In Europe, the area of medtech is thriving due to creativity and innovative, patient-focused products while at the same time investing in them. Every medical device or digital health platform that was recently created through innovative thinking has been produced by these founders. Looking at these amazing success stories will provide many ideas for aspiring entrepreneurs and innovators in medtech.
A business begins with a well-defined clinical problem.
Many founding entrepreneurs use this, and the lack of, when creating new companies (or products). Many founders look for technology to start their companies, but they should first understand the true patient and clinical problem before creating a solution (product). An understanding of the real clinical problem allows for solutions (products) that:
- Fill an unmet need for a patient
- Have measurable and quantifiable results
- Are readily adopted by health care providers
Ultimately, this approach supports the founder’s credibility and the potential for a successful business.
Develop a Diverse Group of Professionals
Developing a new medical technology involves a broad mélange of capabilities including engineering, clinical knowledge, expertise in regulatory issues, and business strategy. Founders in Europe tend to focus on developing teams that:
- Incorporate both technical and medical capabilities
- Contain advisors with expertise in regulatory and reimbursement
- Develop teamwork across experience-based professions
A solid team with a solid mix of those skills is better able to deal with many of the challenges associated with developing new technology, getting regulatory approval, and taking the product to market.
Engage Early with Regulatory Authorities
The regulatory process for obtaining European approval for medical devices, software, and diagnostics can be complicated due to differences in the regulations across various health economies within Europe. Founders are successful when they work with the relevant regulatory authorities as early as possible to:
- Clarify what is required to receive regulatory approval.
- Avoid any unforeseen or costly delays while their products are in development.
Ensure that their products comply with both the CE mark and regulatory approvals from appropriate health authorities.
Engaging with the regulatory authorities in advance can reduce risk and allow products to come to market sooner than would otherwise be the case.
Funding and Investor Relations
Finding financial backing is often a challenge for medtech entrepreneurs. Successful medtech entrepreneurs tend to:
- Develop a long-term relationship with investors who are familiar with the healthcare industry.
- Clearly articulate both clinical and market value for their products.
- Create a realistic set of milestones and growth plans.
Medtech investors in Europe are increasingly looking for entrepreneurs who can demonstrate both innovative ideas and a clear path to commercialization.
Focus on Clinical Evidence and Clinical Outcomes
Technology can’t solve every problem. Successful entrepreneurs know that to establish confidence in their products, grow adoption rates, and create competitive edges, they need to:
- Produce solid clinical evidence
- Publish clinical trial results
- Collaborate with hospitals and physicians
Strong clinical data establishes trust among clinicians, accelerates product adoption, and creates a unique selling proposition in a competitive marketplace.
Build Networks and Gain Mentorship
Strong networking is essential when growing in Europe’s diverse med tech market. Successful founders have:
- Attended and participated in events (eg. Industry conferences, innovation centers)
- Received mentorship from experienced entrepreneurs engaged with cross-border collaboration
By establishing these types of relationships, founders gain transformative experiences; they can learn invaluable information, build new partnerships, and develop new business prospects, all of which will help them grow.
Adaptability and Agile Learning
The medical technology (medtech) sector grows rapidly due to regulatory updates and new technological developments. Successful entrepreneurs will:
- Determine how quickly their market is changing
- Listen to input from their clinical end-users
- Continuously improve upon their products and business models
Entrepreneurs often succeed through their flexibility and willingness to learn quickly.
There is a clear path available for aspiring medtech entrepreneurs to transform their use of technology into real-life outcomes through the following actions: solving real-world clinical issues, building strong teams with complementary skills, communicating with regulators early in the development process, focusing on funding options, creating clinical evidence, using business partnerships, and developing an adaptive and flexible business model.
The European medtech ecosystem has great potential, and examples of successful medtech entrepreneurs offer valuable lessons for early-stage entrepreneurs to create meaningful solutions for patients.
