Special Startup Series: Making affordable wound management a reality

Kerala based RMmedi Innovations that was incubated at KIIT Bubneshwar, is working on an indigenous medical device that could help in wound management in a cost-effective way

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Certain types of injuries involving deep wounds could prove fatal for a patient if these are not managed properly. One of the best examples is diabetic foot wounds which if not provided timely medical care, can lead to severe complications. These forms of complex wounds require specialized treatment modalities and one such option is Negative Pressure Wound Therapy, also called NPWT to ensure timely healing or wound optimization so that other reconstructive procedures may be carried out.

The procedure involves enveloping a non-healing wound so that to create a tightly enclosed environment, followed by the application of negative pressure through foam or gauze. Although a relatively new treatment modality, it has become quite popular among surgeons the world over, also a testimonial to its efficacy in wound management. In addition to this, a decrease in the number of dressings and relatively pain-free application and maintenance results in improved patient satisfaction.

However, the current NPWT devices in the market are mostly expensive, making the technology inaccessible to the medical professionals in government hospitals as well as small scale private hospitals, especially in far off areas. Despite the advancements in medical care, it would be ironic if such a device is not universally available to all.

In such a backdrop, the Kottayam (Kerala) based medical technology startup, RMmedi Innovations is working on a new prototype of the NPWT device that would be much affordable and thereby more accessible. The founders of the startup, Dr Joseph Thomas, Stephan George, and Digo Sebastian are bound together by their passion to create an affordable solution targeted at helping poorest of the poor.

Talking about the inspiration behind their idea, Dr Joseph Thomas, Director and Co-Founder, RMmedi Innovations says, “The government-funded healthcare system more often than not struggles to meet the basic healthcare needs of the people and hence specialized care by and large stood neglected. This is where we want to make a difference.”

Inception

The story of the venture goes back to the days when Dr Joseph Thomas used to work as a surgical resident (trainee) at the Government medical college hospital in Kozhikode, a city in the south Indian state of Kerala. He would often come across patients in need of specialized medical care, who could not access the specialized treatment because it was unaffordable.

“The patients one encountered there were mainly from the lower socio-economic strata. Most depended entirely on the government-funded healthcare system and could barely manage basic sustenance on their own,” Dr Thomas says while adding, “As surgical resident trainees, being most directly involved in the care of the patients, one of the unofficial parts of our duties involved overcoming these situations by creating solutions through improvisations using whatever freely available tools or devices or even used spares that we could get our hands on ‘jugaad’ as it is known in India.”

While Dr Thomas admits that these may very well have been within grey areas of safety and ethics, but the ‘jugaad’ often got the job done. “It gave me tremendous satisfaction when these improvisations worked. To many patients, it meant the salvage of a limb, maybe life and restoring their ability to earn a livelihood for themselves and their family.”

It was during his second year of residency that he got together with a friend Stephen George, who back then was doing his Masters at Indian Institute of Technology (IIT) Bombay. After several months of trying several things including dismantled handheld vacuum cleaners and aquarium aerators, he put together a simple device inside of a bread box for 4,000 Indian rupees. Despite its crude appearance and apparent lack of sophistication, it had in place multiple safety features, pressure and leak monitoring capabilities and adjustable time and pressure settings, pretty much most of the essential features a standard NPWT device required.

RMmedi Innovations team: Joseph Thomas, Stephan George, and Digo Sebastian.

Encouraged by his mentor, veteran plastic surgeon Dr N.C. Sreekumar, he carried this prototype device with him to Kozhikode and ran a trial pilot study. The results showed similar efficacy and safety when compared to the standard devices in the market. However, lack of time and the pressures of residency led to the project being pushed to the back of his priority list for a couple of years.

Three years later during a casual discussion on this matter with Dr Stanley Mathew the head of the Department of general surgery, Dr Thomas was advised to meet Dr Venkateshan a renowned bio-medical engineer, working at the Manipal Institute of Technology (MIT). Dr Venkateshan has been a guide and mentor to multiple young entrepreneurs throughout his distinguished career.

