Life science product development
Prolifex Bio helps life science innovators solve the technical, product, manufacturing, regulatory and commercial problems that stand between promising technology and a real product.
01The gap
They fail in the space between a working result and a product you can manufacture, get approved and sell. That space is full of unglamorous problems: undefined requirements, unexplained variation, unqualified suppliers, unsettled claims, unmapped buyers.
Each one is solvable. Together they’re why good technology stalls for years, and they’re rarely what a founding team was put together to handle.
That’s the work we do. We’re practitioners, not advisors. We work with your team, in your systems, and step away once they can run it.
02What we solve
It works in our lab and nowhere else.
Performance that depends on one operator, one instrument or one lot isn't really performance. Before anything can be transferred, scaled or claimed, you need to know the operating window and name the failure modes.
Everyone agrees it's promising. Nobody agrees what it is.
A technology becomes a product once someone writes down what it must do, for whom, and how that'll be proven. Until then, every engineering decision is aimed at a moving target.
We can make ten. We can't afford to make ten thousand.
Making one is a technical problem. Making thousands at a cost the market will bear is a different one, and it's usually found too late to fix cheaply.
The pathway changes depending on who we ask.
Regulatory strategy is a product decision, not a filing exercise. Claims drive evidence, evidence drives studies, and studies drive budget and timeline. Getting that order wrong is the costliest mistake you can make.
The product is real. The first paying customer isn't.
Enthusiastic users aren't the same as an organization with budget to buy. Map the commercial path with the same rigor as the technical one, and do it earlier than feels necessary.
03How we work
Most stalled programs are held up by one thing at a time. Work that doesn’t move it feels productive and changes nothing. So we find it first, define it so it can be verified, then close it out alongside your team.
We find the real constraint, which often isn't the one you called us about. That means digging into the data, documents and decisions, and talking with the people doing the work.
Before anyone builds, the problem gets defined in terms you can verify: requirements, specifications, acceptance criteria, and the evidence that closes out each one.
We work alongside your team, in your systems, on your documents. No report from the outside, and no parallel program to reconcile later.
The engagement is built to end. Your team holds the documents, understands the reasoning, and can run the process without us. That's the outcome that lasts.
Most programs are held back by one thing at a time. Work that doesn't move it feels productive and changes nothing, so we find it before anything else.
Experience tells us where to look, but it doesn't replace data. Every recommendation should hold up on something other than seniority.
Documents land in your quality system, in your format, ready to use. A deliverable that needs translating before anyone can act on it isn't finished.
The measure of an engagement is what your team can do afterward that it couldn't before. Dependence is a failure, not a business model.
04Innovation Readiness Assessment
Fifteen questions across the five domains. You get a readout of where the program really stands, which area is holding the others back, and a next move for each.
No account and no gate on the result. It runs in your browser, and nothing is sent unless you choose to send it.
Overall readiness
49/100
Consolidating
ConstraintCommercial Readiness is holding the rest of the program back.
Start here
Describe the problem in your own words. You'll get a thoughtful reply from someone who has solved something like it, not a scheduling link and a discovery call.