Rishi Roongta

Regulation doesn’t have to slow you down — with the right system, it accelerates you. After more than three years of development and optimization, our Easy13485 QM Service is now fully mature. — built on over 25 years of experience leading successful medical innovation projects. A unique part of our commitment: we take responsibility for all Framework Non-Conformities identified by the Notified Body — at our own cost 💵 . This keeps the regulatory risk for start-ups predictably low and allows them to focus on product and funding milestones. 2025 we added a comprehensive Academy to the Easy13485 QM Service Framework — more than 150 role-based trainings that allow every team member to become audit-ready independently. This closes one of the biggest gaps in regulatory reliability for early-stage companies and simplifies #onboarding for #fast-growing teams. 𝗢𝘂𝗿 𝗯𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗺𝗼𝗱𝗲𝗹 𝗶𝘀 𝗱𝗲𝗹𝗶𝗯𝗲𝗿𝗮𝘁𝗲𝗹𝘆 𝘂𝗻𝗰𝗼𝗻𝘃𝗲𝗻𝘁𝗶𝗼𝗻𝗮𝗹 While most #eQMS systems focus on automating recurring documentation tasks, #Easy13485 eliminates them by design. 🦉 Instead of making regulatory work faster, we make most of it unnecessary — replacing traditional consultants and, in a way, 𝗰𝗮𝗻𝗻𝗶𝗯𝗮𝗹𝗶𝘇𝗶𝗻𝗴 𝗼𝘂𝗿𝘀𝗲𝗹𝘃𝗲𝘀. We’re excited for this year’s #4CUnplugged, of Medical Innovations Incubator GmbH not only to meet our existing customers but also to engage with new start-ups as a premium partner. Ready to take on new projects in 2026.

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In a rapidly evolving healthcare landscape, experience-centered AI is poised to drive the next wave of innovation. Unlike incremental point solutions that address isolated inefficiencies, this approach integrates AI seamlessly across all touchpoints - creating a cohesive, patient-centric system. By focusing on outcomes, not just outputs, experience-centered AI empowers both patients and healthcare providers, improving communication, trust, and health outcomes. With tools designed to reduce administrative burdens and personalize care, this paradigm shift promises more affordable, efficient, and empathetic healthcare. The key to success will be fostering trust through responsible, transparent AI development that protects privacy and mitigates bias. #AIinHealthcare #PatientExperience #Healthcare #DigitalHealth #AI https://lnkd.in/gey7mU2i

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Embracing Innovation in Family Health Management The launch of Luffu by Fitbit founders exemplifies the relentless pursuit of innovation in health technology. By utilizing AI to track family health patterns and flagging significant changes, this platform promises to enhance preventative care. At ElevenX Capital, we recognize the potential of such solutions in transforming family health management. As investors, how important do you believe it is to integrate AI into health monitoring for long-term wellbeing? #investing #innovation #venturecapital #entrepreneurship

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Growth that depends on talent is vulnerable. Growth supported by system is durable. Private equity environments demand commercial engines that can be tuned, measured, and scaled through compressed timelines. My colleague John van Berkum outlines how Strategic RevOps strengthens that foundation: https://lnkd.in/e4QDQq7W

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AI and Health Tech in Focus   AI Tool Used to Help Predict Postpartum Depression Researchers at Harvard University’s Massachusetts General Hospital have developed an AI tool that helps predict the risk of postpartum depression (PPD) before discharge from the hospital. Approximately 15% of women suffer from PPD which is responsible for suicide and self-harm and about 10% of all pregnancy related deaths. The researchers trained the algorithm based on about 29,000 mothers using electronic health records data including medical history, medication data, age, race, ethnicity, education, marital status, insurance type, number of births, mode of delivery, number of prenatal visits, length of delivery stay as well as an existing but more modest predictability score for PPD called EPDS. Incorporating this data resulted in an ability to predict more than three times the baseline risk of PPD. Using this model can help care teams identify those at risk for PPD and provide resources and support services such as referral to social workers, psychotherapy, psychiatry or medical therapy before they have an impact on the mother, child and their families. VC Investors are always adjusting their "Play Book" with a variety of options for investing. Mikal Ventures is one of those alternatives, offering curated solutions to real world problems. Reach out if you have questions on how we can be of assistance and bookmark https://mikalventures.com/ for additional insights and information.

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I spoke with Christien Louviere of BDE Capital about his journey from a $330mm exit to becoming an independent sponsor. Christien shared excellent insights for folks looking to partner with business owners, rather than buy sellers out completely. Below are a few of the topics we covered: - Why he moved from “zero-to-one” startups to a buy-then-build strategy - How Christien's background shaped a focus on growth vs. cost-cutting - Why 20–40% rolled equity is central to his deal structures—and how it builds trust with sellers - Using scenario analysis with AI tools to evaluate management teams and uncover hidden key-person risks - How to identify when a $3–5M EBITDA company truly has a middle management layer—or is still founder-reliant For anyone investing in or buying small businesses, Christien’s approach provides a fresh lens on growth, alignment, and deal structuring. 🎥 Watch the full interview here → https://lnkd.in/ekfkaiej 🎧 Listen on Spotify: https://lnkd.in/e86Agx6V

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