Designs on Manufacturing
Keeping the manufacturing process in mind when designing medical devices saves companies time and money.
Design is an integral part of any manufacturing process. It affects every aspect of a product, from aesthetics and durability to cost and functionality.
At the dawn of the industrial age, craftsmen gave little thought to the relationship between product design and manufacturing. Late 18th-century musket makers, for example, crafted the entire weapon themselves, using saws and files to shape each part and fit them together. No two muskets were exactly alike because the craftsmen shaped each part to fit only the mating parts of the same gun. As a result, parts from one musket could not fit into another.
Eli Whitney changed that. At the turn of the 19th century, the renowned inventor developed a system to manufacture muskets with interchangeable parts. He redesigned each part to a specific dimension with a limited tolerance and controlled the dimensions of each component by creating a manufacturing process that depended on fixtures, machinery and gauges rather than the skills of musket craftsmen. The process (modeled after a similar system in France) eventually helped Whitney produce thousands of muskets with interchangeable parts for the federal government in preparation for the War of 1812.
Historians have written that Whitney spent the rest of his life publicizing the idea of “interchangeability.” His concept caught on with other manufacturing geniuses, most notably Henry Ford, who used the assembly line to mass produce Model T automobiles in the early 20th century.
The idea of making interchangeable parts to simplify and accelerate the assembly process revolutionized the manufacturing industry. Modern-day companies use the concept that Whitney touted more than two centuries ago to get products to market more efficiently and economically. Now, however, the process is better known as design for manufacturability, or DFM.
Design for Manufacturability: A ‘Critical’ Component of the Process
Though DFM has been around since Whitney’s time, corporate executives only recently have realized its true value. The concept particularly has taken hold with medical device design firms, which are facing increasing pressure from customers to get their products to market quickly—and DFM helps them achieve that.
“Design for manufacturability is critical,” said Kenneth A. Fine, president and co-founder of Proven Process Medical Devices, a Mansfield, MA-based medical device development and manufacturing firm. “Often what happens with a [medical device] design is customers want to drop steps—they want to rush right from a prototype to the finished product. But design for manufacturability takes time and analysis. It takes an understanding of the process.”
Photo courtesy of Johnson Medtec.
Ideally, design/manufacturing firms should become involved with their customers at the ideation stage to foster a symbiotic relationship for the product’s design. Establishing a good working relationship with customers as early as possible helps the third-party provider avoid misunderstandings that could lead to costly manufacturing delays.
Communication is one of the key ingredients to establishing a good working relationship with customers, design experts said. Keeping customers involved in the design and manufacturing process also is important.
Foster-Miller Inc., for example, holds weekly meetings with customers to keep them apprised of their projects’ progress and to solicit input on the development of the product’s design. Customers, however, do not have to be present at the product-development firm’s headquarters in Waltham, MA to see the latest design sketches. An electronic documentation system enables OEMs to peruse design plans from their own offices or homes.
“In the first few weeks, we will have an ideation session and develop concepts based on the product requirements,” said Robert Andrews, medical division manager for Foster-Miller. “The customer is involved up front, from concept development all the way through to manufacturing. Communication and [early] involvement is key.”
Early involvement in the design process not only gives customers more input into the development of a medical device, it gives design engineers an opportunity to gather the data they need to create a solid DFM process. The data, however, can vary depending on whether the design firm also will manufacture the product for its customer.
Photo courtesy of Proven Process Medical Devices.
Foster-Miller relies on its team of more than 300 engineers, scientists and support personnel to devise a manufacturing plan for its customers. Since the company also offers manufacturing services, design engineers must determine the kinds of materials that will be used to make the medical device and understand the structural makeup of the product. At the start of the design process in the development phase, Andrews noted, engineers will study the product’s concept to determine how the product will be manufactured.
Once the necessary information has been gathered, Foster-Miller’s engineers can begin to craft a custom-designed manufacturing plan. The plan is one of several services the company provides medical device firms that are looking to ensure the success of their new ideas.
Several years ago, Foster-Miller—a wholly owned subsidiary of QinetiQ North America—introduced Innovation Express, a series of services to help customers identify, target, design and manufacture products. The services span the entire product development cycle and are organized according to three phases: Technology Forecasting, Product Development, and Manufacturing System Development. Foster-Miller turns these steps, often viewed by companies as hurdles along the path to innovation, into opportunities to introduce marketable products.
Andrews said the company’s understanding of manufacturing enables it to provide an array of services to clients who seek Foster-Miller’s expertise at various stages in the product development cycle.
Photo courtesy of Foster Miller Inc.
At Hiemstra Product Development, a medical device design and development firm in San Francisco, CA, DFM is part of its operating standards as well. The 17-year-old company works with early stage startup firms and Fortune 500 companies, transforming intellectual concepts and rough napkin sketches into fully developed product plans.
As is the case with Foster-Miller, Hiemstra Product Development provides its customers with manufacturing services. Besides its prototyping and clinical trial services, the company assembles implants, surgical tools, catheters and catheter-based delivery systems.
Most of the companies Hiemstra Product Development interacts with are early stage startup firms that need FDA approval for their new product. Because these firms are focused on obtaining that approval, they are not as concerned about the manufacturing process for the product, explained Doug Hiemstra, company founder and president. As a result, DFM takes on a less traditional role.
“Design for manufacturability takes on a different role when you are trying to get FDA approval,” Hiemstra said. “To get FDA approval, the company may only need to make 100 units. But if they are going for a commercial launch of the product, they may need to make 10,000 a month. Design for manufacturability has a different meaning in those two instances.”
