Shows
Let's Combinate - Drugs + Devices181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?Discover how ampoule(ampule) drug delivery systems could revolutionize the pharmaceutical industry in this eye-opening video. Learn about the potential impact of this innovative technology on drug administration and patient care.In this episode of 'Let's Combinate Drugs and Devices,' host Subhi Saadeh is joined by Eric Suglalski, Founder and CTO of Archimedic, to discuss the often-overlooked role of ampules in drug delivery. Eric highlights the stability and contamination resistance benefits of ampules, despite the industry's shift towards vials and pre-filled syringes. He elaborates on the time and cost factors that make transitioning to pre-filled syringes challenging for...
2025-03-2620 minLet's Combinate - Drugs + Devices176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric SugalskiIn this episode of Let's Combinate Drugs and Devices, host Subhi Siddhey welcomes Eric Sugalski, founder and CTO of Archimedic. Eric shares insights into the complexities of working as a CDMO, emphasizing the importance of recognizing whether a sponsor company needs overflow capacity or specialized expertise. They discuss common pitfalls, such as companies getting in their own way by misaligning their needs with their outsourcing strategy and the detrimental effects of premature concept lock. Eric highlights the value of giving design firms creative space, the importance of early user research, and the impact of timing and market readiness on...
2025-02-1926 min
The Champions of Purposeful Change PodcastBuilding Tomorrow’s Medical Technology – Eric Sugalski, President & CEO – Archimedic
Tune into Real-World Branding this week to hear from Eric Sugalski, President & CEO of Archimedic. We discuss Eric’s career path, the merger and transition from Smithwise to Archimedic, the current state of business, and how small service businesses are managing COVID-19 (and what they are doing with masks!). Archimedic helps innovators struggling with technical, regulatory, and manufacturing challenges accelerate their next new products along the path to market.
http://blog.finchbrands.com/archimedic-podcast
The post Building Tomorrow’s Medical Technology – Eric Sugalski, President & CEO – Archimedic appeared first on Finch Brands.
2020-04-2723 min
Real-World BrandingBuilding Tomorrow's Medical Technology – Eric Sugalski, President & CEO – ArchimedicTune into Real-World Branding this week to hear from Eric Sugalski, President & CEO of Archimedic. We discuss Eric's career path, the merger and transition from Smithwise to Archimedic, the current state of business, and how small service businesses are managing COVID-19 (and what they are doing with masks!). Archimedic helps innovators struggling with technical, regulatory, and manufacturing challenges accelerate their next new products along the path to market.
2020-04-2623 min
MedTech MindsetMaintaining Agility & Quality in Device Software Development with Rightley McConnellIn 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 rmcconnell@psi-software.com.
2019-08-2941 minMedTech MindsetData Flow Medtech Innovation with Seth GoldenbergIn 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?
2019-07-3135 minMedTech MindsetSecuring Funding with Adam Dakin, Part IIIn 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
2019-06-1327 minMedTech MindsetSecuring Funding with Adam Dakin, Part IIn 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
2019-06-0628 minMedTech MindsetStaking Your IP Claim with Gregory BernabeoIn 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?
2019-05-0740 minMedTech MindsetOvercoming Pediatric Device Innovation Challenges with Matthew MalteseIn 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
2019-03-2548 minMedTech MindsetNavigating Regulatory with Monica FerranteIn 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
2019-02-1847 minMedTech MindsetBranding in MedTech with Bill GullanIn 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
2019-01-1543 minMedTech MindsetSaving Infants in Respiratory Distress with Stephen, Anna, & Sunil JohnOn 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...
2018-12-0431 minMedTech MindsetClinical Evidence Insights with Joe PopowiczIn 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.
2018-11-0144 minMedTech MindsetActively Protecting Seniors with Wamis SinghatatWe'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.
2018-10-3131 minMedTech MindsetA MedTech Mindset with Eric SugalskiWelcome to Medtech Mindset, a production of Smithwise. This episode is a great way to tell if this podcast is for you.Eric Sugalski and Dan Henrich sit down to discuss the big picture of bringing a new piece of medical technology to market. We touch on product development and designregulatory pathwaysclinical evidencego-to-market strategyintellectual propertyother themes. In coming episodes, we'll explore these topics in more detail with guests who are experts in these areas and guests who have recently been through the process.
2018-10-2938 min