Orthogonal

To get a software-enabled #medicaldevice to market, you need an integrated data strategy that grows with your product and meets the unique needs of stakeholders like the #FDA, insurance payors and healthcare providers. Orthogonal and MATTER Chicago's latest joint #webinar featured a panel of #MedTech experts who spoke on the challenges of meeting stakeholder requirements for connected #medicaldevices. Listen to the recording and read the key takeaway points here: https://lnkd.in/eNRh8YvH #digitalhealth Kwame Ulmer, Christian Johnson, Jennifer McCaney

The hype for #generativeAI tools like #ChatGPT is felt in nearly every industry, and #MedTech is no exception. But the discussion on the role of generative AI inside #medicaldevices has been more measured. As it stands, the technology is simply too immature and unpredictable to meet the device industry’s benchmarks for safety and effectiveness. However, like other technologies over the last 100+ years, we expect that generative AI will eventually work its way into the functioning of medical devices. What will it take for generative AI to become a tool in the toolbox of medical device manufacturers, and what does the history of MedTech teach us about how this might happen? Join Orthogonal for a #webinar on May 21st, 2024 at 11 AM CDT as we discuss possible roadmaps for including generative AI inside medical devices. We’ll take a look at how the MedTech industry has incorporated other new technologies into medical devices, as well as the specific aspects of generative AI that pose new and interesting challenges to this adoption. Register for this expert #medicaldevice webinar: https://lnkd.in/ectZ8wwC #SaMD #AI

#GenerativeAI has become a massive buzzword across every industry since the release of #ChatGPT a mere 17 months ago. In #MedTech, there’s been significant efforts to apply it to different parts of the industry. But barring specific use cases, generative AI is unlikely to be a core component of medical devices anytime soon. However, like other new technologies introduced over the last 100+ years, we expect that generative AI will eventually work its way into the functioning of medical devices. What will it take for generative AI to become a tool in the toolbox of medical device manufacturers, and what does the history of MedTech teach us about how this might happen? Join Orthogonal for a #webinar on May 21st, 2024 at 11 AM CDT as we discuss possible roadmaps for including generative AI inside medical devices. We’ll take a look at how the MedTech industry has incorporated other new technologies into medical devices, as well as the specific aspects of generative AI that pose new and interesting challenges to this adoption. Register for this expert #medicaldevice webinar: https://lnkd.in/ectZ8wwC #SaMD

Join us on Tuesday, May 21st, 2024 for a webinar on the future of Generative AI in MedTech! In MedTech, efforts to apply this cutting-edge technology have been significant. However, its integration into medical devices raises critical questions regarding safety and effectiveness under design controls. Orthogonal, along with industry experts, will explore the potential of Generative AI in medical devices. We'll delve into its challenges, regulatory implications, and opportunities, drawing insights from MedTech's history with new technologies. Don't miss out on this insightful discussion! Register now: https://lnkd.in/gbbGqJWt #GenerativeAI #MedTech #Webinar #SaMD #MedicalDevices #FDA #AI

TOMORROW! Join Orthogonal at 11 AM CDT as we delve into strategies for developing Software as a Medical Device (#SaMD) under design controls with an eye towards ongoing releases. We’ll discuss ways to take advantage of software’s ability to evolve faster than hardware that allow you to rapidly expand your SaMD’s capabilities and improve both patient outcomes and your bottom line. You’ll leave this #webinar with a high-level knowledge of best practices that can be immediately implemented into your product strategy. We look forward to seeing you there! Register: https://lnkd.in/efEeDm8B #medicaldevice #MedTech #digitalhealth

We’re happy to announce that Orthogonal’s Melissa Gill will join Bernhard Kappe and Randy Horton as a speaker at our upcoming #webinar on April 30th, 2024 at 11 AM CDT. As Senior Delivery Manager, Melissa has deep experience releasing, supporting, maintaining and updating #SaMD and connected #medicaldevice products and programs. We look forward to hearing Melissa’s perspective on best practices for developing ongoing releases of SaMD after initial deployment. Register for this expert SaMD Webinar: https://lnkd.in/efEeDm8B #MedTech #software #digitalhealth

What’s the deal with #cloudcomputing for #medicaldevices? Michelle Lott, RAC, #regulatory strategist and owner of leanRAQA invited Orthogonal’s Chief Solutions Officer and AAMI cloud computing Working Group co-chair Randy Horton as a guest on her RAQA Today #podcast. Listen to the episode: https://lnkd.in/eXTyd9Df? #cloud

When manufacturers of Software as a Medical Device (#SaMD) overlook planning for subsequent releases, they can find themselves facing significant technical, quality and regulatory debt when working on their product’s post-launch evolution. How do you take a forward-looking approach to developing SaMD that lays the groundwork for both short- and long-term success? Join Orthogonal for a webinar on April 30th, 2024 at 11 AM CDT as we review best practices for developing SaMD under design controls with an eye towards ongoing releases. We’ll be discussing ways to take advantage of software’s ability to evolve faster than hardware that allow you to rapidly expand your software’s capabilities and improve both patient outcomes and your bottom line. Register for this expert SaMD Webinar: https://lnkd.in/efEeDm8B #MedTech #medicaldevice #software #webinar #digitalhealth

Orthogonal is on a quest to catalog all FDA-cleared Software as a Medical Device (#SaMD). Since its original publication in January 2024, our Ultimate Running List has grown to 562, a 16% increase! Big thanks to everyone who has contributed. Do you know of any SaMD missing from our list? Help us out by filling out the form on our site or by emailing us at SaMD-list@orthogonal.io. With your help, we can make this list a valuable resource for the #MedTech and #digitalhealth communities. https://lnkd.in/eRyNbGGN

It takes a lot of work to prepare Software as a Medical Device (#SaMD) for an initial launch – so much work that planning for subsequent releases can go overlooked. How do you take a forward-looking approach to developing SaMD that lays the groundwork for both short- and long-term success? Join Orthogonal for a webinar on April 30th, 2024 at 11 AM CDT as we review best practices for developing SaMD under design controls with an eye towards ongoing releases. We’ll be discussing ways to take advantage of software’s ability to evolve faster than hardware that allow you to rapidly expand your software’s capabilities and improve both patient outcomes and your bottom line. Register for this expert SaMD Webinar: https://lnkd.in/ewWW3Zbb #MedTech #medicaldevice #software #webinar #digitalhealth