SILC - Small incision lenticular cutter

Childhood cataract is the leading cause of childhood blindness globally and is prevalent in 1 for every ten thousand children with there being a higher prevalence in low-income economies (estimated 13.6 for every ten thousand children). Globally this accounts for 7.4% - 15.3% of pediatric blindness and 10 million blind-person years with each child accounting for an average of 50 blind-person years for an estimated 200,000 children currently with this rare disease with an additional 20,000 to 40,000 per year. Cataract significantly affects a child's visual development and has the potential to cause irreversible damage to it.

Childhood cataracts however are treatable through surgery which involves removal of the eye's clouded lens and for older children the insertion of a synthetic intraocular lens. Surgery is a simple, 15-minute procedure that can almost immediately restore an individual's vision. Out of 28M cataract surgeries performed worldwide, 21M cataract surgeries are performed in LMICs annually. However, phacoemulsification (phaco), the expensive, gold standard cataract treatment which involves the use of ultrasonic energy to fragment the cataract into small pieces and aspirate the fragments through a small, < 3 mm incision, is not designed for the treatment of cataracts in LMICs. It requires significant initial capital expense and equipment, high, recurring costs for reusable components, and repeated maintenance. Moreover, it is not time- or cost-efficient, requiring 10-15 mins and can cost up to $475 per procedure for pediatric cataract surgery, with most of the cost being attributed to the surgical consumables.

Manual small incision cataract surgery (MSICS) on the other hand is 1/4th of the cost of phaco, does not require capital equipment or high initial expenditures, is 2.5x more efficient, and can even treat mature cataracts. However, patients undergoing MSICS have the lens removed through a 6-7.5 mm incision resulting in poor post-operative recovery and sub-optimal visual acuity outcomes. The astigmatism induced by MSICS requires visual correction with expensive, cylindrical eyeglasses; however, their rate of adoption is low in MSICS patients. MSICS requires up to 30 days of recovery time, unlike phaco, which only requires up to 3 days. This extended recovery period increases the financial burden of treatment for patients and their caregivers, perpetuating a cycle of delayed care, advanced disease progression, and worse surgical outcomes. Customer discovery through the National Science Foundation I-Corps™ Teams (NSF I-Corps) program, including stakeholder interviews with high volume eye care systems (HVECS) globally, validated a significant clinical and market need for providing gold-standard visual outcomes to all patients at an affordable price point.

Directly addressing the root cause of the problem (a large incision required to remove the entire cataract in MSICS), we developed a proprietary cataract fragmentation technology that can seamlessly integrate into the widely used MSCIS technique to enable gold standard outcomes by manually fragmenting and removing the cataract through a small incision while maintaining a comparable time and cost profile to MSICS. Achieving fragmentation of all grades and types of cataracts via a low cost, handheld, manual device through a phaco-sized incision will (1) eliminate the need for expensive capital equipment and maintenance, (2) provide gold standard visual acuity outcomes, and rapid recovery for all patient populations, (3) reduce intraoperative ocular trauma and stress by eliminating the use of ultrasonic energy, and (4) improve time- and cost-efficiency. The device is designed for safe use through its minimal and tailorable profile, which maintains pressure in the eye during surgery.

Moreover, the device fits into the existing surgical workflow and training paradigm, significantly reducing the learning curve for new surgeons by simplifying incision creation. In LMICs, our invention enables health equity and helps eliminate avoidable blindness by drastically improving cataract surgery access and outcomes. Specifically, by reducing the size of the incision required to perform MSICS, our device has the potential to eliminate the need for expensive, astigmatism-correcting glasses and an extended recovery period that affects the most marginalized cataract patients.

Through our NSF I-Corps interviews, we discovered that HVECS could improve both clinical and financial outcomes for eye care systems by adopting our innovation and offering a mid-tier surgical package that can capture a growing middle-class segment that desires improved outcomes in comparison to MSICS and is unable to afford phaco at its current price point. 

India faces the greatest burden of blindness (8.8M) with cataracts being responsible for 24% of all blindness and MSVI in South Asia. Given the large population and childhood cataract prevalence, India has approximately 280,000 to 320,000 visually impaired children out of which 14% (39,200 to 44,800) are estimated to be due to cataract.

