The versatile Noor Medical Hybriclave

1/3 of patients in the developing world suffer from post-operation infections which unfortunately result in 17 million deaths annually. The lack of a capable medical instrument sterilization device is a problem that countless rural health facilities have faced for quite some time. Josh Guenther, Country Director for LifeNet International, stated in a recent interview that “We have been staring the sterilization issue in the face for years, and it seems that Noor Medical may have a valuable solution.”

Noor Medical’s Hybriclave can utilize a diversity of energy inputs to achieve adequate sterilization conditions in order to safely sterilize medical instruments. Our solution, following the tenets of frugal innovation, has been designed to be robust enough to function in the often harsh conditions found at rural and peri-urban health facilities in low-resource contexts. We aim to make safe surgery a reality - worldwide. 

Through its products and services Noor Medical helps health clinic operators who often do not have access to proper medical instrument sterilization devices and materials improve patient outcomes by cost effectively reducing post-operative infections and improving the safety of medical staff. Post-operative infections impact not only the sufferer of the ailment, but also those in contact with them - including family members and their local community. This is in addition to the more direct impacts on health clinics themselves, which would be aided by having to deal with fewer re-admittance's after surgeries, thus freeing up valuable hospital bed space.

In African countries, infection is the most frequent complication in surgery and up to 20% of women who have a cesarean section develop a postoperative wound infection. In 2019 research carried out by Sway et al., and published in the International Journal of Women’s health found that “Cesarean section is the most common operative procedure performed in

sub-Saharan Africa (SSA), accounting for as much as 80% of the surgical workload.” Safe surgery is thus an extremely pertinent issue when accounting for the health outcomes of women in low-resource regions, such as SSA. 

Noor Medical’s pioneering product is a hybrid solar PV-battery autoclave (Hybriclave). The Noor Medical Hybriclave can operate either with solar energy, with a PV-battery system, other thermal energy inputs such as cooking gas, or conventional electricity, when available. We thus enable health facilities with unstable electricity supplies to maintain safe medical equipment sterilization processes even in times of power shortages. Steam jet technology, co-developed with Fraunhofer FEP (https://www.fep.fraunhofer.de/), allows the autoclave to produce vacuum conditions without the use of a conventional electrically driven vacuum pump - thus saving energy for producing steam and providing greater sterilization flexibility for a wider range of materials, e.g. porous or tubular instruments. The Hybriclave is built to be robust enough to survive in harsh environments, while maintaining simplicity as to be easily repaired with locally available materials. Additionally, Noor Medical offers digital services such as educational material on how to use the Hybriclave as well as proper sterilization process guidance

Noor Medical has identified five principal stakeholder groups that will be impacted by our product. 

1) Medical staff: This group requires a device which will allow them to have safe/sterile equipment at all times & the capacity to sterilize instruments/equipment (independent of power shortages).

2) Pregnant women in developing countries: Require sterilized medical instruments to reduce the chance of complications and to have a faster recovery.

3) All others requiring surgical interventions: Require sterilized medical instruments to reduce the chance of complications and to have a faster recovery.

4) Public health institutions and private clinic networks: These stakeholders will have advantages in the delivery of quality care due to increased resilience against disruptions in electricity supply - allowing them to  continually provide safe surgical interventions.

5) Production workers: One of Noor Medical’s goals is to have the final assembly of the device in Kampala. For instance, our insulation covers for the pressure vessel component are currently sewn by local women. 

Product development has thus far been informed through interviews with stakeholders at healthcare clinic networks and by partners who have worked and produced other medical hardware solutions for low-resource contexts.

In low-resource contexts there are two major factors related to product availability which affect the provision of high-quality and affordable care for women, new mothers, and newborns. The first is related to the high-cost of standard medical equipment which is frequently found in Global North contexts. The second is the design of such equipment, which fails to meet the robustness requirements required by low-resource contexts. Our Hybriclave is designed to overcome both of these challenges and has been designed from the ground up to serve the needs of low-resource settings - increasing their access to safer surgery.

