

    #363: Bringing a Self-Funded Medical Device to Market

    Dr. Lee Hunter, an orthopedic surgeon and founder of Hunter Medical Devices, details his journey of self-funding a stainless steel arm positioner for elbow and wrist arthroscopy. He explains how an initial licensing failure taught him critical design lessons, leading to a simple, effective device that he brought to market without venture capital. Hunter discusses the importance of utility patents, maintaining a lean quality system, and the strategic decision to eventually sell the IP while retaining the company.

  • Let's Combinate · 1h 30m

    009 - “Cutting Through the Noise” with Charles Ventura

    Charles Ventura, CEO of Hemotek Medical and President of Ventura Solutions, discusses his career transition from biomedical engineering at Baxter Healthcare to founding his own companies. He details the development of the V Needle, a safety device for dialysis to prevent venous needle dislodgement, emphasizing the importance of systems engineering, risk management (ISO 14971), and user-centric design. Ventura also provides strategic advice for early-career engineers, highlighting the necessity of mastering regulatory frameworks like FDA 21 CFR Part 820 and ISO 13485, as well as practical skills in statistics and project management to secure their first roles.

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