Maintaining Agility & Quality in Device Software Development with Rightley McConnell

The past few years have been tough for early-stage MedTech ventures seeking funding, but Vessl Prosthetics—a woman-led startup from London, Ontario—managed to beat the odds. In this LinkedIn episode, Eric Sugalski interviews Sydney Robinson, Founding CEO of Vessl Prosthetics. Sydney shares how her team successfully oversubscribed their Pre-Seed Funding round and provides practical tips for other early-stage founders to succeed in fundraising.

This interview with Mark Copeland (aka The Value Analysis Whisperer) cracked open the black box of Value Analysis Committees (VACs) and shared the secrets that MedTech companies need to know. Cope discussed the complexities of this process and delivered powerful insights on how MedTech companies can prepare to clear this significant hurdle when developing and commercializing medical devices for healthcare. 

In this episode, Rightley McConnell, VP of Operations at Precision Systems, Inc., covers how to maintain quality and speed when developing medical device software. Rightley and Dan discuss:Challenges to device software development for complex systemsUse of AGILE methodology in a regulated environmentApplicable standards including 21 CFR 820, ISO 13485, ISO 14971How quality can remain central at each development phaseAnd more. Rightley can be reached at [email protected].

In this episode, Seth Goldenberg, VP of Vault Medical Device & Diagnostics at Veeva Systems, cover data flow throughout the product lifecyle and how advanced data management can speed devices along the path to market. Seth and Dan discuss:How data management and access impact the product lifecycleWhat the device industry can learn from pharma's data practicesHow EU MDR is changing the data landscapeWhen in a device company's growth does a cloud system start to make sense?

In Part II of this two-part episode, Adam Dakin, Managing Director of Dreamit Health, covers funding trends in medtech and how to pitch to institutional investors. Adam and Dan discuss:Medtech funding trends and how they've changed in recent yearsInvestor perspectives on medtech vs. digital healthHow to build value to make your startup attractiveTips for success at the pitch table

In this episode, Adam Dakin, Managing Director of Dreamit Health, covers funding trends in medtech and how to pitch to institutional investors. (Part I of II)Adam and Dan discuss:Medtech funding trends and how they've changed in recent yearsInvestor perspectives on medtech vs. digital healthHow to build value to make your startup attractiveTips for success at the pitch table

In this episode, Gregory Bernabeo, Patent Attorney and Partner at FisherBroyles, covers intellectual property ground rules and special topics in the medtech space. Greg and Dan discuss:Why a patent isn't what (exactly) what you thought it wasIs my medtech innovation patentable?Are patents valuable if I can't afford to litigate?Can medtech innovators protect their IP rights and publish their research?What's important when selecting a patent attorney for my medtech project?

In this episode, Matt Maltese, Executive Director of the PA Pediatric Medical Device Consortium and Dan Henrich discuss:Current barrier to pediatric device innovationHow pediatric specialists operate without pediatric devicesRisk/Benefit rationale for small patient populationsCurrent industry and FDA initiatives to bring more devices to market for kids

In this episode, regulatory expert Monica Ferrante, VP of Regulatory and Quality at Aspire Bariatrics, talks regulatory strategy and approvals for new medical devices coming to market.Monica and Dan discuss:FDA risk classifications and how to steer down various regulatory pathwaysHow FDA is changing in recent yearsTrends in regulation--are medical devices under-regulated by FDA?Formal vs. informal pre-submission meetings with FDAHow to go about finding trustworthy regulatory support

In this episode, branding expert Bill Gullan, President of Finch Brands, speaks with Smithwise Marketing Director Daniel Henrich about what branding is and why's it's critical in the world of medtech ventures. Bill and Dan discuss:What branding is, and what it's notHow company identity and go-to-market strategy are reflected in a brandWhen is the right time to worry about branding? Developing market and buyer insightsNaming your product and company