S5E9 Jon Montcrief | Medical Device Engineering Leaders 8

Being an Engineer · 1 Mar 2024 · 39m · Episode 9

What this episode covers

Jon Montcrief, Director of Process Development and Sustaining Engineering at Becton Dickinson, discusses his career path from chemical engineering to medical devices and the specific challenges of leading engineering teams in a highly regulated industry. He details the impact of supply chain disruptions and regulatory hurdles, particularly regarding PFOA elimination and EU MDR compliance, which can delay material changes for years. Montcrief also explores the future of medical technology, highlighting the proliferation of surgical robots, the potential for 3D printed custom implants, and the use of AI to manage documentation and reduce repetitive engineering mistakes.

Other shows on the same ground, closest first.

  • OnTrack · 45m

    Supply Chain Challenges in Medical Device Manufacturing

    Supply chain executive Simon Hinds discusses the unique complexities of medical device and life sciences supply chains, contrasting them with automotive and consumer electronics. He explains how regulatory barriers, traceability requirements like CFR 21 Part 11, and mutual recognition agreements impact sourcing and manufacturing strategies. Hinds details the challenges of scaling from prototype to volume, managing tier 1-3 supplier risks, and navigating geopolitical tariffs through diversification and postponement strategies.

  • 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.

  • Embedded.fm · 1h 04m

    305: Humans Have a Terrible Spec Sheet (Repeat)

    Amanda Wozniak, a principal engineer at Amazon Robotics with a background at Analog Devices, the Wyss Institute at Harvard, and NxStage, discusses her career in biomedical engineering and hardware development. She explains the gap between academic theory and practical engineering, detailing how parasitics and non-ideal component behavior often cause circuit failures that textbooks ignore. Wozniak also shares insights on navigating the FDA regulatory process for medical devices, the challenges of managing complex robotics projects, and the importance of avoiding burnout by recognizing engineering as a team sport rather than a solo endeavor.

  • People of Packaging · 35m

    323 - Nerding Out on Medical Packaging & Ditching PVC with Keith Smith of Vonco

    Keith E. Smith, President of Vonco Products, explains how his company is helping medical device manufacturers transition away from PVC by using proprietary technology to weld polypropylene on existing radio frequency (RF) equipment. He details the regulatory and supply chain challenges of replacing PVC in blood and IV bags, noting that material changes affect shelf life and require extensive validation. Smith also discusses how Extended Producer Responsibility (EPR) laws and tariffs on materials like foil are driving innovation toward more sustainable, single-stream plastic solutions and refill pouches for consumer goods.

  • Global Medical Device Podcast · 1h 02m

    #339: UDI and the State of EUDAMED

    Richard Houlihan, founder of EirMed and former head of the European Commission's IT team for EUDAMED, explains the history, delays, and technical complexities of the European Database for Medical Devices. He details the shift from legacy systems to the new UDI Device Module, highlighting the massive data collation efforts required for compliance with the Medical Device Regulation (MDR). Houlihan warns that while the database is delayed until Q2 2025, companies must start preparing now to avoid legal sales bans and vigilance reporting failures.

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.