Principally, competition comes from other medical equipment manufacturers working in the autoclave market:

-Conventional autoclave (e.g. tabletop autoclave): The most expensive of the solutions. Effective, but require dependable  electricity and regular maintenance to protect critical components.

-Non-electric autoclave alternatives (e.g.pressure vessels utilizing cook stoves): Have a large variation in quality and can only use one energy input. 

-Boiling water: Cheapest solution but has a very low sterilization effectiveness. 

-Chemical sterilants: More effective than boiling water but require specialized training for effective use (e.g., correct storage and handling).

Additionally, other autoclaving substitutions which offer non-traditional, non-business competition are groups and users that promote sterilization through methods such as boiling water, chemical sterilants, etc. These methods are not effective but have become commonplace in certain contexts. Overcoming this competition requires a degree of education, which we pursue via our partners which already provide staff training to clinic networks (e.g., LifeNet International provides comprehensive sterilization training to the staff at its franchised health clinics). Ultimately, Noor Medical is unique in combining its education and training aspect along with a device that can utilize multiple energy inputs to provide critical medical instrument sterilization regardless of the operating context.

Our Hybriclave integrates existing technologies into, what is in effect, a gravity autoclave. The key differentiation is the approach of frugal innovation, focusing on robustness and utilizing locally available materials in order to facilitate easier repairs. Efforts have been made to increase the thermal efficiency of our pressure vessel such that power from outside sources is utilized most effectively. The application of multiple energy inputs ensures redundancy for providing medical instrument sterilization, while our focus on providing PV power input and battery backup is a first in the autoclave industry. Additionally, we are co-developing steam jet technology to provide vacuum conditions in the autoclave device without the need for outside electricity running an electric vacuum pump. This provides wider applicability of our device in sterilizing medical materials that are porous and aids in reducing sterilization cycle time, including drying, thus reducing the chances of cross-contamination.

Most recently, we have integrated remote monitoring capability into the autoclave via our battery management system. This allows the user of the autoclave to monitor outcomes from e.g. a web application control panel that we have developed. This also opens up the possibility for data regarding the use of the device to be uploaded into the cloud - perhaps to be monitored by healthcare clinic networks. It also provides an avenue to reduce human error, by automating part of the sterilization process, such as maintaining temperatures above the sterilization threshold for the required time, or providing a digital checklist before starting a sterilization cycle.

he world-wide first steam sterilizer for surgical laundry was designed and produced by Mathias Lautenschläger in 1887. Since this time, steam sterilization has maintained its primacy as the sterilization method of choice for medical purposes. The steam sterilization process is highly energy efficient due to the latent heat released when steam condenses on items. Given its wide acceptance globally, tackling the medical instrument sterilization issue in low-resource settings naturally gravitated our efforts toward steam sterilization. 

Powering the steam sterilization process in low-resource settings became our principle challenge. Advances in lithium-ion technology (price per kWh has fallen 90% since 2010) and the utilization of robust electrical components within the device allowed us to develop a power system capable of using various energy inputs - including electricity and other thermal sources, e.g. cookstoves. Thus, utilizing a proven technology for the sterilization of medical instruments, combined with a design approach to provide additional power inputs, allowed us to develop an autoclaving device more suitable for low-resource settings. 

Other product features rely on technology which has also been widely used - but now repurposed. For instance, internal electrical components for the heating coil utilize industrial grade wires so that they may withstand temperatures up to 400C (far beyond anything our units would be subjected to).

Additional product footage can be viewed in this video: https://drive.google.com/file/d/1cQ74BXDIySAnlWcZARu3vg2_so3lMEtP/view?usp=sharing (including the prototype Hybriclave monitoring system at 1:06).

Noor Medical has developed a theory of change framework that takes into account the needs and outcomes of the following groups: 

1) Medical staff:

-Need: Having safe/sterile equipment at all times & the capacity to sterilize instruments/equipment (independent of power shortages)

-Outcome: Medical staff can perform safer surgical interventions

-Impact: Fewer post-operative infections and infection-related mortalities. Social and Economic impacts include a stimulation of the local economy due to fewer healthcare related costs. 

