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Challenges for Startup Companies in Medical Device Product Development

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Challenges for Startup Companies in Medical Device Product Development

New medical devices, both those used by patients as well as those used by medical staff, are providing new options in treatment for patients of all ages and with many different types of conditions. Developing an idea for a new product or one which can greatly improve on an existing device on the market is a starting point for many new companies.

Unfortunately, the time and the cost of medical device product development and approval creates obstacles for many startup companies. The vast majority of these companies do not see their idea come to fruition due to failure to meet specific requirements for approval and failures during development and testing.

Partnering with Experienced Contract Manufacturers

One way for startup companies to address the challenges of medical device product development is to partner with an experienced company. These contract manufacturers offer the expertise, experience, and equipment to turn the design into a prototype product and then move into production once approval is granted.

The process from concept to approval can be years, and this is a time where the company does not have incoming revenue. By choosing a contract manufacturer to assist with design and medical device product development, the time to market can be reduced.

By choosing a specialized company offering molding services for the medical device industry, you also have a partner with working experience of the verification and validation processes, as well as FDA standards. This also helps to avoid spending months working on the project only to find some component will not be in compliance.

With these companies as partners, startup companies in the medical device field have the benefit of their experience as well as their production capability. It also reduces the need for the startup company to fund production in-house, helping to manage costs until the device is approved and sold.

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