Establishing clear and efficient communication as part of the design transfer process can be a key component to decreasing the time it takes to bring a product to market. Specifically, providing formal manufacturability feedback early in the design phase is critical to ensure success for today’s medical device manufacturers. This article examines this and also provides a machining case study that offers additional insights.

By Kevin Shutes

Kevin Shutes is the VP of business development for RevZero Inc. The company offers precision machining services from prototypes through full production. Shutes can be reached at 952-380-9966 or

The perils of an ineffective design transfer process, or the transition from design to production, have been well documented: high component costs, fragmented supply chains, inaccurate specifications, and delays in production. The pressure on R&D engineers to get complex devices to market more quickly than competitors can be palpable, and contract and component manufacturers have been forced to engage concurrently with design engineers in the prototype stage to provide manufacturability feedback often before the device has been fully developed.Sophisticated manufacturing partners have realized that manufacturability feedback mechanisms can be automated by building review phases into their quality systems and by ensuring the shop floor can meet the increased speed to market requirements by deploying the right manufacturing technology in the most efficient layout possible. By taking a nuanced approach to the design transfer stage, manufacturers and developers can benefit by reducing both costs and the opportunity for unexpected setbacks.

Automating Design for Manufacturability Feedback

Providing formal manufacturability feedback early in the design phase has increasingly become a requirement, not simply an exercise in good customer service. As device manufacturers accelerate their drive to outsource prototyping and production, traditional machine shops are finding it difficult to meet both the regulatory requirements and the speed-to-market demands driven by the competitive device market. By building manufacturing feedback mechanisms into their quality system and customer contracts, however, forward-looking contract manufacturers have found a straightforward way to communicate this valuable data in both a formal and inexpensive way.For example, the first article inspection reportlong a staple for most manufacturersshould include Design for Manufacturability feedback as part of the overall quality documentation. Generic Certificates of Conformance can be replaced with a report that includes SPC and Cpk analysis, unexpected manufacturing variances (such as longer cycle time for a specific feature), and even down to the minute details including tooling usage variances and lead-time information on raw materials. Combined with material certifications, this statistical package gives device engineers everything they need to enhance their prototype designs.

By taking a holistic approach to all of the manufacturing costs, tolerances, and manufacturing variables encountered during the early prototype runs, data is captured and communicated in order to allow designers to eliminate potential costs before volume manufacturing needs to begin.

RevZero's Minneapolis operation manufactures medical device components in one of their lean-inspired Swiss screw machine cells.

Device designers understand that the earlier manufacturing feedback is introduced into the design process, the better, but collecting manufacturability data from component manufacturers is often a haphazard, informal affair. During the 1980s, product designers who completely integrated their design processes got their products to the market faster with fewer errors. This gave them a significant edge as product lifecycles, particularly in consumer electronics, began to compress. Today, these ideas are not only required to compete in pretty much every industry, they have been formally incorporated by the regulatory agencies to ensure design of products impacting public safety has been strictly verified before the product is introduced to the market. When lives depend on thorough product design and unerring manufacturing execution, it is no longer acceptable to work out the kinks after a product has been introduced.

In the prototype production environment, contract manufacturers need to be more flexible and responsive than ever. Product design engineers and manufacturing engineers must engage simultaneously, sometimes both internally and externally, testing a variety of configurations over a short time period in order to eliminate waste in product development timelines. Speed, after all, can make all the difference between a blockbuster new product and an also-ran in markets both highly regulated and highly competitive.

Integrating the Shop Floor to Support Design for Manufacturability: A Case Study

Jeff Smith, engineering manager at RevZero Inc. introduced a cell-based layout that reduced transference of raw materials, centralized measuring tools, and reduced the opportunity for error in the company’s Swiss screw machine department. Smith noted that what really makes a shop run efficiently is the way the machines are arranged to minimize wastefrom an operator movement perspective and by eliminating slower and more costly secondary operations.“I want to drop a part complete right off the machine, email my SPC data to the quality lab, and then send the parts directly to final cleaning and passivation,” states Smith.

He designed each four-machine cell in a thirty-two foot square, with three different models of Citizen Swiss screw machines in each cell. By leveraging three different technology platforms, components can be routed to the most cost-effective machine based on the geometry, size, and complexity of the part. Four separate work surfaces ensure proper line clearance and product segregation, but are strategically located close together in order to share non product-specific tooling and inspection equipment, and to reduce the need for redundant operators.

RevZero's Stat Pack simplifies Design for Manufacturability, and formalizes SPC data collection for prototyping and volume production.

Smith notes, “This cell design actually uses 8% less floor space than the traditional layouts I’ve seen at larger production houses if you account for work tables, proper maintenance clearance, and walkways.”

By integrating data collection into the lean-inspired Swiss cell, manufacturability and quality inputs from operators are collected via device history logs, barcodes, and digital inspection equipment. After final inspection, this data is analyzed by the engineering department to determine positive or negative manufacturing variances, and select portions of this information are published via the “stat pack” that is shipped to customers.

Integrating detailed manufacturing feedback in the documentation at RevZero has already started to reduce cost, and portions of these savings can be passed on to end customers proactively. By simply standardizing the design for manufacturability feedback mechanism, real cost savings can be realized by eliminating guesswork on both sides before the critically important stage of design transfer to manufacturing begins.


A smooth transition from design to production requires manufacturability feedback early in prototype stage, and manufacturers and developers will both benefit by standardizing the feedback mechanism. Cross-functional review meetings both internally and externally combined with data-supported reporting mechanisms and efficient deployment of technology on the shop floor increases the opportunity to meet speed-to-market, cost, and volume production demands.


For additional information on the technologies and products discussed in this article, see MDT online at or RevZero Inc. at