I’m pleased to share a new book series called From Pitch to Purchase that looks to improve startup best practices across a variety of disciplines. The first book in the series focuses on HealthTech Startups.
The catalyst for this book was a meeting with an early stage startup that was getting classic Lean Startup advice which works great (in theory) but the reality is that Lean simply doesn’t work out-of-the-box in a Healthcare context. We’ve come across this many times now, so this book is our attempt to set the record straight.
You can buy From Pitch to Purchase in HealthTech on Amazon and read an introduction to the topic below.
Lean Startup and HealthTech
The Lean Startup methodology, popularized by Eric Ries, has become a go-to framework for building businesses and products worldwide. Its core principles—rapid iteration, customer feedback and validated learning—have transformed the pace of innovation and new product introduction. However, when it comes to B2B HealthTech, a sector with enormous complexity and regulation, applying these principles can be fraught with challenges.
This doesn’t mean sacrificing the agility and customer-centric focus that Lean promotes; rather, it involves a thoughtful integration of these principles with the rigor and precision demanded by healthcare customers. Let’s take a closer look.
The Regulatory Roadblock
One of the most significant challenges in HealthTech is regulatory compliance. While the Lean Startup methodology encourages the rapid development and release of a Minimum Viable Product (MVP) to gather early customer feedback, HealthTech products must often pass rigorous regulatory approvals before they can reach the market. For instance, medical devices and software that impact patient care typically require FDA approval or CE marking in Europe. This process can take months or even years, making it difficult to iterate the Build-Measure-Learn cycle quickly or release an MVP.
Lengthy Sales Cycles: A Patience Game
The sales cycles in B2B HealthTech are notoriously long, often taking months or even years to close. This is a stark contrast to the Lean Startup’s emphasis on rapid feedback and quick pivots. In healthcare, the decision-making process involves multiple stakeholders, including clinicians, IT departments, procurement teams and compliance officers. Each of these players has different priorities and concerns, further complicating and extending the sales cycle. The delay in receiving customer feedback hampers the iterative process, making it difficult to validate learning and make timely decisions.
The Complexity of Decision-Making
In most industries, the Lean Startup methodology encourages close engagement with end-users to refine the product based on their feedback. However, in B2B HealthTech, purchasing decisions often involve a complex web of stakeholders. Each of these stakeholders—from doctors and nurses to IT administrators and compliance officers—has a say in whether a product is adopted. This complexity can lead to mixed signals and unclear feedback, making it harder to validate hypotheses and pivot when necessary. The intricate decision-making process can obscure clear signals from customers, complicating the validation process that Lean Startup depends on.
High Stakes, High Risks
The Lean Startup methodology celebrates experimentation and even failure as essential components of learning. But in HealthTech, the stakes are significantly higher. A product failure could result in patient harm or legal liability, not just a dip in user engagement. This high-risk environment forces HealthTech companies to be more cautious, often opting for thorough testing over rapid iteration. The risk-averse culture in healthcare makes it challenging to take the iterative risks that the Lean methodology advocates, leading to a more cautious approach to product development.
Evidence-Based Adoption
HealthTech products often require substantial clinical evidence to support their efficacy and safety. This evidence is typically gathered through pilots and clinical trials, which are time-consuming and expensive. While the Lean Startup methodology favors quick market entry and learning through customer feedback, HealthTech products must first build a robust foundation of clinical evidence before they can be widely adopted. The need for clinical trials and evidence-gathering slows down the iteration process, requiring significant upfront investment before market entry.
Integration Challenges
HealthTech products don’t exist in a vacuum. They must often integrate with existing healthcare IT systems, such as Electronic Health Records (EHRs) and comply with specific interoperability standards. This need for seamless integration complicates the rapid deployment and iteration process that the Lean Startup methodology promotes. Integration requirements can delay the release of an MVP and slow down the feedback loop necessary for quick learning and adaptation.
Customer Development Constraints
Lean Startup encourages constant customer engagement to refine the product. However, in the healthcare sector, accessing healthcare providers and patients for testing and feedback can be challenging due to ethical concerns and privacy laws (e.g., HIPAA, Privacy Impact Assessments, Security Threat Risk Assessments). As a result, gathering direct customer feedback is often more complex and time-consuming. Limited access to end-users restricts the ability to gather direct feedback, making validated learning more challenging.
Pricing Models and Reimbursement Complexities
Pricing in HealthTech isn’t as straightforward as in other industries. Often tied to complex reimbursement structures and value-based care models, pricing can be difficult to test and iterate on. The Lean Startup methodology encourages flexibility in pricing and business models, but in HealthTech, these elements are often constrained by existing healthcare systems. Testing different pricing strategies becomes more challenging, complicating the application of Lean principles to pricing and revenue models.
High Development Costs
The Lean Startup methodology promotes low-cost experimentation, but in HealthTech, the costs of development can be prohibitively high. The need for R&D, research studies, clinical trials and regulatory approval requires significant investment before any revenue can be generated. High upfront costs and long timelines contrast with the Lean principle of starting small and scaling based on customer feedback.
Navigating a Risk-Averse Culture
The Lean Startup methodology thrives on a culture of experimentation and acceptance of failure. However, the healthcare industry is inherently risk-averse, with a strong focus on patient safety and regulatory compliance. This conservatism can inhibit the adoption of Lean principles, as there is often resistance to iterative development and the associated risks. The conservative nature of healthcare organizations can slow the pace of innovation and the application of Lean principles, leading to slower product development cycles.
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The Lean Startup methodology, if applied directly to healthcare, will be met with stiff resistance, but it’s not insurmountable. By understanding the unique demands of the healthcare industry, HealthTech innovators can strategically adapt Lean principles to fit their context. This doesn’t mean sacrificing the agility and customer-centric focus that Lean promotes; rather, it involves a thoughtful integration of these principles with the rigor and precision required in healthcare.
With persistence, creativity and a willingness to iterate within the constraints of the healthcare environment, HealthTech companies have the opportunity to revolutionize the industry, bringing transformative solutions to market that improve patient outcomes and drive sustainable growth.
The journey may be complex, but the rewards—both for patients and for the companies that serve them—are well worth the effort.
You can read the full book, packed with actionable insights and without the fluff.
Advice is the easy part. Turning it into action and applying it intelligently to your unique situation is where things get tricky. That’s where the Evidology Group can help. Contact us at info@evidologygroup.com or click here.

