Optimal Medical Device Prototyping for Getting to Market Sooner

Feb 18, 2021

Bringing a new Medical Device from conception to production, into the market is a process that can take years. It costs a lot and requires substantial manpower – technical and non-technical. For new medical device developers, getting your device into the market, and having it taken up well by end-users is a big deal. If the end-users find faults in the device’s operation, or if there are production issues, it is close to impossible to restart the process of designing and eventually production. For established OEMs, time is of the essence, and establishing the quality of their brand is vital to business success.

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Why Medical device Prototyping So Important?

Your best bet to achieve a successful launch is to ensure that you don’t skip medical device prototyping – a key phase in the design and development process. Best practices in the process of launching a device will also bring in huge savings in terms of time, resources and expenses.


There are three core elements that are to be considered at the Proof of concept stage:

  1. Functionality of the medical device
    Does the product perform the function that it was conceived to do?
  2. Compliance with regulatory requirements
    The FDA has set forth a number of limits and regulations. FDA approval is given to market the medical device, only when every one of these requirements is met.
  3. End-User Experience
    Physicians, nurses, technicians, or patients themselves are the end-users of the medical device. If they find that the device is defective or has some shortfall compared to other medical devices, their experience will not be positive.

If these core elements are not carefully assessed, planned, and tested through prototyping, then problems may arise at the FDA approval stage, production stage, or with the end-users which can negate profitability and brand leadership in the market.

Best Practices: Medical Device Prototyping Shortens Timelines

When you create a prototype to test your set of parameters (based on its Functionality, User Experience, and Regulatory compliance) you will find yourself creating a number of iterations, each iteration displaying improved performance (also called a Minimum Viable Product). Each iteration is rigorously documented for design control, risk management, and also as part of regulatory submissions. This continues until the prototype fulfills all the required parameters.

It stands to reason therefore that whoever is responsible for listing out the evaluation parameters for the prototype should be someone who has vast experience and knowledge in the requirements for medical devices. Involving your in-house R&D team is imperative. Secondly, involving your Contract Manufacturer who will be responsible for production can add valuable experience and also provide Design for Manufacturability (DFM) capabilities which will help you circumvent production issues, use the best materials and eliminate waste. You can also opt to outsource prototyping to a specialized medical device prototyping company.

How to Shorten the Development Process?

If you miss one necessary evaluation parameter (especially regulatory), it will affect your timeline, profitability and possibly endanger your device’s market success. Gaining important knowledge takes years of research and hands-on experience. A good way of finding success by finding a medical devices contract manufacturer with experience to serve as a trusted partner that can guide you through the challenges presented of successfully bringing your product to market.

The advantage of partnering with Quasar at the conception stage will enable Quasar to supplement your in-depth product knowledge with our prototyping capability, design for manufacturability capability, regulatory requirements, and market intelligence. This complimentary partnership will eliminate development mistakes and decrease your time-to-market tremendously. Consequently, you will also reduce the overall costs of launching your product.

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