Today, medical device makers, which have historically focused on research, development and manufacturing, are far from having a single role within the healthcare-delivery supply chain. Instead, value models transform the role of the medical device industry from supplier/seller to collaborator, one aligned with other stakeholders to focus on long-term care of the patient, from early diagnosis and patient selection, through novel therapies and to tracking long-term results.
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In this evolving environment, medical device companies need to be both adaptable and proactive, particularly by developing multi-stakeholder relationships and demonstrating commitment to improving patient outcomes. For device makers, this involves rethinking a product-centric, transactional business model — one that mostly involved interacting with a physician or provider as gatekeeper — and addressing the concerns of a new and broader set of stakeholders. These include hospital administrators, payers, employers and patients-as-consumers who are now more involved in how products not only contribute to clinical results, but also price and cost considerations. Collaboration is increasingly imperative to success.
Collaboration depends on understanding how data flow and analytics are driving healthcare transformation. Big data and cloud platforms are poised to overcome past inoperability challenges of data generated by multiple silos. Solutions that consolidate and analyze diverse data sets and unlock value all the way down to point of care settings are remedying the flaws produced by fragmented, outdated legacy systems in clinical, financial and operational departments. With a more complete, detailed picture of patients and populations, the hope is clinicians will be able to provide patients with better care and more informed treatment decisions.
This data flow is triggering a revolutionary shift in medical-device regulation. In the past, the first hurdle for medical-device companies has always been to produce evidence for regulators to obtain approval to market their product. For higher-risk products, this evidence traditionally has been built from randomized controlled clinical trials, the gold standard for ensuring the safety and effectiveness of medical devices on the market. But such trials can be limited — they offer proof usually generated by a niche pocket of patients under very controlled circumstances.
Today, measuring the value a medical device brings to patients in real-world settings has become a primary objective. As part of the federal 21st Century Cures Act, passed in 2016, there’s new pressure on the capacity of medical device companies to use real-world data — patient and outcome information gathered outside of randomized controlled trials — to meet that goal. Real-word data, for example, are being generated by electronic health records (EHRs), claims and billing activities, hospital and lab information, product and disease registries and patient-generated data from digital apps and wearables, among other sources.
The U.S. Food and Drug Administration is encouraging medical-device companies to provide evidence on real-word outcomes (PDF) to determine the performance of a product, both pre-and post-market, to reduce the time and cost of clearance and engage in continuous product evaluation. This shift isn’t a surprise, since the FDA has been using real-world data and real-world evidence — the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data — to monitor post-market safety and adverse events and to make regulatory decisions.
This loosening of restrictions, among other FDA guidance recently released, presents significant opportunities for device makers. For example, last year, the FDA became the first regulatory body in the world to approve the most recent iteration of the Sapien valve, the Sapien 3 transcatheter aortic valve replacement from Edwards Lifesciences, to treat high-risk patients whose surgically placed aortic or mitral bioprosthetic valves were old and worn out. In its decision, the FDA relied on real-world evidence to evaluate the benefits and risks of off-label valve-in-valve-use procedures, clinical data sourced from the Transcatheter Valve Therapy Registry, a partnership of the American College of Cardiology and the Society of Thoracic Surgeons. FDA officials wrote that this approach made it possible “to accumulate more data faster, without the need for costly and time-consuming formal clinical trials.”
Real-world data hold much promise for medical-device makers, as a source of data support to improve product safety, value equation pricing and competitive advantage, as well as identifying both broad and sub-population clinical effectiveness over time. But there’s still a long way for medical device makers to go in truly embracing big data analytics to improve the design, manufacture and sales of their products. For example, a recent survey of life sciences organizations revealed almost 70 percent of biotech and pharma companies say they’re now using data very effectively, compared to only 30 percent of medical-device companies.
Healthcare lacks an adequate infrastructure to enable high-quality, nearly real-time and low-cost real-world data generation for medical devices and the collaboration it enables. Many obstacles need to be resolved by stakeholders including those surrounding data reliability and quality, governance and patient privacy issues. But there are efforts underway: One example of a multi-stakeholder-based solution is the recently established National Evaluation System for Health Technology, or NEST, a neutral, third-party entity created by a grant awarded by the FDA to the Medical Device Innovation Consortium. One goal of this voluntary network composed of representatives from the FDA, device industry, clinician groups, payers, health systems and patient groups is to integrate data from clinical registries, electronic health records and medical billing claims to gather more comprehensive evidence of medical device safety and effectiveness. So far, 11 key demonstration projects are underway to provide proof of concept, the framework for public-private partnerships to create scalable approaches to evidence generation across device types and the total product life cycle. NEST is also soliciting a second round of recommendations from medical-device stakeholders, including manufacturers, health systems, providers and health payers for additional test-case concepts.
Device companies possess a valuable combination of product expertise and disease-state knowledge “beyond the device” that can be leveraged to offer integrated services and solutions, such as consulting and episode management, improving outcomes and reducing costs. According to a PwC Health Research Institute report, seven of the top 10 medical device companies have initiated organizational changes reflecting a shift toward service-based offerings. The future of the medical device industry will be shaped by how strategically companies are prepared to interact with these complex stakeholders by identifying opportunities, differentiating and delivering effective value-based products and services.
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