What's Trending in MedTech? | Milken Institute Global Conference 2024

Investment Climate & Market Trends

• The 2023 investment climate has constrained M&A activity and cooled IPO environments, forcing a shift from speculative hype to real value propositions and clear patient outcomes.
• While overall investment levels have dipped, the specific areas of innovation interest (digital health, AI, cardiovascular, genomic/IVD) remain stable, though investors are becoming more nuanced regarding problem-definition and adoption likelihood.
• Tight funding has prompted startups to double down on defining specific pain points for practitioners and patients, moving away from "buzzword-driven" development toward solutions with proven economic viability for payers and providers.
• 2024 is anticipated as a significant year for women's health and increased investment in founders of color addressing unique needs throughout the lifespan.
• A major trend involves the convergence of consumer tech and medtech, driven by the necessity for devices to be engaging and intuitive for home use, particularly as aging populations and chronic disease rates rise.

Patient-Centered Design & Evidence Generation

• The FDA and industry partners are transitioning from "informing" patients to "integrating" them throughout the entire product lifecycle, from conception to real-world post-market surveillance.
• The FDA's Total Product Life Cycle Advisory Program (TAP) is being used to de-risk innovative technologies by accelerating regulatory questions and explicitly requiring engagement with patient groups to identify pain points and desired outcomes.
• The Medical Device Innovation Consortium (MDIC) has developed a patient-centered benefit-risk framework with the FDA to convert patient input into reliable, reproducible data rather than anecdotal stories.
• A specific "NEST Mark" program (National Evaluation System for Health Technology) allows FDA-endorsed real-world evidence submissions to pre-resolve questions about data quality and methodology, expediting review times.
• J&J received the first FDA approval for an ablation device powered entirely by real-world evidence in August, signaling a shift toward faster, cheaper evidence generation outside traditional clinical trials.
• Real-world evidence (RWE) is increasingly used to support reimbursement and coverage decisions, with companies that collect this data early gaining a competitive advantage in demonstrating value to payers.

Artificial Intelligence & Digital Health

• Industry leaders distinguish between traditional Machine Learning (ML) and Generative AI (GenAI), noting that ML is currently more mature for regulated medical devices (e.g., Abbott's Ultrion for coronary imaging), while GenAI faces higher risks like hallucinations.
• Abbott and other major players are approaching GenAI cautiously for external medical products, focusing initially on internal administrative use cases like reducing clinician documentation burnout and "pajama time."
• FDA regulators emphasize that current AI approvals (over 700 devices) primarily focus on safety and validation of training data to prevent bias and ensure representative patient populations.
• A key regulatory concern is preventing "cognitive bias" where clinicians over-rely on AI clinical decision support systems, with AI intended to augment rather than replace clinician judgment.
• The proliferation of wearable data creates a challenge of "data without insights," necessitating technology that converges vast streams of data into actionable, single-number metrics for patients and providers.

Regulatory & Systemic Shifts

• The FDA is pursuing "reliance" strategies through the International Medical Device Regulators Forum (IMDRF), allowing the U.S. to accept safety and efficacy evaluations from other jurisdictions to accelerate global health impact.
• Abbott has embedded "Innovating for Access and Affordability" principles into its R&D and commercial teams, ensuring new products (e.g., FreeStyle Libre) are designed for mass accessibility and not just cutting-edge capability.
• The "Home as a Healthcare Hub" initiative aims to address provider shortages and hospital closures by developing interoperable systems that allow home care to function seamlessly with provider networks.
• Reimbursement challenges are often tied to novelty rather than innovation itself; devices must fit within existing Medicare benefit categories or demonstrate distinct value to hospitals to secure commercial success.
• Small companies can leverage existing real-world data to avoid expensive clinical trials, provided they creatively design data collection strategies that satisfy regulatory requirements.

Emerging Areas Lacking Attention

• Technologies that allow for continuous, point-of-care data collection outside intensive settings are viewed as having transformative potential but are currently underappreciated compared to established solutions like diabetes monitoring.
• Care pathways require significant simplification to eliminate the need for "self-advocacy," ensuring equitable access for patients regardless of their healthcare literacy or resources.
• There is a critical need for diversity and inclusion in engineering and leadership teams to ensure medical devices do not inadvertently perpetuate health inequities among women and people of color.
• Remote health technologies, such as Abbott's "Virtual Clinic" for neuromodulation, are expanding global access by allowing device adjustments from home, reducing the burden of clinic visits.