THE SMART PVD

The estimation of blood loss remains a major challenge in the management of Postpartum Hemorrhage in the developing world, leading to 50% of maternal deaths in the first 24 hours after birth. In Uganda alone, postpartum hemorrhage accounts for approximately 25% of maternal deaths.

The current technologies used in blood estimation are highly subjective and usually result in errors. Others pose financial burden to the already struggling health systems due to their complex approach in implementation. These challenges in turn contribute to the delay in the timely diagnosis of PPH and delayed management of the condition resulting into complications or death. 

Our team has designed the Smart PPH Volumetric Drape (SMART-PVD), an easy-to-use and low-cost device to improve the accuracy of blood estimation by birth attendants empowering them with the ability to detect the onset of postpartum hemorrhage to save the mothers life within the first hour after child birth. 

Uganda’s maternal mortality ratio as of 2016 was reported at 336 deaths per 100,000 live births translating to approximately 15 women dying every day due to preventable conditions like hemorrhaging, hypertension among others. Postpartum hemorrhage (PPH) is one of the major causes of maternal mortality in developing countries like Uganda contributing 25% to maternal deaths. It is commonly attributed to uterine atony that occurs within the first hour of delivery leading to severe bleeding. Therefore, delay in recognition of PPH exposes women to the risks of blood transfusion, anemia, and ultimately death that could have been prevented by on time and accurate estimation of blood loss. Unfortunately, it has been reported that health workers have significant difficulty in estimating blood loss. Furthermore, the existing blood estimations techniques such as visual estimation has been considered inaccurate by several studies whereas weighing of soaked cotton and blood collected in bags, kidney dishes are deemed time consuming for busy settings with cost implications related to its implementation. Despite the ineffectiveness of these techniques, they are still the standard of diagnosis of PPH in most developing countries leading to delay of initiation of treatment resulting into maternal morbidity and mortality.

The team proposes the Smart Postpartum Hemorrhage Volumetric Drape (SMART-PVD), a device designed for the purpose of uniform collection and accurate measurement of blood lost during and after childbirth. This device will ensure that birth attendants detect the onset of PPH so that initiation of treatment is timely to prevent adverse conditions related to hemorrhaging. The device is made up of a reusable blood level sensor to detect the amount of blood collected in the disposable blood collection system during delivery after which it alerts the birth attendant of an intending PPH case basing on threshold values used to define PPH in a clinical setting.

The SMART-PVD is comprised of features built from locally sourced materials that provide efficient estimation of blood loss. These features include;

• Two pairs of elastic belts used to secure both the drape and mother in position to allow for uniform collection of blood
• A low-density polyethylene pouch that is standardised to collect not more than 1000mls of blood and transparent to provide visibility to the user.
• Blood filter that will be used to collect foreign materials that are usually mixed up with the blood during delivery

This project will directly benefit the health workers (clinicians, mid-wives and nurses) who attend to women at birth by allowing accurate and timely estimation of post-delivery blood loss that is critical in decision making for life-saving intervention in the immediate post-partum period. It has been established that the nurse to patient ratio in Uganda is 1:5 to 1:10. Availing tools to the health workers, which are automated, will reduce the burden on them to using rudimentary techniques like weighing soaked cotton while monitoring postpartum bleeding, without compromising the standard of care.    

The women will benefit indirectly in terms of lives saved at birth as a result of this project through the early detection and hence intervention of PPH.

The SMART PVD is entirely user-centred; right from the initial phases of development, the health workers who are also the direct beneficiaries have been involved. Our team comprises of an Obstetrician and a midwife who clearly highlighted the challenges faced during child birth.  As we enhance the prototype, their input shall be greatly considered; recruiting more mid-wives into the clinical trial as the study clinicians who shall be trained on how to use the device and hence employ it during the study.

