Feasibility assessment and launch strategy for medical products
Before investing in development, registration and manufacturing, we simulate the full launch under uncertainty: financial feasibility, quality design and market entry strategy, integrated in a single model.
The “average” number lies
Most medical product business cases rest on a single optimistic scenario and hand-entered costs disconnected from the actual formulation. And almost all of them make the same invisible mistake: they treat regulatory delays as fixed dates, when they are the project’s largest source of uncertainty and cost of capital. The result is a case that looks solid in the spreadsheet and collapses in reality.
What we do differently
- We simulate thousands of scenarios, not one.Instead of an “average” NPV, you get a distribution: probability the project is profitable, worst case, and the value of reducing uncertainty before deciding.
- We connect the technical with the financial.The formulation drives cost, cost drives margin and margin feeds cash flow. Design decisions stop being separate from profitability.
- We wire regulatory timing to money.ANMAT and ANVISA delays enter as variables that affect the financial outcome, which is exactly where most models fail.
- We evaluate the entry sequence.Argentina first, Brazil first or in parallel, and how to stagger product variants. Sequence is a strategic variable, not an operational detail.
What you receive
- A decision report with the distribution of outcomes (probability of success, percentiles, worst case), not a single number.
- The financial read (NPV, IRR, risk) connected to product design and market strategy.
- A recommended market sequence and variant portfolio, with its rationale.
- Explicit, editable assumptions so you can stress them with your own data.
Who it is for
- Medtech and biotech founders deciding whether and how to launch.
- Investors evaluating a project who need a defensible case, not an optimistic one.
- Innovation teams comparing formulations or entry strategies before committing budget.
The honest framing
This is a prospective simulation framework (Quality by Design): input prices, milestone probabilities and calibration are declared assumptions, replaced by your data as it becomes available. It is not a prediction or a guarantee of results: it is a rigorous way to decide under uncertainty and to see what happens when things do not go as in the best case.
Frequently asked questions
How is this different from a regular business plan?
A business plan usually relies on a single scenario and costs disconnected from design. Here the formula determines cost, regulatory timing affects cash flow, and the output is a distribution of scenarios, not an optimistic number.
Do I need all the data to start?
No. We start with declared assumptions and sector experience, and replace them with your real data (bench results, quotes, regulatory timeline) as you get it. The model is calibrated with you.
Is it useful for an investor pitch?
Yes. A case that shows probability of success and worst case, and that proves you understand regulatory risk, is far more credible to an investor than an optimistic linear projection.
Does this replace registration or the quality system?
No: it comes before. It is the decision stage. If the case holds, you move on to multi-jurisdiction registration, the quality system and, in operation, the DocQMS Regulado platform.
You may also need
Medical device registration and approval
Strategy and management of your device registration with ANMAT, ANVISA, FDA and CE, coordinated in a single base dossier.
View service ComplyISO 13485 Quality Management System
Implementation of your audit-ready QMS, aligned with the FDA QMSR now in force.
View serviceDeciding whether to launch?
Tell us about your product and we will assess whether, how and in which order to launch it.