As medical devices have become more advanced through the implementation of sophisticated technologies within the finished product, the amount of expertise required to efficiently design and engineer the device has grown. This article discusses the value of close collaboration between all members of a product team from the designers to the manufacturers.

By Robert R. Andrews
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.

It is never too soon to consider manufacturing.
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.

View of DFMA analysis being performed on a small motor assembly. DFMA software from Boothroyd Dewhurst Inc. gives engineers tools for deciding where cost is necessary in a design and where cost can be removed without compromising product function. Engineers simplify the product design until it is as streamlined as possible and the part count has reached a cost-effective minimum. For the motor assembly pictured here, the original design (left) has 19 parts and the redesign (right) has 7 parts, a reduction of 63%. The graph, which shows cost estimates for manufacturing each design, indicates that the redesigned motor assembly would reduce total product cost by 31% from $48.99 to $33.82.
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.

Seeing Over the Next Horizon
Fetal heart monitoring solution based on sonar technology
Technology forecasting has taken on a new importance among project development teams, which have witnessed rapid advances in technology push many products out of market-leading positions. By identifying developing technologies that will impact the market two, five, or ten years down the road, accurate technology forecasting can ensure the longevity of a product even in the face of rapid industry change.1

Because all technologies pass through a maturity curve, it is helpful to plot them on a timeline. Older technologies are mature today, while newer ones develop over time. Categorizing technologies in time horizons according to their development stage will indicate at which point these technologies can be integrated into product development.

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. This not only empowers them to make recommendations from an informed and experienced standpoint, but it also allows for “technology transfer.” Defined as the novel use of a proven technology in an application other than that for which it was originally designed, technology transfer has yielded innovative solutions to some of today’s most vexing engineering challenges.

An example of technology transfer is a military sonar mine detection-based technology that was developed to obtain high-resolution internal imaging of overweight patients, in the face of the increasing obesity epidemic. This enabled imaging devices to resolve objects at twice the distance of current systems. Similarly, a fetal heart monitoring solution was developed based on the same sonar technology used by the navy to detect enemy submarines.

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 and materials, while showing the cost impact of each decision. This allows designers to improve the manufacturability of their product through simplification.

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 reaped from the fact that DFMA helps internal and external teams work together better by serving as a communication tool.

Process Failure Mode, Effects, and Criticality Analysis (FMECA) is another resource tool 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 and equipment can be identified and improvements made before the final product is produced. The development program considers overall design, operating, and service problems, and addresses process and safety problems. As process FMECA is closely tied to the design process itself, it reinforces the need for communication and collaboration early in the development program. In fact, timeliness is probably the most important factor in differentiating between effective and ineffective implementation of the FMECA. More often than not, the process FMECA is started too late in the program to realize its full benefit.
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.

Complex regulatory processes associated with developing hybrid medical devices that combine drugs and/or biologics are an example of the type of new challenges manufacturers face in today’s market. While greater expertise is needed to navigate the regulatory process, opportunities for product novelty and innovation abound in the fast-growing combination products market, which is set to reach $9.5 billion by 2009.
1 Andrews, R., “Medtech executives can improve strategic planning with a structuring method for exploring emerging technologies,” May 2006, MX magazine.
For additional information on the technologies and products discussed in this article, visit the following websites:

  • Robert R. Andrews is Medical Division Manager for the commercial group at Foster-Miller Inc., a QinetiQ company. He has more than 25 years of medical device experience managing product development and operations. He can be reached at 781-684-4639 or