Handbook

The medical technology industry is highly regulated to ensure the safety of the general population. The tragedy of thalidomide in the 1950s and 1960s drove home the need for governments around the world to control the release of drugs onto the market. More recently, problems with heart valves, breast implants and pacemakers have shown that medical devices are also capable of causing injury to the patients they are designed to treat. Regulatory bodies around the world monitor the development and marketing of many thousands of medical devices to ensure that the products allowed on the market are of an appropriate quality.

From the point of view of the manufacturer, the successful development of a medical device can be a slow and very expensive process. Typically, an implantable medical device will be “in the pipeline” for at least 5 to 10 years before the regulatory bodies around the world approve it for general sale. The cost of the process of development and regulatory approval depends on the device and its complexity but, typically, $10 million -100 million per device would be indicative industry standards. Furthermore, the longer the time taken to gain regulatory approvals, the longer a company must wait before it can begin to recoup this financial outlay by selling the product on the general market.

It is therefore vitally important for research bodies and companies to understand the regulatory process governing the sale of medical devices in each country. It is also important for them to invest the appropriate funds to ensure that the product development and manufacturing processes are performed according to the standards required and that the regulatory approval process is completed as efficiently and quickly as possible.

Understanding the approval process and the manner in which regulatory bodies operate is critical to success. It is important to liaise with the regulatory bodies frequently and treat the relationship in a positive manner. Their requirements, although sometimes apparently onerous, ultimately improve the performance of a medical device company and their products.

BIOM9410 is designed for people who are, or will be, involved in any aspect of the development, manufacture or distribution of medical technology. This can range from involvement in basic research at a university or research institution through to product development and clinical trials of the product or a position in regulatory affairs in a multinational medical device manufacturing company. All stages of the development process are regulated to various extents, and it is vitally important that each person at each stage is aware of the requirements he or she must meet. The course aims to give you a broad overview of the regulation of medical devices around the world.