Vicki Anastasi/Global Head, Medical Device and Diagnostic Research/ICON plc
A decade from now, value-based healthcare, enabled by wearable and electronic health record (EHR) technologies, will be revolutionizing medical device markets. Manufacturers will contend with a changing constellation of customers, from payors to clinicians and patients. It will be important to consider what outcomes they will value most. Anticipating these changes is necessary to ensure the relevancy of today’s development process—from product design through clinical trials, marketing strategies, post-marketing and product refinement. Several trends are clear:
1. Patient-directed care
Patients will continue to take a larger role in medical decision-making. Furthermore, the maturation of wearables, smartphone apps, and networked medical devices will grant widespread access to personal health metrics. Expect patients, armed with real-time data about their current care and potential options, to not only drive fundamental changes how clinicians deliver care, but also directly influence product specifications and marketing strategies.
2. Technology ecosystems will enhance products and trial access.
Many devices will come to market with companion apps and wearables to enhance outpatient outcomes, especially by monitoring symptoms and treatment adherence. Apps that integrate external datasets will augment many devices’ utility, such as high-pollen alerts for asthma inhalers. Most of all, interoperable networks of electronic medical records will enable instant trial feasibility modeling, exact patient identification, and direct recruitment of patients during normal physician visits — without the use of advertising. Social media analytics and patient-friendly informed consent will also contribute to making clinical trials a more regular component of clinical care.
3. Real-world evidence-defined value.
Value will increasingly be defined in terms of meaningful outcomes, including clinical, financial and patient status. As regulators will require more real world evidence, payors will too, and perhaps even collect it themselves through smart watches and other wearables. Planning for real world evidence collection will become a core component of early development, particularly for manufacturers to continue to control a device’s value story.
4. Payer and provider cost constraints and consolidation
Insurers, hospitals and physician groups will continue consolidating to maintain margins and gain buying power. Capitation and other risk-sharing mechanisms will drive formulary decisions based on device impact on total costs, including both episode-related costs, such as length of stay, and broader measures, such as mobility and depression. Aging populations will shift the device payer mix toward Medicare.
5. Outsourcing development partnerships
In the past decade, device manufacturers outsourced production to strategic partners who provided increasingly technical electronics, materials and precision fabrication expertise. In the next decade, manufacturers will outsource clinical development processes for similar reasons.
Contract research organizations already are introducing critical innovations, such as adaptive trials and wholly owned site networks, to drive down development costs and timelines. This includes incorporating real-world data at every development step, including EHR-based feasibility and recruitment, remote site preparation, enrollment support, risk-based monitoring, and direct post-market data collection through EHRs and registries.
Strategic partnerships with CROs to integrate these capabilities will be a key part of the future model for lowering clinical development costs, increasing success rates and–critically–meeting patient, physician and payer needs for evidence of real-world value.
[Want to stay more on top of MDO content? Subscribe to our weekly e-newsletter.]