Best Ring Forward

How one doctor’s vision becomes a sight-saving reality in cataract surgery

by Joanna Lee

As the saying goes: “Dreams don’t work unless you do.” This holds true for Dr. Suven Bhattacharjee, the inventor of the B-HEX® Pupil Expander 1 (formerly known as the Bhattacharjee ring). Seeing his innovation reach a developed stage — expanding from India into various corners of the world — has been worth every sweat and teardrop in bringing his dream to life.

The B-HEX Pupil Expander is a hair-thin, disposable 6.5 mm flexible hexagonal device with notches at corners and flanges at sides, which offers eye surgeons easy insertion through small incisions and good control at the site of action with its well-thought design.

Expanding from one man’s vision

Dr. Bhattacharjee is the founder and director of Med Invent Devices, the company that markets the innovative pupil expander device. It took him five years to develop the product from scratch, and even longer to patent it while facing multiple roadblocks, including a life-threatening health crisis, before his eureka moment.

Without giant financial backings, team support, or sophisticated labs — and being told his invention wouldn’t work — with hard work and dedication, the fruit of his labor has resulted in the B-HEX being registered with the US FDA for use in the United States, while also emerging as the preferred pupil expansion device in India.

According to a 2020 online survey in India, 42% of responders favored the B-HEX as their preferred pupil expansion device, while 41% choose iris hooks, and 8% went for the Malyugin ring.

“This result was a pleasant surprise,” shared Dr. Bhattacharjee. “Expanders are closed rings and require a single incision for insertion, whereas hooks require at least four incisions. Expanders also cost more than hooks. In India, the B-HEX costs four times that of iris hooks, which have been popular for years because cost is an important determinant,” he explained.

With no marketing budget or any sales representatives, the success of B-HEX is remarkable, largely due to its ease of use. “No wet labs or hands-on demos were given to any surgeons. They just watched videos and were good to go,” Dr. Bhattacharjee said.

The B-HEX has also been used in vitreoretinal surgery and manual small incision cataract surgery (SICS).

Spurring surge in device’s usage

Dr. Bhattacharjee attributes the expansion of B-HEX’s popularity to the overwhelming response from surgeons around India.

“We owe a debt of gratitude to them,” he said. “The B-HEX has been used across the length and breadth of India from individual practices to large corporate hospitals. We haven’t been able to make inroads into government hospitals probably because of complicated purchase systems.”

“We receive messages from experienced as well as rookie surgeons expressing gratitude for how the B-HEX has made complicated surgery easier, safer, and affordable,” he expressed.

The B-HEX had also been mentioned by a number of key opinion leaders on several occasions during conferences and meetings. Dr. Bhattacharjee said it has been meaningful for him. For instance, Dr. David Chang demonstrated the use of the B-HEX during his surgery at the “Spotlight on Cataract Complications” session during the AAO 2021 meeting. A video on the AAO website by Prof. Dr. Deepak Edward and Dr. Michael Henry from the University of Illinois in Chicago showed the B-HEX being used in a challenging phaco surgery with a glaucoma tube shunt. Dr. Bhattacharjee also shared words from Prof. Dr. J. S. Titiyal, head of ophthalmology at the All India Institute of Medical Sciences: “The B-HEX is simple, user friendly, and with marvelous results.”

There are also YouTube videos highlighting the advantages of using the B-HEX, as posted by Dr. Pradip Mohanta, Dr. Deepak Megur, Dr. Sourabh Patwardhan, and Dr. Soosan Jacob from India, as well as Dr. Neto Rosatelli from Brazil.

The rising popularity that the B-HEX now enjoys is a far cry from the early days when Dr. Bhattacharjee’s research papers and patent applications had been rejected several times.

Limitations play into growth strategy

After the device’s test and launch in India, which saw its growth in popularity, it appears it was time to scale up fast and make the B-HEX available in all countries.

“Since Med Invent Devices has a limited reach, we have been strategically adding value to the B-HEX to make it attractive for acquisition by an MNC. Towards this, we already have globally granted patents and trademarks, clinical validation, US FDA registration, and user testimonials indicative of superiority over competition,” Dr. Bhattacharjee shared.

He believes that acquisition by or collaboration with an MNC will make the B-HEX available to a global user base worldwide and translate into more rapid growth in its market share.

When asked why they didn’t go for distribution contracts outside of India, he said: “These would require long-term commitments on supply and pricing, which would be a deterrent in the process of acquisition.”

“The B-HEX was registered with the US FDA to make it legally usable and so that it could be showcased in the US. We deliberately did not register in other countries as that is best done by the acquirer,” Dr. Bhattacharjee explained.

