Medical devices play an important role in the delivery of many health care services. Defined broadly, medical devices are items that are used for the “diagnosis...cure, mitigation, treatment or prevention of disease” and are not absorbed or metabolized by the body. The term applies to everything from common medical supplies such as latex gloves and syringes to advanced imaging equipment and implantable devices such as cardiac defibrillators. More recently, we’ve seen medical devices serve as extensions of a physician’s hands in surgery. The medical device industry is thus an important component of the larger health care system and plays an essential role by developing new medical technologies that can improve the ability to diagnose and treat illnesses or injuries. Recent studies by the Congressional Research Service (CRS) have estimated that the United States is the largest single market for medical devices and accounts for about 40 percent of worldwide sales. In addition, total U.S. spending on medical devices was $119 billion in 2011, $125 billion in 2013, and $172 billion in 2015 respectively. Medical device companies are located throughout the United States, but the industry has a larger presence in California, Massachusetts, and Minnesota.
Challenges and Opportunities
Medical device development companies are constantly trying to overcome design and manufacturing challenges to get their products in the market. While improving product quality and reducing manufacturing costs are always a concern, the FDA and ISO regulators can also present issues. Product compliance is a top priority for these firms who cannot go to market without approval from regulatory bodies. While industry regulations are warranted and likely to remain difficult, achieving regulatory compliance can sometimes restrict design creativity and development.