Product Realisation
Bringing a new medical device or medical diagnostic product to market carries certain risks, and many companies incur additional costs and unnecessary delays by failing to fully understand these risks.
Over the last 10 years, Runfold Medical has applied our specific experience and knowledge into developing a proven process for delivering product realisation for Class II and Class III therapeutic and diagnostic medical devices.
Typically, most companies adopt a four-stage process. Firstly, they identify a technology and clinical need, then begin product design and development activity using an internal or external deign resource. Secondly, they commit more time and financial resources to completing the product design and development process before, thirdly, handing it off to an internal or external manufacturer. A fourth stage involves regulation, which is critical as all medical devices require regulatory approval before they can enter the marketplace.
Often called in to redesign or re-engineer products when things have gone wrong, our direct experience shows how costly these project handoffs can be. Which is why at Runfold Medical, we take a different approach and ask a different set of questions:
- Has the product been designed for manufacture - can it be made?
- Are the proposed materials suitable - e.g. physical properties, biocompatible materials, shelf life, sterilisable and so on?
- Have the user and product requirements been sufficiently understood?
- Have the proposed manufacturing processes been fully considered - e.g. sterilisation and packaging?
- Is there a manufacturing setup and investment strategy for the product design and development phase?
- Can the product be manufactured to the required specification for the target cost?
- Are the product design and manufacturing processes scalable?
- Who is responsible for verification and validation?
- Was the regulatory pathway for the product and its associated risks identified at the start of the project?
- Have the regulatory requirements for the product been effectively managed to ensure timely regulatory submission and approval?
- Has project risk management been effective across the entire project team?
Runfold Medical's Product Realisation process removes the risk of project handoffs with an integrated cross-functional project team. This means from day one your project benefits from the creative input of our industrial designers and development engineers, as well as invaluable input from our manufacturing, process and quality/validation engineers. Add to this, timely contributions from Supply Chain, Regulatory and Intellectual Property, and you have a highly experienced project team with a proven track record committed to your success.
