The minimal viable product myth in diagnostics innovation

Sitting down with Dr. Henry Fatoyinbo, Senior Director of System Engineering at molecular diagnostics company Binx Health, this isn’t necessarily what you’d expect to hear. But, after two decades in the diagnostics industry, Henry understands the problems at a granular, deeply practical level. In this conversation with PA's Dr. Alessandro Marturano, Henry reveals why so many well-funded companies with genuinely strong science still end up with nothing to show for it, and what to do about it.

Before joining Binx Health, Dr. Henry Fatoyinbo was Head of Engineering at DNA Electronics, spent time at Orphidia, and built his foundations in microfluidics and lab-on-chip through PhD and postdoc study. He knows that success rests on making diagnostic platforms work in the hands of a stranger, in a clinic, every time. So, when Henry says the industry’s favourite three letter acronym, MVP, is a confession rather than a milestone, it’s worth listening. How can MVP go from declaration to delivery?

The research company that thinks it is a product company

The most expensive mistake diagnostics companies make is a category error. A company raises money, hires a team, starts burning through runway, and genuinely believes it’s developing a groundbreaking product. But it isn’t. It’s still doing research. It just happens to be doing research with a Gantt chart taped to the wall.

“If an organisation is reliant on a single technology, but it’s not really well-understood or characterised yet, they’re still in research mode,” Henry says. “And research mode in this industry tends to not sit well in a time box.”

The tell is usually the consumable. Diagnostic cartridges aren’t laboratory prototypes. They’re manufactured objects that must perform identically across batches, across climates, across shelf lives, and in the hands of operators who have never read the design history file. The engineering required to get from a working assay in the laboratory to a cartridge that survives a shipping container in July isn’t a finishing touch. Companies that treat it as such discover, usually around month 18 of their next funding round, that they’ve been paying product development salaries for research outcomes.

But, as Henry points out, the bootstrapping logic is understandable. Founders believe non-dilutive funding will keep coming, and want to preserve optionality. So, they make defensible choices until the month the consumables budget lands on their desk and they realise how much ‘validation’ is actually open-ended characterisation work with no end point.

“What is good enough?” he asked. In research, the answer is usually “a bit more.” In product development, the answer has to be a specification with a signature on it.

The killer application is not an inventor’s question

Diagnostics companies, Henry says, rarely fail because they chose the wrong application. More often, the challenge is that people choosing the application don’t yet have the breadth of market experience to make that call with confidence.

“The killer application is based on people who have got experience in industry, who see where the value of an innovation is useful, who understand the systems that contribute to reimbursement, who understand the uptake of diagnostic testing in a variety of different healthcare situations. That can only be attained by people who have worked at a high level within industry for years, who can come in from the outside and look at an innovation objectively rather than passionately.”

So, passion is the energy source of the founding team. It’s also the reason the same team, alone, will struggle to identify where in the clinical pathway their platform actually changes a decision. That question warrants a different kind of answerer. Someone who’s watched reimbursement codes win and lose product launches, who’s seen a technically superior test beaten by a worse one that fit the existing workflow, and who understands that a diagnostic result has to be a change in clinical behaviour. And no amount of sensitivity and specificity will save a product that doesn’t create that change.

Companies that find their killer application early on rarely have the most brilliant science. They recognise, early, that they needed to hire or partner up with other entities to find answers.

The slowest-moving team sets the pace

Henry has experienced the next pitfall directly: where systems engineering stops being an org chart box and starts becoming a survival mechanism. A diagnostic platform is a fluidics system; an optical or electrochemical detection system; a thermal system; an embedded software stack; a cartridge with reagents, surface chemistry, and manufacturing tolerances; a user interface; and a data layer that connects to the lab. Each of those is a sub-team, with its own technology readiness level. The maturity of the platform as a whole is the minimum of those levels, not the average.

“If the maturity of one team is still very, very low, because essentially they’ve not resolved or understood how to resolve a problem that is critical to your product, no matter how much you can accelerate all of the other developments, you will never be able to get yourself into the clinical testing or verification stage,” Henry says, “because the critical component or sub-assembly has not matured yet.”

This is where the systems engineering function earns its keep. By walking the floor, assessing maturity objectively, naming the rate-limiting sub-team, and making the uncomfortable call about whether to invest, hire, or buy technology that closes the gap. Henry is unsentimental about the last option. If the chemistry doesn’t work and the expertise exists outside the building, bringing it in is often faster and cheaper than the year of internal learning the team’s pride would prefer.

What winners actually do

“The diagnostic companies that win will be the ones who do not rush to market first,” says Henry. “Because the problem is, when people think that getting to market first is the end all and be all, that’s where the science and engineering is not rigorous.”

These companies know which mode they are in, staff for the question rather than the hope, let the slowest-maturing sub-team set the honest pace of the platform, and have the organisational patience to be rigorous in a market that seems to reward noise.

If any of this sounds familiar, then the single most valuable 30 days you can spend is to find out, honestly, whether you’re in product development or still in research. The answer determines almost everything else.