The technical feasibility process (TFP) is the stage in the medical device design cycle when conceptual designs are developed and refined prior to initiating the formal design control process. TFP has long been a rarely discussed subject among medical device professionals, yet it is crucial in the development process both from a technical and business perspective. When NOT efficiently or adequately carried out it can lead to significant challenges downstream. The main goal of the early stage project team during TFP is to create conceptual designs that generate evidence for making the risk-based business decision of initiating the design control process. Often this goal must be achieved under organizational pressure to quickly deliver a design of sufficient quality and performance to attract investors, and/or receive internal endorsement to initiate the design control process.
Despite the pressure, it is important to prevent a rushed, poorly assessed, or poorly understood design requirements and base knowledge from being handed over to the development team. Sufficient evidence and information must be provided to decision makers, and it is preferable that this evidence be documented. Throughout this iterative process it is ideal that the project team can quickly pivot as the design and requirements evolve. Therefore, a major challenge during this process becomes achieving the objective of gathering sufficient evidence and knowledge without over-burdening the project team.
To help medical device project teams with this balancing act, particularly start ups, we are sharing the top 3 tips we encourage all our clients to consider implementing for a successful TFP. By following these recommendations, teams can maintain a lean and agile program while also slowly building up towards complying with quality processes, specifically design controls:
1. Documentation Strategies:
It is our recommendation that project teams begin generating documentation describing their design as early as possible in the TFP without overtaxing the project team. Quickly creating minimally detailed test reports and design description specifications and documentation is ideal for the early stages of prototype development. We recommended limiting these early reports to a purpose, results and conclusions/next steps as a design/prototype evolves. Further, we recommend that the review process for these reports be restricted to only the project team in the spirit of avoiding overly scrutinizing and too many back and forth discussions.
2. Document Revisions:
Going hand-in-hand with documenting a design is the use of document revisions. It is essential for understanding design progression, as well as providing a means of traceability throughout the project. The use of document revisions should be applied not only to components, subassemblies, and devices, but also to any documentation generated. To assist with traceability, it is also helpful to include a BOM with component/subsystem/device revisions to provide reference from where this data originated. This helps make it possible to track changes and informal design decisions prior to the implementation of formal design control and design change processes. When revising documentation and up-revving documents, including a short summary describing changes between document revisions is strongly encouraged. Lastly, by implementing document revisions during TFP provides a baseline version of the device and associated components/subsystems that were used to close TFP, and form the basis of the design and development plan at the start of the design control planning phase.
3. Purchasing Controls:
As a project team begins creating very early prototypes, they are almost certain to begin working with suppliers, providing either components and/or technical services. Requiring team members to follow purchasing controls and acceptance activity procedures ensures a certain level of quality early in the TFP. It will be necessary to gradually roll out and work through acceptance activities with suppliers as the design evolves and is better understood, and this controlled roll-out should be defined in the purchasing controls SOP. It provides reassurance to the project team in several ways:
- Suppliers have been appropriately and sufficiently vetted and have been added to the approved suppliers list.
- Processes are in place internally, and at an approved supplier’s facility, to ensure a sufficient level of quality and to prevent issues/non-conformities that could confound test results.
- Changes (both internal or external) are being monitored and reported as necessary to ensure design documentation remains up to date and in alignment with test results
- Any gaps with accumulated test data and reports are known or can be easily identified and addressed.
By following these 3 tips, project teams are put in the best position to kick off the design control process armed with an excellent source of information and evidence, as well as the ability to trace the design and have complete knowledge of the reason behind design decisions made. For new organizations, following these recommendations also helps begin to form a culture of quality with clearly established and understood expectations.
By Thomas Moore, President at PTL Solutions Inc. and Marc Lukacs, PhD, Vice President – Engineering at PTL Solutions Inc.
Thomas Moore has worked in the Medical Device Industry for almost 20 years and has extensive experience leading projects that are compliant with FDA and ISO regulations. These products included medical devices of all types, classifications and involved all manner of regulatory pathways. Most recently, Thomas has consulted for several medical device manufacturers to help review and improve their QMS and accompanying documentation. Thomas manages PTL Solutions Inc., a medical device consulting firm providing quality and regulatory support.
Marc has over 15 years experience working for medical device manufacturers, and direct experience establishing a Quality Management Systems (QMS) starting from zero. Marc has developed QMS that are compliant with FDA regulations, ISO 13485, ISO 14971 (risk management), ISO 62304 (software) and MDSAP for several organizations. These QMS were developed for organizations developing medical devices that included electrical and mechanical hardware, software, and wearable technology.