From Idea to FDA Clearance: What Nobody Tells Medtech Founders with Darcy Bachert

Building medical device software is hard. Building it the right way is harder. And getting it through FDA approval while managing cybersecurity requirements? That's what Darcy Bachert has been doing for 17 years.Darcy runs Prolucid Technologies, an ISO 13485-certified software development firm in Toronto. They work with medtech companies across North America, Europe, and Australia.And in that time, he's seen the same mistakes repeatedly.The biggest one? Founders build products that solve problems nobody has. Or they build something physicians won't adopt because it adds complexity instead of making their lives easier.In this conversation, Darcy talks about IEC 62304 and why it matters when choosing a software partner. The Canadian medtech ecosystem and why Toronto is a major hub. And why quality systems and cybersecurity need to be built in from day one, not added at the end.This episode is practical if you're building a medical device or working with medtech startups.Episode Breakdown:00:01 Welcome and intro00:30 Darcy's background and Prolucid Technologies overview01:15 The origin of the name Prolucid Technologies01:58 Why clarity matters more than code04:18 Common challenges beyond software development06:11 Toronto's medtech ecosystem06:57 IEC 62304 and choosing the right development partner09:17 ISO 13485 certification and investor confidence12:04 Realistic timelines for medical device software15:32 Cost expectations and budget planning18:45 Building quality systems from the start21:20 Integrating cybersecurity throughout development24:15 When and how to do penetration testing27:30 Cybersecurity mistakes startups make30:42 The MTI program and Canadian medtech resources33:18 Canadian vs US medtech markets36:22 Physician adoption challenges40:18 Trevor: Don't invent your problem41:36 Darcy: Find partners who've done it before43:05 Christian: Balance user adoption with reimbursementThe Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity experts providing essential security solutions for the medical device industry. Learn more by visiting https://bluegoatcyber.com.If you're interested in our services or partnering with us, schedule a Discovery Session: https://meetings.hubspot.com/blue-goat-cyber/discovery-sessionChristian Espinosa is the CEO and Founder of Blue Goat Cyber. Trevor Slattery is the Chief Operating Officer at Blue Goat Cyber.Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/Blue Goat Cyber on Instagram: https://www.instagram.com/bluegoatcyber/Blue Goat Cyber on Facebook: https://www.facebook.com/bluegoatcyber/Blue Goat Cyber on YouTube: https://www.youtube.com/@BlueGoatCyber/?sub_confirmation=1