Barriers to medical device innovation

Abstract

The US Food and Drug Administration (FDA) has defined a medical device as a health care product that does not achieve it’s purpose by chemical action or by being metabolized. This means that a vast number of products are considered medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices in three classes, depending on the risk of the device. Since Class I and II devices have relatively simple requirements for getting to the market, this review will focus on “implantable devices”, which, in general, belong to Class III. The European Union and Canada use a slightly different classification system. While early generations of medical devices were introduced without much testing, either technical or clinical, the process of introducing a Class III medical device from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medical devices may be considered to have started in the 1920s with development of artificial hips. The implantable pacemaker was another milestone and pacemakers and cardioverters/defibrillators have since saved millions of lives and created commercial giants in the medical device industry. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably.

Implementing Responsible Research and Innovation Practices in SMEs: Insights into Drivers and Barriers from the Austrian Medical Device Sector

“…Ethical issues, such as access to, and pricing of, medical devices are also considered to be important dimensions of policy-making [57]. Entrepreneurial performance is often driven by the prior experiences of entrepreneurs at incumbent companies [50] and benefits from user involvement in the development of medical devices [58,59].…”

Spatial Distribution of Total Number of Medical Devices in Turkey: A Classification Analysis

“…1 Changing market demands and patient expectations are shaping health care and other service industries. As health care costs increase, health care companies must be able to develop products that best meet patient needs.…”

“…Furthermore, integration of the medical device industry will improve policies and increase cooperation between various stakeholders. 1 Studies have shown that incorporate patient's expectations into the innovation process improves public health in many countries. 3 A medical device can be described as "a health care product that does not achieve its purpose by chemical action or metabolization. "…”

“…4 Therefore, financing is a key element for continued medical device innovation. 5 These devices play a major role in the practice of medicine 1 and are an important part of the European manufacturing sector. They provide a key input into the health care system.…”

“…6 The worldwide medical devices market is still improving, but an imbalance between developed and developing countries still exists. 1 As a candidate of European Union (EU) membership, Turkey arranges its medical device industry closely with those in the EU. 7 In Turkey, health care is predominantly financed by the public sector, which is responsible for 63% of its total expenditures.…”