Company & Product Profile
The master record that makes the software contextual, not just a pretty agenda.
BaiOS · Venture planning for diagnostics
Business planning for IVD startups.
BaiOS turns an assay into a living plan. Performance evaluation and the conformity route, runway and European funding, all in one place. It is not task management. It tells you which study to buy with the cash you have.
The problem
A test that works, and no plan that survives IVDR.
The in vitro diagnostic regulation (IVDR) moved most tests into notified body scope. The plans did not move with it. A spreadsheet does not know that a notified body queue is on your critical path. BaiOS does.
01
No operator on the plan
The founder runs assay development, 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
Evidence planned apart from the cash
Scientific validity, analytical performance and clinical performance are three studies with three budgets and three durations, tracked outside the financial model.
04
The notified body queue is nobody's line item
The wait for a conformity assessment slot is a real date on the critical path. It rarely appears on a plan until it is late.
05
Reimbursement arrives as a surprise
A CE mark is permission to sell, not a decision to pay. The coding and coverage work starts after the launch date is already promised.
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.
Analytical performance study
Performance evaluation
€120K
▲ on track
ISO 13485 certification
Quality system
€45K
● pending
Notified body submission
Regulatory · IVDR
Jun '27
▼ 8 wks
First distributor revenue
Commercial
€180K
▲ 12% vs 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 tells you which study to buy with the cash you have, or what it unlocks.
02
Not Asana with a lab coat
Task tools (Asana, Notion, Monday) have no diagnostics logic: no gates, no product profile, no runway that knows what a milestone is.
03
Not an FP&A app
Runway and Pigment don't know what a performance evaluation is, or that revenue and the next round are two different clocks.
04
Not a regulatory consultancy in a box
BaiOS plans the company. It does not write your technical documentation, and it does not pretend the conformity route is automatable.
05
Not US-only
The venture tools built for this market ignore IVDR 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
Other segments
The same engine, a different regulator.
Your living IVD plan — evidence, regulation and money in one place.
From a working assay to the next financeable or revenue-generating milestone. Set it up before you pitch, not after.