Article
Building Interoperability in SaMD: Tools and Best Practices
The energy was palpable at the 2024 MedTech Conference in Toronto. In a convention center full of MedTech innovators, you could see how everything, from groundbreaking AI advancements to the consumerization of medical devices, this industry is helping shape the future of healthcare (and human health!). At the conference last October, we had the opportunity to dive deep into conversations with 18 leaders and pioneers from various companies. We are pleased to report that the insights were eye-opening and inspiring.
Below are all of the interviews we conducted. You can view each one on our YouTube channel.
Across the 18 interviews, these were some of the key themes that came up repeatedly:
AI has matured in MedTech to be far more than just a buzzword; it’s a driving force behind a growing portion of the value created by medical devices. Across the board, industry leaders discussed how they already see clinical and business value from AI and emphasized its great potential to transform diagnostics, monitoring, and therapeutics. As one expert put it:
“AI is transforming diagnostics, but regulatory challenges remain.”
While it was not a huge shock to hear that AI adoption is not all smooth sailing, a standard set of challenges kept arising, including provider adoption barriers, safety and effectiveness concerns, and the need to build up stepwise our collective trust in how to use this technology appropriately, the message was clear: AI holds immense promise. But first, companies must address these hurdles head-on. The good news is that those companies are actively working to clear those hurdles.
Let’s face it: if you work with Software as a Medical Device (SaMD), connected device systems, or digital therapeutics (DTx), you’re familiar with the regulatory maze but likely still get lost. Whether it’s FDA approvals or globally navigating laws and standards, the road to market can sometimes feel like a riddle wrapped in an enigma surrounded by mystery. One industry veteran noted:
“Navigating global regulations is still the biggest barrier to MedTech innovation.”
One key takeaway is the importance of early engagement with regulatory bodies like the FDA. Collaboration, not confrontation or avoidance, can lead to more predictable and faster device approvals and subsequent device enhancements.
From virtual consultations to remote patient monitoring, digital health solutions are changing how we interact with healthcare systems. One leader highlighted:
“Telemedicine is becoming mainstream, but integrating it with existing systems is the real challenge.”
In other words, we need to stop thinking about how to deliver remote care to patients as a means to itself. Instead, we must consider integrating in-person and virtual care as part of a larger, more effective omnichannel healthcare and wellness system.
As we are all painfully aware, reimbursement frameworks need to evolve and align with their potential for these technologies to expand. The conversations made it clear: digital health is here to stay, but scalability and seamless integration remain top priorities.
If there’s one area where advances in software truly shine with adoption, it’s surgical robotics. These machines aren’t just tools. Their (many) manufacturers aim to redefine what precision medicine means in a surgical context. One executive opined:
“Surgical robotics are no longer just an experiment—they are becoming a core part of modern healthcare.”
The future is about making surgeries more accurate and accessible. A key component of this is a more sophisticated use of AI. Others see remote robotic procedures on the horizon, with the most significant potential impact being bridging gaps for patients in underserved areas.
We no longer have to imagine a world where your wearable device tracks your steps, but it also monitors your heart, predicts health issues, and provides actionable insights. This is no longer science fiction or something you only hear about at the EPCOT Center. It’s today’s reality. Leaders at the conference emphasized the growing role of wearables in early diagnosis and patient monitoring:
“Wearable devices are bridging the gap between home care and clinical settings.”
These innovations aren’t just convenient; they’re life-changing, especially for patients managing chronic conditions. Along with digital health and telemedicine, they are a key building block for omnichannel healthcare.
It’s no secret that MedTech startups need funding to thrive. But securing that funding? That has been and remains a whole different ballgame. One expert pointed out:
“Investment is available for MedTech if you have a clear path to reimbursement.”
The consensus? Investors seek scalable, high-impact solutions, but startups must demonstrate a clear return on investment in patient outcomes and profitability. For now, the valley in between persists for too many MedTech startups.
We coined a new acronym for our interviews at this conference: MTTAIC – Mean Time to AI Conversation.
AI, and especially Generative AI, was the buzzword de jure. Beyond its use in diagnostics, this technology has the potential to revolutionize areas like medical research and patient engagement. However, challenges like trust, patient safety, data privacy, and cybersecurity remain front and center. As one leader summed up:
“AI will be a game-changer, but (first) cybersecurity and data privacy concerns need urgent attention.”
2025 is going to be an exciting and productive year for MedTech. We look forward to bringing you updates from our interviews on October 25th in San Diego at The MedTech Conference 2025.
Related Posts
Article
Building Interoperability in SaMD: Tools and Best Practices
Article
Leveraging AI/ML in SaMD Development: Benefits and Challenges
Article
ISO 13485 Compliance Checklist for SaMD Development
Article
How to Conduct Post-Market Surveillance for SaMD