We chose to initially focus on the Indian cataract market given our partnerships, the burden of cataracts, and high government, philanthropic, and surgical activity in these countries. With this technology and partnerships with established institutes, we are looking to serve children who are affected by cataracts within India. Our primary customers and decision-makers consist of executive leadership, directors of quality, directors of outreach, and heads of department for cataract surgery within HVECS (which are private and charitable), our end-users are cataract surgeons performing surgery for low-middle income cataract patients, and our beneficiaries are patients (adults and children) in low and low-middle income family units.

Our customers’ primary needs are to achieve or maintain self-sustainability and expand their services while ensuring quality surgical outcomes, maintaining time- and cost-efficiency, and eliminating needless blindness due to cataracts. Currently, they are underserved in meeting these needs as there is no surgical solution that offers the operational efficiency of MSICS and the outcomes of phaco, resulting in an inability to provide better outcomes for disadvantaged patients and to capture a large and growing middle-income market. For low-income patients, issues with affordability and acceptability of treatment delay care-seeking behavior, causing the development of mature cataracts, leading to blindness and significant functional limitations. In addition, those who do seek treatment in a timely manner often leave with sub-par visual outcomes and face significant financial burden during a prolonged recovery period, perpetuating a vicious cycle of poverty. Discussions with leading HVECS confirmed that our technology has the potential to provide improved surgical outcomes in comparison to phaco and that the technology can be introduced as part of a mid-tier package to capture the growing low-middle income market segment that is both willing to pay and is interested in quality long-term outcomes. In addition to improving outcomes for patients and economics for eye care systems, our invention addresses a major need for primary end-users, junior surgeons, who perform the majority of MSICS procedures, and who require 3,000-5,000 procedures to achieve outcomes comparable to senior surgeons. The steep learning curve in MSICS is associated with creating dimensionally complex and variable 6-7.5 mm incision. We can significantly reduce the learning curve for juniors to achieve optimal outcomes through fewer surgeries (~20 as found in interviews as compared to the current 3000-5000 surgeries), by enabling them to use a simple 3.0 mm incision.

Our team utilized a spiral innovation model that uses repeated, staged interactions with all key stakeholders to successfully identify an unmet need and bring an appropriate solution to the market. The need was originally identified by our team in 2018 in collaboration with the world’s largest eye care system, AECS, in Southern India, which performs more than 300,000 cataract surgeries annually.

AECS, which pioneered the high-volume eye care system model, is a global leader in surgical training and research, and in the manufacture and distribution of ophthalmic products via its manufacturing subsidiary, Aurolab. Since then, our team from the Center for Bioengineering Innovation & Design at Johns Hopkins University has collectively observed more than 125 cataract surgeries and validated that the large incision in MSICS (due to removing the entire cataract in one piece) is the primary contributor to poor patient outcomes through literature reviews and stakeholder interviews. We interviewed over 160 cataract surgeons and leadership in surgical institutes, training centers, and non-profit organizations globally, including AECS, Dr. Shroff's Charity Eye Hospital (SCEH), H.V. Desai Eye Hospital (HV Desai), the Wilmer Eye Institute (WEI), the International Association for Preventable Blindness, and the Seva Foundation.

Our solution requirements are tailored to the specific needs of our target customers, end-users, and beneficiaries, and we continue to seek regular input from cataract surgeons of all levels, and executives of HVECS to understand technical challenges within cataract surgery, the current state of the cataract market and the trends in patients’ capability and willingness to pay.

With this information we have developed a device that has the potential to achieve phaco-like outcomes, and be manufactured from low-cost and easily available materials, such that it can fit within the required cost-profile for high-volume eye care centers and its many low-middle income patients. As we begin pilot clinical studies at AECS and other HVECS in India, we will simultaneously work with HVECS to characterize the patient acceptability and impact of surgery with our device.  

