Orthopedic AI/ML SaMD Strategy and Presub

OrthoVentions

FeaturedRegulatory StrategyAI/ML

Testimonial

They were proactive, informative, and very well-versed in the regulatory challenges of AI in medical imaging… Unlike competitors, who sometimes take a blanket approach, Innolitics didn't throw the baby out with the bathwater. They recognized the good work already done and built upon it… We reviewed other capable firms, but none showed the same depth of understanding of the rapidly evolving landscape of AI and regulatory requirements. Their proactive stance with the FDA gave us confidence that we were in the right hands, compared to competitors who seemed more reactive.
Dr. Jagi Gill, MD

Dr. Jagi Gill, MD

Founder and Managing Director

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**

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."

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