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Stage – ID3: Develop the Opportunity

Following on from design are those activities that ensure a product is fit for purpose over time, that it is reliable, of consistent quality and performance, and cost effective. Development therefore includes further market analysis, proof of concept, prototyping and design for manufacture - which is where businesses with specialised equipment and skills come in.

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Task Overview

At an early stage of the product’s development stage, it is important to start considering the test and evaluation phases to ensure that the product is compliant to the agreed requirements and design specifications. Clearly, some products will require a more comprehensive test plan than others e.g. something that is going to be subjected to a harsh environment may be required to undergo a series of environmental tests to ensure that it will withstand, things such as temperature extremes, shock testing, vibration testing etc. as opposed to a product that is going to be situated in a controlled and stable environment.

The thoroughness of the prototype evaluation will pay dividends in terms of proving the design concepts and reduce the levels of ‘in service’ maintenance costs. It will therefore be important to build a realistic timeframe of the prototype evaluation into the development programme, thus ensuring that further design enhancements can be made and incorporated.

What you need to do

  • During the development stage, ensure that testability is built in;
  • Build testing / evaluation into the programme plan;
  • Review and update your technical file, including:
    • Materials/technologies that you use.
    • Potential benefits to users and purchasers.
    • Relevant regulations and standards.
    • What tests apply to your product.
  • Then, review your patent searches:
    • Confirm novelty of your technical ideas (many apparently novel ideas have already been patented).
    • Ensure you are not infringing patents for other materials or technologies you intend to use.
    • Review published literature again to double-check that your ideas have not been tried before.
  • Use internationally recognised standards as reference points e.g. British Standards Institute (BSI);
  • Use documented test scripts that will allow repeatability and assist in demonstrating functionality to interested parties;
  • If you can, use an independent test team (not the designers), to test the product to the extremes of its design parameters;
  • Always document the test results for traceability back to the design requirements;
  • Where appropriate, to obtain stakeholder engagement in the design proving stage, so that changes can be incorporated at an early stage and confidence is established by all parties;
  • Begin preparations for any initial patient-based, pre-market studies required for regulatory approval. This may include getting MHRA and ethical committee approvals – allow plenty of time for this.