Andy

Last year, I wrote a LinkedIn Article titled “To be or not to be: Just because you CAN, doesn’t mean you SHOULD.” The point was straightforward. Passion and good science are not enough. They never really were. That post was a reaction to what I was seeing across early-stage biotech and MedTech at the time. The environment has not eased since then. If anything, the bar has moved higher.

The requirements for viability are more stringent today than they were even a year ago. Early-stage capital remains difficult to access, particularly at the seed and Series A stages, unless a company has human proof of concept. Angel investors want de-risking. Most venture funds will not underwrite the earliest technical risk. Government funding used to fill that gap. The uncertainty around the reauthorization of innovation investment programs has made it harder to hit commercially meaningful milestones at exactly the stage when companies need that support most. Until policy catches up, founders are forced to seek private capital that is increasingly selective and unforgiving.

This shifts the question founders need to ask themselves. It is no longer whether an idea is interesting or even whether it addresses an unmet need. The question is whether the idea can survive the current validation threshold. That threshold is no longer defined by enthusiasm or momentum. It is defined by evidence, timing, and a clear path to value creation that stands up to scrutiny.

Commercial realism remains the most common failure point. Founders and CEOs are almost always optimistic about their opportunity, and they should be. If the CEO is not the champion, no one else will be. The problem arises when optimism replaces rigor. Market size is often overstated. Competitive dynamics are underestimated. Pricing and reimbursement assumptions are built on hope rather than data. Real market assessments require primary customer discovery paired with precedent sales data, both top-down and bottom-up. They also require discipline about who the customer is and where adoption will realistically occur.

Differentiation has also changed. Incremental improvements used to matter. Slight changes in dosing or convenience could be enough in some cases, but that still holds only if the market signals that it values those changes. In many therapeutic and digital health categories, that bar has risen. The existence of a standard of care, even an imperfect one, changes everything. Workarounds that are cheaper and good enough are formidable competitors. A fourth- or fifth-line product rarely succeeds just because the total addressable market is significant. Investors are not persuaded by big numbers without a sophisticated explanation of what portion of that market is reachable and why.

Health economics can no longer be an afterthought. Payers are not focused on novelty. They are focused on sustainability. Cost effectiveness, total cost of care, and system-level impact matter early, not late. Clinical development strategies that ignore this reality tend to produce assets that struggle to gain traction even if they reach approval.

Manufacturing and supply chain considerations are now decisive factors in viability. Fully burdened cost modeling should be mandatory, not optional. Many promising concepts fail when exposed to the realities of sourcing, scale-up, tech transfer, and CDMO capacity. Lead times for specialized reagents, limited suppliers, geopolitical pressures, and competition from larger customers all introduce risks that can derail timelines and margins. Profitability estimates that are not grounded in real quotes and realistic assumptions are unreliable. A product that cannot be manufactured profitably at scale is not a product. It is an experiment.

Intellectual property expectations have also hardened. Venture investors continue to favor novel chemical entities with enforceable composition-of-matter claims. Method-of-use claims and simple repurposing strategies remain difficult to defend commercially. Off-label use, generic substitution, and payer resistance erode value quickly. Repurposing can be both capital and clinically efficient, but unless there is a credible way to lock the market through delivery technology, owned chemistry, or a pricing model that holds, it is rarely attractive to institutional capital. The irony is that some of the most efficient paths to patient benefit struggle the most under current investment models.

Clinical adoption risk extends far beyond efficacy. I look at alternatives already in use and ask who they fail and why. I look at early predictors of response and whether patient selection is feasible. I look at whose pain point is being addressed and whether that aligns across providers, patients, payers, and regulators. Evidence requirements vary by stakeholder, and the costs and time required to satisfy them must be modeled honestly. I also look closely at who makes the buying decision and how the product would be sold. Adoption fails as often for psychological and behavioral reasons as it does for scientific ones.

Deciding whether to move forward, pause, or walk away requires discipline. Founders need to evaluate unmet need, solution fit, market opportunity, IP defensibility, validation requirements, development and manufacturing plans, regulatory and reimbursement pathways, financial models, and exit logic together. Weaknesses in any one area can undermine the entire effort. The willingness to stop is not a sign of failure. It is a sign of judgment. In this environment, the threshold for validation is higher across the board, even in areas that remain attractive to pharma and investors.

This is where an experienced, external perspective matters. A short, focused conversation can surface gaps that would otherwise take years and significant capital to discover. Stress-testing assumptions early saves time, money, and energy. Not every idea should become a company. Not every asset belongs in a pipeline. The goal is not to build something at all costs. The goal is to build something that has a real chance of reaching patients and creating value along the way.

Being in the business of innovation means living with uncertainty and learning constantly. It also means making hard calls sooner rather than later. Just because you can still does not mean you should. The difference between the two has never mattered more.