This phase is for refining concepts and initial designing, prototyping, and iteration driven redesign. With Mi3’s Quality Management Systems certified and audited to ISO 13485:2016 via MDSAP our experienced regulatory team can support you every step of this process including providing assistance around intended use, associated risks and proposed classification.

Typically device classification is agreed with your Notified Body. It is important to get the classification determined early in the process in order to understand the regulatory pathway and requirements. Medical device classification is based on the risk associated with the use and enforced by law. Partnering with Mi3 will give you confidence that the business requirements for the product are factored into the design, development and manufacturing processes every step of the way to develop a robust business case to aid securing the vital funding required for commercialisation. The Engineering team at Mi3 are experts in understanding plastic materials, geometrics and manufacturing technologies that allow for concept refinement and are able to advise further in this area.Ĭonsideration of all the facets required to commercialise a new product is a complicated process and all these ultimately feed into the regulatory requirements for the regions of sale and the initial business case for realising the product. The more understanding of the need the more inputs can be created and enhance the product definition at this stage. If there is no or little need for the product then it is unlikely to succeed in the market. Identification of need is only the first step in a series of complex processes required to bring a medical device to the market. The idea for a new medical device typically comes from the discovery of an unmet need. Seven key steps can be identified in the process, along with the critical outputs an experienced contract manufacturing partner such as Mi3 will bring to the process. Partnering with Mi3 on the journey to design & develop your device will ensure that every consideration is made from design planning and regulatory strategy to meeting end-user needs compliantly, cost effectively and ensuring patient safety. Safety is a priority in medical device design as it is a requirement to ensure that devices meet functionality, reliability and safety features. You must carefully evaluate needs, functional requirements, specifications, and more, all while assuring quality and managing risk.

There is so much more to consider when designing and developing a medical device than having an innovative idea and then ‘simply’ manufacturing a product. When commercialising a new concept or device, why is it so important to partner with an expert for medical device design & development? Simply put because a loosely defined and designed product cannot comply with regulatory needs and it will fail to deliver the user defined functionality and benefits.

As a contract manufacturer, we take your product ideas from consultation to concept to production, working alongside you to bring your medical innovation to life. Mi3 are the experts in designing, developing and manufacturing end-to-end advanced medical and surgical solutions with our specialist knowledge spanning across the medical device, IVD and Biotech sectors.

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