Originally published in Dr. Eric Maass's Predictive Engineering Newsletter (Design for Six Sigma and Supply Chain Resilience). Dr. Maass is Six Sigma BELT Guru's Master Black Belt certifying partner. Republished with credit.
This edition looks at meeting multiple requirements for a communication device, along with a serendipity surprise.
The anchor: Multiple Response Optimization for a Communication Device
"Flawless Launches!" The Vice President of Research and Development for Motorola's Government and Public Safety group committed his teams to use Design for Six Sigma (DFSS) for all new products, globally. Bob Epsom set a clear goal: each product launch would be a "Flawless Launch": high yield at launch, no supply chain disruptions, and no post-launch issues for at least the first 6 months after launch.
As I prepared to teach DFSS for engineers at the Motorola site in Penang, Malaysia, I tried to make the experience fun, interesting and relevant. I imagined team design challenges they might enjoy as they learned how to use DFSS for new products. Since this site was part of Motorola's Government and Public Safety group, the far-out idea I came up with was to have them work in teams on developing a communication device for SPIES! Secret Agents! I thought that would be so cool!
I shared the challenge, expecting surprise and laughter, but the engineers took it in stride, very casually, as if it were a totally reasonable challenge. As it turned out, the Penang engineering team actually WERE developing a communication device for secret agents: a product called Covert.
A bright young engineer named CC Ooi (Ooi Chin Chin) became the DFSS Black Belt leader for the Covert project, and she coached Ooi Boon Hoong on a DFSS Green Belt project focused on audio aspects while CC focused on ruggedness. A spy needs a rugged communication device to deal with unpredictable and hazardous situations!
During Covert operations, the main risks were that screw inserts at the housing and chassis interface could dislodge, and that the chassis would crack at the screw interface. These were translated into multiple responses:
- Plastic strain on the right catch and left catch of the housing
- Screw insert pull-out force from drops and impacts
Mechanical simulation (Finite Element Analysis, FEA) was used with Design of Experiments (DOE) and Response Surface Modeling (RSM). There were 5 design factors to optimize for these multiple responses. The regression equations for each vulnerable mechanical interface were used with Monte Carlo Simulation and an optimization algorithm called OptQuest, along with another approach called Yield Surface Modeling (YSM) for stochastic multiple response optimization.
Optimization was accomplished before building a single physical sample or prototype. The team achieved the ruggedness, robustness and reliability required by covert agents. No redesign or rework was required. The Covert product experienced a Flawless Launch.
— Eric Maass
From the field: FDA Drafts Its First Framework for Surgical Robots
FDA has released draft guidance on premarket submissions for robotically-assisted surgical devices, the agency's first comprehensive framework for evaluating these systems. The guidance covers teleoperated, software-controlled systems where the surgeon directs instruments through a leader-follower control architecture.
Why it matters: the testing recommendations read like a DFSS checklist. For input processing functions such as motion scaling and tremor reduction, FDA wants performance testing that verifies consistent, predictable operation within predefined tolerances, across speeds, directions and positions in the surgical workspace. Control systems should stay stable under representative disturbances, such as an accidental bump of the hand controls, without passing that impulse on to the instruments.
In DFSS terms, the regulator has written out the noise factors on the P-diagram. Teams already modeling how their systems respond to variation and disturbance will find much of this evidence is work they are doing today. Read the full story
Links worth bookmarking
- Five Signals From the 2026 Functional Verification Study: Only 5% of IC/ASIC projects reported first-silicon success in 2026, down from 14.4% in 2024. Siemens' Harry Foster looks at why verification is shifting toward building confidence in whole software-driven systems.
- FDA and EU Send Conflicting Messages on PFAS in Medical Devices: The two regulators appear to be on different paths for PFAS use in devices, which matters for anyone selecting materials for products sold in both markets.
- UK Commission Proposes New Rules for Healthcare AI: An MHRA-established commission argues current device rules were built for products that stay largely unchanged after launch, and calls for lifecycle oversight with stronger use of real-world evidence.
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