Medical devices serve a number of purposes from the most mundane to the esoteric. Some are constantly being redesigned and updated to be more effective while others have remained little-changed for decades. Even bed pans—stainless steel, cold, hard, and uncomfortable—have evolved for specialized circumstances, providing more privacy and manufactured with new biodegradable materials. The evolution of medical devices has delivered a great many advances, including the following:
- Improved Palliative Care. Devices ranging from beds to motorized mobility machines (scooters) have facilitated the care, comfort, and dignity of patients across the world. Their low cost and consistent quality have made them ubiquitous in hospitals, clinics, nursing homes, and private homes.
- Better Rehabilitative Outcomes. The consequences of trauma and debilitating disease which had previously left victims bed-ridden and isolated have been mitigated with such devices as prosthetics, insulin pumps, pacemakers, even exoskeletons. Patients are restored to good health in shorter time frames and able to work and play in a broad variety of environments.
- More Accurate Diagnosis. The ability to see within the human body, to observe and record, noninvasively, complex chemical and biological processes on a cellular scale combined with massive data collection and analysis has revolutionized the practice of medicine in the past half-century. Arriving at an accurate diagnosis in a timely manner generally improves outcomes. For example, according to the National Institute of Health (NIH), the ability to detect and treat cardiovascular events early has drastically reduced heart disease death rates from their peak in 1968. Strides in diagnosing and treating diseases in their earliest stages are becoming possible only through the massive advance of technology in medicine.
- Targeted Treatment and Care. Technology in areas as diverse as robotics and materials composition affects the practice of medicine every day. Micro-surgery, intensity-modulated radiation therapy, protein-coated implants, and surgical mesh with antibiotic coatings are increasingly commonplace. Remote monitoring leverages medical assets while non-invasive measurement systems can provide around-the-clock monitoring for intervention as needed.
- Improved Health Outcomes. As medical equipment and devices have evolved and become more effective, quality and length of life have improved. Injuries which would have been fatal in the past are now treated successfully, infant mortality has never been lower in humankind's history, and diseases which have plagued humanity since the beginning of time are in retreat.
Major Current Trends in Device Technology
Innovation in medical devices has always been subject to advances in other fields. For example, the proliferation and improved security of communication networks enabled the development of portable devices and remote monitoring. Discoveries of new materials and coatings have led to safer, more durable devices with longer lives. IT advances in hardware and software enable the capture and analysis of more accurate data with better diagnoses and treatments. In this spirit, there are several advances likely to affect medical devices in the near-term.
Devices are going to continue to get smaller, lighter, and more portable allowing people to receive hospital-level treatment in their own homes. According to Michael Dunkley, Vice President of Program Development at Continuum Advanced Systems, low-cost testing at point-of-care locations is possible because smaller equipment can have a major impact on populations in remote areas where access is limited. Many future devices are going to have multi-functionality, further reducing the cost of maintaining separate devices for diagnosis and treatment.
The explosion of health information over the Internet and increased availability of testing and monitoring devices, including mobile phone applications for personal use, are going to continue especially as patients gain access to genetic testing at lower costs. Easy access to a defibrillator during a cardiac event is now assumed in most urban communities as devices are readily available in homes, company sites, restaurants, retail stores, and public facilities. Diabetes is increasingly self-monitored and treated, and new auto-injectors are going to lead to self-treatment options for other conditions such as rheumatoid arthritis. Patients are going to be increasingly empowered to self-diagnose and treat minor illnesses and injuries in lieu of expensive visits to hospital emergency rooms and clinics.
Interoperability and Connectivity
As devices become more and more connected, the volume of health data captured continues to explode, providing new and more reliable details to improve diagnoses and test the efficacy of new treatments. At the same time, the challenge to manage and convert that massive amount of data into useable and useful information becomes more difficult. Software like IBM's Watson EMR Assistant and WatsonPaths is going to help physicians use decades worth of medical research to guide their clinical decisions for better, more cost-effective solutions.
Probable Future Trends Affecting the Medical Device Industry
Paradoxically, as the cost of diagnosing and treating individual diseases and injuries has been lowered, overall healthcare costs have risen, even as we become less subject to the whims of injury and disease than prior generations. While the price of individual treatments is likely to decline, the growing number of patients continues to inflate total healthcare costs. The $300 billion medical device industry is going to continue to reduce those prices and bend the historical cost curve of healthcare downward even as it reacts to the following trends.
Healthcare providers are combining through mergers and acquisitions as they seek to spread fixed costs of plant, equipment, and administration over a greater base of customers with relatively fixed unit costs and tighter credit. Joel Allison, CEO of the Baylor Health Care System, which recently merged with Scott & White Healthcare, says consolidation is going to continue. "Part of it is brought on by the Affordable Care Act. You're looking for scale to bring you synergies to where you can become more efficient." The shrinking number of major customers for medical device manufacturers is going to drive consolidations in that sector, as well. Companies who are not number one, two, or three in a certain market are going to be particularly vulnerable to being acquired or going out of business.
Competition and Commoditization
While the number of major customers for high-price ticket items (MRIs, radiation therapy equipment) is shrinking, the market for manufacturers who serve individuals is going to continue to grow even as profit margins for consumer-oriented devices tighten. New products are likely to encounter competition in the form of alternative substitutes at lower prices, making early marketing dominance a requirement to discourage new competitors.
Medical device manufacturers who provide more standard products may find purchasers increasingly cost-conscious as they wrestle with their own financial issues. As a consequence, this segment of the industry may also consolidate and move production off-shore to reduce expenses. Medical device developers and manufacturers are going to feel great pressure with products in the early stages of market acceptance that are not yet profitable. In addition, funding of their research and development is going to be harder to obtain due to slower economic growth following the 2008-2009 recession.
Hostile Regulatory Environment
Device manufacturers are likely to face greater costs and longer time to market as the FDA 510(k) process for product approval has been met with criticism and more products are aimed at the individual consumer market. The combination of the sequestration (automatic spending cuts that affect most government services), the medical excise tax imposed by the Affordable Care Act, and the uncertainty of a permanent R&D tax credit is especially onerous to smaller device manufacturers, who make up the bulk of the companies in the industry.
Many of the great medical breakthroughs over the centuries are directly attributable to new devices and tools as well as continuous innovation of older technologies. Without such improvements, injuries, illness, and age would continue to shackle and enslave the population as they did our ancestors. It is impossible to look at medicine without recognizing the role that technology has played, just as it inspires awe to consider where new discoveries can take us in the future.
How do you think technology is changing medicine?