Reducing compliance burdens to give R&D teams more time to innovate
Compliance workstreams are an expensive and time-consuming burden for regulated Medtech companies, often detracting time and resources from R&D teams who could be focussing on more valuable development activities.
For Medtech SMEs, admin-heavy compliance processes are resulting in 20-50% of R&D time being spent on compliance-related tasks; an inefficiency which can cost companies over £100k for each product submission. For R&D teams, the labour-intensive process of achieving and maintaining compliance can be overwhelming, with time required to gather evidence and prepare documentation according to specific criteria and guidelines. SMEs are left with limited options; either hiring expensive regulatory consultants for additional support, or accepting that internal resources will be diverted from more valuable activities.
Streamlining inefficiencies in MedTech compliance
Klaris is reducing the administrative burden of compliance with an AI platform designed specifically for MedTech companies, allowing R&D teams to spend less time on compliance, and more time on valuable research and development. This empowers SMEs to significantly expedite compliance timelines, resulting in bringing important innovations to market much faster. All of this means faster time to market and faster health outcomes for patients.
Building on the latest advancements in agent reasoning, Klaris is providing resource-constrained MedTech SMEs with Enterprise-level compliance power, automating the administrative burden with a platform tailored to a company’s unique requirements, SOPs and regulatory requirements. With Klaris, companies are able to conduct GAP analysis of critical documents in minutes rather than days, with a documentation assistant that validates materials and suggests improvements. The platform also allows companies to automatically generate their own key documentation, according to specific guidelines and industry standards.
Through its multi-faceted approach and strategic approach, Klaris seeks to massively reduce the time and resource burden of achieving and maintaining compliance in the medtech industry.
Strong founder-market fit: Deep expertise in Medtech compliance and AI decision-making
Working with Francesco and Mihai was a pleasure throughout the residency. Bringing AI-driven innovation to Medtech compliance requires a team with a deep AI expertise and experience of navigating complex medical regulations. Mihai and Francesco are uniquely equipped to solve this challenge, combining world-class AI expertise with firsthand experience in scaling regulated medical products.
Francesco brings deep operational experience in the Medtech industry, most recently as Director of Product at Empatica, Francesco helped scale the company from a six-person startup to a 130-employee Series B firm, and leading a team of 60+ engineers across hardware, software, and AI development. During his 10+ years in the industry Francesco successfully delivered 4 FDA clearances and CE marking. These devices are used by thousands of families living with epilepsy and by tier-1 pharma companies. His experience navigating complex regulatory pathways while maintaining rapid product development gives him a unique perspective on balancing compliance with innovation.
Mihai is a leading AI researcher and engineer with over six years of experience developing cutting-edge decision-making algorithms in the self-driving space. As a Research Scientist at Five AI, he led the Planning and Prediction Applied Research team, developing state-of-the-art AI systems for complex urban environments. Along with his PhD in AI decision-making as well as multiple papers in top tier conferences, Mihai has spent years ensuring AI-driven decisions meet the highest safety standards, making him exceptionally well-suited to building AI systems in a regulation and compliance environment.
Throughout the residency Mihai and Francesco combined their sector experience, deep industry network and technical expertise to hit the ground running, meticulously working at pace to validate hypotheses and build product. We are incredibly excited to be backing the team as they revolutionize compliance processes and unlock faster, safer innovation in the industry.
Investment Thesis
Klaris is an example of us backing a team with deep technical expertise and lived-experience of the problem they’re working to solve, which represents a significant market opportunity.
As healthcare regulations continue to evolve, MedTech companies face growing challenges in gaining and maintaining compliance in an increasingly complex environment. With manual compliance approaches currently the industry standard, there is a significant value in an applied-AI solution that can reduce administrative burden through automating complex compliance processes, allowing medical device companies to focus on innovation and patient outcomes. With expertise in building advanced AI within complicated decision-making environments and deep domain knowledge, the team is well-equipped to build an industry-leading solution.
We have been impressed with the team’s dedication and pace of execution over the last few months, with two active design partners providing strong early validation for their solution. Their MVP has already achieved a 99% reduction in GAP analysis time (reduction from 1 week to 1 hour) for a design partner.
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