By Robert R. Andrews, VP of Business Development, Optimum Technologies Inc.
Part 2 of 2
Successful product development of a medical device does not insure market success. The device must get to market in a cost effective and timely manner. Rapid transition of a product from development to manufacturing requires analysis of the processes to be used for production in the development phase as well as production qualification planning and execution. Neglecting these steps can lead to delays to market introduction, missing the mark for quality standards, and missing cost targets.
Given how innovative and unique most medical devices are, it is not surprising that many simply cannot be manufactured using standard equipment. A customized solution can be developed by either modifying existing equipment or developing unique proprietary systems. In either case, planning for manufacturing should begin as soon as a product concept is developed. Engineers will be able to assess whether standard equipment, a modified version of it, or a unique proprietary system is required as the project moves from initial design to process validation.
Manufacturing Qualification
Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) provide opportunities to improve the product development process toward optimizing manufacturing. As an integral part of any manufacturing operation, IQ, OQ and PQ should be considered as soon as a prototype is developed to ensure a seamless transition to full-scale production. Whereas IQ and OQ focus on facility specifications and how the manufacturing equipment operates, PQ helps ensure that high-quality and high product yields are achieved at full-production conditions.
Proper execution of PQ involves running production to identify acceptable tolerances for a wide range of conditions, such as pressure, temperature, line speed, sealing strength in packaging applications, etc. The best strategy is to test the full range of tolerances in the production process, including those for separate components. For example, it is important to test the minimum pressure that will be exerted on a product all the way up to the maximum to ensure the most accurate representation of real-world manufacturing conditions. Failure to test the full range of tolerances at line speed can result in serious manufacturing issues at full-scale production.
Given how innovative and unique most medical devices are, it is not surprising that many simply cannot be manufactured using standard equipment. A customized solution can be developed by either modifying existing equipment or developing unique proprietary systems. In either case, planning for manufacturing should begin as soon as a product concept is developed. Engineers will be able to assess whether standard equipment, a modified version of it, or a unique proprietary system is required as the project moves from initial design to process validation.
Design Tools
Medical device manufacturers should use all resources available to them to move a concept through to production faster and more efficiently. One such resource is Design for Manufacture and Assembly (DFMA), which is a methodology and software toolset used to determine how to simplify a current or future product design and/or manufacturing process to achieve cost savings. DFMA allows for improved supply chain cost management, product quality and manufacturing, and communication between Design, Manufacturing, Purchasing and Management.
Engineering firms familiar with the DFMA philosophy and software are open to a wide range of advanced technologies, and can help medical device manufacturers choose the techniques that will best drive product development and manufacturability.
From a manufacturability perspective, DFMA tools help avoid the “disconnect” that often occurs when the design team puts forth a product that cannot be manufactured. DFMA benefits the design team by allowing them to explore alternatives in processes and materials, while showing the cost impact of each decision. This allows designers to improve the manufacturability of their product through simplification and the selection of the process best suited to the design.
DFMA can also help remedy cost overruns, which are endemic in the product development world. It not only helps medical device companies identify what the main contributors to cost are, but it also provides analytical data as to how much a product will actually cost to produce. Further cost savings can be gained from the fact that DFMA helps internal and external teams work together better by serving as a communication tool and as a method to refine best design practices within an organization.
Process Failure Mode, Effects, and Criticality Analysis (PFMECA) is another resource that can be used to increase the reliability of the product and the manufacturing process. By conducting this analysis, malfunctions in the designed manufacturing processes can be identified and improvements made before refined prototypes are produced. The program considers overall design, operating, and service problems, while addressing process and safety problems. As PFMECA is closely tied to the design process itself, it reinforces the need for communication and collaboration early in the process. In fact, timeliness is probably the most important factor in differentiating between effective and ineffective implementation of the PFMECA.
New Opportunities, New Challenges
Manufacturing can function as either a gateway to success or an obstacle to realizing a final product. As the pace of innovation quickens and regulatory requirements grow more complicated, device manufacturers will need to take special precautions to ensure a cohesive, efficient product development process and a seamless transition from design to manufacturing.
Since the choice of technology will influence the entire project from design to manufacturing, it is critical that medical device companies align themselves with the right scientific institutions and technology providers. External engineering firms have the benefit of working with myriad technologies across multiple industries which empowers them to make recommendations from an informed and experienced standpoint.
For more information, call Bob Andrews, VP Business Development at (508) 765-8100