This solution is overall focused on expanding access to high quality affordable maternal care for women, expanding the health workforce and improving service delivery. The SMART-PVD is designed to ease the day to day work of the health workers in line with blood estimation following child birth. In so doing, they will be able to speculate the likelihood chances of Postpartum Haemorrhage through the alarm that will be sounded. This then allows for on time preparation and intervention thus reducing on the chances of maternal death due to Postpartum Haemorrhage.

The SMART PVD is innovative because it provides:

• Timely alerts: Current methods use visual estimation by midwives, which is limited by the physician to patient ratio of1: 25,725 and the midwives to patient ratio is only 1: 5,000. The SMART PVD gives audible alertsof impending PPH.
• Accurate measurements: Current methods include weighing of soaked cotton and kidney dishes to determine blood loss. The SMART PVD includes a volumetric measurement device for accurate readings
• Sophisticated but simple to use: Other relatively accurate methods of prediction require laboratory techniques that are simply not feasible at lower level settings with limited infrastructure.

The SMART PVD provides efficient and timely measurement without complicated instrumentation, making it easy to instruct users in all regions of Uganda.

The Smart PVD is an early stage prototype that automates the process of blood loss estimation into a single unit comprised of the blood collection module and the blood sensor module in the delivery room.

The blood collection module, which comprises of an impervious polyethylene material whose properties improve the rate of blood collection into a collection pouch that filters blood of foreign material and clots as it awaits to be detected by the sensor. The blood sensor module utilizes a battery powered liquid level sensor to detect the amount of blood collected in the pouch and produces an audible alert that is based on the set threshold limits for defining onset postpartum hemorrhage. 

Our solution, the SMART-PVD is an improvement of the already existing under-buttock drape that has been widely used in India and in several parts of the world in blood collection and estimation. (https://www.researchgate.net/publication/38055080_Interest_of_using_an_underbuttocks_drape_with_collection_pouch_for_early_diagnosis_of_postpartum_hemorrhage) It operates as shown in the link.

The Smart PVD provides a simple, quick and accurate way to estimate blood lost after child birth. This device is comprised of a blood collection module that uniformly collects the blood lost and blood level sensor that detects the collected blood and produces an audible alert. This alert is perceived by the birth attendant as a signal for an intending postpartum hemorrhage (PPH) case. Our intermediate goal is to improve the timeliness of detecting PPH, which will in turn reduce the unnecessary delays in initiating treatment and resource expenditure in the labor room preventing complications and deaths related to postpartum hemorrhage that are a major contributor to maternal deaths in Uganda. This will in turn contribute to the long term goal of improving emergency obstetric care by meeting a key target of the Millennium development goals, which is reducing the maternal mortality ratio by 75%.  The device is currently under its early stages of development with a prototype under testing and development under the guidance of medical device regulators and obstetrics and gynecology experts from Mulago National Referral Hospital. This will help with building credibility with target users and in the long-run allow for user acceptance of the device by the users.

Currently as our solution is still in the prototype stage, we are not able to serve anyone. Our direct beneficiaries being the health workers. However, in one years time, we hope to have tested the device clinically on 70 women thus directly benefiting 10 health workers. Following successful results and launching out through the Ministry of Health in Uganda, we hope to have served and benefited 200 health workers in the country and beyond.

The SMART PVD is still a work in progress and requires rigorous testing before commercialisation. Our next steps within the next year aim at completing product development in order to achieve a minimum viable product that will be used to conduct a feasibility study in one high-volume health facility to ensure an evidence-based technology and further expand our reach to 5 health facilities through a pivotal study. We are currently developing partnerships with Uganda Industrial Research Institute and Experts from the Obstetrics department of the National Referral Hospital to expedite this  process.

Principality's mission is to support provision of high quality maternal and newborn care in Uganda. The goal for this device is to reach as many low-level health facilities that are burdened with many deliveries yet few clinicians with a tool that will drastically improve their work flow. Therefore, over the next five years, we aim to build partnerships with local manufacturing industries in order to have adequate supply of the SMART PVD to at least 100 health facilities that provide emergency obstetric care in Uganda.

