The medical field is replete with companies attempting to come up with the next essential functional device. Annually, hundreds of devices are appraised for medical usage. However, not all of these are successful. Many fail. To be successful, a designer or inventor needs to be certain his or her idea is capable of fulfilling its function. Before it even reaches the production level, it needs to undergo certain assessment procedures. These areas all features of a comprehensive medical device product development process.
Common Errors
When developing a medical device, it is important to seek out experts in development and production. Such companies and individuals will be able to help you navigate safely through certain areas fraught with the potential for errors. Among the issues, informed companies can help you with are such common ones as:
• Regulations: Medical devices are awash with strict regulations. The FDA provides different guidelines for the approval of specific devices. In order for the product to succeed, the FDA must approve all aspects of it including design, materials, and production. Be sure to only work with a company that has the right certification
• Materials: In medical device product development, the choice of materials, including plastic, is of primary concern. They have to conform to certain standards. The company you choose to produce a prototype and produce even minor components for the device must be able to satisfy the tight tolerances and stringent specifications of medical devices.
• Process: It is possible to avoid many of the more common errors by working only with a certified, reliable, conversant production company – one experienced in producing medical devices and their components – often from molded plastic
Medical Device Product Development
Every year, medical devices fail to succeed. The inventor is unable to capitalize on the market. And the fault is often the inability to work in partnership with a qualified medical device product development company.
