Hardware Podcasts

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

Global Medical Device Podcast · 4 May 2022 · 45m · Episode 258

What this episode covers

Shawn Regan, CEO and Co-founder of Rhythmlink International, discusses the company's 20-year journey from a bootstrapped garage startup to an industry leader in neurophysiologic monitoring devices. He details the strategic decision to pivot from reusable to disposable electrodes, the critical collaboration with the FDA to achieve the first MRI-cleared products, and the operational challenges of manufacturing in China. Regan also explains the recent decision to maintain MDD certification in the EU rather than transitioning to the more burdensome MDR, and how the company leverages its in-house capabilities for OEM partnerships with firms like Johnson & Johnson and Stryker.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Rhythmlink International, Green Light Guru, Johnson & Johnson, Stryker, Synthes, SI Bone, Newvasive
Also
SCBIO, FDA, SE Launch

Related episodes from other shows

Other shows on the same ground, closest first.

  • Let's Combinate · 1h 07m

    017 - "Feet First" with Ahmed Zobi

    Ahmed Zobi, Founder and CEO of Syntr Health Technologies, explains how he bootstrapped his company from a university project to FDA 510(k) clearance for the SyntrFuge System, a device that automates the microsizing of adipose tissue for body contouring and wound care. Zobi details the strategic decision to target aesthetics and orthopedics first to generate revenue while pursuing diabetic foot ulcer indications, and describes the intense personal sacrifices made during the grant submission process and the COVID-19 pandemic. He emphasizes the importance of leveraging mentors, conducting customer discovery through the NSF iCorps program, and building a robust quality management system early to navigate regulatory requirements.

    Starting a product companyValidation & product-market fit
    9 chapters

  • Being an Engineer · 42m

    S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA

    Bob Hankins, Director of Engineered Component Development at TE Connectivity, discusses leading global engineering teams in the regulated medical device space, focusing on complex components like catheters and structural heart devices. He shares lessons from his early career at a startup ventilator company, where recalls and FDA interactions taught him the critical value of PFMEA, DFMEA, and rigorous risk-based design processes. Hankins emphasizes the importance of balancing innovation with manufacturing rigor, advocating for a leadership style that empowers engineers through clear guardrails while maintaining strict compliance with ISO 13485 and FDA requirements.

    Medical & health devicesLeadership, teams & culture
    12 chapters

  • Being an Engineer · 51m

    S1E13 A Holistic View on Product Development | Devon Campbell

    Devon Campbell, founder of Prodct LLC, discusses his advisory practice for early-stage biotech and medical device companies, drawing on his experience at Ventana Medical Systems, Quanterix, and Novartis. He explains how his background in machine shop operations and holistic product development—from design to field service—enabled his rapid rise to senior leadership roles. Campbell advocates for dual-career tracks in engineering, allowing brilliant technical contributors to become 'fellows' without becoming managers, and emphasizes the importance of integrating regulatory strategy (FDA, ISO 13485) from the earliest stages of product development to avoid costly rework.

    Starting a product companyCareers & education
    7 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 Hardware Story · 1h 22m

    Episode 1 - The Hardware Story of Inito w/ Aayush Rai | Building a B2C medical hardware company

    Aayush Rai, Co-Founder and CEO of Inito, discusses building a B2C medical hardware company from Bangalore, India, targeting the US market with a home fertility monitoring device. He details the journey from prototyping with Arduino to navigating FDA regulations, securing $15M in funding through a unique angel-first strategy, and the critical pivot to focus exclusively on the iOS ecosystem to achieve product-market fit.

    Fundraising & investorsCertification & compliance
    6 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.