5 Strategies for MedTech Start-Up Success

The medical device industry is competitive.  It demands ground-breaking technologies, a strong market of practical applications and a flexible mind-set to the continually evolving global regulatory landscape. Start-ups and innovation hubs play a pivotal role in driving the medical technology industry growth by developing ground-breaking solutions and attracting investment, contributing significantly to gross domestic product (GDP) by creating highly skilled jobs, know-how and attractive innovation eco-systems.

So, what are strategy tips for MedTech start-up success? 

1. Quality first

A well-defined and robust quality management system (QMS) is crucial in the development of medical devices, because it ensures day-to-day compliance and best positions the company for commercialization. Implementing a robust QMS ensures that medical devices are designed, manufactured, and maintained to the highest standards. As such, keep records straight and make sure the QMS is always prepared for an inspector's scrutiny, whether from a regulatory body or a potential acquirer. 

2. Embrace different perspectives

Innovative technology needs to be cost-effective, applicable, and adoptable by the target market, as such it needs to be applied to real-world needs. Patients, providers, and payer’s perspectives need to be aligned into one common ground, so that the engineered medical device can achieve ultimate success. Usability testing under realistic conditions can go a long way into penetrating the competitive market. 

3. Align money with vision

Every investor comes with their own interests, so it is important to strategically choose partners who can truly deliver a value that is aligned with the vision of the company, i.e. provide not only substantial capital but also wisdom to support the challenging journey ahead. 

4. Develop strong clinical evidence: it will yield!

Investors are looking to fund innovative, scalable technologies that offer strong clinical outcomes for patients; as such, developing strong clinical evidence helps not only regulatory approval to market, but also stimulates more investors to join the run and further develop the device - i.e., in a total product lifecycle approach. It is essential to develop a strong clinical evidence base and have a clinical strategy for pre-market and post-market status, so that it can translate into clinical and economic value to attract more investor’s attention.

5. Reimbursement strategies for new products should be developed as early as possible.

A robust reimbursement strategy ensures that once the device is approved for use, it can be successfully adopted and purchased within the healthcare system or reimbursed by the patient private health insurance. As such, an early consideration of reimbursement helps align the product development with the economic constraints and requirements of the healthcare systems in which the device will be marketed. Understanding the cost structures, payment models, and reimbursement rates of these systems can guide decisions about pricing, marketing, and sales strategies, making the device more appealing to all stakeholders: patients, providers, and payers. 

The MedTech startup ecosystem is complex, but industry leaders, entrepreneurs, regulators, and investors are optimistic that new and innovative products can be brought to market – with the right strategy.

By Ana Catarina Ribeiro Carrão





Photograph: Stock Image