Medical device engineering advisory
Medical device teams lose months to falling yield, unclear test coverage, unknown failure risks and evidence nobody can find. We find the cause and give your team a practical way forward.
Your first 30-minute call is complimentary.
The problems we solve
PCBA · Ramp to volume
“Our yield keeps dropping.”
We separate process, design and test causes. Failures are sorted by station and defect code, reflow profiles are checked against the paste specification, and X-ray is used where optical inspection is blind (BGA voiding, head-in-pillow). We then check test limits and gauge R&R, so real defects are not hidden among false fails.
Production test
“We can't test every board.”
We build the test strategy from design for testability: ICT, boundary scan, flying probe and functional test, each placed where it catches the most likely faults. Coverage is mapped per defect type, so gaps and duplicate tests become visible.
Reliability · Pre-launch
“We don't know our real failure risks.”
We review the design, test results and field history, identify the likely failure mechanisms (thermal cycling, humidity, vibration, wear-out) and analyze them with FMEA, fault tree and life-data methods. Each risk is ranked by severity and likelihood.
Design transfer
“Our prototype works, but we're not ready to scale.”
We assess transfer readiness against ISO 13485 §7.3.8: production-equivalent equipment and fixtures, complete work instructions, process validation (IQ/OQ/PQ), and part revisions and suppliers that match the design. You get a ranked list of what must close first.
Quality investigations
“Our evidence is scattered across reports and logs.”
We collect and cluster the evidence with AI tools, linking each finding back to its source record. An engineer reviews every finding before it reaches you.
Risk management
“Our risk files don't keep up with the design.”
We apply ISO 14971 methods, bring FMEAs up to the current design, and trace each risk control to the verification evidence that proves it works.
Before the pilot build
“We're about to commit to a pilot build. Are we ready?”
A focused session with one of our engineering leaders that pressure-tests DFM, DFT, reliability, diagnostics and manufacturing readiness before you commit budget to the build.
System integration
“Our subsystems work alone, but not together.”
We define the interfaces, plan integration in steps, run early pre-compliance EMC checks (IEC 60601-1-2), and automate repeatable system-level verification.
Facing something that isn't listed here? We focus on your problem, not a fixed menu of services. Tell us what you're facing
For founders, CEOs and engineering leaders
Every credible failure mode scored for severity and likelihood, so engineering effort goes to the failures that would stop a launch or reach a patient.
A fault-coverage map of what your production tests catch and what escapes, so defects are stopped on the line, not in the field.
Reliability, test and quality gaps sized by impact and effort, so your team knows exactly what to fix first and what can wait.
An evidence-backed recommendation for your next milestone (pilot build, design transfer or scale-up), with the actions that close the gap.
How we work
You can stop after any stage. Each one leaves you with something useful.
Stage 1
A structured review of the evidence you already have, with failure-mode hypotheses ranked and evidence gaps identified.
Stage 2
Specialists apply FMECA, coverage, life-data, risk and DFM analysis as the problem requires, and confirm findings with your team.
Stage 3
Findings become actions with owners, acceptance criteria and verification methods, sequenced into a plan.
About Blue Sky
Blue Sky Consulting Firm brings together engineers in reliability, manufacturing test, quality and risk, systems integration, software and applied machine learning, with more than 70 years of combined experience. Our directors do the work, and specialists are matched to each problem. Our recommendations are practical and specific, so your team can act on them.