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In-Depth Conversations with Residents: Congruence Medical Solutions


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Gautam Shetty, PhD, Founder and CEO of Congruence Medical Solutions, aims to challenge the status quo in healthcare by providing device-based injection potential solutions to patients. From his advice to early-stage companies to his experience as a BLUE KNIGHT™ company at Johnson & Johnson Innovation – JLABS (“JLABS”), learn more about Dr. Shetty in the next of our In-Depth Conversations with Residents series.

Q: Tell us the story behind your company. What is the personal and scientific inspiration behind the founding (or your work with) this company?

GS: Congruence Medical Solutions is a drug delivery device company involved in the design, development, and supply of injection devices for applications involving small volume doses (i.e., microliters) of a drug.

Early in my professional career, post-academia, I found that there were limited solutions for microliter dosing despite numerous potential options existing in a lab. It showed me how solutions in a research laboratory don’t always translate to a clinical setting because of the regulatory requirements. There is also inertia, which is a resistance to change to remain comfortable with the status quo. For several clinical applications, this inertia is now indefensible – and in some cases potentially harmful.

My personal philosophy involves following every “no” I receive with a “why not?”. Over time, I was able to gather enough answers to that question to chart a path forward and create a vision for our company.

We are positioning ourselves to be the leader in injection device solutions for small (microliter) volume doses. This will allow us to hopefully solve the problems of inaccuracy and imprecision of microliter dose delivery. Conventional solutions for delivery of small volumes can be inherently wasteful. We feel our work in this space uniquely enables us to provide innovations to minimize waste, a benefit that can be particularly relevant to maximizing the number of doses of vaccines.

Q: Why start a healthcare or life sciences company? What personally drives your mission?

GS: We got to a point where we felt the status quo in this therapeutic area was unacceptable, and the opportunity to advance the next generation of injectable drug delivery solutions was too compelling to pass up. The part of the industry where our company operates in is defined by a philosophy where everyone wants to have something best-in-class, but no one wants to be first-in-class. For a company like ours developing new and innovative products, this can present a challenge, which only drives and motivates us more.

We hope to enable the next generation of injectable therapeutics, such as cell and gene therapies that may be administered as microliter volume doses. In addition, a number of specialized applications such as ophthalmology, targeted organ delivery, pediatrics and critical immune therapeutics could hopefully benefit from our devices.

In the near term, we would like to make our potential solutions available to help minimize waste in vaccine vials. This could hopefully accelerate deployment of COVID-19 vaccines to help better control and end this pandemic.

Q: Did you face any obstacles creating your start-up? What, if any, advice would you give to early-stage entrepreneurs? What shaped you into the innovator we see today?

GS: Obstacles or barriers are a pre-requisite for a startup. If there were no barriers or obstacles, what you intend to do would either be done already, or someone could easily replicate it. If I were to offer advice to any future entrepreneur: obstacles or barriers are not necessarily a bad thing. In fact, they can be an essential ingredient to ensuring a sustainable competitive advantage.

Another thing I would share is that creating a vision for your company may be difficult, but it is much easier than preaching patience for the journey to realize that vision. No successful enterprise is built on an island of one. It takes a village, and ecosystems such as JLABS have an important role in that regard.

While the tangible aspects of the JLABS ecosystem (i.e., the lab space, equipment, etc.) are obviously great, the intangible benefits of being part of the JLABS family and receiving mentorship are even more amazing. Our experience with JLABS is just beginning and yet, the exposure we have received and the doors that have opened for our company…we couldn’t have imagined any better outcome.

Learn more about Congruence Medical Solutions at https://microliterdose.com.

Johnson & Johnson Innovation – JLABS @ Washington, DC is open for business. Learn more and join us in pursuit of accelerating innovation in service of our patients: https://jji.jnjinnovation.com/join-jlabs-dc.


This interview is from Johnson Innovation and represents a selection of activities from across our Innovation Centers, JLABS and JJDC. The information in this blog is for informational purposes only. The information is either proprietary or licensed to Johnson & Johnson Innovation LLC, its parent company or any or any subsidiaries or affiliate companies ("JJI and Johnson & Johnson ") or is provided by or proprietary to third parties. In case of third-party information, please note that only those third parties that provided or own this information are responsible for it. JJI and Johnson & Johnson are not affiliated with companies participating in BLUE KNIGHT™, and by providing this information, JJI and Johnson & Johnson do not endorse these third parties or any of the information provided in blog. This content is not intended to influence the use, sale, recommendation, or promotion of any products or services of JJI and Johnson & Johnson. JJI and Johnson & and Johnson are not responsible or liable for any actions you do or do not take in relation to this information and are not responsible for any use of this information by you. By providing the information in this blog, JJI and Johnson & Johnson do not make any representations, warranties, or assurances, express or implied, as to the content or the information presented in this interview and is not responsible for any use by or alterations of this information by you. JJI and Johnson & Johnson hereby expressly disclaim any and all guarantees, representations, warranties, or assurances and assumes no responsibility or liability, direct or indirect in relation to the information in this blog.