Few students enter college knowing with certainty that their initial choice of major will become their true calling. Sanjana Singh, now a Product Development Manager GCMI, was no exception. Like many, she questioned whether biomedical engineering was the perfect fit.
The turning point in Sanjana’s journey came during a third-year elective in Medical Device Development, taught by A. Vijayrajan. With over 30 years of industry experience, Vijayrajan had not only established himself as an expert in the field but also went on to found InnAccel Technologies, a company dedicated to investing in early-stage medical device startups in India. His insights and mentorship brought clarity to her path, inspiring her to delve deeper into the world of medical device innovation and development.
“Moving away from theoretical study into specific examples of applications for new technologies in medical devices piqued my interest,” Sanjana says.
After completing her undergraduate studies and an internship with InnAccel, Sanjana joined the startup full-time in 2016, contributing to the development of its non-invasive fetal heart rate monitor technology. Her role encompassed hardware development, heart rate data refinement, grant writing, and building quality management systems per ISO 13485, all integral to advancing the project.
In 2017, she was accepted into the Master of Biomedical Innovation and Development (MBID) program at Georgia Tech.
“What was being taught in the MBID program at Georgia Tech was philosophically similar to the work I was doing at InAccel,” she says. “It felt like the right next step for me. Perhaps the stars simply aligned. Perhaps I should give myself a bit more credit for making the right decision. It’s likely both.”
After completing her MBID studies she joined GCMI full time in 2018, contributing to the design, development and commercialization of devices and technologies with positive health impacts that emanate from startups or teams composed of university researchers, faculty, students and clinician innovators.
Increasingly, medtech innovation and startups spin out from university settings and research, wriggling its way through a Darwinian labyrinth (including the ever present Valley of Death) on its commercialization pathway. Many promising ideas and technologies do not survive the journey, some unnecessarily. The smartest and strongest survive long enough to support viable companies or successfully exit to larger ones delivering positive health impacts, some at truly global scale, against very long odds.
Translating Research to Improve Lives When Big Industry Won’t
Because GCMI is situated within Georgia Tech, the team works to create medical devices that solve unmet clinical needs based on cutting edge technology and research, frequently for problems or populations with markets too small for industry investment like pediatrics.
“Large, profit driven companies invest heavily in R&D, but they’re often hesitant to back early-stage technologies, especially those targeting smaller or niche markets” Sanjana says. “GCMI isn’t constrained in that way. Because of our association and mission, we help create life changing technologies like Omer Inan’s IV infiltration technology, Micron Biomedical’s microneedle arrays and Christopher Saldana’s PPE face shields at the height of the Covid-19 pandemic when healthcare providers needed them desperately. It is immensely gratifying work that directly improves lives and health outcomes.
“GCMI and our clients don’t create ‘me too’ devices. It’s groundbreaking work based on cutting edge technologies that translate the engineering and scientific acumen of our esteemed colleagues into devices and technologies that improve health at personalized levels, at global scale and points in between.”
“Medical device innovation doesn’t work like consumer electronics or software,” says GCMI Interim Executive Director Saylan Lukas. “It works more like aerospace. Because lives are literally at stake it needs more than a place for people to work and high speed internet. It needs certified clean rooms, highly expensive equipment and advanced materials, intensive validation testing and rigor at every level of its pathway to commercialization and positive health outcomes. Most of all it needs brilliant people like Sanjana, who’s experience, perspective, expertise and dedication give our clients’ projects a stronger chance of successfully achieving their next milestone on the path to commercialization.”
Quick Hit Q&A – In Sanjana’s Own Words
What are you most proud of in your work with GCMI?
“When Sarah Cohen left GCMI in early 2021, she left big shoes to fill. At the time, we were developing a venous catheter under her leadership. When more of that project’s leadership responsibilities came to me, I was less than confident. However, the client embraced my role in Sarah’s absence, and together, we achieved positive outcomes. Successfully taking on her role—even partially—is something I’m truly proud of”.
What have been the most impactful learnings since you joined GCMI?
“It’s natural to question your abilities, but don’t let doubt hold you back. Approach your work with as much confidence as you can gather. Second, when brainstorming in a group, remember that unconventional or seemingly odd ideas often lead to breakthroughs. Avoid ‘negative brainstorming,’ where ideas are dismissed before they’re fully explored.
For example, the GCMI team faced the challenge of producing a large number of balloons for a nephrostomy catheter project. Traditional production methods for these balloons require substantial capital expenditure. But by focusing on the key factors—temperature and pressure—we managed to produce them in-house, saving considerable time and resources. It’s entirely possible negative brainstorming would have put an end to that endeavor. Because we stayed positive and left plenty of room for creativity, we succeeded.”
What can researchers or students learn from your experience?
“Researchers often conduct research for research’s sake. If you have a great idea, focus on the aspects that are feasible for translation now, and take action. Don’t wait until every detail of the device is perfect before moving forward. Start with one or two promising concepts, demonstrate that the technology works, and then concentrate on translation.”
What about clinician innovators?
“Don’t be married to your idea in early stages. Be nimble. Don’t consider your experiences alone as fact. Look outward and explore other physicians’ perspectives. Gather input from a wide range of experts before committing significant time and money to expensive prototypes. Objectively assess design feasibility, considering intellectual property availability, freedom to operate, market size, and development costs. This approach helps ensure resources are invested wisely.
Second, know that there is a big difference between consumer products and medical products. Regulatory requirements including quality systems and documentation [for medical products] are intensely rigorous. The path is not as direct as knowing something works, having colleagues agree, producing 10 or 20 test articles, conducting preclinical testing, then launching to the market for clinical utility. Regulatory requirements are rigorous, detailed and have very little, if any, room for compromise.
Carefully distinguish what you want the product to do versus what it actually can do, or what it needs to do. Then select for scale and intensity of impact.
About GCMI
“Based on deep experience and variety in products supported, GCMI knows the requirements for commercialization across the breadth and depth of new medical technologies from the simplest to the most complex. But they know what’s even more important. They know what a technology needs to be within those requirements to actually be successful in the clinic and in the market.
“We can’t get where we want to go, as efficiently and effectively as we need to get there without GCMI.” – Kamil Makhneija, Founder and CEO, Jackson Medical
At GCMI your success is our primary concern. Remember, It’s never too early to get in touch.