Developing a new product is a complex and dynamic process that requires lots of collaboration. It involves multiple stakeholders, including engineers, designers, suppliers and regulatory bodies. One key to successful new product development is managing suppliers effectively, ensuring they meet the required quality standards, cost targets, and delivery schedules. Medical device supplier management is priority number one when launching new products.
Explore our guide for an outline of the five phases of new product development below where we provide tips for strategic supplier management in each phase.
Development Phases
Phase I: Concept Development
The initial stage of new product development is known as the Concept Development phase. During this phase, the principal elements of clinical/marketing input, design feasibility, and user needs are established, and the process can begin. It starts by reviewing customers or marketing requirements, serving as the foundation for developing concepts and models.
Engineers often want the freedom to design concepts and models by sourcing unique parts from unconventional sources. These sources could be big box hardware stores or auction sites to concentrate on the product’s overall functionality without being restricted by cost or component availability. However, gathering parts from these sources is not reliable because the concepts must undergo testing. Rigorous tests include feasibility analysis, technology evaluation, IP review and regulatory compliance assessment to ensure their viability.
Medical device supplier management in this phase typically involves reviewing the current suppliers of the concept components. This helps you determine if they are approved suppliers who already meet the necessary criteria for a reliable, cost-effective long-term relationship.
If existing suppliers are not on the approved list, Nortech’s supply chain team will coordinate the expansion of the list or recommend alternatives. The goal is to source from approved suppliers to ensure the components and materials used in the concept prototype meet your quality and cost standards.
Phase II: Planning & Architecture
In Phase II, create a project plan. Conduct a risk analysis and determine the technical and regulatory requirements. The requirements document should be finalized, and critical suppliers should be informed of any changes or updates.
It’s important to engage with suppliers during this phase to ensure they have necessary capabilities and capacity to meet your requirements and project deliverables. A regular review and communication process should be established to guarantee any changes or updates are communicated effectively.
Phase III: Detailed Design Development
The next step of medical device supplier management is utilizing the design inputs to develop design outputs. These design outputs become the basis of the Device Master Record (DMR) and are initially released. Now the focus shifts from conceptualizing the product to refining the design. The goal during this phase is to ensure the product design is functional and also manufacturable in the long term. Focus on optimizing manufacturing processes to guarantee it can be consistently produced at scale and cost-effectively.
Having well-established and functional working partnerships with approved suppliers is crucial in moving the design closer to the production stage. It’s especially important when considering supply chain risk management best practices.
Phase IV: Test Verification and Optimization Documentation
Phase IV of medical device supplier management is design verification. The design outputs from Phase III are now evaluated for conformity against the design inputs from Phase II. Next, the pre-production build is performed, and product verification tests are conducted. After this is completed, all documentation in the Bill of Materials (BOM) is moved to production control.
During this phase, suppliers must verify the components and materials used in the pre-production build meet the necessary quality and cost standards. Nortech’s program management and supply chain team will maintain regular communication with suppliers to ensure they are aware of changes or updates to the BOM.
Phase V: Validation and Launch
In the last phase, Phase V, perform a production build for clinical trials. After a final clinical report and risk analysis report is completed, regulatory approvals are obtained, and a market release plan is utilized.
At this point in the process, cost competitiveness is an influential factor but not the only consideration in choosing a final supplier. It’s crucial to evaluate the supplier’s ability to provide the necessary components and products with consistent quality at your desired price to ensure reliability and long-term viability.
Medical Device Considerations
The development and production of medical devices are subject to strict regulations and standards due to the critical nature of their use. The components and materials used in the design of these devices must meet these standards, and supplier management plays a crucial role in this regard.
Regulatory standards require traceability of the components and materials used in your design. This ensures the safety and effectiveness of the medical device. The manufacturer must demonstrate that these components meet requirements and standards, such as dimensional, strength and material requirements. As a result, it’s common for medical device manufacturers to have a well-established and reliable supply chain with suppliers who have been approved. It provides a higher level of assurance that the components used in the design meet regulatory standards.
How Medical Device Supplier Management Can Help
Keeping customers informed of supplier management progress, timeline tracking and budget status through effective program management is very beneficial. The program manager can establish trust and transparency by providing regular updates and promoting better communication and collaboration between all parties involved.
This frequent and complete communication can reduce confusion and prevent potential issues from arising, ultimately leading to a smoother and more successful project outcome. Additionally, by staying ahead of potential roadblocks, program management proactively addresses challenges and adjusts plans as needed, making sure the project stays on track and within budget.
Maximize the success of your new product development by partnering with Nortech Systems for effective supplier and program management. Our practices, including early supplier engagement, regular communication, and close collaboration throughout each phase, guarantee that components and materials meet necessary quality and cost standards, resulting in a successful launch on time and within budget.
Contact us today for seamless communication and cost-efficient solutions!