2) Pregnant women in developing contexts:

-Need: Sterilized medical instruments to reduce the chance of complications and to have a faster recovery

-Outcome: More women have fewer post-operative infections

-Impact: Shorter time hospitalized, more time spent looking after their family and contributing to the local economy, higher income as a result

3) All other people who need surgical interventions:

-Need: Sterilized medical instruments to reduce the chance of complications and to have a faster recovery.

-Outcome: Patients suffer fewer post-operative infections

-Impact: Shorter time hospitalized, more time spent looking after their family and contributing to the local economy, higher income as a result.

4) Public Health Institutions (e.g., Government)

-Need: Public healthcare networks that are resilient to disruptions in electricity supply and can continually provide safe surgical interventions

-Outcome: Patients suffer fewer post-operative infections. Public health expenditures relating to surgery and post-operative care are reduced.

-Impact: Patients experience fewer post-operative infections and as a result spend less time hospitalized, more time looking after their family and contributing to the local economy and have a higher income as a result. "Unsafe surgery within LMICs has a pronounced impact on their economic potential. Without urgent and accelerated investment in surgical scale-up, LMICs will continue to have losses in economic productivity, estimated cumulatively at US $12·3 trillion (2010 US$, purchasing power parity) between 2015 and 2030

Economic impact." (Lancet Commission, 2015)

Our complete TOC framework is available to view here:

https://docs.google.com/spread...

We’re currently supporting local employment for the manufacture of our prototype devices - with around 5 total beneficiaries. Safe surgery impacts are anticipated once commercialization is achieved, first in Uganda, and the first devices make their way to clinics. Our current clinic partner network data suggests around 60 surgeries take place each month at each of the small rural health clinics.  Roughly 50% of these surgeries are directly related with maternal health. Considering a normal distribution between the remaining surgeries we infer that about 75% of our total beneficiaries would be women. In one year, we aim to have at least one Hybriclave unit in 470 healthcare clinics, providing 28,200 safer surgical interventions. At the end of five years, with over 16,000 cumulative units sold, we anticipate an improvement for at least 12 million surgical interventions. 

Impacts are realized primarily through the reduction in post-operative infections for patients and the amelioration of consequent negative impacts from infections on the wider community. Our target beneficiaries are: rural populations, women and girls and healthcare staff.

With over 5 billion people in the world lacking access to safe and affordable surgical care, the problem that we hope to help address is one where massive impacts can be made. Ultimately, we plan on providing a holistic solution to improve safe surgical conditions - first through the provision of our autoclaving technology and then through added digital interventions. 

Our goals over the next five years include 16,000 cumulative Hybriclave units sold - leading to an estimated improvement in surgical interventions for at least 12 million people. 

Long-term we foresee greater impact potential by leveraging the network effect of our Noor Connect digital companion, which will be integrated into the operation of our Hybriclave device. Clinic networks will be able to determine how many sterilization cycles have taken place, with added functionality for identifying which instruments were sterilized. Data collected at thousands of clinics can lead to some exciting insights on where, when and how often certain surgical interventions have taken place - in relatively real-time. There are certainly some exciting possibilities here. 

Education tools for helping train sterilization technicians on best practices will help expand not only our impact, but that of our partners who are also working in the safe surgery space. When the capacity for health clinics to sterilize medical instruments is created, and the education tools are in place to make sure such practices are carried out effectively, safe surgery can be made more accessible for tens of millions of people around the world.

The introduction of new technology can always present challenges, especially in environments where proper functioning is critical for human well-being (e.g. healthcare). The application of already held knowledge and education are therefore important aspects for the roll out of our device. In this regard, we must overcome hurdles related to the novelty of our device. 

Key medical stakeholders are thus often required when presenting medical solutions to public health clinic networks - gatekeepers that can vouch for the efficacy of its functioning. This challenge is not as pronounced at private medical networks which are often more open to experimentation and the implementation of novel solutions. 

