Medical Device Industry
The medical device industry is a heterogeneous, innovative, and dynamic sector. The global market for medical devices is huge, and it will continue showing a significant growth in the future. The United States remains the largest medical device market in the world: $156 billion (40 percent of the global medical device market in 2017). By 2023, it is expected to grow to $208 billion. The industry includes almost 2 million jobs in the United States, including both direct and indirect employment.
Opportunities in the US market: The United States has a very large aging population and a long track record of chronic disease. In addition, the Patient Protection and Affordable Care Act of 2010 increased access to healthcare services for sections of the population that were previously uninsured. In response, there is a need for cost-effective medical devices to meet the increasing demand for care, the cost constraints of the new healthcare system, and control the rising healthcare spending.
Industry challenges in the United States: The domestic device manufacturing industry is very robust and hosts some of the largest med-tech corporations in the world. Foreign manufacturers can expect hefty competition from American manufacturers, as well as Canadian, Chinese, and European manufacturers. However, the US Food and Drug Administration (FDA) has a complex regulatory and device classification system that may prove insurmountable for some manufacturers.
Future Directions for Medical Devices and Diagnostic Equipment
Doctors using products from the medical device and diagnostic equipment (MDDE) industry have wrought unimagined blessings in the lives of millions of people. Implantable pacemakers and defibrillators enable people with otherwise debilitating heart irregularities to live normal lives. Angioplasty has alleviated symptoms of recurring chest pain in millions of people. Artificial hips and knees have permitted more active and independent lifestyles for millions who would otherwise be invalid. Portable blood glucose monitors enable diligent patients with diabetes to live long and normal lives, escaping the devastating complications of their disease. Where conventional surgery entailed weeks of recuperation, minimally invasive surgical equipment allows serious surgery to be done on an outpatient basis—with recovery completed in a matter of days. Electrical micropulses from deeply implanted neural stimulators in the brain can cause the tremors of Parkinson’s disease to disappear—and even, in other patients, to mitigate the symptoms of depression.
A generation ago X-ray was the only imaging technology, and it could only provide images of bones. Because there was no way to capture images of soft tissues, many surgeries were “exploratory” in nature: doctors had to cut us open to see what was going on. Today, thanks to scanners using computer-aided tomography (CT) and positron emission tomography (PET), magnetic resonance imaging (MRI) machines and ultrasonic and fluoroscopic “movies” of organs as they function, doctors can see with remarkable clarity what is going on inside of us. Most surgeries today occur after imaging technologies have given a definitive diagnosis of the problem to be repaired.1 In fact, the clarity with which doctors can see into the body has given rise to a new medical discipline, interventional radiology—where radiologists whose skill is in imaging are actually performing the minimally invasive surgery too.
We have become so accustomed to these miraculous technologies that most people don’t even stop to think that 40 years ago, none of these existed.
Some would complain, of course, that these unimagined blessings have brought unimagined cost to health care as well. The blessings indeed have been costly—but they need not continue to be so. In this chapter we will outline a path for innovators in the MDDE industry to make their miracles affordable and even more broadly accessible. We propose that executives in this industry can use two “growth compasses” to find their way to the next waves of growth in their markets. While these compasses are good guides to future growth in many industries, we believe they point to future growth in MDDE with particular accuracy. The first compass points to decentralization in the technological terrain of the MDDE industry; the second points toward products that commoditize professional expertise. The more these two waves of growth converge in the same market opportunity, the more growth there will be.
How to Decide Whether to Buy New Medical Equipment
Doctors using products from the medical device and diagnostic equipment (MDDE) industry have wrought unimagined blessings in the lives of millions of people. Implantable pacemakers and defibrillators enable people with otherwise debilitating heart irregularities to live normal lives. Angioplasty has alleviated symptoms of recurring chest pain in millions of people. Artificial hips and knees have permitted more active and independent lifestyles for millions who would otherwise be invalid. Portable blood glucose monitors enable diligent patients with diabetes to live long and normal lives, escaping the devastating complications of their disease. Where conventional surgery entailed weeks of recuperation, minimally invasive surgical equipment allows serious surgery to be done on an outpatient basis—with recovery completed in a matter of days. Electrical micropulses from deeply implanted neural stimulators in the brain can cause the tremors of Parkinson’s disease to disappear—and even, in other patients, to mitigate the symptoms of depression.
A generation ago X-ray was the only imaging technology, and it could only provide images of bones. Because there was no way to capture images of soft tissues, many surgeries were “exploratory” in nature: doctors had to cut us open to see what was going on. Today, thanks to scanners using computer-aided tomography (CT) and positron emission tomography (PET), magnetic resonance imaging (MRI) machines and ultrasonic and fluoroscopic “movies” of organs as they function, doctors can see with remarkable clarity what is going on inside of us. Most surgeries today occur after imaging technologies have given a definitive diagnosis of the problem to be repaired.1 In fact, the clarity with which doctors can see into the body has given rise to a new medical discipline, interventional radiology—where radiologists whose skill is in imaging are actually performing the minimally invasive surgery too.
We have become so accustomed to these miraculous technologies that most people don’t even stop to think that 40 years ago, none of these existed.
Some would complain, of course, that these unimagined blessings have brought unimagined cost to health care as well. The blessings indeed have been costly—but they need not continue to be so. In this chapter we will outline a path for innovators in the MDDE industry to make their miracles affordable and even more broadly accessible. We propose that executives in this industry can use two “growth compasses” to find their way to the next waves of growth in their markets. While these compasses are good guides to future growth in many industries, we believe they point to future growth in MDDE with particular accuracy. The first compass points to decentralization in the technological terrain of the MDDE industry; the second points toward products that commoditize professional expertise. The more these two waves of growth converge in the same market opportunity, the more growth there will be.
Used Medical Equipment
In researching this column and reading many of the comments submitted to the FDA, several key issues became obvious:
- OEMs and third-party service organizations have a clear point of view about servicing and repairing refurbished or reprocessed devices.
- The FDA‘s concerns about device service and repair by OEMs and third-party service organizations have not changed in 20 years.
- The patient must be the main concern of any organization involved in servicing medical equipment.
Third-party service organizations provide a critical service, particularly in cases when OEMs announce the end of life for their medical equipment. Although many users will upgrade—which is almost always an option—many may not, especially users who cannot afford to update to the most current technology. Thus, the current level of regulatory oversight is concerning to many organizations.