Early-stage startups often wonder when the right time is to consider a quality management system (QMS)? Is it ever too soon to start a QMS? Today’s guest is Devon Campbell, founder of Prodct LLC, which helps establish and implement holistic, efficient, and practical product development and manufacturing strategies. Devon and Jon Speer discuss the importance of timing when starting a QMS for medical device companies to ensure future product success.. Some of the highlights of the show include: ● Emerging Trend: Almost all of Devon’s clients have no QMS, or have what they consider a QMS, but isn’t in reality. ● Mentor for MassChallenge: The global, zero-equity startup accelerator has helped more than 1,900 startups and raise more than $4.3 billion in funding. ● Hungry for Knowledge: What’s your core technology? Commercialization strategy? Development strategy? What do you need to do to take it to market? ● Lack of Appreciation: Startups should think through QMS and design control opportunities, strategies, and implementation sooner than later. ● Start Early with End in Mind: Make it easy to pivot later. If you don’t go through the effort that it takes, it’s difficult to backtrack. ● Best Practices: Look far forward and obtain external help and guidance from quality experts. ● Bigger Picture: Work with everyone involved to better understand challenges and changes with a company’s QMS, as it evolves and matures in real time. ● Patients who depend on your medical technology will appreciate your focus on true quality.