S5E7 Matt Zachek | Medical Device Engineering Leaders 7

Being an Engineer · 16 Feb 2024 · 45m · Episode 7

What this episode covers

Matt Zachek, Senior Director of R&D at Werfen, discusses his career path in medical device engineering, emphasizing the importance of technical foundations, grit, and managing ambiguity. He explains how balancing sustaining products with new R&D efforts requires a strategic portfolio approach, often following a 70-10-10-10 rule. Zachek highlights key industry trends, including the integration of AI tools like Google Gemini for research acceleration and the convergence of consumer electronics with regulated medical devices. He also stresses the value of early manufacturing involvement and in-situ empathy to navigate the complex regulatory landscape of hemostasis and acute care diagnostics.

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 34m

    Shaking Things Up: What's Next for the Global Medical Device Podcast

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  • Global Medical Device Podcast · 27m

    Meet a Guru: Ryan Behringer

    Ryan Behringer, a Training and Onboarding Medical Device Guru at Greenlight Guru, discusses his journey from a biomedical engineering student at the University of Cincinnati to a product development engineer at an Omaha startup. He explains how he used the Greenlight Guru platform to manage design controls and risk management, successfully achieving 510(k) clearance for his device. Behringer emphasizes the importance of integrating quality and regulatory knowledge early in the engineering process to avoid checkbox compliance and ensure true product value. He now helps other companies implement these systems to streamline their path to market.

  • Global Medical Device Podcast · 32m

    Understanding the Value of a Medical Device Guru

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  • 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.

  • Global Medical Device Podcast · 26m

    Meet a Guru: Wade Schroeder

    Wade Schroeder, an electrical engineer and medical device guru at Greenlight Guru, discusses his background in IVD and product development, emphasizing the importance of early risk management and robust design inputs. He shares insights on helping startups navigate FDA design controls, citing examples of companies pivoting for the opioid crisis and COVID-19 while maintaining rigorous quality systems. Schroeder advises engineers to record and rationalize all decisions to ensure compliance and facilitate future audits or design changes. The conversation highlights Greenlight Guru's 'Guru Edge' of leveraging experienced professionals to mentor clients through complex regulatory landscapes.

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