During this stage, you refine concepts that will address the needs identified during the Define stage. This iterative process irons out design flaws and risks to reveal the design which best meets the needs of both your users and your business.
Design development methods we use include; creative techniques, brainstorming, visualisation, prototyping, testing and scenarios. A design concept’s feasibility is evaluated to consider human factors, usability, risk and mechanical perspectives. The evaluation results feed back into the next design iteration. Subsequent testing of iterations ensures that you have successfully controlled the use-related hazards and that new risks have not been introduced. The MDA’s smart, innovative approach to device design and development ensures iterations are effectively minimised.
In parallel with device development activities we can support you with your clinical evaluation. A clinical evaluation assesses and analyses clinical data concerning safety or performance of your device (or similar devices or therapies) and determines the need for clinical trials.
We guide you throughout the development process, helping you document changes to device, instructions, labelling and user training as their control is crucial to device quality.
Design outputs are the deliverables from this stage. They consist of production specifications and descriptive materials, which define and characterise the design. Verification confirms that these design outputs are fit for purpose and that the product design meets specific functional and operational requirements.
We support you in creating the design outputs and their verification, for example with design reviews, summary design verification, summary usability evaluation and risk analysis. At the end of the stage, the design process will have brought the product to a point where it is ready for scale up to industrialisation and production.
We work with Design Controls ISO 13485:2016, Risk Management ISO 14971, Usability ISO 62366 and cGMP (Pharmaceutical Good Manufacturing Practice)