Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's

Global Medical Device Podcast · 7 Nov 2019 · 21m · Episode 5

What this episode covers

Sara Naab, co-founder and director of quality and marketing at Sandstone Diagnostics, discusses the journey of building Trak, an over-the-counter male fertility monitoring system comprising a mini centrifuge and companion app. She highlights manufacturing, regulatory hurdles with the FDA, and investor relations as the primary challenges, contrasting them with the relative ease of their design control and quality systems. Naab explains how the company leverages agile software methodologies and a culture of humor to navigate the sensitive nature of sperm testing and achieve recognition as one of the Bay Area's most innovative life sciences companies.

Other shows on the same ground, closest first.

  • 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.

  • 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.

  • 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.

  • Being an Engineer · 46m

    S1E23 A-Team Engineering, From Ireland to the United States | Ronan Jenkinson

    Ronan Jenkinson, a Senior Verification Engineer at West Pharmaceutical, discusses his journey from a small fishing village in Ireland to Silicon Valley, detailing his early career at Phoenix DeVentures where he designed medical devices like catheters and balloon angioplasty systems. He explains the challenges of translating physician ideas into viable products, the critical importance of FDA design controls and verification testing for patient safety, and his pivot into business development to survive a startup's financial struggles. Jenkinson also shares insights on sourcing quick-turn manufacturing partners like Aduro Laser and the mental resilience required in both engineering and extreme sports.

  • Being an Engineer · 37m

    S1E12 Simplifying Quality Management | Jon Speer

    Jon Speer, founder of Greenlight Guru, explains how his frustration with managing medical device quality via Excel spreadsheets led to the creation of a dedicated QMS software platform. He details the transition from chemical engineering to medical device systems, highlighting the specific pain points of manual data merging and the high validation burden for electronic records. The episode covers Greenlight Guru’s development, its focus on design controls and traceability matrices, and the regulatory challenges of FDA submissions and ISO 13485 certification for startups.

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.