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 systems
• Use of AGILE methodology in a regulated environment
• Applicable standards including 21 CFR 820, ISO 13485, ISO 14971
• How quality can remain central at each development phase

And 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 lifecycle
• What the device industry can learn from pharma's data practices
• How EU MDR is changing the data landscape
• When 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 years
• Investor perspectives on medtech vs. digital health
• How to build value to make your startup attractive
• Tips 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 years
• Investor perspectives on medtech vs. digital health
• How to build value to make your startup attractive
• Tips 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 was
• Is 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 innovation
• How pediatric specialists operate without pediatric devices
• Risk/Benefit rationale for small patient populations
• Current 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 pathways
• How FDA is changing in recent years
• Trends in regulation--are medical devices under-regulated by FDA?
• Formal vs. informal pre-submission meetings with FDA
• How 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 not
• How company identity and go-to-market strategy are reflected in a brand
• When is the right time to worry about branding?
•  Developing market and buyer insights
• Naming your product and company

On this episode, we sit down with Stephen and Anna John, a brother-sister team of medical device developers, working to bring life-saving respiratory therapy to the developing world. Their device, NeoVent, is a low-cost, mechanical solution to deliver two levels of air pressure to infants in respiratory distress without the need for continuous electric power.

Stephen and Anna grew up in rural Nepal, where their family worked to meet the medical needs of an undeserved population. Their father, Sunil, is a pediatric cardiologist and continues to split his time between practicing in Kalamazoo, Michigan and Nepal. Sunil is serving as a clinical advisor in the development of NeoVent. 

They're working to bring NeoVent to market through their company, AIM Tech. You can contact them through their website or by sending an email to [email protected].

"Every year, over one million infants die of severe respiratory illnesses, making it one of the leading causes of under five mortality in the world. 99% of those are in low to middle income countries, which shows you that there are good treatments for these conditions, but they're not reaching most of the world." -Stephen John, CEO, AIM Tech

In this episode, Joe Popowicz, founder of Emergent Clinical Consulting, sits down with Smithwise President Eric Sugalski to talk about clinical evidence strategies surrounding new medtech.

They cover pre/postmarket data needs, regulatory pathways, Value Analysis Committees, Significant Risk vs. Nonsignificant Risk, Institutional Review Boards, and more.

See more and find contact info for Joe on the Smithwise.com blog. 

We're joined this episode by Wamis Singhatat, VP of Product Development and CTO of Active Protective, a medtech company working to bring a really cool new piece of technology to market. Their product is a smart belt that can detect a fall in progress and deploy airbags to cushion the hips of the wearer. You can see a video of the deployment in action on the Smithwise blog. 

Wamis sat down with Smithwise President Eric Sugalski to discuss their strategies for bringing this product to market.