Does this sound familiar? You’re a class I or II medical device manufacturer rushing headlong to get your next great product to an increasingly competitive global market. Quality and compliance used to be your design team’s product development beacons, but now cost and time-to-market must also map the path. There’s intense pressure to generate short-term revenue weighing on every design decision, and during testing you discover a problem. Thinking about solutions, you are reluctant to revisit earlier design ideas, you still need to address the punch list of regulatory details, and time is tight. To hit the targeted launch date, communication with manufacturing and overseas suppliers must happen flawlessly. That’s the diagnosis. Here are the treatments.

Get plenty of upfront design time

Market pressures are shrinking medical product development timeframes from the standard 4- to 5-year cycles of yesterday to a more streamlined 2- to 3-year window—or less. Given this, it’s hard not to perceive upfront engineering tools and techniques as speed bumps. Taking more time early in the concept stage may seem counterintuitive. “You’re slowing me down,” is a common design-team refrain.

In fact, an upfront engineering paradigm encourages the team to identify, qualify, and quantify program risks and decisions before proceeding too far down the development path where design options become limited and costs mount up. During the feasibility stage it’s best to keep multiple concepts, technologies, and system-level designs in play while the situation is still pliable, and delay commitment to a single concept until as late in the process as possible. If you scrutinize options before the constraints of the detailed design phase, you are likely to make better system and technology decisions, shorten time-to-market, and realize a more robust design.

The payoff for this front-end investment comes in the form of a variety of development-cycle dividends. Suppose, for example, you encounter changes in market-demand forecasts and want to scale up or scale back a design, or even trim a project or program from the portfolio. If you’ve already vetted a number of design options upfront, you can more quickly consider alternative concepts, secure buy-in, and make a sound business decision. Put simply, previously conducted feasibility studies turn rough subjective debates into objective decisions.

In addition, upfront engineering can actually eliminate late-stage problems or, at least, reduce their probability, severity, and impact on product delivery. The fact is that if companies took a leap of faith and spent more time and effort doing engineering work in the feasibility stage—wringing out the risks—the investment would be repaid with shorter cycle times and a variety of other benefits in the remaining product design, verification and validation, and commercialization phases.

Keep designs simple

For medical device companies, there is a core set of tools that should be applied early in the design cycle to help teams refine product design concepts. Voice of the Customer (VOC) techniques capture product needs, preferences, and expectations from across the spectrum of customers. Value Engineering (VE) translates VOC data into functional requirements enabling design decisions from a cost versus benefit perspective. And Design for Manufacture and Assembly (DFMA) is a parts consolidation and costing tool that is considered by many to be an integral part of a VE approach.

More specifically, DFMA, developed by Boothroyd Dewhurst (Wakefield, RI), is a two-part methodology grounded in an unwavering focus on product and process simplification: Design for Assembly (DFA) guides the design team through a part-reduction exercise, which leads to improved assembly efficiencies and better overall product performance; Design for Manufacture (DFM) looks at alternate material choices and manufacturing methods, resulting in added cost savings.

Taken together, DFMA provides a structured framework for concurrent engineering discussion and knowledge building starting in the concept stage (or earlier) when impacts can be most significant. By making the product design efficient from the start, DFMA mitigates, if not eliminates, problems that might otherwise be found later during product development and production. In the medical device world, with its stringent design control constraints and expectations, DFMA brings producibility (part manufacturing, tooling, assembly, and testing) information to key decision points that are often devoid of detailed data.

DFMA’s systematic and quantifiable approach leads to elegantly simplified products, significantly shortened cycle times, improved quality and reliability, and dramatic material and manufacturing cost savings. Over its three-decade history—across industries, applications, and customers of all sizes—DFMA has delivered reductions averaging 45% for product development cycle times, 50% for total product cost, and 54% for part count.

Pay attention to volume

For design teams in high-volume medical manufacturing (where product quantities range from 100,000 to millions per year), DFMA, and DFMA-like best practices, are becoming more common in the product development process. Teams work harder now with suppliers to consolidate parts and simplify or eliminate fabrication and finishing operations. Because of the sheer volume, every fraction of a penny saved upfront means millions of dollars of cost avoidance. The math is easy to do. The savings are obvious and motivational. Designers broadly understand the value of the methodology, although a quantitative DFMA analysis produces more substantial benefits than the informal methods still employed by many.

In low-volume, high-mix manufacturing environments (where annual quantities can range from less than 100 to as many as 30,000, with multiple products assembled on a single line, in some cases) the situation is typically quite different. In this environment, the pervasive design-engineer mentality is that anything of minimal cost—such as a screw, nut, or washer—is not worth thinking about. If there is uncertainty about stress loads or failure modes, the default solution is to add hardware. But if each piece of hardware costs a penny, and you put 100 extra in each device, and you manufacture 10,000 units a year, the cost impact to each product (while not as great as in a high-volume setting) can be large and becomes even more significant when you consider the company’s entire portfolio.

Also, many wrongly believe that parts consolidation results in more complex parts and drives up capital costs for tooling, a serious concern for this segment. Implementing engineering analysis (such as DFMA, finite element analysis, robustness testing, and other techniques) early in the process is often dismissed as too much effort with limited value-added. But DFMA can actually lower total tooling costs while simultaneously lowering unit manufacturing costs.

Furthermore, with every additional part and subassembly there are also hidden costs—part numbers, drawings, vendors, inventory, quality, reliability, and even potential damage to your brand. And there are operational logistics costs to consider as well. When you’ve got low-volume, high-mix assembly lines, high part-count products can make supply chain management and line changeovers much more difficult.

DFMA-led product simplification can address these problems and lead to significant savings in value stream design and factory operating costs. Going back to basics—whether in high-volume or low-volume manufacturing settings—a DFMA analysis upfront saves money. After all, a penny is worth far more when products are scaled up to commercial levels.

Seek supplier collaboration

Feeling competitive pressure from low-cost suppliers, a leading medical device manufacturer was looking for ways to squeeze additional margin from a successful, high-volume device. To reassess and benchmark target costs, they participated in a DFMA Guided Analysis workshop, which included several engineering and purchasing team members and, most importantly, a key supplier who could provide real-world material and process knowledge.

Stepping through the DFMA analysis field-by-field, we altered the parameters with information provided by the supplier. When we got to the end, the cost estimate for the part differed by only one penny from the actual cost. Given the confidence of this validation exercise, a subsequent DFMA-driven brainstorming and redesign effort by the team uncovered missed opportunities worth approximately $2.5 million in potential savings—and this was for a “mature” product that had already been put under the purchasing microscope numerous times.

This target-costing capability in DFMA can be used by OEMs as a powerful partnership tool. It can provide the quantitative foundation for supply chain design and cost collaboration. If procurement and purchasing personnel tap supplier process and material insight and expertise, the result can be mutual agreement that provides cost and margin benefits to both parties.

The global medical device market would benefit significantly from “upfront engineering”. By following this treatment, costs will drop, cycle times will shrink, quality will improve, and the product life cycle will be more predictable downstream. This is the device maker’s prescription for robust productivity.