Originally Published MPMN July/August 2005

MPMN 20

The Future of Medical Devices: 2025 A.D.

Mark Ettlinger

Twenty years from now, healthcare as we know it will have changed—dramatically. The basic reasons for these changes are in the headlines every day. Indicative influences, such as demographics, government policies, and social needs, will force the healthcare industry, its providers, and our government to rethink how treatment is delivered and who pays for it.

In the future, we may no longer have the luxury of always saving people. Economics will prevail as the principal influence upon the standard and level of care provided. However, with prudent planning, perhaps this dire circumstance can be prevented. Medical device manufacturers have a key role to play in developing devices that can contribute to lowering healthcare costs, as well as providing more effective, faster, safer, and less-invasive treatments for a variety of diseases.

Are all of the technologies of tomorrow in the research labs today? Probably so. After all, 20 years ago the knowledge of today’s cutting-edge techniques were well known in the scientific communities. Research and application testing of such areas as genetics, stem cells, and tissue biology, as well as their implications, required significant resources, technological advances, and time to prove efficacy. Safety issues are still being verified clinically. Now, with the clinical applications and positive indications growing and advancing steadily, the art and science of these fields are likewise transitioning in the technology and engineering phases.

So it makes sense that tomorrow’s technologies are in the works today. Just as we saw shape-memory alloys, plastic materials, and advanced fabrication technologies go from laboratories to manufacturing facilities, genetic treatments, tissue engineering, and nanomachines will be at the core of many leading devices and implants of the future.

One area that we are already seeing advances in is materials development and selection. Materials and their associated processing technologies will play a significant role by reducing side effects of medical devices and enabling the wider use of combination devices. These products incorporate mechanical features and functions as well as biological, pharmaceutical, or active therapeutic material. Testing for near-term solutions and interaction of drugs, chemicals, and materials will enable more and varied application of these devices.

One way new materials can affect healthcare may be in the fight against nosocomial infections in hospitals. Nosocomial infection and the propagation of antibiotic-resistant strains of bacteria have contributed to a problem that the Centers for Disease Control and Prevention estimates costs American hospitals $11 billion a year in treatment.

Hospitals are quickly learning the utility of following standards of practice and procedures analogous to those that industry uses in manufacturing devices and drugs. And the application of new materials and coating technologies to indwelling catheters, surgical devices, and implants, as well as the building materials and the handheld items (from pens to clipboards) will help hospitals meet their goals of reducing infections and the associated costs.

Features of Future Medical Devices

What will medical devices look like in 20 years? Presently medical devices and systems are used for care, diagnosis, and interventional treatment. In the future, pharmaceutical and biotechnology drug treatments will likely reduce the market for certain surgical devices. However they will increase use of the implantable and nanobased targeted drug-delivery devices.

As patents run out on critical drugs, their generic equivalents will reduce the cost of treating certain disease states. Likewise, says Lester Fehr of ArthroSurface (Franklin, MA; www.arthrosurface.com), “…cost stratification will bring more and more generic devices into the market. The newer devices will tend to be wearable, implantable, and portable.”

Percutaneous vascular and endoscopic access devices, which enable minimally invasive procedures, will have to leap new hurdles in an era when noncritical intervention done outside the traditional hospital-based operating room is the preferred mode of treatment. In a cost-conscious world, regulatory allowances will be made for technologies that enable diagnostic procedures and treatments to be performed in a clinic or office ambulatory surgical centers setting.

As the biotechnology of tissue regeneration improves, replacement organs and tissue-engineering advances will provide radical new options for addressing the most serious disease conditions. Tissue engineers are on the verge of breakthroughs that will grow entire organs, including hearts, livers, and kidneys. This builds off of the significant strides made in developing artificial skin for burn patients and bone substitutes that help repair osteoporosis and fractures.

Fully implantable, self-contained artificial hearts will be able to extend the lives of patients whose heart disease is beyond repair. An artificial pancreas, combining skin-based sensors to measure blood-glucose levels, a handheld computer to analyze the information, and an implantable infusion pump that adjusts glucose levels as needed, will provide diabetics with a more accurate and less painful way to monitor and treat their conditions.

Not Just Minimally Invasive

The trend toward minimally invasive medical techniques that we are seeing now will move toward a least-invasive approach. Certainly, the drive for endoluminal procedures (i.e., oral access via the esophagus through the stomach wall into the peritoneal cavity) will enable surgeons to perform abdominal and soon cardiothoracic surgeries with local anesthetic, instead of general.

Further advances in scale and materials will yield similar devices for vascular, cardiac, and neurological surgeries. Integrated laparoscopic and endoscopic procedures will play a transitional role as further advances are made and computer-assisted and image-guided procedures become more prevalent outside of the major teaching hospitals.

