144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo

Let's Combinate · 10 Jul 2024 · 35m

What this episode covers

David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery, details his career trajectory from BD to SHL, Emergent BioSolutions, and finally Kindeva. He distinguishes between pen injectors, auto-injectors, and wearable devices, emphasizing that while connectivity is inevitable, it often adds unnecessary complexity and use errors if not carefully managed. DeSalvo discusses the challenges of transitioning between sponsor and CDMO perspectives, noting that successful partnerships require transparency rather than assuming the other side has the better view. He highlights the importance of balancing innovation with commercial viability, citing early experiences at BD where advanced technologies failed to reach the market due to cost and lack of payer demand.

Other shows on the same ground, closest first.

  • The Builder Circle · 1h 05m

    S1 E6: Pivots, Trials, Errors, and Validation in Product Development with Madhavi Gavini

    Madhavi Gavini, CEO of Droplet, discusses the company's journey from a medical device concept to a consumer skincare platform, detailing three major pivots: shifting from rare skin diseases to daily skincare, moving from a B2B dermatologist channel to direct-to-consumer sales during the pandemic, and scrapping an over-engineered chip-reader system to reduce costs. She explains how Droplet manages insourcing core engineering and capsule automation while outsourcing precision manufacturing to partners like East West, and emphasizes the importance of rigorous lifecycle testing to prevent firmware failures. Gavini highlights the sunk cost fallacy, noting how scrapping half a million pre-ordered chips allowed the company to pivot the app’s functionality from simple tracking to multi-mode treatment, ultimately creating a more valuable product for users.

  • Global Medical Device Podcast · 47m

    #461: Why Manufacturing is Part of Product Development with Mike Dolphin

    Mike Dolphin, CEO of GuideStar Medical Devices, explains why manufacturing process development must be integrated into product design rather than treated as a post-development step. He details the engineering of a closed-loop epidural safety device, emphasizing early decisions on injection molding and radiation sterilization to ensure scalability. Dolphin highlights the financial and timeline risks of using contract manufacturers for iterative development, advocating for in-house manufacturing to reduce costs and accelerate FDA 510(k) clearance.

  • Global Medical Device Podcast · 21m

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

    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.

  • IoT For All Podcast · 41m

    Bringing IoT Products to Market | Soracom's Ryan Carlson & Kenta Yasukawa | Internet of Things Podcast

    Ryan Carlson and Kenta Yasukawa of Soracom discuss the hidden challenges of bringing IoT products to market, breaking down the process into exploration, validation, acceleration, and commercialization. They highlight specific pitfalls such as 'shiny syndrome,' environmental interference in RF testing, and the high cost of overnight shipping for devices lacking remote management capabilities. The conversation emphasizes the necessity of early legal and security involvement, stakeholder alignment through visual business cases, and the role of AI in accelerating prototyping.

  • The Hardware Entrepreneur · 39m

    #028 - Meet the creators of FitBit for medication, with Peter Havas of PillDrill, USA

    Peter Havas, co-founder and CEO of PillDrill, discusses his journey from a successful food-tech startup to creating a medication management system inspired by the Fitbit. He explains how PillDrill’s design principles of simplicity, flexibility, and dignity address the psychological stigma of medication, while leveraging a direct-to-consumer strategy to gather critical user feedback. Havas also details his reliance on the Brinc accelerator for manufacturing connections in Shenzhen and his philosophy on managing startup risks and investor relationships.

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