Shen Hsin-Wei, Vice President of Medical Affairs, BizLink Biotech Venture Capital

In the world of medical entrepreneurship, truly valuable ideas rarely come from a momentary flash of inspiration. Instead, they are born out of real, persistent clinical needs. These overlooked, unresolved, or only partially addressed problems—so-called Unmet Clinical Needs—are embedded in the routines of everyday clinical practice.

For those who aspire to build a medical startup, beginning from these needs not only increases the likelihood of success, but also makes it easier to create solutions with real impact. Rather than starting from technology and then searching for a market, it is far more effective to let the problem lead the innovation.

Why Start from Clinical Needs?

1. Problem-Driven Thinking Reduces the Risk of Failure

Many startup teams invest massive resources into developing a technology without first asking:

“Who is this for, and what problem are we actually solving?”

The result is that products cannot be implemented in practice, or they discover—after years of development—that the market has little interest.

By contrast, when you begin with a clearly defined clinical pain point, you can ensure that product development remains aligned with real-world needs, significantly improving market fit.

For example, a Taiwanese company observed that in neurosurgery, traditional sheet-type artificial dura mater is difficult to handle and often leads to cerebrospinal fluid leakage and infection. They instead developed a foam-type artificial dura mater, breaking away from conventional formats. This not only solved a key clinical problem but also created a new niche market.

2. High Professional Barriers Create Competitive Advantage

Healthcare is a highly specialized field. Understanding the nature of the need itself requires deep clinical knowledge and experience. Precisely because of this, few people are able to truly see the essence of the problem, and even fewer can propose the right solution.

For founders who start from the clinical need—and who themselves have medical expertise or close collaboration with healthcare professionals—this becomes a powerful source of differentiation.

For instance, Velano Vascular recognized the pain and infection risks caused by repeated venipunctures in hospitalized patients, and developed the needle-free blood draw technology PIVO. Without changing the core clinical workflow, they dramatically improved both patient experience and risk management. This kind of innovation, rooted in detailed clinical observation, is difficult for others to replicate.

3. Combining Business Value with Social Impact

Meaningful medical innovation is not just a tool for making money—it is also a way to solve structural social problems. When you address a major clinical need, you simultaneously generate business value and social impact. Such projects are often more likely to attract government grants, hospital partnerships, and strategic investment.

For example, the development of GLP-1 class drugs not only improved the quality of life for diabetes patients, but also massively expanded the therapeutic market for metabolic diseases. Likewise, the evolution of targeted cancer therapies emerged from a deeper understanding of cellular abnormalities and gave rise to a substantial industry around companion diagnostics and personalized medicine.

How to Discover Unmet Clinical Needs?

1. Direct Observation of Clinical Workflows

Entering hospitals, clinics, or long-term care facilities to conduct contextual inquiry is often the first step in discovering unmet needs.

You might observe:

• Physicians spending excessive time navigating electronic systems

• Nurses repeatedly moving heavy equipment between wards

• Surgeons having their view obstructed by surgical smoke

For example, a plastics research institute in collaboration with hospitals found that smoke generated by electrosurgical units not only impaired visibility but also increased exposure risks. They subsequently designed a new type of electrosurgical device with built-in suction, improving both operative efficiency and safety.

2. Interviewing Clinical and Care Staff

Direct interviews with frontline staff help surface what might be called “tolerated problems”—issues that everyone lives with but no one has solved.

A nurse might say, for example:

“We’ve always used this device, but it’s actually very hard to clean and it breaks easily.”

Feedback like this rarely appears in product manuals, yet it reflects real friction in daily practice.

Such in-depth interviews should involve diverse roles: physicians, nurses, technicians, social workers, case managers, and even patients and family members. Each perspective may reveal a different layer of unmet need.

3. Leveraging Data and Policy Trends

Beyond field observation and interviews, founders should also look at data and policy directions to identify structural needs.

Organizations such as the World Health Organization and national health insurance agencies regularly publish data on healthcare expenditures and major public health challenges. These can help forecast future resource allocation and policy focus.

Areas such as home care, telemedicine, dementia care, and aging populations are global challenges. Innovative solutions in these domains are more likely to receive policy support and backing from both the public and private sectors.

Turning Needs into Ideas: From Problem to Solution

1. Clearly Define the Problem

Describe the who, where, and what of the need as concretely as possible. For example:

“During referral and transfer, dialysis patients often experience treatment delays because medical records are not standardized across facilities.”

2. Understand Existing Solutions and Gaps

Investigate whether existing products or services are already trying to solve this problem.

• If yes, why is adoption still low?
  – Is it due to cost?
  – Workflow complexity?
  – Limited effectiveness?

Answers to these questions will help you identify your entry points and differentiation.

3. Design an Initial Solution

Combine technology, workflow design, and business model thinking to propose a Minimum Viable Product (MVP). Then, validate it as early as possible with target users and iterate based on real feedback.

Finding Problems That Are Truly Worth Solving

The first step in medical entrepreneurship is not to build a new technology, but to find the right problem.

Unmet clinical needs are the starting point of innovation and the most valuable source of inspiration for founders. When you use design thinking and cross-disciplinary collaboration to turn these needs into solutions that are accepted, adopted, and scaled, you are no longer just a startup founder—you become a driver of healthcare transformation.