ReadySuite:

 We developed a low-cost, durable laparoscopic surgery system code-named “ReadySuite” for use in resource-limited settings to address challenges of cost, durability, and dependency on electricity and carbon dioxide.

The ReadySuite is a comprehensive set of prototypes including the ReadyKit which is the low-cost hardware laparoscope device, ReadyView; Software with Tele-mentoring interfacing, and ReadyLift; a retractor tool to mechanically lift the abdominal wall during surgery to eliminate the use of carbon dioxide and electricity.

Specifically, we are addressing the following challenges: making the technology more affordable, portable, robust, smart, and almost maintenance-free.

The ReadySuite obviates the need for expensive monitors and cables and prevents loss of function during power outages. The prototype is sealed with medical-grade epoxy, making it amenable to sterilization by submersion. In total, the ReadySuite laparoscope optics and the 3D printed casing can be assembled for the cost of goods equal to $120.

Work Completed:

We have constructed prototypes that we exposed to surgeons to collect initial feedback and to determine the functional parameters. 

Demonstrate Feasibility: In order to address the identified concerns, two prototypes have been developed: ReadyKit laparoscope and ReadyLift retractor. Laparoscope Optics. A 4.5mm diameter color complementary metal-oxide-semiconductor (CMOS) detector was selected for video and image capture. The resolution of the CMOS camera was determined through imaging a 1951 resolution target. 

Surgery is the foundation of cancer treatment, but patients in low- and middle-income countries (LMICs) have limited access to surgery due in part to shortages in equipment. Laparoscopic surgery is the standard of care in high-income countries for many cancer excisions in the chest and abdomen. It avoids large incisions by using a tiny camera and fine instruments manipulated through keyhole incisions, but is generally unavailable in LMICs, aside from limited tertiary centers. Each operating room requires an expensive laparoscopic camera, viewing monitors, and related equipment (~$215,000 for initial purchase in each room). Current technology uses fragile fiber optic cables and cameras/lenses that require constant repair, necessitating expensive service contracts. Laparoscopic surgery is rarely accessible in LMICs due to the high cost of installment, lack of qualified maintenance personnel, unreliable electricity, and shortage of consumable supplies. 

Patients in LMICs would benefit from laparoscopic surgery, as advantages include: smaller incisions, decreased pain, improved recovery time, minimized post-surgical infections, and shorter hospital stays. After laparoscopic surgery, patients could return home and work more quickly, reducing impoverishing health expenditure. Previous studies have shown that few hospitals in LMICs offer laparoscopic surgery, but infections can be decreased with laparoscopic rather than open surgery, and patient satisfaction is good. Laparoscopic surgery could also minimize the stigma associated with certain surgical conditions.

Patients in LMICs should have access to laparoscopic surgery and do not suffer the healthcare delivery disparities hence we want cancer patients, complex gynecological cases, and any surgical case that require laparoscopic systems as our key target. We specifically want to address this challenge because of the following reasons:

1. Reduction of postoperative complications.  Initial experience with laparoscopic surgery in LMICs has shown a reduction in infection rates. Laparoscopic surgery has also been shown to reduce the risk of post-operative internal scaring, which can cause bowel obstructions later in life. 

2. Laparoscopic surgery is the standard of care in high-income countries (HIC) and should be for those from resource-limited settings for many surgical conditions, including treatment of cancer. All patients, regardless of their geographic location, should have access to the standard of care.  Surgeons in LMICs are interested in learning to perform laparoscopic surgery, and while uncommon, there are several initial reports of surgical groups in LMICs that are performing basic laparoscopic cases. 

3. Prevention of stigmatization. Surgical conditions can cause deformity and stigmatization in any culture. However, previous research has shown that in certain cultures, persons who have lost internal organs are no longer considered to be “whole persons” and may be denied opportunities or considered undesirable marriage partners. 

4. Financial benefits. The proposed laparoscopic system provides substantial cost savings to health systems compared to the currently available technology.  

Interviews were performed with surgeons who practice laparoscopic surgery to establish the need. These surgeons were chosen because they understand the technical demands of laparoscopy and are familiar with challenges in LMICs. Common themes from the interviews included: 1. Access to laparoscopic equipment is rare in LMICs. Surgeons in LMICs are often using broken equipment or improvised combinations, as the camera, light source, light cord and endoscope are all different pieces that must be separately cleaned after each use and reassembled. 2. Simplicity of design is preferred – it requires less maintenance and simple designs are easier for learners. 3. There are few technicians to maintain the equipment, which impacts safety. 4. Lack of consumable supplies (such as CO2) and power-outages are common. This makes it difficult to use insufflation as a method to obtain exposure in the abdomen. 5. Current laparoscopes require sterilization by autoclave, which is not available in many LMICs. Rather than sterilizing equipment, many surgeons are covering the equipment with sterile cloth sleeves, which is cumbersome. Sterilization by chemical submersion is preferred. 6. The image quality and safety profile should be equivalent to the current standard of care. 7. The lens is often foggy from condensation inside the abdominal cavity.

Work Completed:

We have constructed prototypes that we exposed to surgeons to collect initial feedback and to determine the functional parameters. 

Demonstrate Feasibility: In order to address the identified concerns, two prototypes have been developed: ReadyKit laparoscope and ReadyLift retractor.

The prototype is sealed with medical-grade epoxy, making it amenable to sterilization by submersion. In total, the ReadySuite laparoscope optics and the 3D printed casing can be assembled for the cost of goods equal to $120.

The ReadySuite is a comprehensive set of prototypes including the ReadyKit which is the low- cost hardware laparoscope device, ReadyView; Software with Tele-mentoring interfacing and ReadyLift; a retractor tool to mechanically lift the abdominal wall during surgery to eliminate the use of carbon dioxide and electricity.

