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For decades, the medical device industry has reaped rewards by providing new technologies and solutions that improve healthcare delivery. Now, more than 8000 new medical devices enter the U.S. market each year1 as the industry faces sweeping changes that will not only impact the life cycle of many existing products, but also future innovations. New payment models, patients replacing physicians as stewards of their care, a changing regulatory framework, and data as a central solution to implement these strategies are all converging trends requiring medical device makers to prepare their organizations to adapt to the future.
A patient-centric model of care, which has been identified by the Institute of Medicine as one of the key actions for improving our nation’s health,2 is being adopted across healthcare. The IOM defines patient-centric care as “providing care that is respectful of and responsive to individual patient preferences, needs and values, ensuring that patient values guide all clinical decisions.” This idea of personalized medicine is already seen in daily practice with concierge medicine services. Surveys show that patients expect the same responsiveness and convenience from health care providers as they do from top consumer brands and institutions.3
As patients shoulder more of their own healthcare costs, they are also demanding payers and providers provide both outcome and pricing information so they can make better-informed decisions about treatments. Recognizing the overall patient experience is a growing business imperative within healthcare organizations, with provider payments also tied to performance on measures of patient satisfaction and engagement.4 These measures also implicate a broader role for medical-device makers in the patient’s continuum of care, beyond delivering a technological solution to a more comprehensive healthcare experience.
The new generation of mobile devices and apps have changed the traditional concept of a medical device being purely and exclusively an instrument or system that interacts with a patient and used within a hospital setting or physician’s office.5 In addition to the commercial use of digital technology, there is a growing trend toward using it for clinical studies. Clinical trial software companies have been gaining momentum like TransMed Systems in Oncology and monARC Bionetworks in interstitial lung disease. Today, mobile computing can both capture and continuously monitor personal healthcare data and stream it back to the patient, physicians, and caregivers, enabling them to provide higher-quality care and better overall disease management.6 Big companies like Apple and nimble startups like Klue are making inroads with wearables, and others are providing data infrastructure by partnering with hospitals to allow them to better streamline and leverage data like Medopad and Gray Matter Analytics. By extension, the medical-device industry has an evolving and essential role to play in assisting both clinicians and healthcare consumers in their decision making at point-of-care settings, from bedside to outside of hospital walls.
What It All Comes Down To
The competitive landscape for medical devices over the next decade is likely to look very different than it does today as a patient-centric model relentlessly pushes forward, creating both opportunities and challenges for the industry. Now is the time for medical-device makers to build off past successes, prepare for collaboration and innovation, and promote their positive role in evolving healthcare value frameworks.
In the case of pulmonary embolism (PE) for instance, BTG is now looking beyond the immediate concrete goal of improved efficacy and safety. That’s a worthwhile scientific and engineering goal. But beyond that we are talking and working with hospitals on the how physicians work together to tackle PE as they already do with heart attacks or strokes. Hospitals, manufacturers, and payers can increasingly partner to not just look at individual procedures, but develop better complete systems around the procedure.
We will surely hear more from Amazon on this, but also from teams at companies like Imbio and Pulsara, which are partnering with the medical device world to focus better on the patient and delivering value-based care, including in pulmonary embolism for instance.
The fragmented healthcare ecosystem is not yet prepared for a real patient-centric health system, and much work lies ahead. Though collaboration is often the key to innovation, the new era of healthcare delivery may seem to be placing unrealistic expectations on both the public and private sectors when it comes to sharing data, expertise, and funding, with an end result that provides value to all stakeholders.
Dr. David Hahn is Senior Vice President of Medical and Clinical Affairs, Vascular at BTG International Inc.
1. "Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities," C. Lee Ventola, MS; PT 2008 Jun; 33(6): 348–359; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2683611/
2. Crossing the Quality Chasm: A New Health System for the 21st Century. Institute of Medicine; Vol. 6. Washington, DC: National Academy Press; 2001.
3. "Patient Loyalty: It’s up for Grabs," Accenture; https://www.accenture.com/t20160322T034105__w__/us-en/_acnmedia/Accenture/Conversion-Assets/DotCom/Documents/Global/PDF/Strategy_7/Accenture-Strategy-Patient-Engagement-Consumer-Loyalty.pdf
4. "Patient Satisfaction Reporting and Its Implications for Patient Care," AMA Journal of Ethics, 2015 July; Shivan J. Mehta, MD, MBA; https://journalofethics.ama-assn.org/article/patient-satisfaction-reporting-and-its-implications-patient-care/2015-07