Technical personnel such as engineers and designers need to have input on a device's features and intended functions.
In the fiercely competitive medical device and instrumentation industry, speeding time to market is important to edge out competitors and begin generating revenue for products that often carry long and expensive research and development cycles. Pushing products through the development life cycle is essential for distinct market presence.
A common obstacle to successful market launch is the transition of medical products from design to manufacture. Problems at this stage often lead to unnecessary costs and significant delays. To ensure a seamless handoff from design to manufacture, companies must begin planning for transition early in the product design phase and assemble cross-functional teams. Further, medical device companies should conduct regular reviews to ensure that the project is moving according to schedule. OEMs must also train the manufacturing team and maintain morale far beyond the transition phase—this is critical to ensuring that quality products are delivered to market. Implementing these tips and techniques can help smooth the transition from the product development stage to full-scale production and help products reach the market on time and on budget.
1. Plan for the Transition Early
Figure 1. (click to enlarge
) Cost of change during product development. OEMs should have clear product requirement specifications before the design activities begin.
The first and perhaps most important step in a smooth transition from design to manufacturing is to start planning early. Making changes to the product design once the handoff to manufacturing has occurred will only create additional costs and time delays. The cost of change increases as the product development cycle time progresses (see Figure 1
Planning for transition must begin in the product development stage, well before the software and system verification and validation efforts have been completed. The timing is critical because manufacturability, testability, and serviceability must be considered during the design phase. Further, planning in advance allows the manufacturing team to be involved in the initial design reviews and to verify that the concepts meet the objectives of design for manufacturability and assembly (DFM/DFA).
Managing the cost of change also means making sure that the product requirement specifications are solid before the design activities begin. To do so, companies must gather input about the desired features and intended functions of a device or instrument from all stakeholders, including marketing, regulatory, safety, and technical design personnel. Once a comprehensive list of potential features and functions has been developed, the company must begin making trade-offs to satisfy cost, time to market, and product size parameters. For example, a project that has a six-month development cycle might need to trade-off custom software for a commercial off-the-shelf product to shorten the development time. Clearly defining these requirement specifications up front in the development cycle is paramount to reduce the risks associated with product changes.
Further, medical OEMs must make manufacturing a priority during the design process by involving production and quality control personnel as well as key vendors. Input from these parties can help avoid additional design revisions at later stages. Although change during the development process is inevitable, using the appropriate resources early on can minimize the probability of major change downstream.
At this point, the manufacturing team should begin developing detailed instructions for instrument assembly and setting up the production area during the pilot-build phase. Such preparation ensures rapid start-up once the transition phase is complete.
2. Assemble Cross-Functional Teams
Forming and utilizing cross-functional teams, composed of mechanical, electrical, compliance, systems, manufacturing, and quality engineers, can also smooth the transition from design to manufacture. The team should include members of the supply chain, such as buyers or planners, as well as suppliers, program managers, marketing personnel, and industrial design and human factors experts.
Members of these teams must bring a broad knowledge base. Combining their diverse skill sets and areas of expertise enables a holistic approach to device manufacturing and the regulatory approval process. Together, they can devise well-defined goals and objectives for each phase of development that minimize manufacturing obstacles and ensure that the devices adhere to FDA and European Union (EU) regulations.
Cross-functional team members can work closely together to review product requirements, address technical risks, and manage instrument costs. Assembling the experts and cross-functional teams early on facilitates manufacturability, serviceability, reliability, and a manageable supply chain for a given product.
Team dynamics play an important role in the efficiency of any multidisciplined project. The principles of “Forming-Storming-Norming-Performing,” or FSNP, can be utilized to develop a strong team. First proposed as a theory of group dynamics by American psychologist Bruce Tuckman in 1965, the FSNP concept provides an excellent starting point for the development of efficient teams in today's medical device industry.1
First, the forming stage is simply when team members are chosen and thus form the group of people that will be working on the project. Once the team is set, storming, or the process of confronting each individual's ideas and perspectives, takes place. This is the stage in which the team grows and becomes comfortable working with one another. Following the storm of ideas, challenges, and solutions is the norming stage, in which individuals feel more comfortable with their roles and begin working well together. It is typically during the norming stage that team members agree upon and establish common standards and procedures to increase efficiency. Finally, the team begins performing tasks efficiently and functioning as a true unit. Team members and vendors that are familiar with each other and have been through previous successful transitions can accelerate this process.
It should also be noted that a product can actually move through product development and transition to manufacturing too quickly. Moving too rapidly can result in a product that may require redesign to address manufacturability, serviceability, or reliability. By contrast, going too slowly could mean lost opportunities for the OEM.
