I have recently come across an article about how to become a pope, which sounded like a strange title, but it analyzed the steps needed for someone to become a pope. It was practical and logical. I thought it would be possible to create a similar guide but for digital health companies to succeed.

I have been watching the field closely for over one and a half decades and I have seen many companies thrive and vanish.

If you are an entrepreneur, a developer or an inventor with an idea, or an investor looking at upcoming stars, here is how a company can succeed in digital health.

Address a real-life patient or clinical need

I see a lot of start-ups focus on the technology they can develop, even though it won’t be of any help to a clinician or a patient. Every company that tries to bring something into the delivery of healthcare should start with identifying a real-life patient or clinical need. The technology only comes after that.

Build a team that can bring it to practice

No inventor or entrepreneur can do it alone. You need a lot of views and perspectives, plus even more experience, to transform an idea for that need into a practical tool or technology people can use.

Engage stakeholders early and continuously.

This includes patients, clinicians, payers, and regulators. Co-creation reduces resistance later and improves product-market fit. With patient design, you can involve patients at the highest level of decision-making.

Ensure data privacy and security from the start.

Even if your technological idea could change healthcare, nobody can use it if it’s dangerous and leads to privacy breaches. Compliance with HIPAA, GDPR, or other regional regulations is not optional. Trust can be lost in a second.

Prove its technological claims in peer-reviewed studies

The rules of evidence-based medicine apply in healthcare. If you can prove your technological claims, efficiency and safety through peer-reviewed studies and clinical trials, healthcare will adopt your product. If you cannot prove it, even if the idea is transformational, nobody in healthcare can use it. That’s a simple yet crucial rule.

Get regulatory approvals

Once your technology is proven in studies, get the necessary regulatory approvals in the regions you plan to deploy it. This is painful. It’s complicated, expensive and takes a lot of time. But without it, you are operating in the wild west.

Build reimbursement pathways

A great product without a viable business model in healthcare will stall, unless you can get a government fund you. Explore models that would help you sustain your business. Look at new kinds of packages that include medications with digital health products to be reimbursed by healthcare providers more effectively.

Build partnerships, not just products

Hospitals, insurers, pharma companies, and even tech platforms can be allies or gatekeepers. Know the ecosystem and engage strategically.

Communicate benefits clearly to the public

Avoid overpromising with buzzwords like “AI revolution” or “digital twin of health” unless the technology backs it with evidence. Healthcare rewards depth over flash.

Iterate and validate

In general, plan for long-term impact, not quick exits. Many vanish because they optimize for acquisition, not sustainability. Build something that can adapt and grow over decades, not quarters.

This list isn’t meant to prescribe what every digital health innovator must do. It’s not a rigid formula or a guaranteed blueprint for success. Instead, it’s a mirror—reflecting how incredibly difficult it is to bring an idea to life in healthcare. The road from concept to impact is steep, messy, and filled with regulatory, clinical, and human complexity. But those who understand this from the outset, and still choose to take the journey with patience, humility, and evidence, are the ones most likely to create lasting change.

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