The host of sterilized instruments presently provided for surgeries will be gradually replaced by mechanisms of actuating “arms” and articulating cannulae with various detachable end-effectors for multipurpose applications. Everything from cutting through suction and irrigation through stapling will be accomplished by these “smart” instruments that can be handheld or attached to external fixation platforms. These systems will also be integrated for image-guided, remote, and robotic control of surgeries.

New Age of Imaging

Imaging, like drug delivery, is taking on two modalities—systemic and local. The systemic methods include whole-body computer-aided tomography (CAT), magnetic resonance imaging (MRI), and integrated positron emission tomography (PET) scans. The local imaging is provided by ultrasonic, microoptics, optical coherent tomography (OCT), and other light- or energy-based imaging systems, which use catheters and probes to provide discrete images of tissue and structures.

Certainly, in the future we can imagine micro x-ray and microwave-active and feedback devices. We can also imagine combined or integrated devices, where multiple imaging modalities are incorporated on single catheters, so that diagnoses and treatment can be immediately implemented by the surgeon or specialist.

Combined devices will incorporate not just imaging modalities, but biological, pharmacological, and possibly radioactive ingredients as well. A current-day example is drug-eluting stents. Many other combined devices are on the drawing boards of companies right now. Infusion ports and implants, pacemakers, and future implantable monitoring devices will not only exclusively deliver a chemical or electrical therapeutic treatment, but also monitor and regulate that treatment regimen. They will also be able to communicate that information to external, wearable telemetry systems, which will, where applicable, feed information to clinical databases via mobile cellular telecommunication devices.

With the addition of biologic and genetic microlabs, implants—both passive and active—will be able to monitor physiological conditions, disease states, and enzyme production, while providing potential active functions. Neurological implants may provide key interface mechanisms for those suffering from blindness, Alzheimer’s, dementia, and even amputations where interactive function may be restored by prosthetics that interface with such devices.

Molecular and gene-based diagnostics will detect diseases earlier in their progressions, improving patient outcomes and lowering treatment costs. This will allow physicians to target specific drugs to match the patient’s genetic makeup. Molecular imaging diagnostic tests will be able to detect cancers and other disease conditions at the molecular level before they have spread and caused major damage.

Combinations of current diagnostic technologies such as ultrasound, MRI, and PET, will provide physicians with a more precise picture of how a disease progresses and how it responds to various treatments.

Technologies to Watch

Miniaturization of medical devices will allow for more-targeted delivery of therapies. Their smaller size will enable more minimally invasive and noninvasive procedures, which could move care from hospitals to the outpatient setting. Miniaturization will also benefit younger patients because technologies, such as pacemakers, implantable cardioverter- defibrillators, and brain-stimulation devices, can be placed in younger patients who can’t use today’s adult-sized models. And moving even smaller, nanotechnology breakthroughs will create microscopic devices to deliver treatment to individual cells.

Information technology innovations will allow critical medical data, including images of the operating field, to be processed and transmitted rapidly over great distances, saving both patients and physicians time and speeding delivery of treatment. Information from devices such as pacemakers and blood-glucose test kits will be monitored over the Internet or via wireless connections. Specimen-based tests currently performed at a laboratory or a doctor’s office will be performed using home-based versions and the results immediately transmitted to a physician. Physicians will transmit commands remotely to activate or adjust a patient’s implanted device, for example an implantable defibrillator or brain-stimulation device.

Certain existing treatments, such as acupuncture, homeopathic, and other alternative-care therapies, are poised for growth in the new market. Generic medical devices will play a role here as the cost of manufacturing production will always be driven by the need for increased efficiency.

Conclusion

How will the medical technology industry do its part to fulfill the future needs of healthcare? For those of us who design and develop medical devices, our mission must be to overcome the challenges of cost versus innovation. Our focus must be to create products that reduce cost, while at the same time improve standards of care.

Four New Factors Affecting Development

1. Reduced funding pool for new product development. Many venture groups and corporations will find the performance gains limiting and financial risks increased under cost-conscious regulations and reimbursement structures. This trend started after the dot-com bust with significantly lower venture investments in seed funding
for start-ups.

2. Integration and the streamlining of multifunctional systems. Open architectures in all aspects of medical device development will likely be a forced issue and empowered by FDA.

3. Single-use and reuse: The multiuse of devices will play a more significant role, but only after infection and sterilization issues are addressed on the product design side, as well as enforcement of hospital systems and standards.

4. New marketplaces. Nonprofit buying groups will likely form around or in parallel to the existing for-profit corporations. This will open new channels for smaller manufacturers.

Copyright ©2005 Medical Product Manufacturing News