Given the opportunity to participate in this Challenge, we seek: 

• Mentors with experience in implementing innovations in rapidly developing health systems. As India will be our beachhead market, we are looking for mentors who have knowledge and know-how within that ecosystem. Though the technology aims to serve underserved populations within developing nations, we foresee challenges in making this technology accessible for families with children with cataracts given the requirement for specialized surgery and limited availability of facilities and hospitals that can provide the current standard of treatment.
• We seek to connect with stakeholders in government insurance programs in developing nations leading the implementation of policies that will impact reimbursement for cataract surgery (for adults and children).
• Mentorship in identifying suitable manufacturers and distributors for our technology and developing impact-oriented contracts that would enable our customers to provide our technology to their beneficiaries (cataract patients) at an affordable price.
• Legal support as we develop our intellectual property portfolio and strategy while pursuing national filings globally. This includes mentorship in navigating non-disclosures while creating robust partnerships and customer relations.
• Access to MIT Solves’ network to unlock new funding opportunities

Compared to existing solutions, we designed our device for use in LMICs. The device and its associated procedure are less invasive than current techniques, fits within the MSICS workflow (with a smaller incision), can be used for all cataract grades, maintains surgical dexterity of movement, do not require electricity or maintenance, and has the potential to meet the cost and time constraints of HVECS. 

The device is composed of inexpensive, accessible materials, and can be manufactured and packaged inexpensively at scale (confirmed by Ingenarious Consulting (IC)); a product development firm specializing in ophthalmic medical devices). By enabling non-ultrasonic fragmentation of even mature cataracts through a 3 mm incision in a time- and cost-efficient manner, our device has the potential to reduce the complexity and skill required for surgery, improve the acceptability and accessibility of cataract surgery in LMICs, increase the surgical volume and capacity of eye care systems, and provide improved visual and financial outcomes for more than 21 M patients annually. Our technology will potentially be a mid-tier option between the current MSICS and Phaco procedures, and can potentially capture 70-80% of the current MSICS patient population. HVCES can therefore capture an entirely new market segment and afford to provide free surgery to low-income patients with superior outcomes to conventional MSICS. Stakeholders have expressed strong interest in a procedure with the potential to provide gold standard outcomes while being affordable, eliminating the constraints of phaco equipment, and generating more revenue per MSICS patient in surgeries for the adult populations. 

In the case of childhood cataracts, both MSICS and Phaco surgeries are used in treatment, with MSICS generally being used in more complex cases. Current research indicates that MSICS is used in approximately 40% of pediatric cataract surgery cases in India. Given the potential of our technology to provide gold-standard outcomes at a much lower price point, we anticipate that institutes would be willing to provide this surgery to potential patients. Due to a more affordable price point, we anticipate that more families who have children with cataracts would avail of this technology due to the cost savings they would incur. Mission-driven HVECS could subsidize these surgeries even further if the surgery is at an affordable price point and make surgery more affordable for low-income households.

As MSICS is a widely taught surgical technique in LMICs and provided our technology has a potential short learning curve (< 10 surgeries) that fits within MSICS surgical training models, surgeons would have the opportunity to provide high-quality cataract surgical treatment for children in surgical hospitals and centers across LMICs. 

We plan to initially target markets with a high cataract burden, and established cataract surgical systems who have mature training programs and are supported by national programs supporting accessible cataract surgery. The scale of these market combined with the accessible institutional capacity available to serve them will allow out technology to be used effectively in populations with rare diseases.

Clinical validation showing safety and efficacy is critical to creating impact with our solution by driving technology adoption and increasing acceptability of treatment. In the coming year, we will conduct pilot clinical studies to demonstrate the safety and effectiveness of the procedure with our technology compared to phaco and MSICS within HVECS in India, beginning with the Aravind Eye Hospital in Madurai. By Q4 2023 we will initiate large-scale clinical studies to generate the evidence needed to bring more focus to the clinical and social value brought about by surgery with our technology to HVECS and their patients as compared to the current standards of care.

By 2027 Sight Design Surgical aims to enable this procedure in the top 5 major mission-driven HVECS in India who cater to 40% - 50% of the total cataract surgical volume in India (6 million surgeries annually) in which 40 – 60% of the population consist of our target demographic. We also aim to sell the cataract surgical system to mission driven cataract surgical centers in other low- and middle-income countries where we have validated problem-solution fit, such as Nepal, Guatemala, and Benin.

Target 1: Ensure gold-standard clinical outcomes for patients who would otherwise receive MSICS surgery

Indicators

a) Safe surgery with < 3 % EC loss, without intraoperative complications like iris prolapse or capsular tear for patients with any grade of cataracts

b) UCVA 6/12 or better in at least 90% treatment population and astigmatic error no more than 0.5 D) at 30 days

Target 2: Achieve greater acceptability and equitable outcomes for patients receiving cataract surgery. 

