Build Readiness Review

10 business days. You’ll know what to build, what it will cost, and what stands between you and regulatory review.

A$4,500 + GST, fixed.

Half of it credited back when we build together.

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Some of the healthcare teams we’ve helped

Aged Care Quality and Safety Commission
Addend AI
ECC
Jeetay Raho

Most healthcare builds fail before the first line of code

Three things go wrong, and all of them happen before anyone writes code.

The wrong thing reaches the top of the list

What gets built first is agreed before anyone tests the assumption holding it up.

Compliance gets bolted on late

Designed in, it costs almost nothing. Added at the end, it costs months.

You have no way to check the work

If you’re not technical, nothing tells you whether what’s being built is sound.

Give us 10 business days and you will have all three settled before you commit a dollar to the build.

What happens, day by day

1 to 2

Go deep on the problem, the users, the constraints, and what you’re assuming

Problem Statement. One page. What you’re actually solving, and which assumption would hurt most if it’s wrong.

3 to 5

Work out what should be built, and more usefully what shouldn’t

Build Recommendation. Scope, with an explicit Not Building list and the reasoning behind each cut.

6 to 8

Architecture and regulatory path

Architecture Direction with the irreversible decisions flagged.

Regulatory Path Map: your likely classification, the standards that apply, and the documentation that must exist at each gate.

9

What could sink this

Risk Register. Ranked across technical, clinical, regulatory and delivery.

10

The plan

Estimate and Delivery Plan your engineers, your board and your auditor can all read.

5 actionable documents. No slide deck.

The cost of finding out later

An architecture decision reversed at month 9: roughly a quarter of your engineering budget.

A build that fails review: 3 to 6 months of rework, plus the launch you already announced.

A Build Readiness Review: 10 days, and a fraction of what the build costs.

The question isn’t whether you can afford it. It’s whether you can afford to find out later.

Good to know

Everything is yours. Take it to any builder you like. It’s written so another team can pick it up and work from it without us.

Half comes off the build. Build with Blue Arrow within 30 days and A$2,250 comes off the price.

The answer might be don’t build it. Narrow the scope, validate a clinical assumption first, buy instead of build, or wait. Those are legitimate outcomes and we’ll say so plainly. A review that can only conclude “yes, build it, with us” isn’t a review.

What it needs from you

About 8 to 10 hours of meeting time

A 90-minute kickoff, two short sessions, one 60-minute readout

Whatever already exists: prototype, code, documents, business context

A decision-maker in the room. The one thing we can’t work around.

What it doesn’t cover

This is regulation-aware product judgement, not regulatory affairs. It is not a formal IEC 62304, ISO 13485, TGA or FDA conformity audit, not a legal or privacy opinion, not clinical evidence generation, and not a full line-by-line code audit.

Where you need those, we’ll say so and point you at the right specialist. Fixed-price work stays honest when the boundary is well defined.

Is this for you?

Built for

Healthtech founders kicking off a build, or mid-flight and unsure it’s sound

Researchers and clinicians turning a prototype into a product

Teams where regulation is in play: SaMD, EMR, patient data, device connectivity

Boards and investors who want a defensible plan, not a pitch

Not a fit if

You know exactly what you’re building and need hands, not judgement

Scope, sequence and regulatory path are already settled and signed off

You can’t give us access to a decision-maker or the existing work

You want the answer to be yes regardless

Before you decide

How much of our time does this take?
About 8 to 10 hours across the 10 business days. A 90-minute kickoff, two short working sessions, a 60-minute readout, and sharing whatever you already have. We do the rest.
Can you quote the build once this is done?
Yes, and the number will be worth relying on. Quoting beforehand means guessing at the first-release boundary, the integrations you genuinely need, and what the regulatory path demands. Those three move a build price more than anything else. After 10 days we’re pricing something defined rather than something imagined.
What if we already have code?
We read it first. Most founders arrive with something inherited from a freelancer or an earlier team, and it’s rarely as bad, or as good, as they fear. We work out what’s worth keeping, what needs replacing, and what either choice does to scope and cost. Assessing it is part of the review, not an extra line on the invoice.
How is this different from a freelancer or an agency?
A freelancer builds what you specify. An agency runs its standard process over your problem. We work out what should be built first and why, then build it. That includes the architecture calls, the regulatory path, and the occasional conversation where we tell you not to build something yet.
Do you handle the regulatory submission?
We write the IEC 62304 software documentation, and we write it alongside the build rather than after it, which is what prevents an expensive retrofit later. This review maps which documents each gate needs. The authoring itself is scoped separately once the classification is clear, and we’re happy to size that effort for you. Formal audits, legal and privacy opinions, and clinical evidence are specialist work, and we’ll point you to the right people.
We already have a spec. Do we need this?
A spec records what somebody decided to build. It rarely says why an item sits at priority 1 rather than priority 3, or what happens to the business case if that call is wrong. Prioritisation is not the ordering, it is the reasoning underneath it. If you can already say what’s in the first release, what you’re deliberately leaving out, which standards apply, and why the order is what it is, you don’t need a review and we’ll quote the build directly.

The person behind the work

Who you’ll actually be working with

Hamza Muhammad, founder of Blue Arrow Consulting

I’m Hamza, founder of Blue Arrow. 18 years in product development, 7 of them in healthcare products: EMR, remote patient monitoring, DICOM, SaMD, and the IEC 62304 documentation that has to hold up when somebody checks it. Delivered across Australia, the US and the UK.

I’ve also been a healthcare founder, so I know what this actually feels like from your side. When you’re juggling the raise, the clinicians, the roadmap and the build all at once, clear thinking becomes the scarcest thing you have. Decisions get made because something has to be decided, not because anyone had time to test them properly.

I’ve worked with small teams moving fast without the structure to make it stick, and with well-structured teams that had lost the ability to move at all. Both problems cost real money. The work is finding which one you have.

Think of me as a co-founder for 10 days. You work with me directly, and there’s no handoff to a delivery team you have never met.

Connect on LinkedInhello@bluearrowconsulting.com.au

Start with a conversation

A 20-minute call, free. We work out whether this is the right thing for you. If it isn’t, we’ll say so on the call.

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Prefer to write first? hello@bluearrowconsulting.com.au