In healthcare, we track everything—blood pressure, glucose levels, cholesterol—but what about mental health and quality of life? For years, medical technology has been designed, approved, and adopted based on clinical biomarkers alone. Yet, anyone living with a chronic condition knows that well-being is more than lab results.
We are missing the whole-person picture.
I recently sat down with Dr. Katharine Barnard-Kelly, a Chartered Health Psychologist and leading voice in patient-reported outcomes (PROs), on Inside MedTech Innovation to explore why mental health, social well-being, and patient experience must be integrated into MedTech innovation.
Dr. Barnard-Kelly has spent her career proving that what patients feel matters as much as what their test results say. She has worked with regulators like FDA and NICE to establish new ways to measure psychosocial health and ensure that technology actually improves patients' lives.
The Gap Between Clinicians and Patients
One of the most shocking takeaways from our conversation: Patients and clinicians often leave the same appointment with completely different understandings of what was discussed. In a study Dr. Barnard-Kelly conducted, clinicians were asked to recall what they discussed with their patients. Patients were asked the same question. In half of the visits, they did not agree on a single thing. That is not just a communication issue—it is a healthcare failure. How can we make shared decisions about treatment when we are not even aligned on the conversation?
Why the FDA Qualified a Mental Health Measure
The regulatory world has long relied on clinical outcomes like A1C, time-in-range, and hospitalization rates to approve medical devices. But what about:
The burden of disease management on daily life?
The emotional impact of using complex medical technology?
The mental toll of living with a condition that requires 24/7 attention?
That is why Dr. Barnard-Kelly and her team developed INSPIRE, one of the first FDA-qualified medical device development tools (MDDT) focused on psychosocial health. It is proof that patient-reported outcomes (PROs) are becoming an essential part of regulatory decisions.
Using AI to Reduce Burnout and Improve Care
Dr. Barnard-Kelly did not stop at research—she turned her findings into actionable technology.
Her company, Spotlight-AQ, developed an AI-driven tool that helps clinicians quickly assess a patient's unmet needs—mental, physical, and social—before they even walk into the appointment.
In just three minutes, the tool generates a simple visual “bubble graph”, where the biggest bubbles represent the most pressing patient concerns. The result?
More focused appointments
Better conversations between patients and clinicians
Lower clinician burnout
Improved health outcomes
Spotlight-AQ is already being used in clinics across the US and UK, proving that personalized care does not have to be time-consuming.
Why This Matters for MedTech Innovators and Regulators
The future of MedTech depends on more than just better devices and drugs—it depends on whether those innovations actually improve patients' lived experiences. Regulators are shifting toward real-world evidence, and mental health must be part of that movement. Investors are looking for products with strong patient engagement. Clinicians are burned out and need tools that make whole-patient care possible without adding to their workload.
The industry is at a turning point.
What’s Next?
MedTech has the opportunity to redefine how we measure success. It is not just about clinical improvement, but also about whether people can live better lives with technology.
The question is: Are we ready and willing to make psychosocial health a standard part of MedTech innovation?
🎧 Listen to the full episode here: https://open.spotify.com/show/0idCTXcel0SvjHLalRoxIl?si=bed31e6a426d4fc0