A LOW-COST CPAP DEVICE DEVELOPED IN INDIA FOR INDIA – A TESTAMENT TO CO-CREATING

ACROSS DISCIPLINES

ANDREW LOGAN Department of Human Biology, Stanford

University Palo Alto, California, USA

+1 9548549193 Alogan9@alumni.stanford.edu

ABSTRACT

Respiratory Distress Syndrome (RDS) is internationally recognized as a major cause of morbidity and mortality in premature infants. Unfortunately, RDS treatment in the developing world is still in its infancy. In India, RDS occurs in higher frequencies than in the West and has a greater burden of illness. The use of continuous positive airway pressure (CPAP) has been shown to be an effective way to stabilize the surfactant-deficient lung existing in RDS infants.

We had an opportunity to address this unmet clinical need during a Medical Technology Jugaad-a-thon (Hack-a-thon) sponsored by CAMTech (Massachusetts General Hospital) in Bangalore, India. Over a 48 hour period, multidisciplinary teams were formed, they developed ideas, and finally, they prototyped new inventions.

DR. JAGDISCH CHATURVEDI

Associate Consultant, Department of Otolaryngology, Apollo Hospitals

NO 15, Type 5, NIMHANS Quarters, Dairy Circle, BRC Campus

Bangalore, Karnataka, India +91 9650928582

jagdischc@innaccel.com Although hack-a-thons are not

reinventing the wheel, they are providing a launch pad for multi-cultural, cross-generational, and inter-disciplinary co-creation. However, an average product development cycle for a medical device is 24-36 months. We must find creative ways to facilitate and simplify the rest of the product development process for a novel medical device. Key Words: Medical Device, Continuous Positive Airway Pressure, India, Hack-A-Thon, Innovation, Respiratory Distress Syndrome

INTRODUCTION

Respiratory Distress Syndrome (RDS) is internationally recognized as a major cause of morbidity and mortality in premature infants1,2. RDS is the most common pulmonary disorder in newborns, and its incidence is directly proportional to infant prematurity3. Premature infants often develop RDS within the first 24 hours following birth and display tachycardia, nasal flaring and expiratory grunting during normal ventilation. The acute course of the disease typically lasts for two to three days during which infants must receive treatment4,5. Otherwise, systemic tissue deoxygenation will occur and organ failure will result in death6.

The use of continuous positive airway pressure (CPAP) has been shown to be an effective way to stabilize the surfactant-deficient lung existing in RDS infants7. Studies following the implementation of CPAP demonstrated that this intervention reversed airway closure and improved the survival of RDS from 23% to 70%8. In addition, clinicians learned that exogenous surfactant could also be used to treat preterms. The introduction of antenatal corticosteroids and advanced care technologies in the 1990s improved survival rates further and few infants in the US died exclusively from RDS after this time period (Fig. 1)8.

Period Years RDS-Specific Intervention

Period Years RDS-Specific Intervention

1 Before 1950 No widely used treatment

2 1950–1969 Oxygen

3 1970–1989 CPAP

Mechanical ventilation

4 After 1990 Antenatal corticosteroids

Surfactant

Advanced care technologies

High-frequency oscillation

Extracorporeal membrane oxygenation

Figure 1: Timeline of the advancements in RDS treatment8

Following the advancements in the treatment of infants and preterms, the mortality rate for RDS declined rapidly from the early 1900s to the mid-1990s. However, it is difficult to quantify the impact that each RDS-Specific Intervention (Fig. 1) had on the survival rate. One study compiled a rough estimation of this impact based on an extensive literature review and various discussions with experts in the field8. They assumed that in the absence of any intervention, the mortality rate would be close to 100%, a figure similar to what is seen in low-resource settings today. The greatest decline in mortality occurs from the appropriate use of oxygen and CPAP (Fig. 2). With the addition of surfactant and advanced prenatal care, approximately 98% of infants can be saved.

Figure 2: Speculative increase in RDS survivors based on intervention8

Unfortunately, RDS treatment in the developing world is still in its infancy8. In India, RDS occurs in higher frequencies than in the West and has a greater burden of illness. This results from a substantial proportion of young mothers lacking proper nutrition, who are severely underweight, and who often undergo rapid multiple pregnancies. These conditions all predispose mothers to birth complications and premature labor. Conservative studies estimate that approximately 200,000 Indian infants develop RDS annually9. Moreover, approximately 40% of births in India occur at home10. If infants delivered in a non-hospital environment develop RDS, they must be transferred to a primary health care clinic and then to a tertiary referral hospital. Infant ventilation must be controlled throughout this treacherous transfer. Altogether, the Indian mortality rate for infants who develop RDS is approximately 40% to 60%11.

Many companies have tried to improve RDS survival rates in low-resource settings by transferring over effective technologies from the west. However, as is

so often seen in the healthcare space, these technologies are maladapted to resource-constrained settings. Western technologies often require skilled technicians, pre-existing infrastructure and governmental assistance8. There is a pressing need for an India-specific, affordable solution to treat and transfer infants with RDS.

METHODOLOGY

We had an opportunity to address this need during a Medical Technology Jugaad-a-thon (Hack-a-thon) sponsored by CAMTech (Massachusetts General Hospital) in Bangalore, India. A medical device hack-a-thon is a two-day event that brings together engineers, clinicians, entrepreneurs and end-users to develop disruptive innovations to improve health. This event provided a platform for individuals from diverse backgrounds to co-create devices for resource-constrained settings. Over a 48 hour period, multidisciplinary teams were formed, they developed ideas, and finally, they prototyped new inventions.

