Costed decision paper
Costing a medical-device certification before deciding to want it
Extending an existing quality system to the medical-device standard would open a market. I priced it honestly — including the part that cannot be bought, only earned on real projects.
- Of the required system already exists, works and has been audited
- ~60% reuseOf the required system already exists, works and has been audited
- Internal effort, roughly a third of one person over six to seven months
- 400–500 hoursInternal effort, roughly a third of one person over six to seven months
- Estimated first-year cash well under the market range for a company this size
- Low end of benchmarkEstimated first-year cash well under the market range for a company this size
The client
A software development company with a working, audited quality management system under the general standard, selling increasingly into health technology, and repeatedly asked by prospective clients whether it could sit in their supplier file as a certified design partner.
The engagement
A pre-project decision paper: scope, plan, cash cost, internal effort, reuse analysis and market benchmark, put to the leadership as a go or no-go rather than as a proposal.
The problem
Certification decisions get made on vibes in both directions — either 'it is just paperwork, we mostly have it' or 'it is enormous, let us not'. Neither survives contact with an auditor. And the specific trap in this standard is that the documentation can be written in weeks while the thing actually being audited is evidence from real projects run under design controls, which cannot be produced retrospectively.
What I did
I wrote it as a decision paper, not a proposal, and put the uncomfortable finding in the executive summary: the binding constraint is not documents, it is having run real projects under medical-device design controls, so the timeline is governed by project reality rather than by writing speed. Then I made the economics legible — cash cost separated from internal effort, internal effort converted to money at a stated rate so the fully loaded figure appears, and the result compared with a published market range so leadership could see whether we were estimating optimistically. The reuse analysis was itemised clause by clause rather than asserted as a percentage in a slide: what carries over as is, what needs tightening, and what is genuinely new. And I proposed the certificate scope wording deliberately, because the commercial value of the certificate depends entirely on whether a manufacturer's procurement team can drop it into a supplier file without argument.
What was built
A plan to extend the existing quality system into the medical-device standard as one integrated system rather than a second parallel one, with the certificate scope worded so a device manufacturer can place the company directly in its supplier file, explicit non-applicabilities documented, and the three genuinely new blocks — design controls, risk management and software lifecycle classification — identified as the real work.
On the table at the end
- Certification plan with a phased timeline from a stated start date
- First-year cost: cash range and internal effort range, plus fully loaded economic cost
- Reuse analysis against the existing quality system
- Proposed certificate scope wording and documented non-applicabilities
- Market benchmark for comparable certifications
What it changed
Converted 'we should probably get certified' into a decision with a number: first-year cash, internal hours, a realistic certification date, and the honest statement that the binding constraint is operational evidence from real projects rather than documentation.
How it ran
- 01
State the real constraint first
Operational evidence from projects run under design controls, not documentation — put in the executive summary rather than the risks appendix.
- 02
Itemise the reuse
Clause by clause: what transfers from the existing system as is, what needs tightening, what is genuinely new.
- 03
Separate cash from time
External cash range, internal hours range, and a fully loaded figure at a stated internal rate — three numbers, not one.
- 04
Benchmark the estimate
Compared against a published market range for comparable companies, so the plan can be checked for optimism.
- 05
Word the scope commercially
Certificate scope and documented non-applicabilities drafted so a manufacturer's procurement can accept it without a conversation.
Other work
All case studies →- Health tech
The estimate that covered a third of what the client thought they were buying
Two documents described two different products and both carried our logo. I stopped the contract, wrote the discrepancy register, and split the release into a fundraising build and a regulated one.
- Aviation
Twenty days of discovery that priced a year of build
An airport group needed to replace a security-credentialling system under a sovereign compliance regime. Twenty person-days of discovery produced five approved deliverables and an effort envelope the fixed-price contract could stand on.
- Software services
Nineteen estimates, one register, five minutes to an answer
Four years of pricing lived in spreadsheets nobody could open. I rebuilt the commercial history into one register — what was estimated, what it sold for, what happened next — and found that half the formulas were already dead.
Something similar on your plate?
Thirty minutes, no deck. I will tell you whether it is worth doing at all.