Lasers & photonics
on two aspects: Technological need and maturity level. For the maturity approach, we make the distinction between the lifecycle of the product and the maturity levels of the technology itself. This prevents blind spots during development, helping to reduce risk and increase predictability. At the same time, it helps all MedPhab partners to speak the same language and ensure consistent and high-quality delivery. The lifecycle approach is based on the objective and level of control that is needed.
The MedPhab one to five lifecycle maturity chart articulates the pilot line’s position in a medical device development process flow. It helps to identify the lifecycle status and the scope of the development request. Furthermore, it gives a rough indication of a typical product development process flow, as well as the regulatory requirements and costings that need to be considered when maturing technology across the different phases. Many of these aspects might not necessarily be clear to companies seeking collaboration with MedPhab, especially in the case of novel technologies. For this reason, the chart is intended to trigger productive discussions between the customer and MedPhab partners in relation to project type, expected outcome and MedPhab’s bandwidth of development services within a product development cycle. Each phase is outlined in detail and all MedPhab partners are trained in this way. This enables a smooth transition from early stages of development, starting at fast learning, and continuing towards ISO13485 production. With the increasing level of maturity, the level of control increases, and clear attention points and deliverables are defined for each phase, improving transfer towards production. Typically, research organisations are used in the early stages of development, and industry partners handle the majority of the production. However, most relevant partners are chosen on a case-by-case basis. For example, there might be a need to investigate manufacturability in an early stage, meaning contribution from an industry partner is essential. Alternatively, research organisations can support tackling a complex issue in production, such as optical simulation supported tolerance analysis – a process that helps determine the level of precision required to ensure product performance.
Components of structured development During the development, customers work with the co-development partner within projects, following practical guidance on what is required for each phase in the pilot line. By taking this approach within our structured way of working, we eliminate confusion that predominately occurs when talking about phases, such as project management, concept development, process design, engineering, qualification and
Medical Device Developments /
www.nsmedicaldevices.com
production. All these names can have different meanings in different organisations, and even for different individuals, so standardising them ensures everybody is on the same page.
Project Management Project management can be described as the process of leading the work of a team to achieve all project goals within the given constraints. Development projects can fail because sufficient time was not spent identifying the short- and long-term objectives of the customer, and translating these into actionable items for the team. Project management helps to identify the scope of a project, including activities, planning, related deliverables, intended use and regulatory aspects.
Design
Design is typically the responsibility of the customer, but MedPhab partners can contribute to design work in various ways. It is necessary for there to be clarity as to the nature of the design or what the design needs to fulfil (requirements). Throughout the lifecycle, this will evolve from requirements towards a final design. In the early stages, focus will be primarily on addressing the requirements and learning regarding critical parameters to fulfil them. Particular methods are used to address the evolution of the design, such as the design FMEA (Failure Mode and Effect Analysis), which is used to assess risks related to the design, and DfX (Design for excellence), which is an all-encompassing philosophy providing design guidelines for the design and production process.
Engineering
Engineering is the improvement of technical solutions towards a design that meets the requirements and towards processes that can be applied in a controlled manner. Focus is on the production process, although the process always has a relationship with the design. Some of the main aspects are understanding the process flow and the related risk assessment. It might be necessary to develop specific tools for production, or to undertake experiments to fine tune the design. Learning cycles should be applied from phase to phase to get to process verification and validation.
Equipment
Equipment requires special attention, as it needs to be fit for the intended use. Uptake is typically done via Installation Qualification (installed and ready to use), Operational Qualification (fit for use) and Performance Qualification (released in relation to the product with consistent results). With respect to testing, it might be necessary to make a test strategy in the end to cover the important aspects of the function, design and potential failures. Measurement systems are typically modified and
63 50%
The financial support the EU provides to 20 large enterprises
over two years. Europa
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