A PREMIUM BOUTIQUE CONSULTING FIRM FOR NOVEL MEDICAL DEVICES
Bringing innovative medical devices to the U.S. market, FASTER.
Your strategic partner for navigating FDA, reimbursement, and the path to market
Successfully Navigate FDA
Solve Market Access
Your Innovation. Our Expertise.
From neurotechnology to cardiovascular devices, AI, and beyond, we help ambitious MedTech companies navigate complex regulatory, clinical, and reimbursment challenges.
Integrated strategies for growth-stage medical device startups with FDA know-how.
Complex devices succeed when regulatory, clinical and reimbursement decisions are made together.
The right team to help you succeed.
Strategy
Regulatory and reimbursement strategy, mapped in a focused report and aligned from the start.
Expertise
In-depth knowledge of your device, paired with firsthand understanding of how FDA works and what it expects, built on deep agency relationships and ongoing analysis of evolving FDA policy.
Execution
Submissions developed alongside your team, built to secure FDA input that de-risks testing, clinical and capital decisions.
Representation
A partner for pivotal FDA meetings, grounded in deep agency insight and relationships, preparing your team, joining you at the table and translating the intent behind FDA’s feedback into clear direction.
Why Work With Mittal Consulting
What if regulatory could actually speed up your path to market?
We partner with growth-stage medtech and diagnostic startups to navigate novel, ambiguous pathways where early decisions carry the highest stakes. From securing Breakthrough Device Designation to crafting compelling FDA submissions, our specialized team anticipates agency pushback before it happens. Watch how we help founders protect their runway, de-risk their regulatory roadmap, and bring life-changing technologies to patients faster.
Members and Partners
Trusted by MedTech Innovators
“I would say it’s been a wonderful experience. Kristen, Shu and team have been extremely professional and met all of our expectations on coming up to speed with the device area, supporting information and research you conducted, and applied your past knowledge and experience to help shape the critical topics of the submission. All in all, I would highly recommend (and will use again) your consulting services.”
“We feel incredibly fortunate to have met Kristen and her team. We are an early-stage startup with multiple medical devices, both hardware and software, in development. Before we even agreed to work with them, they reviewed all of our prior regulatory history including multiple meetings with the FDA, and key publications, allowing them to propose a realistic and informed schedule. The whole team has been professional, prompt, and helpful. 100% recommend.”
“Mittal Consulting was an exceptional regulatory partner in preparing our Pre-Submission to the FDA. They went above and beyond to prepare us for and represent us in person at our FDA meeting in D.C. The meeting was extremely productive, in large part because their team had done such a strong job clearly explaining our device and the key regulatory questions in the written Pre-Submission, allowing us to get meaningful, actionable feedback from FDA on the path forward. Their team brought rigor, deep regulatory expertise, and a strong understanding of the nuances of our neurotechnology platform. We went into the meeting well prepared, confident, and aligned on our strategy. Just as importantly, they were thoughtful, responsive, and genuinely great to work with. I would highly recommend Mittal Consulting to any medtech company navigating a critical FDA interaction. 10/10.”