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«innovations Mahad Ibrahim, Aman Bhandari TECHNOLOGY | GOVERNANCE | GLOBALIZATION Jaspal S. Sandhu, and P. Balakrishnan mitpress.mit.edu/innovations ...»

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innovations

Mahad Ibrahim, Aman Bhandari

TECHNOLOGY | GOVERNANCE | GLOBALIZATION

Jaspal S. Sandhu, and P. Balakrishnan

mitpress.mit.edu/innovations

Making Sight Affordable (Part I)

Aurolab Pioneers Production of

Low-Cost Technology for Cataract Surgery

Blindness from causes treatable by modern medicine afflicts millions of people

every year. Cataracts, the single largest cause of preventable blindness, can be treated by a simple and quick surgical procedure that restores sight; sadly, extreme poverty and its consequences limit access to the medical technologies and infrastructure needed for the surgery. As a result, the crush of blindness continues unabated worldwide.

In theory, the solution to this public challenge seems simple: increase access to care and reduce the cost of the medical technologies needed to restore sight enough to permit cataract surgery to be performed on a mass scale (see inset text box “The Burden of Blindness”). In practice, in the one place where the goal of restoring sight affordably to the many has been achieved, success has required three decades of effort by a dedicated team led by a visionary leader: Dr.

Govindappa Venkataswamy, an ophthalmic surgeon in Madurai, India. The living legacy of Dr. Venkataswamy’s leadership is the Aravind Eye Care System, one of the largest eye care systems in the world, with five hospitals in the Indian State of Tamil Nadu, together performing over 200,000 cataract surgeries a year. Dr.

Venkataswamy refused to accept that people must remain blind solely because they lack money. His thirty-year crusade has addressed the financial, organizational, and technological barriers to affordable eye care treatment.

Dr. Balakrishnan is the Managing Director of Aurolab, a non-profit manufacturing unit of the Aravind Eye Care System, Madurai, India. He received his bachelor's degree in mechanical engineering in India and doctorate from University of Wisconsin, Madison.

Mahad Ibrahim is a PhD student in the School of Information at the University of California, Berkeley. He received his bachelor's degree from Cornell University and a master's degree from the University of California, Berkeley.

Aman Bhandari is a postdoctoral fellow in Pharmaceutical Health Services Research, University of Maryland School of Pharmacy.

Jaspal S. Sandhu is a PhD student in the College of Engineering at the University of California, Berkeley. He received his master's and bachelor's degrees from the Massachusetts Institute of Technology.

© 2006 Tagore LLC innovations / summer 2006 25 Ibrahim, Bhandari, Sandhu, and Balakrishnan The Burden of Blindness Of the estimated 161 million people worldwide who suffer from some form of visual impairment, 90 percent live in developing countries.* In 2000, blindness is estimated to have cost the world economy $US20-25 billion in lost productivity; blindness and low vision cost India alone an estimated US$4.4 billion annually.** The need for constant care of the blind placed by families and communities exacerbates the impact of blindness, creating a significant burden in resource-poor settings.

Beginning in the early 1970s, the World Health Organization deemed blindness such a critical issue that they created and the International Agency for the Prevention of Blindness. Spurred on by this global effort, the government of India along with nongovernmental organizations focused on building the capacity to diagnose and treat cataracts in India’s rural areas—where 70 percent of the population lives. This monumental task required training more ophthalmologists, increasing the number of hospital beds dedicated to eye care, and expanding ophthalmic services into the hinterland using eye screening camps and primary health clinics.

