Wara Samar
22nd May 2025
Mittal Consulting Helps Startups Think Big—and Navigate FDA Fast
At the heart of every transformative medical technology lies a team navigating the complex journey from concept to clinic. For early-stage medtech startups, this path can be especially daunting—marked by stringent regulations, limited resources, and the constant pressure to get life-saving innovations to patients faster. That’s where Mittal Consulting steps in.
Founded by Kristen Mittal after years of experience in large and mid-sized MedTech companies, the firm was born from a simple observation: the world’s most promising early-stage innovations often struggle to access the same quality of regulatory guidance available to industry giants.
“I saw a gap where mission-driven startups were building life-changing technology but lacked the resources to navigate complex regulatory pathways,” said Kristen. “Mittal Consulting was founded to close that gap.”
In 2023, Kristen brought on her partner, Mridul Mittal, as co-founder to scale the business. Together, they’ve cultivated a nimble, expert-led team spanning the U.S. and Europe, combining biomedical engineering expertise with deep regulatory knowledge and top-tier scientific writing.
Built for Startups, Designed for Impact
Mittal Consulting is purpose-built to serve MedTech startups. Unlike traditional firms, their approach is tailored specifically to the needs of early-stage companies navigating the earliest—and often most uncertain—phases of development. Their support spans the full lifecycle of a device’s journey, from pre-submission strategy and global market entry planning to FDA clearance and post-market considerations.
“We are the only regulatory services firm built specifically for startups,” Mridul emphasized. “We work with companies who are trying to do something never heard of before, especially first time founder physicians or engineers—and we give them the strategic advantage they need to do it right.”
That includes a recent high-profile success with Siloam Vision, a medical device company developing a novel Optical Coherence Tomography (OCT) system—the iCam OCT—to detect Retinopathy of Prematurity (ROP) in newborns. Earlier this April, with Mittal Consulting’s guidance, Siloam Vision earned their second FDA Breakthrough Device Designation for the iCam OCT, marking a major milestone for the company.
“We led the strategic development of the Breakthrough submission, clearly communicating the device’s clinical value and aligning with FDA’s expectations,” Kristen explained. “The designation was granted in just 60 days—on the first attempt.”
With the Breakthrough status now secured, Mittal Consulting and Siloam Vision are working closely on a comprehensive marketing application, with FDA clearance targeted for 2026.
A Mission Grounded in Access and Excellence
At its core, Mittal Consulting is driven by a vision: a world where every patient has access to safe, effective, and advanced medical devices. Their mission is to empower MedTech innovators by offering streamlined, strategic pathways to market—fueled by values of authenticity, executional excellence, and client success.
This mission takes on even greater meaning as they partner with innovators across geographies—from Europe to APAC—helping non-U.S. startups confidently enter the U.S. market and navigate unfamiliar FDA pathways.
“We speak their language,” said Mridul. “And we connect them to our trusted network that helps de-risk their journey—from regulatory strategy to commercialization.”
Also Read: Asia Family Office Foundation Joins MedTech World’s Hong Kong Roadshow
Building the Future with MedTech World
Mittal Consulting is keen to deepen its collaboration within the MedTech World community, seeking partnerships with early-stage companies, clinical innovators, and investors working on novel or high-impact technologies.
“We’re looking for partners who could benefit from early regulatory strategy, Breakthrough Device Designation, or integrated reimbursement support,” said Kristen. “Whether it’s a startup building their first device or an established company moving into a new area, we’re ready to help them get to market faster—with fewer surprises.”
Over the next year, the firm plans to expand its services beyond regulatory submissions to offer end-to-end guidance, including clinical trial planning, go-to-market strategy, and investor-focused regulatory positioning.
“Startups need a flexible, trusted model,” Kristen added. “Our goal is to meet them where they are—and help them move forward with clarity and speed.”
A Trusted Partner for a Global Innovation Ecosystem
For the MedTech World community and beyond, Mittal Consulting offers more than regulatory support—it offers a strategic partnership. From navigating FDA or EU MDR pathways to preparing for investment and commercialization, the firm equips innovators with the expertise and structure to scale.
“You didn’t build a MedTech company to do Regulatory, WE DID,” said Mridul. “We’re a partner who understands how to navigate the complex MedTech entrepreneurial journey. Because for our clients, it’s not just about launching a device—it’s about transforming lives” Mridul concluded.
To learn more about Mittal Consulting or explore collaboration opportunities, visit mittalconsulting.com or connect with them during MedTech World Bay Area event June 27th, 2025.
Up Next: MedTech World Bay Area
Join us at MedTech World Bay Area on June 26 & 27, 2025, for a focused two-day event connecting sponsors, investors, and high-potential MedTech startups. In partnership with MedTech Innovator, this exclusive gathering offers direct access to 100+ emerging companies and key industry leaders redefining healthcare innovation. Whether you’re seeking strategic partnerships or looking to stay ahead in MedTech advancement, this is where real connections happen. For sponsorships or to secure your spot, contact [email protected].
