Company & Product Profile
The master record that makes the software contextual, not just a pretty agenda.
BaiOS · Venture planning for medtech
Business planning for medical device startups.
BaiOS turns a device programme into a living plan. Design controls and clinical evidence, the conformity route, runway and European funding, all in one place. It is not task management. It prices the next milestone before you commit to it.
The problem
A device that works, and a plan that stops at the CE mark.
The medical device regulation (MDR) made the evidence heavier and the timeline longer. Most seed-stage plans still price the old one. A spreadsheet does not know that your risk class decides your burn. BaiOS does.
01
No operator on the plan
The founder runs engineering, funding and the board update alone, with no CFO, no PMO and no regulatory or quality lead.
02
Two clocks, one model
First revenue and the next round are different dates with different requirements, and the financial model only has room for one of them.
03
Design controls priced as paperwork
The ISO 13485 design record and the ISO 14971 risk file are engineering months with a cost. For software, so is IEC 62304. They are budgeted as documentation.
04
The class decides the company, and it is decided late
A Class IIa path and a Class III path are two different companies with two different burns. Classification is treated as a formality until it is not.
05
Clinical evidence arrives as a shock
Clinical evaluation is mandatory for every class, and claiming equivalence to an existing device is far harder than it used to be.
06
European funding is a maze
CDTI, ENISA, EIC, Eurostars, equity and loans, each with its own timing and eligible costs. All of it planned in disconnected spreadsheets.
Milestone-to-Money
How BaiOS connects the gate to the money.
The gate ↔ money relationship is the soul of the product. Change one assumption and the runway, the gates and the funding gap move with it.
Map the product
One master record: company, product, intended use and a living product profile. The plan is contextual, not a pretty agenda.
Sequence the gates
Decision gates, not tasks: each carries minimum criteria, evidence, cost, date, dependencies and a RAG status.
Price each milestone
Every milestone is linked to a cost and to the funding it unlocks. "What if the notified body takes two quarters longer?" is answered in seconds.
Track the runway
Burn-to-milestone and cash-out date, with the revenue line your plan actually has. A runway that knows what a gate is, recomputed server-side.
Design verification
Design controls
€210K
▲ on track
Clinical evaluation report
Clinical evidence
€95K
● pending
Notified body audit
Regulatory · MDR
Apr '27
▼ 6 wks
Seed close
Investment
€1.8M
▲ on plan
The engine
Milestone to money, in one chain.
Anyone can tell a founder they have twelve months of cash. The useful sentence names the next milestone, what it costs and what unlocks it. Change one assumption and the runway, the gates and the funding gap all move with it.
The living plan
MilestoneGate criteria · Evidence
CostPrice per gate · Dependencies
RunwayBurn-to-milestone · Cash-out
FundingGrant · Bridge · Round
The two areas
Two areas, one connected model.
R&D planning is what has to be proven. Financial planning is what it costs and who pays for it. Nothing here is independent: a change in the intended use moves the cost, the timeline, the risk and the story with it.
R&D planning
What has to be achieved, in what order, who runs it, and what proves it.
Living product profile
Intended use and performance claims kept alive, not a dead PDF. They are the base of every assumption.
Development Roadmap
A development roadmap you build against your own conformity route, every step costed and dated.
Regulatory Gates
The differentiator: decision gates you define for your pathway. Criteria and go/no-go, not a task list.
Team, capacity & suppliers
Whether the team can actually run the plan, and the CROs and CDMOs it depends on.
Risk register & IP
Living risks with runway impact, and the patent families and exclusivity date the plan has to fit inside.
Financial planning
What it costs, where the money comes from, and what the investor is told.
Financial Plan & Runway
Beyond cash in, cash out: burn-to-milestone and cash-out date.
Milestone cost & funding gap
What each milestone costs, what is funded and what is still missing. Per milestone, not in a total.
Mixed Funding Planner
Equity, grants, loans and business development in one place. It is the European non-dilutive map that US tools ignore.
Scenario Planning
Every assumption automatically impacts cash, milestones and reporting.
Market model
Population, uptake and pricing. It is the revenue line the whole plan is aiming at.
Investor & Board Reporting
The investor and board figures, on one screen, reading from the live plan.
Positioning
What BaiOS is not.
Every alternative owns one slice of the problem. BaiOS ties gate ↔ money together, with European funding logic and Adbaio advisory built in. None of the others have that.
01
Not an eQMS
Greenlight Guru and Qualio hold the quality record beautifully. Neither prices your plan, and neither knows how much runway the next design freeze buys.
02
Not a requirements tool
Jama Connect and Matrix Requirements trace requirements to tests. Traceability is not a company plan.
03
Not Asana with a lab coat
Task tools (Asana, Notion, Monday) have no device logic: no gates, no product profile, no runway that knows what a milestone is.
04
Not an FP&A app
Runway and Pigment don't know what a clinical evaluation costs, or that revenue and the next round are two different clocks.
05
Not US-only
The venture tools built for this market ignore MDR and ignore European public funding entirely.
BaiOS + Adbaio
The software keeps the plan alive. The advisor keeps it right.
Adbaio without BaiOS is a great plan that goes stale in a PDF. BaiOS without Adbaio is eighty empty fields a founder abandons. Together they are a living plan with expert judgement embedded in it. The software retains, the advisory reviews it monthly.
Pricing
One workspace, priced by how far you plan.
Monthly, no lock-in. Prices exclude VAT; 21% is added at checkout for Spanish buyers.
Basic
€220/mo
- One company workspace
- Milestone & runway planning
- Email support
Advanced
€280/mo
- Everything in Basic
- Scenario modelling
- Funding & gate tracking
Pro
€390/mo
- Everything in Advanced
- Advisor collaboration
- Priority support
Your living device plan — evidence, regulation and money in one place.
From a working prototype to the next financeable or revenue-generating milestone. Set it up before you pitch, not after.