Material sourcing by our manufacturing partner is also an area of concern. Sourcing certain complex components not available locally will require building a strong international partner network in order to secure supplies. This relates as well to the certification of our device. International certifications such as a CE Mark in Europe may not be possible with a device built for robustness in low-resource settings - lacking certain features to be expected for autoclaves on the European or US markets. Resources pursuing certification in individual countries within our target market may therefore be required.  

A more recent challenge is related to the current  global health situation. Restrictions on movement in many countries within our target market may reduce the speed by which we can achieve field testing results and ultimately the certification and full commercialization of our device.

Addressing the novelty of our product will require integrating an educational component with the roll out of our device. Recently we were selected by the BW Goes Mobile grant committee to further develop our digital companion service, Noor Connect. This service will be available within the sterilization monitoring application as well as on our website.

Coalition building with healthcare partners in low-resource settings will also be crucial to enter our target market and build valuable case-studies on the usage of our device. Having success stories to share with other networks will help us expand our impact. 

Challenges related to manufacturing and sourcing components for final assembly in Uganda (which aligns to our plan to have a positive economic impact in the areas we serve), is an area that we’re continually exploring. Thankfully, we’re not the first to attempt this and we’re hoping to learn from partners and other stakeholders who have secured supply chains in order to realize this vision. 

To address concerns on the global health situation’s impacts on our operations and development we’re pivoting much of our product development energy toward the digital Noor Connect service. Concurrently, we’re exploring the possibility of having remote field trials carried out at a local university partner in Uganda (to overcome international travel restrictions). Importantly, we will continue to look for ways to maintain our momentum during this time.

Full-time staff: 3

Part-time staff: 3

Contractors: 4

Noor Medical is a multinational and interdisciplinary group of entrepreneurs united by the vision to improve humanity’s access to safe healthcare through safe surgery. We got to know each other during our Master’s program in Environmental Governance and quickly noticed that we are all inspired by the power and potential of social entrepreneurship yielding positive social and environmental impacts via South to South and North to South cooperations. We are eager to follow our vision to improve healthcare outcomes in remote clinics around the world. Everyone on the core team has past experiences with entrepreneurial endeavors, either having started other companies or by having worked directly in relatively new companies. This is coupled with experiences in mature enterprises - further augmented by the valuable expertise of our active advisory board composed of experts in rural healthcare, surgery and business development. We continually look for innovation internally and value self learning, believing that Noor Medical’s success ultimately hinges on the continued development of our team and personal capabilities.

For our team, the problem of a lack of affordable and capable medical instrument sterilization equipment in low-resource settings was first encountered when Saji Zagha, CTO of Noor Medical, who traveled to Chad to oversee the construction of rural healthcare clinics sponsored by Adventist Health International. It was there that he came face to face with the challenges present at rural health facilities who cannot use traditional sterilization equipment due to the lack of reliable electricity.

We delineate between the following partner groups: 

1) Healthcare clinic networks: Include private clinic networks such as LifeNet International, One World Health Uganda, and FullSoul Uganda. These clinics often have innovative healthcare delivery models themselves and are quite eager to test new technologies. 

2) Research institutions (including universities): Ensign College of Public Health (Ghana) and Makerere University (Uganda), have both been helpful in providing initial feedback on our product. We are currently working toward a collaborative research project for user-interface testing with medical students there. 

3) Healthcare organizations: Orgs like Us is an organization of healthcare NGOs and businesses developing hardware solutions for low-resource contexts. We meet on a bi-quarterly basis to discuss our work and share knowledge. We are also partnered with many other healthcare organizations working in our field (see www.noor-med.com for more). 

4) Production & prototyping partners: This includes organizations like Fraunhofer, who we are developing a non-electric vacuum system with, as well as our prototyping partner in Kampala, Bodawerk, whose services are allowing us to rapidly iterate through designs in the field. 

