As a manufacturer, you are pioneering technological advances to help patients. You understand that your product must be regulated for patient safety, but are also concerned with over-regulation that may stifle innovation. Perhaps you have invested time, money, and resources in a new product only to have to recall it for some unforeseen adverse effect.
In comparison to your colleagues in the pharmaceutical industry, there are far fewer guidelines as to how to develop your product for safety and efficacy.
How do you know the best way to do this?
- IDEAL recommendations are not only for researchers and editors; they extend to manufacturers as well. IDEAL calls for manufacturers to prove that devices have a unique, sustainable advantage over those already on the market.
- At the same time, IDEAL recommendations are in accordance with the notion that creativity and innovation should be fostered and that overly stringent requirements may inhibit this. The focus of IDEAL is the continuous evaluation and assessment of surgical innovation, not to get in the way of device manufacturing.
- Devices and implants should be monitored as early as possible with appropriate methodology for the stage in the process of innovation (not necessarily a large-scale RCT) so as to identify problems early and thus not waste precious resources on pursuing the development of products that are unlikely to work.
- In the U.S., IDEAL collaborators have worked directly with the Food and Drug Administration and with manufacturers to discuss this balance of regulating devices and encouraging innovation.