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Tampere region making regulatory compliance a competitive advantage for health tech start-ups and university innovators

Tampere region making regulatory compliance a competitive advantage for health tech start-ups and university innovators
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“Regulatory compliance is an essential part of the journey and a typical struggle, especially for the newcomers. We know from experience that this struggle causes months and years of delays in reaching the market. Thus, it is crucial to give local innovators, and start-ups access to tools and knowledge that create an early advantage on their demanding regulatory journey.” Juho Väisänen, Program Manager, Innovation Services of Tampere University and Development Manager of SPARK Finland. Lean Entries shares their recent success stories in educating local health tech innovators and encourages regional business units, incubators and universities to engage into discussions with them and repeat the successes in your region.

Business Tampere, the regional economic development agency, encourages the local innovators to establish more businesses in the Region, surrounding them with world-class know-how and support for reaching the global healthcare market. The comprehensive training program on global regulatory essentials in health tech is aimed for local start-ups and innovators.

Tampere is a region with remarkable biomedical research. The Tampere University holds an array of disciplines from medicine to health tech sciences and our region is targeting to increase local pharma and health tech industry to match the academic dimension.”, describes Harri Ojala, Director of Investments and International Operations at Business Tampere.

Business Tampere and the University of Tampere are encouraging the local start-ups operating in the health tech industry to proportionate their resources up to the industry requirements via support and training.

Juho Väisänen, Program Manager, Innovation Services of Tampere University and Development Manager of SPARK Finland adds:

Regulatory compliance is an essential part of the journey and a typical struggle, especially for the newcomers. We know from experience that this struggle causes months and years of delays in reaching the market. Thus, it is crucial to give local innovators, and start-ups access to tools and knowledge that create an early advantage on their demanding regulatory journey.

Business Tampere, Tampere University and SPARK Finland collaborate with Lean Entries Ltd. to provide an educational program on global regulatory essentials in health tech for the local start-ups and innovators. The success of the local start-ups is one of the driving forces in the Tampere region. Tommi Uitti, Startup Ecosystem Community Manager at Business Tampere, explains:

With Lean Entries and their unique service concept, a combination of webinars and Entries, the digital fast-track tool into the medical device regulations, we give the local innovators a chance to excel in regulatory compliance early on and turn it into their competitive advantage.

The training series is held in English. It includes series of online sessions focusing on regulatory topics that are common to all health tech innovators globally. Depending on the needs of the participants, the remaining of the series will be tailored to take into account topics most relevant for the local industry.

Concurrently, the digital regulatory tool Entries, which starts off from a minute pathway into medical device qualification and classification, is freely available to all local start-ups, university innovators and students until the end of 2021. The number of trainees and Entries subscribers in the Tampere region averages over 100 individuals. The overall satisfaction rate of the ongoing training program has reached 8.8 on the scale from 1 to 10, training content reaching an average of 9.3.

I have previously joined entrepreneur and fundraising events organised by Business Tampere and have found them very useful. As a founder and scientist, all information concerning a start-up, besides the core-tech that we mainly know thoroughly, like this regulatory essentials training series, has been very useful and valuable. Thank you!”, commented a biomedical scientist from the Tampere University attending the program.

Heikki Pitkänen, the CEO and founder of Lean Entries describes

This is why we want to collaborate with such innovative regions as Tampere. Regulations, just like funding rounds, take time and experience to master, and we can cut that time remarkably for the entrepreneurs by providing the regulatory knowledge in a format that can be digested in a snapshot.

Discover more

Lean Entries, as a part of Labquality, provides a wide range of regulatory expertise in the global health tech market. Lean Entries is known for its unique digital regulatory services (Entries) and the Regulatory Essentials in Health Tech training series. Their services have put tens and hundreds of academics and start-ups on a steep learning curve to build sufficient early-stage regulatory know-how and to turn regulatory compliance into a business advantage. The decades of expertise at Lean Entries cover a wide range of innovations from medical device software and artificial intelligence to implants. They represent Finland in the Advisory Board of Healthcare Standards (ABHS) of CEN-CENELEC.

More about their autumn training series and digital services at: https://www.labquality.fi/koulutus/regulatory-essentials-in-health-tech/

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