Product Design With the Manufacturing Process in Mind

Medical device manufacturers face a myriad of challenges in bringing new innovations to market. Quality standards in the medical marketplace exceed those of most other industries and the fast pace of innovation in this market makes the technology horizon unpredictable and places a large cost on even small delays in product launches. The emergence of combination products, which add a biologic or pharmaceutical element to the medical device, is further complicating the product development process. For these and other reasons, it is critical that medical device companies take manufacturing into account early in the process to speed breakthrough products through development to commercial market.

Collaboration at the outset of the project is perhaps the most important step toward realizing a successful end product. By bringing together researchers, marketers, engineers, senior level executives, and outside engineering and manufacturing experts, medical device companies can gain a panorama of interdependent information about regulatory and quality standards, unmet needs in the marketplace, emerging technologies, and manufacturability. If the various members of the product development team do not communicate early in the process, the device may soon become un-manufacturable, unmarketable, or doomed to regulatory failure.

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.

Bringing Partners into the Fold
The more advanced medical devices become, the greater the need for outside expertise, which is generally sought in the areas of manufacturing and engineering. If the engineering firm offers market research and technology forecasting capabilities as part of its portfolio of expertise, then it should be brought into the project development process before a concept has even been established. The role of the engineering firm also includes helping identify manufacturing partners to join the development team. Selection of manufacturing partners will depend largely on the technology planned for use in the device and the materials from which it will be constructed. In many cases, more than one manufacturing partner is required due to the complexity of the device.

Due to the intense collaboration required to bring a new medical innovation to market, synergy between internal teams and external partners is quintessential. Medical device firms should consider characteristics like management style, reputation, problem-solving approach, workflow patterns, and personal compatibility when evaluating potential partners.

Some medical device companies may be tempted to turn to contract manufacturers that offer “free” or discounted engineering services. However, because contract manufacturers are focused on production and not design, they have a tendency to “force fit” their capabilities, components, processes, or equipment into the manufacture of the product, potentially resulting in a suboptimal design.

From Soup to Nuts
Working with one partner that understands the entire product development process is central to ensuring a seamless transition from design to manufacturing. Without a lead partner, projects become piecemeal and ultimately require rework. Design firms that simply “pass” the project onto manufacturers once a prototype has been completed will find themselves often making major design adjustments later on. Understanding the needs of the manufacturer during initial design can avoid “patching up” flaws in manufacturability, which are not only costly, but can also delay a product launch. The following two examples illustrate what happens when external design firms do not consider manufacturing early in the development process.

Tasked with creating a design concept for a console used in clinical environments for direct patient care, the contracted design firm finalized the prototype and passed it to the manufacturing team. By this time, significant funds and a large amount of time were dedicated to the console design. The manufacturing team recognized that the concept as designed possessed numerous flaws and ergonomic issues, and would require costly assembly in the field. Revamping the design concept in the manufacturing stage also proved costly. Had the design firm and manufacturing team been one, design flaws would have been uncovered early in the design process, avoiding costly rework and continual product evolutions.

In the case of one diagnostic device development project, the external design firm did not consider what would be feasible in terms of manufacturing throughput. To produce the product in the volumes desired, the contract manufacturer would need to employ more workers on the manufacturing line than physically possible. This, too, could have been avoided by a cohesive product development team.

Real-World Manufacturing
Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) provide additional 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. Testing parameters can be defined by taking the average of the minimum and maximum tolerances. 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.

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