During this event, we formed a team consisting of a clinician, a medical device entrepreneur, an undergraduate mechanical engineering student, and a master’s fluid engineering student. In addition to the expertise gained from the various members of the team, the hack-a-thon also invited senior engineers, clinicians, and businessmen to serve as mentors. Our team discussed our project widely and multiple mentors got involved. We utilized physicians from the United States, Uganda, and India. We received expert mechanical design consultations from senior engineers in India. Lastly, Indian and American

mentors helped us develop a sound business plan and development strategy.

RESULTS

Considering the Indian healthcare system as well as the large impact demonstrated by the initiation of oxygen and CPAP treatment (Fig. 2), we have decided to develop a low-cost, easy-to-use CPAP device for neonates. The proposed solution is a novel device aimed at transforming a variable input pressure into a consistent positive airway pressure that prevents the alveoli within the lungs from collapsing. The input pressure is generated by physically pumping a bag full of air. The transfer of air to the neonate is facilitated by nasal prongs. Lastly, the device incorporates a humidification system that provides warm humidified air. The target cost of this reusable device is 15,000 INR.

The intellectual property for this device has already been secured and the solution concept has been frozen. Following the final presentations at the CAMTech Jugaad-a-thon, the novel CPAP device won a 60,000 INR Covidien Prize and now has the backing of Massachussets General Hospital and GE Healthcare. In addition, we have secured acceleration services from an indigenous medical device incubator13. The next step is to develop and finalize design concepts.

CONCLUSIONS AND FINDINGS

We believe that this low-cost, easy-to-use CPAP device can help maintain the airway of neonates during a critical period and reduce many of the unnecessary infant deaths that occur all over the developing world. However, this project would not have been possible without the Jugaad-a-thon.

This hack-a-thon provided a co-creation space where individuals from various fields could join together and develop critical solutions for a short period of time. We strongly believe that there exists a desire to innovate new solutions in each and every one of us. Unfortunately, the development process for most medical devices typically lasts for approximately 36 months12,13. This time commitment can be especially daunting for those of us with professional and familial commitments. Hack-a-thons allow all of us to explore our inventive side in a low-commitment setting. They provide a safe space for invention, an assortment of talented individuals, prototyping materials, and clearly defined clinical needs.

In the spirit of design thinking, these hack-a-thons also encourage participants to empathize with their users, to collaborate with experts from various industries, and to develop rapid prototypes of their ideas for immediate validation. At various phases during the development of the CPAP solution concept, we would make immediate and exciting progress and then suddenly stumble into a hurdle. During this time, it was invaluable to have mentors upon whose expertise we could rely on. We continually went through an iterative cycle of brainstorm, struggle, and consult. Although hack-a-thons are not reinventing the wheel, they are providing a launch pad for multi-cultural, cross-generational, and inter-disciplinary co-creation. We strongly encourage innovators from all disciplines to engage in this form of collaborative work whenever possible.

However, it is also critical to consider the extensive process following concept generation and prototyping. As mentioned above, a conservative estimate

for the developmental cycle of a medical device is at least 24-36 months12,13. The development cycle for a product stemming from a hack-a-thon includes, but is certainly not limited to, all of the steps outlined below (Figure 3).

Months Deliverables in Product

Development

1

Concept Generation Team Formation Filing of Provisional Patent

3

Team Incorporates to a Legalized Entity Proof of Concept Testing

6-9

Iterate Prototype Bench Top Testing Feedback from Clinicians

12

Final Device Specifications Filing of Final Patent Apply for IRB Approval and Clinical Testing

18-21 Finish Clinical Trials 24-27 CE / FDA Approval

27-36

ISO Manufacturing Marketing Point of First Sale

Figure 3: Product Development Pathway for Hack-a-thon Products

We must find creative ways to facilitate the rest of the product development process. Creating additional opportunities for co-creation is one option, as the benefits of working with a multidisciplinary team in the field of medical technology do not stop after the concept development phase.

Engineers on the team can work to prototype further solutions. When a functional prototype is developed, engineers can interface with clinicians about product testing. The clinicians, who already understand the product, can help expedite the patient and clinical testing phases. Lawyers are needed to ensure proper filing of intellectual property. Government officials can oversee the process and ensure that development occurs in an ethically-acceptable manner. Finally, if the device fits the design criteria and proves to be efficacious, business experts can drive the product to the point of first sale. This method of product development has the potential to be more effective and expeditious than current methods.

There is no shortage of critical healthcare problems in the developing world. We believe that there is not a shortage of brilliant people to solve all of these problems. Hack-a-thons provide us with a fantastic launching pad for medical device development. We must now shift our focus to facilitating the next steps in the product development pathway. By decreasing the cost of participating in extended collaboration, we can ensure that our CPAP project and other projects make it to market. Only by working together and drawing on each other’s expertise can we can develop innovative solutions to tackle the critical health issues plaguing the developing world. All of us are smarter than any of us.

REFERENCES

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ACKNOWLEDGEMENTS

We are grateful to Massachusetts General Hospital and CAMTech for organizing the Jugaad-a-thon in collaboration with GE – Healthcare, USAID, and the Omidyar Network. We would also like to acknowledge all of the contributors to our project as well as all of the Jugaad-a-thon participants. Finally, thanks are given to Covidien for helping us drive this project forward.