Cataracts represent the single largest cause of preventable blindness worldwide. In India, cataracts are responsible for approximately 80 percent of blindness.*** According to the last World Health Organization (WHO) National Programme for Control of Blindness (NPCB) survey, 12 million people in India are blind (defined as less than 6/60 visual acuity), and 3.8 million people yearly suffer from newly formed cataracts. India currently has the capacity to perform about 1.6-1.9 million cataract operations per year, but 5-6 million operations per year would be needed to tackle the accumulation of cases.**** * The 10th Revision of the of the WHO International Statistical Classification of Diseases, Injuries and Causes of Death defined low vision as visual acuity of less than 6/18, but equal to or better than 3/60, or corresponding visual field loss to less than 20 degrees, in the better eye with best possible correction. Blindness is defined as visual acuity of less than 3/60, or corresponding visual field loss to less than 10 degrees, in the better eye with best possible correction.

Visual impairment includes low vision as well as blindness.

** Shamanna BR, Dandona L, Rao GN, Economic burden of blindness in India, Indian Journal of Ophthalmology, 1998;46(3):169-172.

*** Vajpayee RB, Joshi S, Saxena R, Gupta SK, Epidemiology of cataract in India: combating plans and strategies. Ophthalmic Res. 1999;31(2):86-92.

**** Vajpayee et al., 1999.

The development of the Aravind Eye Care System (AECS) to tackle such a serious problem required a sequence of innovations, both organizational and technical, starting in 1976. This case focuses on Aurolab, the manufacturing arm of Aravind, which has developed critical eye care technologies for the Aravind hospitals. A subsequent case in Innovations will describe the development of the Aravind hospital system itself.





Aurolab was founded as a non-profit Indian medical device organization in innovations / summer 2006 Making Sight Affordable (Part I) Cataracts The lens of the human eye is responsible for focusing light on the retina—the inner surface of the eye—to create images. A cataract is a clouding of this normally transparent lens that impairs vision. Cataracts are most often associated with aging, but can develop due to trauma, at birth, or due to metabolic causes, as well as potentially being a result of environmental factors.

Advanced cataracts can cause complete blindness, but almost all cataracts are treatable. Surgery is the only intervention that can treat cataracts. Cataract surgery involves removal of the clouded lens; typically, this lens is replaced with a permanent, artificial implant known as an intraocular lens (IOL). The IOL focuses light on the retina, replacing the functionality of the natural lens.

Before the IOL, cataract surgery was performed using a procedure known as ICCE, or intra-capsular cataract extraction, that involved removal of several parts of the eye. This surgery typically subjected patients to bed rest of a week or more. Since much of this surgery was performed before the wide availability of IOL, patients were often fitted with external, aphakic eyeglasses, also known as “coke bottle” glasses (see Figure 1).

Extra-capsular cataract extraction (ECCE) came later, and involved removal of the cataract through an incision in the lens capsule. Notably, ECCE left intact parts of the eye that were removed during ICCE. The only option for visual correction during ECCE was an artificial lens implant, the IOL.

Compared to ICCE, ECCE required less post-operative care—patients could often go home the same day—and resulted in far superior visual outcomes. Despite this, long after ECCE became the standard of care across the industrialized world, ICCE remained widespread in the developing world.

1992 with the mission to manufacture intraocular lenses at an affordable cost for the Indian market. For cataract surgery to be a viable option in any setting including developing countries, the synthetic intraocular lens (IOL) is an essential component (see inset text box “Cataracts”). Since its founding, Aurolab has played a unique and pioneering role in tackling the challenges of access to affordable ophthalmic technologies in developing countries.1 Aurolab is driven and sustained by a strong social and spiritual mission to make high quality and affordable medical technologies and supplies; to date, this has mostly involved the technological inputs for cataract surgery.

Aurolab is one of a very small number of non-profit medical device or pharmaceutical companies worldwide, and its unique capabilities in transferring vital eye care technology to India have been paramount to its success. Aurolab’s technology development model has three phases. First, Aurolab identifies essential ophthalmic technologies and supplies that are inaccessible because of high cost or limited availability in the Indian market. Next, it assesses the potential of indigenous innovations / summer 2006 27 Ibrahim, Bhandari, Sandhu, and Balakrishnan Figure 1. Visual rehabilitation of aphakia with spectacles. Left: Intact aphakic spectacles—poor optical correction at best. Right: Partially destroyed aphakic spectacles, leaving only unilateral correction.

