Life sciences and diagnostics companies are innovating at a fast pace to combat the constantly changing landscape of biology and disease. Patient lives and doctors' trust rely on dependable products, while your company's reputation hinges on well-designed, effective products and timely product launches. Given the complexity of successful product development and launch, it's crucial to consider key factors that can prevent manufacturing delays, regardless of the current development stage. Building a Successful Product To achieve success, a product needs a strong foundation: clearly defined requirements and a solid system architecture. While it's tempting to jump into building prototypes, having a roadmap guided by requirements and architecture prevents wasted effort and costly rework. Key Considerations in Product Development Successful product development requires several key elements: User Needs: Product development involves balancing various design inputs, including market requirements and user needs driven by a variety of stakeholders considering regulatory, manufacturing, service and clinical needs. Product Requirements: These design inputs must be efficiently collected, synthesized and organized into a clear set of product requirements. Life Sciences Complexity: Life sciences devices have an added layer of complexity due to the connection between the physical device and biochemistry, which are often developed and optimized in parallel with the associated instrumentation. System Architecture: The system architecture must incorporate all system requirements and clearly illustrate key design decisions that impact product performance, form-factor and functionality throughout the product life cycle. A well-designed architecture considers the design team structure and can be used to plan projects and manage the team efficiently. Traditional vs. Iterative Approaches Traditionally, product requirements are set before developing the system architecture. However, the complexity of life sciences products and external pressures (like time-to-market) often lead to a parallel and iterative process. Experienced designers, engineers and manufacturing experts play a crucial role early on by identifying essential product requirements and determining what's technically feasible within the system architecture. Design Review: Detailed and Early It is possible that you are further along in the development process with your teams already generating designs and building prototypes. While there is still value in revisiting and aligning on product requirements and architecture, you can charge forward fully leveraging the work your team has already accomplished and consider an independent and non-biased review of your design/prototype. Technology Readiness Levels (TRLs) are an industry standard which provide an objective assessment on whether the technology is ready for commercialization. By understanding your TRL, you can ensure you’re mitigating risk and ready for a successful launch. Manufacturing Test and Supply Chain Strategy Successful transition of a product design into full-scale production requires managing the supply chain and design and implementation of manufacturing tests. With so many things to manage as a product is developed, these areas are often only given cursory consideration early in the development process, which can lead to increased costs and delays as you prepare for new product introduction. This oversight can result from miscommunication between R&D and manufacturing teams within your organization or from working with external design firms that lack full-scale production capabilities. Development of the overall manufacturing test strategy should begin as early as the system architecture definition. A manufacturing test expert should be involved throughout the design phase to adapt the test strategy in response to specific design decisions and to determine the right time to initiate test equipment design and implementation, ensuring a smooth transition to production. Key decisions at the PCBA level, such as opting for in-circuit or functional tests, should be determined prior to board design to prevent expensive redesigns later. End-of-line testing for life sciences products may require special considerations due to the potential use of biological agents such as fluids, bacteria and viruses. Regarding the supply chain, a common pitfall is when engineers select components from small, local, specialized suppliers. While the component may be functional for a one-off engineering prototype, the supplier may not be viable for higher volume production. This decision is propagated through final design phases, but when the life sciences manufacturing site becomes involved, the supplier could be deemed unusable. Poor component specification, lack of quality standards or long lead times could lead to disruption in your timeline highlighting the importance of considering supplier capabilities early in the design process. Power of Partnership with Plexus We’ve highlighted a number of important considerations as you design and launch a new product. Each product development program has its nuances and unique challenges, so there is never a one size fits all solution. If your go-to-market strategy involves a design and manufacturing partner, early engagement can provide you an optimized path to a commercialized product, but whatever stage of development you are in, it is never too late to engage Plexus. The Plexus product development process is designed to efficiently collect and synthesize design inputs into a comprehensive set of product requirements. This is informed by decades of product design and development history and experience launching 150 products a year powered by our experts including: User-Center Design team members specialize in studying, understanding and documenting end-user needs, which helps bridge the gap between a product marketing team’s vision and engineering services constraints. Life Sciences Technology Managers translate the needs of biochemistry and diagnostic assay development teams into engineering requirements and ensure the product development strategy appropriately considers biochemistry and specialty technologies for your life science instrumentation. Systems Engineering team members specialize in writing an architecture document, which effectively decomposes a complex system into manageable subsystems. We assess the Product Maturity Level to determine if the overall product is ready for market. These assessments are driven by our Systems Engineers, but all of our technical disciplines will be utilized as necessary. Plexus also follows the Advanced Product Quality Planning (APQP) process throughout the product lifecycle. APQP combines industry standards into one tool to manage reviews, approvals, communication, knowledge sharing, reporting and metrics. Working with a healthcare and life sciences design and manufacturing partner with experience in these processes and standards will set you up for a successful product launch. If you need a comprehensive review of your existing design or prototype, a Design for Excellence (DFX) analysis will help you determine gaps between engineering prototypes and manufacturable units. Plexus has decades of experience in successful product launches and our 500 dedicated design and development engineers can carry out a suite of DFX services to ensure you have a well-designed product ready for full-scale production. Key DFX analysis for PCBAs: Design for Fabrication Design for Assembly Design for Test (Schematic, Access, Strategy) Electronic Lifecycle Analysis Restriction of Hazardous Substances (RoHS) Key DFX analysis at the subsystem or system level: Design for Component Fabrication Tolerance and Interference Design for Assembly Material Compatibility Process Flow Attachment and Retention Cable and Harness Label and Packaging At Plexus, our design and development teams work seamlessly alongside supply chain and manufacturing to enable a smooth product transition. Our Life Science Technology Managers collaborate closely with you and our teams to develop the most effective product development strategy. By embedding supply chain experts within the design process, we ensure supplier decisions are considered from the earliest stages. As your manufacturing partner, we also provide access to Plexus’ extensive supply chain network, creating opportunities to engage preferred suppliers and achieve more competitive component pricing. Our goal is the same as yours: a successful and timely launch of life-changing products. Connect with our team to learn more about Plexus’ commitment to your success.