To scale our solution locally, we will expand our network of supply through implementing partners in National programs on maternal health as well as build a distribution channel to government health facilities through the Ministry of Health.  We shall also support users by incorporating a training module that will have an effect on the outcomes of intended usage which will in turn improve the quality of care provided to mothers.

Economic barriers-capital is needed to finance product development locally, clinical trials and mass production once in the market.

Political barriers- This is in form of the weak medical device regulatory pathway as well as clinical trial pathway in the country which are crucial for transitioning of the device to the market.

Technological barriers- access to development technology, well trained and knowledgeable individuals is a local challenge and this is crucial to device development; copying of the device and producing it elsewhere is another technological barrier..

Threats to the device include copying, which we are barring against by applying for patent protection. Other barriers to entry include high costs of clinical trials and a poorly streamlined clinical trials pathway that some members of this team are working at aligning for several locally made devices to come. Local costs of production are low but national partnerships are crucial to our success.

The SMART-PVD team is a team that started off with the SMART PVD as a classroom design project. The team was later taken under mentor-ship and guidance by Principality Med Tech. Principality Med Tech is a limited by guarantee company focusing on translation research in medical devices targeting Maternal and Child health.

Full time staff - 3

Part-time staff -4

Local Industry Collaborators -1

International Collaborators- 1

Our team is made up of:

• Clinical personnel; an Obstetrician and a Midwife who provide the clinical guidance to the team; giving the team a user centred approach to the design
• Biomedical Engineers; The team has three biomedical engineers who provide the technical knowledge on the device improvements.
• Local Industry Collaborators; At the Uganda Industrial Research Institute who are responsible for the initial testing and development of the device
• International Collaborators; This is through Dr. Andrea Gobins who provides the translation knowledge to the team.

The SMART PVD team has partnership with four main organisations for mentorship on device development, initial pilot study and device production.

These are:

• Makerere University College of Health Sciences; Department of Obstetrics and Gynaecology for research guidance 
• Kawempe National Referral Hospital where we plan on piloting the device in the maternity labour ward
• Uganda Industrial Research Institute that will focus on initial development and testing of the SMART-PVD leading to a Minimum Viable Product.
• RICE 360 under Rice Institute for Global Health; This is through Dr. Andrea Gobins; the main focus is on guidance on medical device translation.

Our key customers and beneficiaries are:National Medical Stores; key suppliers of medicines and devices under the Ministry of health; Projects involved in Maternal and New-born health; Private health facilities with obstetrics departments; Medical equipment and supply companies; Pharmacies that supply medical devices and supplies; Non-Government Organisations seeking to procure quality maternal health supplies.

Our value proposition is such that we can overall provide affordable, efficient and safe Smart PPH volumetric drapes for accurate estimation of blood loss during delivery; Timely management of PPH in mothers during child delivery; Improved workflow for clinicians.

These benefits shall be provided for by conducting the following activities: Research and development to improve the product design; Extensive clinical studies and trails to improve efficiency, ensure quality and safety of product.

We shall access our customers through the following channels: Global distribution through our key partners (Makerere University and Ministry of Health key in research and development, clinical trails;Uganda Industrial research Institute key in the development of design of the PVD;Nice House of plastics key provider of raw material; Uganda National Bureau of standards and National Drug Authority regulatory authorities involved in product and package approval); Advertisement through our website; On-line markets such as amazon; Medical equipment/supplies companies.

At the end of this funding period, we hope to have obtained a Minimum Viable Product, clinically assessed through a pilot/feasibility study aimed at obtaining safety data. [Year 1]

The evidence from this pilot study will support the application for a larger pivotal study.

The results obtained from these two studies will overall build user confidence by justifying user safety and effectiveness of the device. 

 In addition, the team will ensure to begin setup of a manufacturing lab following the Good Manufacturing Practise guidelines obtained from the RICE360o Institute for Global Health bench marking through Dr.Gobin. 