Specifically, we are addressing the following challenges: making the technology more affordable, portable, robust, smart, and almost maintenance-free.

Laparoscope Optics. A 4.5mm diameter color-complementary metal-oxide-semiconductor (CMOS) detector was selected for video and image capture. The resolution of the CMOS camera was determined by imaging a 1951 resolution target.  The CMOS camera achieved finer resolution at working distances of 40mm and 100mm (working distances typically used during laparoscopic surgery). In order to achieve comparable light intensity to the commercial laparoscope, we designed a custom LED ring to illuminate the abdominal cavity, with an outer diameter less than 5mm and the inner diameter to accommodate the aperture of the CMOS detector.

The ReadySuite obviates the need for expensive monitors and cables and prevents loss of function during power outages. The prototype is sealed with medical-grade epoxy, making it amenable to sterilization by submersion. In total, the ReadySuite laparoscope optics and the 3D printed casing can be assembled for the cost of goods equal to $120.

Although our product is at a proof-of-concept level we expect to serve over 4,000 patients including cancer and maternal cases that require cancer surgery in Uganda per year.

Laparoscopic surgery, which is the standard of care for many cancers and pin-hole surgeries in high-income countries, is almost non-existent in LMICs. This represents an extreme health care disparity and undermines the principles spelt-out in SDG 3: Good Health and Wellbeing and this should be eliminated. Access to Laparoscopic surgery in LMICs has huge social and financial impact and benefits as clearly articulated in the following reasons:

1. Reduction of postoperative complications. Infection is a major concern in LMICs, as antibiotics are expensive and patients recover in cramped facilities with many other patients on the surgical ward. Initial experience with laparoscopic surgery in LMICs has shown a reduction in infection rates.

2. Laparoscopic surgery is the standard of care in high-income countries (HIC) for many surgical conditions, including treatment of cancer. All patients, regardless of their geographic location, should have access to the standard of care

3. Financial benefits. The proposed laparoscopic system provides substantial cost savings to health systems compared to the currently available technology.  Laparoscopic surgery would benefit individual patients by reducing catastrophic health expenditure. Currently, almost all surgeries are performed through large incisions and patients spend many days recovering. With the increased accessibility of this technology over 18 million patients suffering from Cancer in LMIC’s will not suffer much by missing standard surgery and also the many other women that require these services.  

Specifically, we shall,

1: Optimize prototypes for implementing sustainable laparoscopic surgery. 5 prototypes will be developed based on feedback from surgeons.

2: Conduct technical bench-top tests on the improved design. After these modifications are completed, a series of bench tests will be conducted to establish the resolving power, field of view, depth of focus, lens distortion, and light intensity of the ReadyView laparoscope using imaging target standards.

Aim 3: Establish the feasibility and acceptability of the innovation. We shall interview more surgeons and engineers.

Aim 4: Navigate the regulatory process and prepare documentation for certification. Through training, mentorship and consultations, we shall familiarize ourselves with the regulatory processes recognized and used worldwide and choose what is feasible most fit for this device and prepare documentation.

Aim 5: Acquire knowledge and develop a manufacturing and business plan. The team unanimously agreed to register a private startup in Uganda (Spin-out), but we still need more knowledge on strategy and financial plan.

The regulatory framework in Uganda is not clear and it might affect the execution of the project. 

Also, we expect that we shall experience difficulties in sourcing manufacturing resources and investments. We are backing on mentors at Makerere University. 

I (Belinda Patricia) the team lead, I am a third-year Biomedical Engineering student at Makerere University in Uganda. I have already acquired skills in research and engineering design. I have also participated in training for product development and medical device design. 

Ssebufu Alex is a student of Mechanical and Manufacturing degree at Kyambogo Unversity in Uganda. 

Kato Husein is a Business student with experience and aspirations in marketing and offers dynamism to the team. 

Martha Namayanja is a Biomedical Engineering student at Makerere University with great enthusiasm for research and innovation. 

We are also in the humble hands and mentorship of Mugaga Julius. 

Julius is a graduate Fellow at Makerere University with training in Biomedical Engineering and Bioinformatics.  Julius has over 7 years in R&D work and has helped bring multiple products to market. 

Dr. Robert Ssekitoleko; is a lecturer in biomedical engineering at Makerere University and the Ugandan director of the Duke – Makerere (Duke-MUK) BME Partnership. He has received international recognition from multiple organizations for his work in BME projects in Uganda. He will work with our team to facilitate focus groups in Uganda, provide engineering expertise on device development for resource-constrained settings and will serve as the on-sight biomedical engineer.

Tamara Fitzgerald, MD, PhD, Pediatric Surgeon and Global Health expert, who has over 15 years of experience in clinical and basic science research. She has completed a doctoral degree in biomedical engineering (BME) and has worked in Uganda on surgical capacity building for over 6 years.  

We are working with Badaye Technologies. Development Badaye Technologies Limited (BTL) is an incorporated Research, Technology Innovation Consultancy and manufacturing company. They have developed local capacity to manufacture technologies in Uganda. 

We are also mentored by Design Cube Makerere. SAn incubation center in Makerere University based at College of Health Sciences. They offer services in product development skills, business development and medical device regulation expertise. 

I am a female leader very passionate about solving the hardest needs of the world mainly affecting people from Low and Middle-Income Countries where I am based. Our innovation will address the surgical challenges facing women and girls. Winning the HP Girls will accelerate the processes of our development. 

We are addressing a great need that is creating healthcare disparities between people living in High-Income Countries and those residing in resource-limited settings affected by cancer and requiring complex pin-hole surgery. Winning a Pozen Social Innovation Prize will go a long way in driving ReadySuite to great success and reaching the bedside.