Medical sector innovators face a tough question: How do you innovate in a highly regulated industry?
Mikko Juuti, Tero Saksman and Rosa Tegnvall from Kasve Ltd. know the answer: take regulations into account at the earliest stages of commercialization. On Wednesday, December 9 keynote speakers from Kasve Ltd. held a truly inspiring mini workshop on the commercialization of medical devices and software.
“Innovating in a regulatory industry and commercialization of medical devices and software can be overwhelming if you don’t have the right resources and tools. Our job is to make healthcare and medical technology sector start-ups’ workload manageable,” says Kasve CEO Mikko Juuti. “We provide both experts and professional expert services for projects related to business development, quality management, product development, contract manufacturing, B2B marketing and project funding.”
Juuti started his presentation with some relevant questions: What is innovation? What makes a good innovation? And last but not least: is good innovation good business?
“Innovation means that you are turning an idea into a solution that adds value from a customer’s perspective. And in the health tech and med tech fields, the end customer is always the patient. That’s why innovation is not just about technology,” says Juuti.
According to Juuti, a good innovation can be labeled with words like technological advantage, novelty, customer value and usefulness. Unfortunately, none of those terms makes an innovation into a good business idea…unless there is a strong business case behind the innovation.
Commercializing health tech innovations is not easy. It is time consuming but it can also be highly profitable, as the market is looking for new solutions and digitalization is changing healthcare processes.
“Fortunately, investors know that investing in healthcare innovation can be lucrative. But before they are willing to invest, they will evaluate the project and start-up itself very carefully,” Juuti says.
If the start-up has done its homework carefully from day one, it is easy to answer the questions that investors will ask: What is the innovation all about? How is the Intellectual Property (IP) protected? Does the company have an interesting business model? How big is the addressable market? What are the company’s growth plans? Is the team capable of transforming the innovation into a business? What kind of quality management system does the start-up have?
“Once again, if you have started systematically documenting everything in the early stages of your project, you’ll benefit from it when you are looking for venture capital investment,” explains Juuti. “Raising a million euros might sound impossible, but it is doable. After all, health tech is one of the fastest growing markets in Finland.”
If the health tech market is demanding from a funding point of view, it is also demanding from a regulatory point of view. Hundreds of standards and guidelines, and thousands of individual requirements makes for a complex business environment.
“Quality management is business leadership. In the medical device field, if a company does not comply with the standards, they have no business. Health tech product manufacturers must be able to show compliance,” points out Rosa Tengvall.
The regulatory compliance of CE-marked products is time-consuming and needs lots of resources due to fragmented information sources. Since EU and U.S. have unique requirements it is challenging to keep up with the information needed.
“That is why we at Kasve created a digital SAAS platform called QAiRA,” Tero Saksman explains.
QAiRA is an AI toolkit which helps the companies in the health tech market to keep record of the latest legislation, guidance and standards, and show the evidence of compliance of their products. QAiRA also helps to manage the product lifecycle.
“QAiRA is a module-based platform. The Newsfeed module has 21 information sources, and the Regulations module fully covers EU, and 80 % of U.S. regulations. QAiRA reduces significantly our client’s manual work and it helps them to keep up to date with the health tech ecosystem,” Saksman says.
Kasve Ltd. offers experts and professional expert services for projects related to business development, quality management, product development, contract manufacturing, B2B marketing and project funding.
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