Your manufacturing floor is on fire. High scrap, line down, NCRs - and one misstep away from a fatal error.
You're under pressure to fill backorder without triggering a quality blow-up. But what if you could stop the fires before they start?
Process Validation | New Product Launch | Manufacturing Transfer | Internal Audit | Serving U.S. and European Medtech Companies
Feeling the Heat?
You’ve developed a reputation as an unreliable supplier, and you’re losing business to your more predictable competitors.
If your most skilled operators call out sick, or worse, leave the company, your line is crippled. Your new operators just can’t replicate what they do, leaving you completely dependent on a small handful of people.
Shortcuts keep the line running, but all it takes is one sharp auditor to bring it to a screeching halt. Your people learn that speed and delivery are rewarded over quality and compliance, pitting Manufacturing and Quality against each other.
While your engineers are fighting fires, no one is validating your new product launch. You’re stuck in a reactive cycle, jeopardizing your chance to stand out from all the other startups that no one’s ever heard of.
How Did We Not See This Coming?
You’ve been treating these as isolated issues – not enough engineers, a manual process that’s hard to replicate, one rogue operator who improvises work instructions – when really, you have a flawed system. The separation of the Manufacturing team from the device design process is what sets your manufacturing up to fail. How can you validate a manufacturing process that you don’t fully understand?
You Had Tunnel Vision – So Did I
There’s only one way to validate without deep process understanding – poorly. Now I know, you’ve got a product launch deadline to meet, you’ve already made commitments to customers based on that date, and you don’t have time for lengthy validation – you’ve got to keep moving. I’ve been on that floor, fighting those fires as a Senior Manufacturing Engineer leading NPI programs for a major strategic distribution agreement – putting a new fire out every day, knowing there was no other choice but to keep moving. When finally, I connected the dots and saw that the chaos wasn’t random, but rather, the way the system worked.
Now, the Path Is Clear
Design & Manufacturing Partnership
Your manufacturing team is integrated into the design process before design freeze. This approach allows you to create both a strong product design and a strong manufacturing design.
Redefine Validation
We bring your hidden process assumptions to light and create a validation strategy built for real-world manufacturing challenges.
Frictionless Manufacturing
Your team stops fighting fires and builds the structures that move your business forward.
I've Seen This Before
The problems on your floor aren’t new to me – here’s what I’ve delivered working inside growing medtech companies like yours:
Working alongside our injection molding supplier and internal team, I confirmed a single process adjustment that reduced scrap by $576.4k across all catheter products. Adjusting a non-validated process parameter eliminated trapped air in the catheter hubs, reducing yield loss from over 50% on some product lines to effectively 0% globally.
Facing a 2-month supplier delay on an NPI program critical to a major strategic distribution partnership, I uncovered process details from our legacy product line that had been hidden as operator tribal knowledge. The detailed gap analysis engaged leadership to raise the CM’s quality expectations and secure additional support for the next program.
I reduced audit and quality risk by influencing leadership to initiate a CM replacement project. A single facility tour revealed a pattern of ISO 13485 nonconformances which leadership had not previously recognized.
I’ve spent my career building validation expertise in the medical device industry, utilizing statistical techniques including Gauge R&R, Process Capability, and Design of Experiments to identify sources of variability and determine the factors that drive the most significant improvements. My experience is grounded in Class II vascular catheter manufacturing processes including bonding, UV curing, and injection molding. I’ve also supported rapid care EEG manufacturing.
If you’re interested in working together, I’m currently accepting inaugural clients and have capacity for major projects.