The major differences in the DFM plan for those two examples are cost and speed. Because cost is not a major factor for companies seeking FDA approval for their products, design engineers at Hiemstra’s firm typically focus instead on crafting a prototype that can be made quickly and efficiently. In addition, the device’s design should be easy to repeat on the manufacturing floor, Hiemstra pointed out.
Since its focus is solely on medical devices, Hiemstra’s company typically does not have a difficult time deciphering the kind of manufacturing process its customers need. That process, Hiemstra said, does not stray much from the classic medical device design and manufacturing process that is common in the industry today.
Designing Machines for Manufacturability
Design professionals at Johnson Medtech agree that DFM is a critical part of a product’s design process. But along with the product’s components themselves, designers also have to keep in mind the design and function of the machines that manufacture the device, experts from the company said.
When Johnson Medtech designs a medical device component for a customer, it also designs the equipment to manufacture that part. By designing the manufacturing equipment in addition to the part, the Shelton, CT-based company can develop a more efficient and less costly manufacturing process for its customers, explained Jim Dick, senior vice president of Johnson Electric, which created Johnson Medtech, its medical business group, in December.
“We have designed our medical manufacturing facilities according to a process that we don’t ever have to change. That’s very different from traditional [manufacturing] techniques where, say, the same mold machine is used and different tools are switched day in and day out. If you buy a winding machine, for example, it is designed to be flexible because the company wants to sell it to anyone. But when we design a winding machine, we design it to do exactly what we need it to do—maybe for one particular motor—and that’s how it is used,” Dick said.
Early involvement in the design process gives engineers the opportunity to gather the data they need to create a solid DFM process. Photo courtesy of Proven Process Medical Devices.
The company’s medical device design and manufacturing philosophy—which involves strict project timelines and 24-hour access to prototyping services—has enabled the company to significantly reduce the amount of time it takes to deliver a prototype to its customers, Dick said. And that quick turnaround time ultimately helps get the product to market faster.
Johnson Medtech’s non-traditional approach to medical device design and manufacturing has helped it gain a strong foothold in the international marketplace. Earlier this year, the company announced a global network of Medical Innovation Centers, facilities that feature a full range of design and rapid prototyping services for medical device subsystems and components. The centers are scattered throughout the world and are designed to help companies accelerate the time-to-market process by up to 50%.
The Innovation Centers are located in Methuen, MA; Vandalia, OH; Hong Kong and Shajing, China; Dresden, Germany; Yokneam, Israel; Murten, Switzerland; and Isle of Wight, United Kingdom. The Innovation Center in Shajing is part of “Johnson City,” a colossal industrial complex that consists of 26 manufacturing buildings, a bank, a hospital, a health club and a kitchen that serves 80,000 meals a day to 30,000 employees. The “city” offers CNC milling services as well as precision grinding, injection molding and clean room services.
“We’ve designed a whole new medical manufacturing process. It’s something that’s very different from what we do in our other divisions,” Dick said. “It’s a process that involves precision, engineering and technology, and it works very well together.”
Research and Risk Analysis Are Important, Too
There is no doubt that DFM is important to the medical device design process. But other factors must be considered as well for an OEM to achieve an efficient, cost-effective manufacturing process, design experts noted.
One of those factors is thorough research. Without the proper research data for a new medical device or component, design firms and their customers are setting themselves up for failure, experts said. The kind of research that typically is conducted varies depending on the design company and the services it offers, but most firms tend to evaluate either the clinical need for the product or users’ needs. Some firms also perform market research.
Hiemstra’s company, for example, concentrates on user needs. Before design engineers can start asking questions, though, they must figure out who will be using the product, Hiemstra said. “The user could be multiple people—patients, clinicians or someone else [who] touches the product,” he clarified. “It’s imperative to identify the users—the people [who] touch the product—to see what their needs are. Then we can start asking the questions, such as, what does the product need to do? What does the [medical] procedure look like?”
Proven Process, on the other hand, focuses more on the market for its customers’ concepts. Fine said his company addresses two issues with potential clients: the overall market for which the device is being made, and the size of the market for the product.
Fine’s company also assesses the overall risk of undertaking a project. That includes determining whether a potential customer can adequately fund the project and calculating the chances the product will be successful. “At the end of the day, we really want to be involved in enterprises and products that will be successful,” Fine concluded.
Program managers and engineers at Foster-Miller similarly assess program and product risk for clients, and find ways to eliminate the risk if one is identified. But the company also attempts to determine the kinds of risks the product poses, such as user hazards and its tendency to fail.
For Ximedica LLC, analyzing the risk of any potential project is a necessary part of the DFM process. “Hand in hand with DFM thinking and discipline is having a clear cost and annual quantity targets for the device,” said David C. Robson, vice president of development for the Providence, RI-based medical device designer and developer. “Without these, the team is designing in a vacuum and bad things can happen. This must be part of every development program and is an essential and rational component to responsible risk management.”
* * *
Often overlooked and undervalued, DFM can add significantly to companies’ bottom lines. A design process that incorporates DFM is key to increasing efficiency and getting new innovations to market quickly. It also can help improve the quality of medical devices and ensure consistent delivery. To achieve success, design firms must make DFM a natural part of their design process, as Hiemstra Product Development and Foster-Miller have done. As Hiemstra put it: “It’s not like we have to turn DFM on in the process. We are thinking about it all along. It’s something we are always considering.”