Velentium offers a selection of services that represents the entire lifecycle of a device. Our engineers, developers, SMEs, manufacturing technicians, and production managers who support those services work together continuously: they aren’t segregated by project stage.
Having production engineers working side-by-side with concept designers gives us an unusual vantage point on both the design and manufacturing processes. In this series, for which we are joined by Production Manager Devin Carroll and Technical Manager Soumendu Bhattacharya, we aim to share some of our insights.
Today, we’re resuming our series on Design for Manufacturing. We want to look at Scenario B, the more typical approach where Production is not involved in the design and development process until the Release / Transfer to Manufacturing Phase, and point to situations where a project is better served by this approach than by early optimization.
The two most obvious reasons why device designers don’t involve production engineers in the early lifecycle phases are:
- Potential IP exposure
Often, R&D projects simply don’t have room in their schedule or budget to perform manufacturing optimization. The project has a mandate and a deadline to deliver a proof-of-concept so the company can secure funding for development and production that it doesn’t yet have. In these scenarios, optimizing for production early on is a luxury that the project can’t afford. And even if it can afford to, the overhead can be hard to justify: why spend resources on design optimization before you have a prototype proven to be workable, or that you may not secure the funding required to fully develop? Or, in another permutation, what if your goal is not to mass-produce the device yourselves, but to develop a proof-of-concept that can be sold to another company?
Design firms that outsource their manufacturing and don’t have access to in-house production engineers may have exposure concerns about involving third parties. Even with NDAs in place, cybersecurity measures, and other precautions, the farther the design travels and the more organizations are given access to it, the greater the chances that proprietary information, IP, and trade secrets may leak. If design details are kept under wraps until just before manufacturing, even if a leak does occur there are fewer opportunities for anyone, such as a rival design firm or a malicious actor, to capitalize on the opportunity. IP, including business strategy surrounding projects in active development, is always easiest to control when the number of parties working on it are kept to a minimum. For companies expecting to recoup R&D investment by selling the design, rather than by bringing the device itself to market, this second reason is especially critical.
Finally, although it is a less-common reason, some designers may feel that bringing manufacturing considerations to bear too soon may stifle innovation. Manufacturing is naturally motivated to work with proven solutions, to follow well-understood, well-worn processes, and to re-engage approved vendors and suppliers. To achieve innovative and elegant solutions, designers may feel that they need the freedom to disregard known pathways and work unconstrained by manufacturing concerns.
It’s important to recognize that placing fewer constraints (in the form of manufacturing concerns) on the design early means that there are more constraints on the design later. Design freedom can be imagined as a see-saw: maximizing early design freedom means pushing the weight of production optimization farther down the line. By the time of manufacturing transfer, fewer optimization options will be viable, due to the timeline of the approval process. No device designer would greenlight mass production before the design has passed its clinical trials and received regulatory approval -- at which point every aspect of the design that affects its essential clinical functions are locked. Any proposed design change which could impact clinical function or performance would require repealing and repeating a number of approval steps, which typically weights the cost-benefit equation pretty heavily in favor of rejecting the change. Still, there are many types of optimization that can still be made: changes to suppliers and processes are mostly still on the table, and many component optimizations may be also.
In our next and final post of the series, we’ll lay out a pro-and-con summary of Scenarios A and B, alongside some example situations showing the strategic benefits of each approach.