Despite these limitations, in the Asia Pacific they have sold the B-HEX directly to surgeons in Japan, China, Korea, Nepal, Bangladesh, Indonesia, Malaysia, Thailand, and the Philippines, as well as to surgeons in the USA, Canada, Brazil, Germany, Italy, Oman, Slovenia, Azerbaijan, and Rwanda, among others.

“It is worth mentioning that in all countries outside India, the surgeons went out of their way, used physician privileges, incurred high import duties, and did the paperwork just to use the B-HEX. They did all this despite the fact that other devices were easily available with local distributors,” he noted.

Soon, the B-HEX will be available in more countries in Europe and around the world, as Dr. Bhattacharjee and his company are at different stages of talks with a few MNCs through investment bankers.

Challenges of gaining acceptance in the West

“It is a challenge to convince some surgeons that the first mover’s product is not necessarily the best product,” he said. “They get used to certain devices and do not like moving out of their comfort zone.”

However, he shared that evidence for the B-HEX’s effectiveness recorded in peer-reviewed scientific publications2,3,4,5 and videos by early adopters and key opinion leaders are removing that initial barrier to acceptance.

For example, Dr. Bhattacharjee said the surgeons are used to an injector for some pupil expanders. “However, the injector is only a means to circumvent the problem of snagging of the corneal incision when these biplanar rings are inserted into the eye or removed from the eye. It only overcomes a design disadvantage in the ring and is actually counterproductive for a pupil device,” he added.

“The injector tube occupies precious incision space, calling for larger incisions. Moreover, it is not helpful to have the control away from the site of action for pupil devices,” Dr. Bhattacharjee explained.

On the other hand, the B-HEX’s disruptive planar patented design allows it to glide through much smaller corneal incisions with the B-HEX 23G forceps.

Of future foresights and immense satisfaction

Dr. Bhattacharjee envisions the B-HEX in the future as a “necessary inventory in every ophthalmic operating room” because surgery in an eye with a non-dilating pupil or intraoperative miosis, such as intraoperative floppy iris syndrome (IFIS), can lead to vision-threatening complications.

“When IFIS strikes suddenly and the pupil becomes small during surgery, the surgeon prefers a simple device which is easily manipulated, passes through small incisions, and does not come in the way of other instruments. The B-HEX is the only device that checks all these boxes,” he said.

Above all, the joy of creating something that is “societally useful” has been described as phenomenal for Dr. Bhattacharjee. “That we have been able to make surgery easier for our colleagues, safer for our patients, and affordable for healthcare systems is immensely satisfying.”

“As a product, the B-HEX is fully developed. But in terms of reaching market potential, it is in its infancy. If morning shows the day, the B-HEX has clearly indicated the future. The right partner will catalyze its growth and help achieve market dominance,” concluded Dr. Bhattacharjee.

References

1. Bhattacharjee S. Pupil-expansion ring implantation through a 0.9 mm incision. J Cataract Refract Surg. 2014;40(7):10611067.

2. Chakraborty D, Mohanta A, Bhaumik A. B-HEX pupil expander in vitreoretinal surgery – A case series. Indian J Ophthalmol. 2020;68(6):1188-1191.

3. Sarosh R, Rashid O. B-Hex, an ace up the sleeve for small pupil phacoemulsification. Rom J Ophthalmol. 2022;66(1):61-68.

4. Bhattacharjee, Suven. B-HEX Pupil Expander: Pupil expansion redefined. Indian J Ophthalmol. 2017;65(12):1407-1410.

5. Salviat, Flore & Febbraro, Jean Luc & Zuber, Kevin & Yavchitz, Amélie & Moran, Sarah & Gatinel, Damien. (2022). Evaluation of a uniplanar pupil expansion ring in small-pupil cataract surgery: a feasibility study. Int Ophthalmol. 2022;42(2):489-496.

Contributing Doctor

Dr. Suven Bhattacharjee is an eye surgeon, innovator, and entrepreneur. He is a consultant at the Nayan Eye Centre, Kolkata, India. He is also the founder and CEO of Med Invent Devices, a startup with many awards to its credit. He holds international patents for his invention, the ‘B-HEX Pupil Expander’, which has redefined pupil expansion in cataract surgery. The B-HEX has made complicated small pupil cataract surgery safer with more predictable outcomes. He was adjudged Top Innovator & Gold Medalist at the DST - Lockheed Martin - India Innovation Growth Program 2016. He has received Technology Commercialization training at the Stanford Graduate School of Business. He has received the AIOS Dr. P. Siva Reddy International Award, Col Rangachari Award for overall best paper, Sante Vision Award for best Cataract Paper, ASCRS best paper of session, AIOS International Hero Award, CS Reshmi Gold medal for best video and APACRS Video award. suven@medinventdevices.com