Indicators: 

a) Decreased burden of surgery on the patient and caregiver (faster time to recovery and functional independence after surgery, faster return to work)

b) Improved visual function – ability to perform tasks requiring attention to finer details

c) Increased number of individuals seeking surgery for their second eye

d) Improved Number of females taking up the procedure as compared to current offerings

e) Improved care seeking behavior bringing down the average age of individuals seeking treatment

Target 3: Improving self-sustainability in HVECS

Indicators

a) Reduction in the number of surgeries required for fellows and junior surgeons to achieve optimal outcomes

b) Increase in the volume of cataract surgery utilizing the new procedure and the associated revenue generated

c) Allocation of revenue to build surgical or monitoring capacity within communities

 Activities/ Inputs:  

We provide a low-cost handheld cataract fragmentation tool to HVECS to provide gold-standard outcomes to low- and middle-income patients, who would traditionally undergo MSICS surgery, without significantly increasing the procedural cost to the patient or hospital while maintaining the time efficiency of the procedure. 

Outputs:  

• Patients receiving this surgery can return to work quickly due to the short recovery time of 1 week compared to 2-3 weeks in MSICS surgery, and therefore face a significantly reduced financial loss. Due to quality outcomes, patients do not require expensive astigmatism correcting glasses, further reducing the financial burden on the individuals.  
• HVECS providing this surgery to the communities they serve can improve their standing among the community through the quality of outcomes achieved. This procedure helps HVECS enable their mission and provides an additional revenue stream for the long-term sustainability of the healthcare system to provide quality care to underserved communities in their vicinity. 
• Junior surgeons can achieve gold-standard outcomes for their patients using a modified MSICS procedure without significant training (< 20 surgeries) as compared to taking 3-5 years (3000-5000 surgeries) to achieve those outcomes with the current MSICS technique. 

Outcomes:  

HVECS can build their surgical capacity to treat more patients in the community and expand services to include more primary care options such as vision centers in more rural communities.  

Junior surgeons become proficient in the surgery and train other surgeons in other systems and private care facilities. As the procedure gains popularity, it will encourage surgeons to build upon the body of knowledge in training and techniques for more complicated cases.  

Patients can enjoy a higher quality of life with reduced potential for follow-up surgeries and future complications.  

Impacts:  

Short term:  

Due to the low barriers in access and cost of care, we foresee that this technology would (1) enable more equal gender distribution of patients by enabling more women to avail of surgery due to the low barriers to accessibility and affordability of care, (2) patients are more likely to seek treatment earlier and for another eye, (3) enable patients to seek treatment earlier through word-of-mouth of quality outcomes, (4) improve CSRs in the region and country by providing an avenue for HEVCS and other mid-tier hospitals to build capacity and procedural quality. 

Long-term:  

We anticipate an improved reputation of hospitals providing the new procedure, therefore leading to an increase in patients who seek care at the institution. This can bring in more revenue and help expand hospital services by word-of-mouth (which is the prominent mode of dissemination of information). The additional revenue generated would enable institutes to build vision centers (currently a model followed by larger established institutes) that provide primary care and referral services to the communities within the region. Through these initiatives, we anticipate (1) a reduction in the prevalence of mature cataracts within populations served (2) and scaling of the procedure through adoption by the government and small-scale hospitals and private clinics. 

At Sight Design Surgical, we work closely with our partners to develop and test innovative technologies that enable affordable and equitable access to quality surgical outcomes utilizing the spiral innovation model that takes the commercial, technical, clinical, and organizational elements associated with any product or service to successfully create impact.

Our current technology offering in the cataract space is a proprietary hand-held, low-cost, cataract fragmentation system that utilizes polymer science, mechanical engineering principles and low-cost manufacturing techniques to meet the need our customers (HVECS) and beneficiaries (low and low-middle income patients) within LMICs.

Our device is designed to fit into the current MSICS procedure and function intuitively to reduce the learning curve of residents and junior surgeons (estimate < 10 surgeries to achieve optimal outcomes). Functionally it is designed to capture the cataract in the eye without causing harm to surrounding ocular structures such as the corneal endothelium, iris and lens capsule and fragment all grades of cataract of varying size and hardness.

A tested ergonomic design enables compatibility with popular hand postures of cataract surgeons conducting MSICS techniques.

