Medical Technology Innovation Process

Delivering advanced medical technologies into the hands of patients, physicians and other end users is a continual and complex process.

The incremental nature of medical technology innovation and the wide range of device types pose unique challenges for the industry, unlike those faced by the pharmaceutical or biologics sectors. The medical technology innovation process is interactive and involves significant collaboration with physicians and other end users. Real-world experiences with a product, both positive and negative, are critical to the design of the next generation of a technology.

The next medical technology breakthrough could be the work of a few dedicated individuals, such as physicians or engineers, whereas the next major pharmaceutical discovery will be made by a team of lab researchers after years of intense experimentation. In addition, medical technology innovation often builds on advances in other evolving fields, such as computers, communications and materials science.

In manufacturing, medical technology companies strive to continually improve their processes by constantly monitoring their production and other external data, and feed that information back in a closed quality loop. Clinical outcomes, patient and physician preferences and other after-market data are collected continually by medical technology firms to improve the next generation of a device.

Key Innovation Points:

Smaller companies, which make up the vast majority of medical technology firms, often are the incubators for the most cutting-edge innovations.

• The decision to develop a new medical innovation is not made solely by the manufacturer, but often depends on a consensus of key stakeholders including: physicians and other health care providers, institutional payers and other sources of reimbursement, and patients and consumer groups.

• Medical technology innovation typically consists of incremental improvements to existing technologies.

• The average lifecycle for many advanced medical technologies is short, just 18 months. In contrast, some pharmaceuticals have market lives measured in decades.

• Unlike in the pharmaceutical industry, patent protections for medical technology can often be successfully challenged or circumvented.

• Lack of resources and experience often prompt smaller firms to collaborate with larger medical technology companies in areas where the larger firms have more expertise, such as FDA regulation and payment strategies.

• Medical technology manufacturers consistently monitor their production processes and post-market performance of their devices so that any aberration is detected and evaluated and appropriate corrective action is taken to prevent any problem from reoccurring.

-April 2004