Real-world uptake of an innovative pupil expander device for cataract surgery: Implementation lessons learnt

Abstract

Cataract surgery in the eyes, where the pupil does not dilate despite using eye drops, is fraught with vision-threatening complications. About 11 per cent of eyes undergoing cataract surgery have non-dilating, small pupils. The increasing prevalence of benign prostatic hyperplasia (BPH), hypertension, diabetes and medications used for the same are the contributing factors. The recent Food and Drug Administration (FDA) approval for the use of miotic agents in the treatment of presbyopia will lead to a further rise in the number of non-dilating pupils. While pharmacological agents and other methods have been used, mechanical pupil expander devices are the only fail safe option. However, available devices had a steep learning curve and limitations which made them difficult to use, unpredictable and unsafe. With its patented single plane, hexagonal, notches and flanges design, the US FDA registered B-HEX Pupil Expander (Med Invent Devices Pvt. Ltd., India) overcame these limitations and fulfilled an unmet need. The B-HEX is machinable, rapidly produced, consistent, easy to use, safe, and affordable. Despite such advantages, implementation hurdles have restricted its availability to healthcare systems worldwide. Peer acceptance has been steadily growing, with the B-HEX becoming the market leader in India, as evidenced by numerous publications, videos and papers presented at international conferences and comments from opinion leaders endorsing its use. However, impractical regulatory requirements and resource constraints remain a great impediment to the global distribution of this novel invention. This has denied many patients the benefits of a superior and more affordable option. Though value continues to be added to the B-HEX by maintaining a strong intellectual property portfolio with internationally granted Patents and Trademark, increasing its user base, and garnering support from key opinion leaders, only a collaboration with the right partner will help scale up the global reach and make it a leader in the global market.