A significant factor to consider in the development of any new medical device is the cost involved in the early stages of the design and development of the product. For a startup company with a new concept, this can include years of work and millions of dollars in costs before the medical device can be approved and marketed.
This time and cost issue is not just relevant to startup companies in the medical device industry. It is also problematic for established companies, with all OEMs striving to find ways to meet all required processes and documentation for approval, but also ensuring all stages for the FDA approval process are completed accurately and with validation and verification.
The Design Phase
In most product development models, the design phase is the third phase in the process. The first is the full development of the concept, and the second is the research and product feasibility phase, where there is also the need to explore the market size and the other products in the same category.
The design phase includes all aspects of the product design development as well as validation and verification of the design elements, materials, and processes. As such, it sets the groundwork for the prototyping and later the final validation.
By using specialized medical device design services, the OEM can outsource this stage of the development to experienced product designers and engineers in the medical device industry.
Saving Time and Money
Engineers and specialists in medical device design can streamline this process, drawing on their extensive experience and expertise from past projects as well as an understanding of production options and methods.
By avoiding the common obstacles and challenges encountered by less experienced in-house teams, these specialists lower costs during this critical phase. Small changes in the medical device design can further reduce the costs of ongoing production, and they may also substantially increase the life cycle of the device, which adds to the benefits of outsourcing for the OEM.
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