Entrepreneurs looking for a promising sector in which to launch projects have a number of reasons to look at med tech. A report on the med tech industry issued in late 2025 reveals steady industry growth, funding momentum, and a shift toward bigger M&A deals.
But taking a medtech device from concept to market launch requires overcoming some significant hurdles. Hannah Herbst, founder of Golden Hour Medical, encountered some of those hurdles as she was developing a medical emergency response innovation.
“Medical devices are notoriously difficult to commercialize because they sit at the intersection of deep technical complexity, strict regulation (for very good reason), and long development timelines,” Herbst shares. “That combination can be intimidating — especially for first-time founders.”
Herbst is one of the inventors behind AutoTQ, the first and only automatic smart tourniquet that comes with Wi-Fi monitoring, USB-C charging, a two-year battery life, and includes user training. Designed by a multidisciplinary team and heavily informed by Herbst’s passion for practical, accessible solutions, AutoTQ empowers anyone with the tools and training needed to stop life-threatening extremity bleeding.
Artificial Intelligence Brings New Capabilities to Medical Device Design
To push past the intimidation Herbst mentions, med tech developers should consider tapping into the capabilities artificial intelligence can provide. AI tools can be leveraged in the development process in a variety of ways — analyzing data, testing assumptions, and providing insights, to name a few — to achieve faster and better results.
“AI has been promising in helping lower the barriers med tech developers face,” Herbst says. “ChatGPT came out about a year into building my company, and it was a real game-changer for my team and me. Being able to use generative AI to ask questions, get high-level explanations of regulations, and sanity-check concepts quickly has made the learning curve far less steep.”
Data analytics, which is one of the key strengths of AI models, is one area where AI can revolutionize med tech design. From R&D to UX optimization to identifying market gaps, AI can help developers engage with more data, find more insights, and streamline decision-making.
“In my experience, AI has been very helpful in the area of data analytics,” Herbst says. “Having AI assist in organizing, summarizing, and exploring datasets saves an enormous amount of time. That said, I recommend you always double-check results, as AI accelerates analysis, but can make mistakes and doesn’t replace critical thinking.”
AI applications can also play a role in testing and quality assurance, organizing documentation, accelerating paperwork, and pressure-testing plans or validation approaches. But in some of the development steps common to medical device design, AI should be relegated to a supplementary tool.
Accountability Should Be Paramount When Using AI in Medical Device Development
As in any industry, medtech developers using AI-powered tools should commit to testing AI-driven outputs to ensure they are accurate and reliable. AI can streamline workflows, but it can also hallucinate. Knowing where AI thrives and where it struggles is key to optimizing its effectiveness.
“AI doesn’t replace years of hands-on experience or expert judgment, but it does help founders become more effective generalists,” Herbst explains. “It gives CEOs faster access to knowledge, making it more feasible for people to take the risk of building in med tech while being less overwhelmed.”
Medical experts have highlighted accountability as a core issue for AI integration in the healthcare space. Medtech developers should be ready to show that their processes involve human oversight and verification that the AI’s outputs are explainable, safe, and reliable.
AI Practices in the Medical Device Industry Must Meet FDA Expectations
Medtech companies leveraging the power of AI in device development must pay careful attention to the guidance and regulations emerging from the US Food and Drug Administration. The FDA, which oversees the development and safe application of medical devices in the US, took a number of important steps in 2025 to address the development of AI-enabled medical devices that provide insights on expectation even when AI only plays a role in the development phase. Staying up to date on FDA expectations and the boundaries they place on development is critical for medical device manufacturers.
“AI can’t replace experienced quality engineers or regulatory professionals who understand how to work with the FDA and design a robust quality system,” Herbst says. “Medical device regulations are nuanced, and while AI can be a great starting point, it can get things wrong. Ultimately, accountability doesn’t sit with the AI algorithm, but with the manufacturer.”
AI brings advanced capabilities to medtech development that the industry can’t ignore. At the same time, it also introduces risks that must be carefully considered and addressed. Understanding the pros and cons is critical to leveraging AI in a way that gains the trust of both patients and practitioners and leads to better healthcare delivery and patient outcomes.
