How to mitigate unforeseen costs during product development

Keeping costs in check during product development

Prototyping ServicesDeveloping a novel medical device idea is governed by two key aspects. The first one is whether your medical device will help solve a medical problem in an innovative and unique way, justifying an investment of time and resources. The second aspect is cost.

Prototyping costs

Medical devices evolve through different iterations of prototypes, going from crude to factory form. You need to allocate time and resources for this tiered prototyping approach and consider every facet of the process carefully:

  • Human resources:
    Do you have staff available in house to run your project and what processes of the development cycle will you need to outsource to a product development services provider?
  • Logistics:
    Do you have the adequate equipment, like 3D printers, and lab or plant floor space available? If not, will you buy additional equipment or subcontract to third parties that specialize in specific product development services and have the right equipment readily available?

Production costs

Your production procedures must be clearly defined to ensure a short turnaround. If your product is not practical or appealing to end-users, you will find it hard to take it to market.

  • Standardization and automation:
    How much of your production process follows widely available procedures? If every part needs to be custom made, or the raw materials are not easily obtainable, your device will not only take much longer to produce, but will also be a lot more expensive. Product development service providers can help you standardize your device’s production requirements.
  • Final product design:
    You need to consider the marketability of your medical device and take things like packaging, shipping, storage, power supply, shelf-life and build quality into account to ensure your product is viable, commercially appealing and worthy of investment.

Costs pertaining to end users

Any medical device needs to appeal to the broadest user base possible. Your market research and design production must keep real-world applications in mind, as healthcare professionals handling your equipment will need to know what they are doing.

  • Training and documentation:
    Your medical device must be adequately documented, easy to use, and be supported by appropriate training strategies.
  • Testing and clinical trials:
    A medical device needs to be thoroughly tested for build quality and safety, as well as medical efficiency. This can start at early stages of the design process and should be supported by product development services providers, should you choose to outsource.

Regulatory compliance

Your medical device needs to adhere to rules and guidelines as defined by the regulatory bodies governing your target market, like the FDA in the United States. If your product’s design, use, or production process does not line up with these regulations, it will not be cleared for market without retooling. This can negatively impact your time to market and eventual profit margin.

Taking your product to market

Through thorough planning from the earliest stages of product development, you will be able to identify key expenses and define your budget accordingly. Outsourcing to product development services providers can be a cost saving alternative to acquiring the resources required for in-house production. It will give you the opportunity to optimize how you employ your own resources to create an appealing and clearly defined exit strategy. In so doing, you are maximizing your chances of successfully taking your product to market.

Technosoft offers specialized in-house development procedures for prototyping, small scale pre-production, device testing, and clinical trial management. We can help you prepare for regulatory compliance submissions to ensure a smooth development process with no unexpected costs.

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