“After looking at our project, he suggested to us to apply for the Biotechnology Ignition Grant (BIG) by the Biotechnology Innovation Research Assistance Council (BIRAC). We had only 10 days to apply for the 11th call of BIG. We somehow managed to put together a proposal, without even the faintest hope of getting the grant. At this point came out biggest game changer. Up until then, we were simply improviser who made a solitary device and thought about making a few dozen more and use it at our hospital and give it to a few other interested doctors,” explains Dr Thomas.

The team decided to apply for the grant through KIIT TBI, in far away Bhubaneswar. While they were not confident enough to get the grant, they made it through the initial screening, aided by the team at KIIT TBI. Dr Thomas credits Dr Nivedita, Dr Namrata and Dr Aseem who he says practically held their hands and guided them from being simple improvisers to think and behave like entrepreneurs. “They guided our project through the selection process and made us think bigger,” he says.

The big moment for the team came when BIG -11 grant funded them with Rs 45 Lakh. The funds allowed them to set up a workshop and restart work on the device. At this point, they were joined by the third partner, Mr Digo Sebastian a mechanical engineer. Stephen and Digo together assembled test models, performed multiple tests and iterations and prepared our clinical trial prototypes. This was the time when three of them formally incorporated the company – RMmedi Innovations.

The focus of R&D is to bring down the cost

Explaining their research focus, Dr Thomas points out that the science behind NPWT is not very complex. “Most school science fairs could have devices with more technological sophistication,” he says adding, “What therapy does is to use an external pump to produce controlled negative pressure which is transmitted to a sterile airtight wound dressing. The negative pressure enhances wound healing by removing wound discharge, increasing blood flow, decreasing infections, shrinking the wound and promoting overall healing.”

However, the device and the treatment was and has remained prohibitively expensive. Therefore, the founders are single-mindedly focused on reducing the cost by developing a device which is both good in quality and affordable at the same time. Currently, the device is in the clinical validation phase with an ongoing multi-centric clinical trial involving 5 major hospitals in South India. The company’s efforts are also on to set up its own supply chains and identify reliable sources for procuring raw materials and parts.

Device prototype.

“We have been actively looking for further funding and have been successfully accepted for the SPARSH grant by BIRAC for the development of a smaller pocket size device. We also won Kerala startup challenge, 2019,” reveals Dr Thomas who is confident that they would be able to make a huge difference in the area.

Overcoming challenges

The greatest challenge for the company has been to maintain quality while bringing down costs. The founders say they have always stressed on maintaining quality at every stage of the product development, and hence improvisations, design streamlining and optimal sourcing have been the mantra. The second major challenge has been about obtaining funding to set up the manufacturing unit.

Dr Thomas explains further, “Licensing and certification have been the other challenges we have been working on. We do realize that it is work in progress, but we are looking at our future with optimism and confidence.”

Way forward

RMmedi Innovations is eyeing the huge NPWT market in India. While the market for NPWT has grown tremendously to be worth an impressive $2-3 billion worth-wide, it is estimated to be having rapid growth with some estimates stating an impressive $600 million in revenue. In India, it is dominated by just a hand full of multinational and local companies. The company intends to tap the huge potential by offering a quality device at an affordable price

Meanwhile, RMmedi Innovations through its future projects aims to develop low-cost 3D printed prosthetics, affordable surgical robotic systems and creating skin substitute alternatives. It aims to provide affordable healthcare solutions that are specific to the Indian socio-economic and cultural realities while achieving and sustaining quality

“At the end of the day, we wish to make a difference, however small that may be. So this is how we have begun, and how we stand. We have amazingly gotten this far, and we hope to go further and create our own wave on the sea this we see in front of us,” says Dr Thomas.

Our best wishes to the founders and their belief in serving humanity.