The design utilizes available materials for fragmenting elements, actuation system and device body that can be produced and assembled with well-known manufacturing technologies to enable low-cost manufacturing at scale. The safety profile is designed to be safer than the leading technologies and procedures such as phacoemulsification by avoiding the use of energy sources such as ultrasonic energy that generate heat and pose risk of damage to ocular structures.

These compelling factors would allow HVECS to implement the technology within the current training and surgical paradigms with ease and efficiently build surgical capacity to allow more patients to avail themselves of this technology. 

We aim to broaden participation of women and minorities to create more opportunities for these individuals to develop their technical, entrepreneurial and leadership skills. We currently include several women residents and corneal fellows-in-training from WEI to contribute to device evaluation and provide feedback on device design and usability. We expect to consult with a diverse group of clinicians (based on experience, ethnicity, culture, and gender), for usability and clinical evaluations within the various cataract surgical systems in India. The organization will consult stakeholder of varying skills in the customer and manufacturing organizations in India to build the training programs and an implementation pathway. 

We are providing cataract surgical institutes with a technology that enables the low-income population they serve to receive gold standard outcomes at an affordable cost to the institute and the patient while enabling the institute to create an additional source of revenue in order to achieve self-sustainability and maintain the quality and cataract surgical volume required to achieve their mission of eliminating needless blindness. Annually, 28 M cataract surgeries are carried out worldwide, with 21 M in LMICs. Given a $15 cost to the hospital for each MSICS surgery, the annual total addressable market is $315 M. Based on our partnerships, the growing trend of cataract, and high government, philanthropic, and HVEC activity in developing nations we chose to focus primarily on India and Nepal during our NSF I-Corps customer discovery, where we interviewed over 100 key opinion leaders in the field of cataract surgery mainly within India and Nepal. These interviews led to further defining our initial target market (2.8 M annual MSICS procedures in India), leading to an annual serviceable obtainable market (SOM) of $42 M.  

Our initial target segment consists of self-sustaining HVECS in India such as AECS.  These HVECs are self-sustainable, relying mostly on the revenue that they generate from paid surgeries and other services. Leadership within HVECS are constantly faced with the burden of balancing their revenue and costs to be self-sustainable while providing care to the underserved.  

These institutes have the capacity to provide better surgical outcomes for their MSICS patients and wish to offer a mid-tier package that would include a foldable IOL in conjunction with our product. A cataract surgery package with the outcomes of phaco, the time-efficiency of MSICS, and mid-tier pricing offers these eye care systems an opportunity to provide MSICS patients a cost-effective alternative and increase revenue generated per patient, allowing them to become self-sustainable and less reliant on external funding sources while enabling equitable high-quality treatment for their patients. We will partner with local ophthalmic manufacturers and distributors within India such as Aurolab, Care Group, or Appaswamy & Associates, who are experts in low-cost, high-volume production of ophthalmic instruments and consumables, to manufacture and distribute our devices. We anticipate that the device will be classified as a low-risk Class B device, which will require registration with the Indian government and sponsorship from AECS.  

We are currently seeking non-dilutive grant funding for the coming 2 years to support the development, manufacturing and clinical validation of the product to first sales in India by the end of 2024 - 2025. For this purpose, we are currently applying for additional funding through the NSF and the USAID Following clinical validation at the Aravind Eye Hospital in Madurai, we will implement the enhanced MSICS technique in Aravind’s training program and simultaneously train key opinion leaders in all 12 hospitals and enable approximately 27,000 enhanced MSICS procedures in the first year.  

Within the first few years, we aim to set-up surgical training programs within the top 5 HVECS in India to create an efficient path for implementing the technology. Revenue generated will supplement developing distribution channels and implementation processes within smaller surgical centers and international HVECS with whom we have validated the problem-solution space with and who are connected to mission driven international bodies such as SEVA organization and IAPB (International association for the prevention of blindness). We will also supplement the revenue created with grants from international organizations to enable self-sustainability and capacity building in smaller surgical institutes. 

We have thus far been able to raise more than $550,000 USD through non-dilutive funding from the Johns Hopkins University, Abell Foundation, VentureWell, and the NSF. This funding has allowed us to validate the problem-solution fit within India, Nepal, and other LMICs, discover product-market fit within HVECS in India and Nepal, and support initial development and proof-of-concept work for our technology. Funding also supported the development of high-fidelity prototypes that will be used for summative usability studies with surgeons of varying experience levels within our beachhead customer segment in India that consists of HVECS.