Pilot production31 May 2022
Developing a medical device from the initial idea or concept through to full-scale production is a challenging task for any company, but especially for SMEs or start-ups developing their first product. In the case of photonics, MedPhab, Europe’s first pilot line for medical devices, can help companies accelerate the time between concept and production. Jussi Hiltunen, research professor at VTT Technical Research Centre of Finland, as well as MedPhab coordinator, explains how MedPhab’s combination of technology and expertise helps product developers bring their ideas to market.
In the field of photonics, delays in product development are frequently caused by the heterogeneous nature of photonic technologies and the fragmented offerings of supply companies. Consequently, the more widespread use of photonics in scattered ecosystems presents major challenges for both end-user companies and manufacturers. To make things more difficult, meeting regulatory compliance can be a challenge when establishing a full supply chain to cover all the required technologies in a product. MedPhab is a consortium of research organisations, as well as industry partners, which aims to bridge the gaps in knowledge frequently seen in these areas and accelerate medical photonic product development by establishing a sustainable open access pilot line.
The challenge we are addressing is the complex nature of the different technologies and types of organisations needed to advance medical photonic products and applications. Manufacturers are responsible for an entire spectrum of development, production and life cycle management. So MedPhab’s approach is to have a single-entry point to access the whole consortium. At the front end, manufacturers can describe their challenge, which is then assessed by medical device professionals, who guide them to the right partners. Depending on the maturity of the development phase and the required technologies, MedPhab can assign both research organisations and industrial supply companies with ISO13485 certification to work together to deliver for customers.
Once the appropriate partners are selected, challenges are broken down according to a standard way of working, allowing them to be addressed in a structured way. This enables a swift delivery of tangible and transferable bodies of work and clear next steps towards a solution. MedPhab has been developed to provide a comprehensive source of relevant knowledge for photonic medical device development, to maintain this ecosystem and to facilitate easy access to these resources.
Structured way of working
The structured way of working in the consortium allows us to streamline a development request based 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 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 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 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 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 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 taken in use by means of Measurement System Analyses (MSA). Logging of results also needs to be considered.
Suppliers need to be selected, and contract and quality management needs to be in place. There is a lot of value in anticipating the supply chain in early stages of development. Making a clear visual overview of the supply chain helps us understand the dependencies and risks. The various partners in a supply chain need to work in one well-organised flow, and logistics planning is of essential importance.
In the production line, the products are made according a fixed Device Master Record (DMR). The DMR contains the “what to make” and the “how to make” (drawings and instructions). The production line needs to be validated, meaning it needs to constantly perform as expected. In the early stages, it is very valuable to have a clear view of batch and/or production targets, such as quantities, cost and yield.
Support from EU for the customers
The structured way of working across MedPhab partners can provide big benefits for the companies developing medical devices. Currently, MedPhab has secured extra support from the European Union to lower the monetary barrier of doing business with MedPhab in the so-called ‘Open Call’ programme. The EU provides subsidised financial support to up to 20 business cases over a two year period, with the 2022 intake expected to complete their projects in 2023. For small and medium enterprises (SMEs) the support is 75% of the costs, and for large enterprises it’s 50%.
MedPhab was established to simplify the product development of photonics-based medical devices. An open innovation pilot line provides a single-point gateway to identify and access the right partners with the best know-how to support customer needs. The companies are guided to incorporate new technologies to enable them to continually innovate and to launch products faster and easier. MedPhab provides support to understand how to complete development while meeting regulatory compliance that covers the full development chain.
In addition to supporting product launch, MedPhab industrial parties also have the capabilities to design and implement the upscale of production, without changes in the supply chain.
The financial support the EU provides to 20 large enterprises over two years.
The financial support the EU provides to SMEs over two years.