Lean Entries - Solving the early stage regulatory hurdle for university researchers and startups

Lean Entries offers a unique and easy-to-use digital tool, Entries, for any innovation team in health tech to identify applicable regulatory requirements. This, in connection with the training and coaching services by Lean Entries, results in months worth of savings for teams to reach the market from the early stages of development. Lean Entries provides incubators, universities and regions with this combination of services as a package. The mission of Lean Entries is to bring down barriers as low as possible for innovator teams so they can build up the crucial regulatory know-how and become successful in the global healthcare market.

Regulatory compliance is a struggle for health tech innovators and startups around the globe. AdvaMed in the USA has stated: “Medtech innovation is driven by small companies and start-ups on the cutting edge of improving patient care. In the best of times, these heavily R&D-focused firms struggle to find the financing and resources they need to navigate tough regulatory pathways in order to bring a new device or diagnostic to market.” 

Lean Entries, one of the newest members of the ECHAlliance and part of the Labquality family of companies, is on a mission to tackle the early-stage regulatory hurdle and create a new baseline of know-how for university researchers, startups, business advisors and other stakeholders in the health tech sector. Lean Entries aims to turn regulatory compliance into a business advantage for the entrepreneurs and to increase the pace and number of successful innovations in the health tech sector for the benefit of citizens and patients in all regions.

During the past year and a half, Lean Entries has delivered its Digital Regulatory Runway service named Entries and the Regulatory Essentials in Health Tech training series to over 200 researchers, startup employees and business advisors within the EU-funded HealthTech Nordic programme and its Nordic partners, the SPARK Finland programme, as well as the Finnish cities and universities of Helsinki, Oulu, Tampere and Turku. 

The named programmes and regions have saved several months of time for their innovators by enabling correct regulatory choices and processes at the early stages of innovation. This was most recently highlighted in a post by the City of Helsinki, an ECHAlliance member, wherein they described that ”Lean Entries holds fine means to transmit a massive amount of challenging information for the startups and researcher teams in our region. The digital platform and webinars they provide enable the efficient formation of a common language and basic know-how on the medical device regulations.”

ECHAlliance welcomes Lean Entries into the community and looks forward to engaging them in fruitful dialogues on the regulatory topic. We agree with our Nordic colleagues in that startups and university teams need support to comply with requirements to save resources and maximise potential in this highly competitive and regulated sector.

Learn more about Lean Entries and their unique concept from their website. Also, read the book European Medical Device Regulations MDR & IVDR – A Guide to Market published and authored by Business Finland and their team.

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 their unique digital regulatory services (Entries) and the Regulatory Essentials in Health Tech training series.Their services have put tens and hundreds of academics and startups 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 covers 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.