We’re proud to have partnered with leading organizations in the Safe Surgery 2020 Movement, including LifeBox and SPECT. Working to provide solutions for the myriad difficulties facing healthcare delivery in low-resource settings requires leveraging the experience of similar organizations and having strong partnerships in the communities we aim to serve.

Noor Medical’s business model is centered on two key concepts: cost innovations in the development of core autoclave components (i.e. low-cost alternatives to existing Western products), particularly suited for resource-constrained customers in emerging markets; and frugal innovation, wherein novel products and services are built atop cost innovations to allow new applications specifically developed for customers in resource constrained contexts (e.g. our power system and steam jet technology to expand the functionality of our Hybriclave system for resource-constrained customers).

Our product is marketed across three main groups who have a stake in medical equipment procurement: Health system administrators (greater surgical efficiency due to fewer postoperative infections), nurses (satisfies operational requirements and builds redundancy in their ability to sterilize medical instruments), and procurement officers (increased affordability when compared to conventional autoclaving solutions). 

Customers can be categorized into two principal types: public & private healthcare networks. These  networks are responsible for providing  material and non-material support to healthcare clinics, often working with a constellation of clinics in a specific region to support their delivery of medical care.  Certain private-networks raise capital through a multitude of fundraising efforts, including using micro financing partnerships to procure medical equipment and lease it on a rent-to-own model for franchised clinics (e.g., LifeNet International).  Revenue streams are derived from the sale of our Hybriclave device. We are exploring the possibility of deriving additional revenues from the inclusion of an autoclaving monitoring service, due to be built into the Hybriclave.

In our product development and pilot testing phase we will continue to pursue a variety of grants and have explored the option of equity financing from social-impact oriented investors. Grants may continue to play a role in financing our development over the next 3-4 years - and may also help support certain health clinic partners to procure our technology. For example, LifeNet International currently works with a partner that raises funding for the procurement of medical equipment at their rural health facilities. 

Our long term vision is to be financially self-sustaining from the sale of our product / services. Currently our efforts are centered on the commercialization of our Hybriclave technology, but we have already begun pursuing the development of our mobile Noor Connect companion software to add additional functionality to our device and provide a platform for medical instrument sterilization education. This is an area of continued development and may prove to be an additional revenue stream in the future. Importantly, we are open to diversifying our service offering to healthcare clinics and thus increase the range of potential revenue streams in order to grow organically without continued outside capital support (from e.g., grants).

We are interested in joining a high-performing network of social-impact enterprises that have learned important lessons in e.g. bringing new technology to low-resource contexts and developing education materials to accompany new products / services. In particular within the MIT Solve Network is our interest with the MIT Tata Center, which provides direct support to enterprises developing healthcare solutions for low-resource settings.

We are planning on expanding our team, subject to funding, to build our operations in Uganda and support piloting activities in additional countries. Regarding legal or regulatory matters, it would be extremely helpful for us to have partners with experience in bringing medical technology to developing markets. The procedures in various countries can differ quite substantially, and we believe having a partner helping us navigate these processes will be critical to our timely and effective commercialization of our Hybriclave technology.  

-MIT Tata center: https://tatacenter-mit-edu.ezproxyberklee.flo.org/service/health/ Key stakeholder in developing healthcare solutions for low-resource settings and would be quite helpful for Noor Medical to initiate pilot testing activities in India.

-Commcare: http://news.mit.edu.ezproxyberklee.flo.org/2020/dimagi-commcare-health-0309 We're seeking a partner to help us provide a data platform tracking sterilization processes at rural clinics.

-BMW Foundation (in accordance with its mission of supporting the Agenda 2030 der Vereinten Nationen) In particular, SDG 3: Ensure healthy lives and promote wellbeing for all.

Noor Medical is working to provide a holistic solution to improve safe surgical conditions - first through the provision of our autoclaving technology and then through added digital interventions as well. These digital interventions include education tools related to safe medical instrument sterilization processes, as well as functions to help staff track such processes (e.g. monitoring autoclave conditions and instrument quality). Our goal is to empower healthcare workers in low-resource settings to more effectively provide safe surgery.