How we work
From evidence to decision, in three stages.
Each stage ends with something your team can use. After each one, you decide whether to go further.
Before stage 1A complimentary 30-minute call to understand your product and the problem. Book it
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Evidence Screen
A structured review of the evidence you already have, with failure-mode hypotheses ranked and evidence gaps identified.
You provide
A problem statement and the evidence you already have: requirements, risk file, test reports, yield and NCR data, complaint or field data. Everything is shared under NDA.
What happens
A structured review against the problem. We form initial failure-mode hypotheses, check test coverage and the risk file where relevant, and identify the evidence that's missing.
You get
A findings memo: hypotheses ranked by likelihood and impact, evidence gaps, and a recommended scope for the Readiness Review.
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Readiness Review
Specialists apply FMECA, coverage, life-data, risk and DFM analysis as the problem requires, and confirm findings with your team.
You provide
Access to design history and device master records, schematics, BOM and layout, test procedures and data, and time with the engineers who know the product.
What happens
Specialists apply the methods the problem calls for, such as FMECA, coverage analysis, life-data analysis, risk-file and traceability review, and DFM/DFA review, and confirm findings with your team.
You get
Detailed findings with supporting evidence, ranked by risk to patients, schedule and cost.
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Decision Package
Findings become actions with owners, acceptance criteria and verification methods, sequenced into a plan.
You provide
Your priorities, constraints, timeline and budget limits.
What happens
We turn the findings into actions with owners, acceptance criteria and a verification method for each, estimate the effort, and sequence the work.
You get
A prioritized action plan, outlines of the verification protocols, and a closing review with your team.
Scope, deliverables and price are agreed in writing before each stage starts.
Why Blue Sky
What makes the work different.
Leaders do the work
The directors you speak with are the people who review your product.
Matched specialists
Reliability, test, risk, systems and software experts join where they apply.
Practical output
Specific actions your team can take, not a generic report.
Faster and focused
A targeted review moves faster than a large contract-manufacturer assessment.
FAQ
Questions before we start.
How is an engagement scoped and priced?
We start with a complimentary 30-minute call about your product and the problem. We then agree the scope, deliverables and price in writing before any work begins. If you need a quick, focused answer, a Scale-Up Readiness Session may be enough.
Do you only work on the services listed?
No. Those are the areas we focus on most, not a fixed menu. Tell us about your problem, and we'll shape the work around it.
How do you handle confidentiality?
We sign an NDA before we review any of your documents, data or designs.
Which product stages do you support?
We work from working prototype through design transfer and production scale-up, and with products already in production that face yield, test or reliability problems.
Do you work remotely?
Yes. Most reviews can be done remotely, using your documentation and data. If on-site time is needed, we agree it as part of the scope.
What do we need to prepare?
A short description of the problem and whatever evidence you already have, such as test reports, yield data, failure logs and risk files. It doesn't need to be organized. Sorting it is part of the work.