Why Biotechnology Is Not the Same as Information Technology

TL;DR ✨

A biotechnology startup cannot operate like another application built in a garage. It deals with living systems, expensive laboratory infrastructure, and results that must be reproducible and safe. The greatest difference is therefore not a lack of ideas, but the cost and duration of every experiment, regulation, and the journey from discovery to a usable product.

From the archive

This article was written in 2014 as a loose adaptation of an older text. The basic differences between software and biotechnology still apply, although specific regulations, funding options, and laboratory technologies continue to evolve.

Personalized medicine, gene therapy, and treatments tailored to individual patients have been discussed for years. From the outside, it may therefore seem strange that such an idea cannot become a product as quickly as a new web service. Biotechnology does not lack innovation. It simply operates in an environment where an iteration does not take one afternoon and a mistake may mean more than a broken screen.

The comparison with a software startup breaks down mainly in five areas.

1. Regulation Protects People, Not a Business Model

A medicine must do more than work. Its developer must also demonstrate its safety, manufacturing quality, and benefit-risk balance.

A new application can be released to a small group of users, their reactions can be observed, and a fix can be deployed the next day. Such an approach would be unacceptable for a medicine or biological product. Development typically includes laboratory research, preclinical evaluation, clinical trials, and review by a regulatory authority. Oversight does not end with approval; safety continues to be monitored after a product enters the market.

This caution is not bureaucracy for its own sake. The product being tested may directly affect human health, and some adverse effects only become apparent in a larger patient population or after prolonged use. The drug development process described by the US FDA provides a useful overview of the individual steps.

2. An Experiment Cannot Simply Be Copied

Software runs in a relatively well-defined environment. Biology is more variable: a cell line, sample purity, temperature, method, or a minor deviation from the protocol can influence the outcome. An interesting result observed once is therefore not yet a product. It must be repeatable, measurable, and confirmed by further experiments.

This changes the pace of work. A software iteration may take hours, while a biological experiment can require days or weeks and consume materials as well as the time of specialist staff. Failure is a normal part of both fields, but it is often considerably more expensive in a laboratory.

3. A Good Idea Is Not the Only Barrier to Entry

The first version of a web service may require little more than a laptop, a cloud account, and time. Depending on its focus, a biotech project may need a safe laboratory, instruments, reagents, appropriate sample storage, waste handling, and expert supervision. Some work can be outsourced to a contract laboratory, but that merely turns the problem into cost, coordination, and waiting for capacity.

Community laboratories and the DIYbio initiative help make safe experimentation and education more accessible. This does not mean that drug development can be moved into a garage. Access to equipment is only the first step; sound procedures, documentation, and biosafety are just as important.

4. An Academic Discovery Is Not a Finished Product

Universities and companies pursue different goals. A researcher needs to demonstrate a new finding and publish it. A company must also solve manufacturing, stability, quality control, intellectual property, regulation, and the economics of the entire solution. This creates a gap between an interesting laboratory result and a product, often called the valley of death.

Technology transfer is not simply handing a paper to an investor. It includes protecting and licensing the discovery, validating its practical use, and building a team that understands both science and commercialization. This journey is the focus of institutions dedicated to moving discoveries from research into practice.

5. Capital Must Support a Longer Journey

A software startup can acquire its first users relatively early and test whether anyone will pay for the service. A biotechnology company may fund research for years without having a product it is allowed to sell. Investors therefore assess not only the idea and market size, but also the quality of evidence, patent position, regulatory strategy, manufacturing risks, and the team's experience.

The project is also judged milestone by milestone. Has an experiment demonstrated the intended effect? Is the result reproducible? Can the substance be manufactured safely? Does proceeding to the next phase make sense? Every positive answer reduces some uncertainty, but none guarantees eventual success.

What the Two Worlds Can Learn from Each Other

Different conditions do not make the experience of software companies useless in biology. Biotechnology can benefit from:

• continuously testing the riskiest assumptions,
• automating data processing and laboratory procedures,
• small interdisciplinary teams with clear responsibilities,
• shared infrastructure instead of buying every instrument at the beginning,
• decisions based on predefined milestones.

The slogan “move fast and break things,” however, cannot be transferred without thought. For a product intended to enter the human body, thorough validation is part of its value, not an obstacle to bypass.

Practical Questions for Assessing a Biotech Project

Before being persuaded by an impressive presentation, it is worth asking a few specific questions:

1. What exactly has been validated? Is it a hypothesis, a laboratory result, an animal model, or human data?
2. Is the result reproducible? Has it been confirmed by repeated measurements or an independent laboratory?
3. What is the path to practical use? Which studies, approvals, and manufacturing steps remain?
4. Who is behind the project? Does the team cover science, clinical practice, regulation, and commercialization?
5. What problem does the solution actually remove? A technically interesting discovery does not automatically make a meaningful product.

Biotechnology is therefore not a slower version of information technology. It is a different kind of business, where speed must be balanced against the quality of evidence and safety. That is precisely why the path from a good idea to a patient takes longer.

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This text was freely translated and adapted to the Czech context from the now unavailable original Techli article “Biotech Startups Are Not Tech Startups”.