--- AI Summary: "\\- Developed FDA regulatory strategy and Pre‑Submission for Gemini AI\ \ platform. \n- Enabled conversion of 2D MRI scans into 3D joint models using AI.\ \ \n- Delivered on time, on target, and within budget." Anonymous: false Assignee: - Yujan Shrestha Last Edited Time: '2026-05-09T20:24:00+00:00' case_study_510ks: [] client_logo: - 18dbd5b7-a754-80fd-93cb-d9d86bf4b131 client_name: OrthoVentions date: '2025-11-09' featured: true medical_panel: Radiology name: We Delivered an AI Regulatory Strategy On Time and On Budget services: - 11abd5b7-a754-8058-b035-f358222cec8c - 28abd5b7-a754-80f8-a6fb-c5adc4aa8993 summary: FDA regulatory strategy and Pre-Submission for an AI platform converting 2D MRI to 3D joint models. Delivered on time and budget tags: - AI/ML testimonials: - 11fbd5b7-a754-80ed-9edd-f3f5ad41bdf6 --- #### Partnering with Innolitics for a Clear, \"On Target\" AI Regulatory Strategy \"They did what they said they were going to do, and they did it within the budget that they said they were going to do. So there were no surprises.\" --- **Jagi Gill MD, Founding Partner, OrthoVentions** 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 #### About the Client **OrthoVentions** is a medical device startup accelerator that partners with the Hospital for Special Surgery (HSS) in New York. They identify promising concepts from top surgeons, then fund and operationalize these new companies, transforming innovative ideas into market-ready products. #### The Challenge: Navigating the FDA for a Novel AI Platform OrthoVentions\' portfolio company, **Gemini**, is developing a cutting-edge Software as a Medical Device (SaMD) platform. The technology uses AI to transform standard 2D MRI images into data-rich 3D models of a patient\'s joint. This gives surgeons unprecedented insight for diagnosis and surgical planning. This novel technology, sitting at the intersection of AI, imaging, and user interface, presented a significant regulatory challenge. OrthoVentions had already engaged two other consulting firms but found them \"suboptimal\" in their understanding of the FDA\'s complex, evolving stance on AI in medical devices. They needed a partner who didn\'t just know the regulations but actively understood the FDA\'s *thinking* and could create a pragmatic, commercially-viable regulatory strategy. #### The Solution: A Proactive and Pragmatic Partnership OrthoVentions chose Innolitics to develop the regulatory strategy and prepare a new FDA Pre-Submission for the Gemini platform. Jagi Gill highlights three key differentiators that set Innolitics apart: #### 1. Proactive FDA Expertise Unlike firms that simply react to regulations, Innolitics demonstrated a deep, proactive engagement with the FDA. \"What gave us a lot of confidence,\" Jagi explains, \"is that they were proactive in their conversations with the FDA, *outside* of projects. They really were trying to gather primary data from what the FDA thinks about this quickly evolving space.\" This proactive insight meant the strategy was based on current FDA thinking, not outdated assumptions. #### 2. A \"Not-Invented-Here\" Mentality Innolitics didn\'t start from scratch. The team conducted a \"fulsome view\" of the existing Pre-Submission, identifying what was strong, what was vague, and---most importantly---where vague responses from the FDA could create future commercial risk. \"They didn\'t take the \'throw the baby out with the bathwater\' approach,\" says Jagi. \"They identified parts of the pre-sub that were very good and parts that had a level of risk\... I appreciated that.\" #### 3. Strategic Project Management Innolitics understood that Gemini was a *platform*, with the immediate goal of launching a Minimum Viable Product (MVP) to be followed by a suite of other products. \"Yujan \[of Innolitics\] understood that this is a platform\... and put some guardrails out from the very beginning\" to prevent scope creep. This was backed by a strong project management structure. The Innolitics team combined deep subject-matter expertise (from Yujan) with dedicated project management, ensuring the project moved forward efficiently. #### The Outcome: On Time, On Target, and On Budget The partnership with Innolitics successfully reset the regulatory strategy for Gemini. The Innolitics team delivered a high-quality, robust FDA Pre-Submission that aligned with both the company\'s commercial goals and the FDA\'s expectations. Most importantly, the project was a model of predictability and reliability. **\"The pre-submission was done on time, on target,\"** Jagi concludes. **\"They did what they said they were going to do, and they did it within the budget\... so there were no surprises.\"**