Hardware Podcasts

127 - "If we do our job, no one will know" with LeRonda Perry

People of Packaging · 27 Apr 2022 · 32m

What this episode covers

LeRonda Perry, Packaging Engineering Manager at Integra Life Sciences, discusses her career path from Michigan State University’s packaging program to roles at Medtronic and DoubleCore Medical. She details the operational challenges of medical device packaging, including supply chain disruptions, the regulatory shift to EU MDR, and the difficulty of hiring qualified staff. Perry emphasizes the critical importance of usability testing in clinical settings, illustrating how effective packaging design ensures life-saving devices function without hindering surgical procedures.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Integra Life Sciences, Medtronic, DoubleCore Medical, Johnson & Johnson
Also
Michigan State University, EU MDR, UDI

Related episodes from other shows

Other shows on the same ground, closest first.

  • Being an Engineer · 20m

    S6E51 Eric Richins | What It's Like Being A Packaging Engineer

    Eric Richins, a packaging engineer at Stryker with 10 years of experience, explains the complexities of medical device packaging, distinguishing between primary, secondary, and tertiary layers and the critical role of the Tyvek sterile barrier. He details the regulatory hurdles of sterilization methods like ethylene oxide and gamma radiation, and the massive documentation required for validating automated packaging lines. Richins discusses the challenges of implementing new automation, such as a carton erector that increased throughput from 400 units in three hours to one every six seconds, while managing the gap between design intent and production reality.

    Packaging designCertification & compliance
    6 chapters

  • Manufacturing Happy Hour · 31m

    A Look Inside Medical Device Manufacturing with Philips’ Natalia Mendez

    Natalia Mendez, VP Head of Manufacturing Medical Devices at Philips, discusses the unique regulatory and operational challenges of medical device manufacturing, comparing it to aerospace and pharma. She emphasizes the critical importance of early involvement of manufacturing, quality, and sourcing experts in the product design phase to ensure supply chain resilience and meet customer needs, such as a 48-hour delivery requirement. Mendez also highlights how regional regulations, cultural preferences, and geopolitical factors influence global manufacturing footprints and product design.

    Design for manufacturing & NPIMedical & health devices
    7 chapters

  • Being an Engineer · 49m

    S5E4 Mark Ross | Medical Device Engineering Leaders 5

    Mark Ross, former Director of Manufacturing at Endologix and Manufacturing Manager at Medtronic, discusses his 20-year career in medical device operations, emphasizing the importance of taking on extra responsibilities and using structured problem-solving tools like DMAIC. He highlights current industry challenges, including supply chain capacity constraints, regulatory burdens, and the complexities of offshoring, while advising engineers to focus on strong job fits and collaborative problem-solving rather than just technical skills. Ross also shares lessons on leadership, such as balancing speed with organizational compassion and utilizing tools like StrengthsFinder to align team capabilities.

    Careers & educationManufacturing partners & offshoring
    10 chapters

  • Global Medical Device Podcast · 30m

    How to Integrate Usability into your Medical Device

    Isabella Schmitt, a regulatory affairs consultant with Proxima Clinical Research, joins host Jon Speer to discuss integrating usability into medical device development. They emphasize that usability must be integrated early with design controls and risk management to avoid costly redesigns and ensure patient safety. Key topics include identifying user groups, conducting simulated usability testing with representative users, and avoiding the trap of treating usability as a late-stage checkbox activity.

    Validation & product-market fitQuality & yield
    6 chapters

  • Being an Engineer · 44m

    S1E35 Harley-Davidson, Device Reprocessing, & Keeping a High Level Perspective | Tim Rempfer

    Tim Rempfer, a senior engineer at Medline Renewal, discusses his career path from designing custom Harley-Davidson components at Sputhe Engineering to reprocessing one-time-use medical devices. He details the technical challenges of reverse-engineering OEM devices to meet FDA equivalence standards and the complexities of designing a new manufacturing facility. Rempfer emphasizes the importance of maintaining a high-level perspective to avoid tunnel vision and shares lessons on professional distance and knowing when to ask for help in high-stakes engineering environments.

    Design for manufacturing & NPIMedical & health devices
    5 chapters

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