This will hence allow for local large-scale local production. The market for the devices will be justified by the partnerships we intend to develop with the health workers, Ministry of Health and Non-Government Organisations.

 As a team, we aim at the SMART PVD saving the lives of mothers at birth as well as goal is to ensuring the birth attendant is able to provide the best healthcare services. While we have carried out iterations to our design and validated the functionality of its parts, we still need to bring it to the optimum standard of medical devices. We also seek to improve our business strategy and build our network of partners in this field. This is the foundation upon which we are applying to MIT Solve. Therefore, being apart of this year's Solve Challenge will expose us to a team of experts in maternal health, technology for health and business from the MIT Solve community that will help us improve our design and bring it to scale. This platform will enable us to meet potential partners and funders to enable our solution move forward to the next level.

• We would like to expand our network with more industrial and clinical mentors to provide guidance on how best we can optimize sensor technology for application in  the detection of postpartum hemorrhage
• We would like to increase our organization capacity by improving and gaining more  exposure in business strategy development
• We would like to acquire funding in order to launch our product and prepare for a pilot study across Uganda

We would like to partner with UN Women and other UN agencies, Non-Government Organizations, consumer companies involved in healthcare advancement, Foundations such as the Vodafone Americas Foundation, Bill and Melinda Gates Foundation and MIT faculty for the purpose:

• Consulting on product design and development
• Consulting on planning to scale and Business Strategy development
• Obtain grant funding to scale our solution

Everyday, over 800 women die globally due to complications related to pregnancy and childbirth. In Uganda alone, 15 women die everyday due to similar complications. Postpartum hemorrhage is major cause of among women in Uganda with 25% deaths. By improving the accuracy of estimation of blood loss, Principality aims at reducing postpartum hemorrhage cases by 18 -20% in Uganda. If awarded the Innovation for Women Prize, it will enable us accomplish the following work:

• Research and development to improve the SMART Postpartum Volumetric Drape
• Expand our partnership channels both locally and internationally to bring to scale our technology
• And finally to create awareness about postpartum hemorrhage and build the capacity of clinicians  through training on how to effectively use the device to improve service delivery and their work flow

Uganda, a low middle income country is still faced with shortage of health workers with only 1 doctor to 8,300 patients and a nurse to patient ratio of 6 per 100,000 patients. Mulago Hospital, the biggest health facility in Uganda receives over 30,000 deliveries yearly and yet the staffing needs range at a nurse to patient ratio of 1:5 to 1:10 which result into poor service delivery from time to time due to severe workload. Therefore by developing a the SMART Postpartum Volumetric Drape, Principality aims at utilizing technology to improve the workflow of birth attendants through making quick evidence-based decisions that will result in timely detection of postpartum hemorrhage. If awarded the Health Workforce Innovation Prize, it will enable us accomplish the following work:

• Research and development to improve the SMART Postpartum Volumetric Drape
• Expand our partnership channels both locally and internationally to bring to scale our technology
• And finally to create awareness about postpartum hemorrhage and build the capacity of clinicians  through training on how to effectively use the device to improve service delivery and their work flow

Everyday, over 800 women die globally due to complications related to pregnancy and childbirth. In Uganda alone, 15 women die everyday due to similar complications. Postpartum hemorrhage is major cause of among women in Uganda with 25% deaths. By improving the accuracy of estimation of blood loss, Principality aims at reducing postpartum hemorrhage through early detection of postpartum hemorrhage thus facilitating initiation of timely treatment to prevent death. This will save 1,600 mother and usd 15,000,000 on government interventions. If awarded the Bill & Melinda Gates Foundation Funded Award, it will enable us accomplish the following work:

• Research and development to improve the SMART Postpartum Volumetric Drape
• Expand our partnership channels both locally and internationally to bring to scale our technology
• And finally to create awareness about postpartum hemorrhage and build the capacity of clinicians  through training on how to effectively use the device to improve service delivery and their work flow