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

Being an Engineer · 19 Dec 2025 · 20m · Episode 51

What this episode covers

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.

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 37m

    Packaging Validation Best Practices

    Jeff Barrett, CEO of J-Pac Medical, explains the complexities of ISO 11607 packaging validation for sterilized medical devices, emphasizing that over a third of validations fail transit testing due to a lack of understanding regarding shipping modes. He details how companies can avoid costly 510(k) delays by conducting feasibility testing, using worst-case scenarios for sterilization, and managing labeling risks, which account for 40% of FDA recalls. Barrett highlights that sterilization validations can cost $40,000-$80,000 and take 16-20 weeks, urging engineers to integrate packaging design early in the process to prevent revalidation issues as companies scale.

  • People of Packaging · 38m

    70 - Charlie Webb from Van Der Stahl Scientific

    Charlie Webb, president of Van Der Stahl Scientific, discusses the rigorous validation and regulatory requirements of medical device packaging, explaining why the process is often more complex than the device development itself. He highlights the critical role of sterile barrier systems in preventing healthcare-associated infections, noting that over 150,000 deaths occur annually in the US due to non-sterile devices. Webb also addresses the challenge of hospitals using inadequate, unvalidated sealing equipment due to budget constraints, advocating for the adoption of microprocessor-controlled systems that ensure reproducibility and reliability.

  • People of Packaging · 32m

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

    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.

  • People of Packaging · 39m

    97 - Medical device packaging and the IoPP with Jennifer Benolken from Dupont

    Jennifer Benolken, a MDM and regulatory specialist for packaging engineering at DuPont and a board member of the Institute of Packaging Professionals (IoPP), discusses her 30-year career in medical device packaging. She explains how her co-op experience at a cardiac pacemaker manufacturer sparked her passion for the field and highlights the importance of being a generalist in a specialized industry. Benolken also details her work with Kilmer Innovations in Packaging (KIP) to solve 'wicked problems' and encourages students to enter the packaging industry.

  • Global Medical Device Podcast · 37m

    Essentials of Sterilization for Med Device Professionals

    Laura Maher, a Medical Device Guru at Greenlight Guru, explains the technical differences between sterilization modalities like gamma radiation and ethylene oxide (EO), including material compatibility issues with silicone and batteries. She details the validation processes, such as bio-burden testing and dose audits, and highlights emerging FDA-recognized modalities like chlorine dioxide that offer safer in-house options. Maher also discusses critical sterility pitfalls, including packaging failures, water system biofilm management, and the risks of bacterial endotoxins from high initial bioburden.

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