For example, a diagnostics OEM developing a clinical chemistry analyzer paid the price for not assembling a cross-functional team at the outset of the project. The company developed the chemistry and assay protocol needed to perform the in vitro diagnostic tests on the bench and commissioned a contract design firm to develop an instrument to automate the process. When the company began transitioning the product to manufacturing, however, it became apparent that the assay protocol required additional functionality that was incompatible with the hardware. As a result, the product was never brought to market.
Most situations may not end in such catastrophe. But by involving both the development and hardware design teams prior to the transition process, the OEM could have saved an enormous amount of time and money and produced a commercially viable and potentially profitable product.
3. Implement Staged Reviews
Continual checkpoints should be set up throughout the product design and development process, including critical design, pilot production readiness, and manufacturing readiness reviews.
Critical Design Review. A critical design review should occur at the completion of the product prototype phase and prior to the release of documentation for the procurement of pilot material. This review must assess product design to ensure that the hardware and software meet system requirements prior to pilot production.
Pilot Production Readiness Review. A pilot production readiness review can help determine whether a product can begin its transition to manufacturing. This review verifies that all appropriate design and program activities are satisfactorily completed and that the program team is prepared to build pilot production units. It ensures that the system design meets all applicable specifications and customer requirements and is mature enough for pilot production units to be built by operations. During the review, team members record findings, deficiencies, and technical issues. They compile an action items list and identify the individuals responsible for resolving them.
Manufacturing Readiness Review (MRR). A final MRR is conducted after pilot production units are built and design validation is complete. This review verifies that the product is ready for full-scale manufacturing. A designated review leader should identify and request personnel from appropriate departments and functions to act as reviewers. Ideally, a review team includes representatives from engineering, operations, strategic sourcing, and quality assurance. The review verifies that all appropriate design, validation, and manufacturing preparations are complete and the program is adequately prepared to move to the production phase.
Because the MRR should be stringent and thorough, some companies use an MRR checklist to understand the status of the design and associated documentation. Ultimately, the checklist can prioritize outstanding tasks that need to be completed to meet schedule and production requirements. During a recent product transition of an automated microbiology system, for example, KMC Systems used its MRR checklist to prioritize remaining development and transition tasks prior to production. Each task was then delegated to either the engineering or manufacturing team for efficiency. The process helped the OEM meet its product launch date.
4. Train the Manufacturing Team
A crucial part of transitioning a product from design to manufacture is the transfer of knowledge and technique from the engineering development team to the production team. An effective training path ensures complete knowledge transfer and minimizes wasted time on faulty products. Many different strategies can be utilized to train the manufacturing team. One of the most important is to allow team members, including assemblers and testers, to be involved in developing the procedures that will ultimately be used to manufacture the instrument or device. Such involvement gives them ownership of and comfort in their work.
Additionally, utilizing a computer-aided design (CAD) or manufacturing execution system that provides simple text and picture-based instructions can minimize training time and ensure quality. For example, certain CAD systems with product data management add-ons can generate enhanced PDF documents based on the geometry used to design the product. These types of systems can help quickly establish a training program and create service manuals for a new product.
Finally, cross-training is a valuable tool that provides flexibility of resources and can enhance efficiency. Cross-training the manufacturing team helps assemblers and testers develop an appreciation and knowledge for downstream and upstream processes. This method also allows team members to provide feedback that could enhance the manufacturing processes. In addition, the manufacturing team needs to be in tune with Current Good Manufacturing Practices as well as other FDA guidance regarding medical device manufacturing.
5. Maintain Morale During and After Transition
Even after the manufacturing team has been trained, it is important to take steps to maintain morale. For example, daily morning stand-up meetings can keep all team members abreast of production goals while allowing them to play an active role in the management of the production cell. A company can also keep a large progress board, which should be updated each time an end product or major subassembly is completed, to communicate the status of each project. Implementing a lean improvement program is also a win-win because it increases team spirit and contributes to a more efficient manufacturing process. For example, allow assemblers and testers to submit suggestions for a way to improve a specific process they perform as well as a basic cost analysis. Each month or quarter, hold a drawing and award a cash bonus to someone who participated in the lean improvement program.
Whether an OEM plans to outsource manufacturing or not, the transition from design to manufacturing can be either a path to success or a roadblock to final product launch. Getting products to market on time and within budget is highly dependent on the transition stage. Manufacturers that take manufacturability into account early and train cross-functional teams can reap rewards of condensed development cycles—which may mean even larger profit margins.
Frank Pawlowski is manager of technologies and solutions and Bill St. Onge is director of manufacturing at KMC Systems (Merrimack, NH).
1. B Tuckman, "Developmental Sequence in Small Groups," Psychological Bulletin 63: 38-99.
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