Source: Apple, et al., 2000. Cataract Surgery with Intracapsular Cataract Extraction and Spectacles, Survey of Ophthalmology, 45:S45-S52 (figure 4.6, p. S48). © 2000 Elsevier Inc. Reprinted with permission.

manufacturing and technology transfer. Finally, Aurolab develops a manufacturing system that leverages the unique capabilities and strengths of Aurolab and India.

Today, Aurolab has grown into an organization with six product divisions (intraocular lenses, pharmaceuticals, sutures, instruments, spectacles, and hearing aids) and more than 200 employees. It supplies the lenses that Aravind uses in more than 90 percent of its annual 200,000 plus cataract surgeries. Recently, work has begun on a new manufacturing facility and business office designed to meet strict global manufacturing standards—both the ISO 9000 standards as well as FDA (U.S. Food and Drug Administration) facility requirements—and to accommodate growth. Aurolab’s intraocular lenses and other products are exported to more than 120 countries via a global network of NGO partners (roughly 6 percent of the global market). Aurolab has managed to be the first organization to provide a solution to producing critical eye care technologies that allows the restoration of sight among the many for whom the required surgery was previously unaffordable.

–  –  –

United States, and one of the most common surgical procedures worldwide. While the procedure requires little post-operative care, it is often prohibitively expensive in developing countries because of the cost of the synthetic intraocular lens and other surgical consumables (the medical goods used during a procedure). Prior to 1992, the bundle of technologies and consumables necessary to perform cataract surgery cost well over US$100, ensuring that cataract surgery using intraocular lenses was beyond the reach of most in the developing world.

Since the vast majority of medical technologies are developed and produced in the West and targeted toward Western markets, developing countries are often at the mercy of external donations. The West’s market for ophthalmic surgical products has been well established for more than two decades, and the international market for intraocular lenses is close to 10 million units with over US$1 billion in sales annually, dominated by only a handful of manufacturers (e.g. Alcon, AMO).2 Yet charity has provided a miniscule and inconsistent supply of lenses for patients who cannot afford them. The story of Aurolab’s success in addressing this issue begins long before its inception in 1992, with the pioneering work of Dr.

Venkataswamy.

In 1976, Dr. Venkataswamy founded Aravind to create an alternative model for delivering health care that would supplement existing government services. Its first project was the initial Aravind Eye Hospital located in Madurai, Tamil Nadu. This first clinic, which consisted of eleven beds in a small rented house, had many of the elements that are representative of Aravind today. In expanding its operations initially Aravind innovated to remove the barriers to health care access in a developing country: clinical training, payment, transportation, community education, and quality of care. As it has further developed it has filled the holes in system-level deficiencies such as human resources, access to key technologies, and equipment maintenance. Despite Aravind’s many successes, the organization soon faced a significant barrier to offering widespread access to effective cataract treatment—the lack of access to affordable intraocular lenses.

There are three surgical options for the treatment of cataract: (1) intracapsular cataract extraction (ICCE) with aphakic glasses; (2) ICCE with anterior chamber intraocular lens implantation; (3) and extracapsular cataract extraction (ECCE) with posterior chamber lens implantation (the standard of care in the United States). The third option provides the best result, but in most developing regions the ICCE surgery using aphakic glasses is the standard of care.

ICCE surgery is a simple procedure that does not require complex tools or equipment, but since the clouded lens and lens capsule are removed, the eye needs several weeks to fully heal. The main drawback of this approach is the use of aphakic glasses to treat a condition called aphakia, or the absence of the eye’s lens.

Aphakia is a byproduct of all forms of cataract surgery because of the need to remove the clouded lens, but uncorrected aphakia results in a visual acuity tantamount to blindness. Aphakic glasses (see Figure 1) present two principal problems.



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