About PATH Medical Devices and Health Technologies
The Medical Devices and Health Technologies Program leads the vanguard in translating innovative ideas into breakthrough health solutions and tools. We accelerate global access to affordable and appropriate health solutions to protect and treat women and children. Contact us at firstname.lastname@example.org.
All too often in low- and middle-income countries (LMICs), medical devices and health technologies are inaccessible because they are too expensive or impractical for use in under-resourced health settings. We respond to these challenges and health system gaps by collaborating with partners and innovators to design, test, refine, introduce, and scale devices and tools with the potential to achieve unprecedented wins for health.
Together with our public- and private-sector partners, the Medical Devices and Health Technologies Program has investigated hundreds of innovations and advanced the most promising and appropriate technologies into affordable commercial products for use in country health programs and global health campaigns. Our work in devices and tools extends across four portfolios to address the diseases and health issues that disproportionately affect women and children in low-resource settings.
Medical Device and Health Technologies Program's global impact
We optimize, adapt, test, and validate emerging concepts, technologies, and product formats that optimize vaccine and pharmaceutical efficacy, stability, safety, and ease of use. We develop and qualify analytical assays to support development of stable vaccine and pharmaceutical products. Some examples of vaccine and drug presentations include oral liquid formulations, sublingual tablets, rectal suppositories, and vaginal inserts.
•Awarded the 2014 William Hunting Award for crucial work to develop a low-dose, heat-stable, fast-dissolving tablet formulation of Newcastle disease vaccine for backyard poultry immunization in LMICs.
•Developed and validated three novel assays to analyze components of a nonreplicating rotavirus vaccine (advancing to phase 3 in 2019). Collaborated with a manufacturer to accelerate the development of a safe, effective, and affordable vaccine to reduce the morbidity and mortality associated with rotavirus infection in infants and toddlers in LMICs.
Health Technologies for Women & Children
Innovative health solutions to address the leading causes of maternal and infant death. We advance medical devices and health technologies that address the primary causes of maternal, newborn, and child mortality and morbidity in LMICs and maximize public health impact by increasing availability and access to these innovations as part of integrated health systems.
Caya® contoured diaphragm—the first new diaphragm design in 50 years and now available in 44 countries, with more than 500,000 units sold from Kessel medintim GmbH.
LifeWrap non-pneumatic antishock garment (NASG): each can be used more than 100 times to help treat women with post-partum hemorrhage. 15,000+ LifeWraps have been sold by Blue Fuzion Group.
More than 20 million doses of 7.1% chlorhexidine digluconate for umbilical cord care distributed across 25 countries for use as an essential newborn intervention to help prevent cord infection and neonatal sepsis.
MSR SE200™ Community Chlorine Maker—an innovative, onsite chlorine generator for treating drinking water as well as preventing and controlling infections has been used in 40 countries.
More than 80,000 NIFTY cups in 40 countries—a feeding cup for preterm and other infants who cannot breastfeed, have been distributed by Laerdal Global Health as the Nifty Feeding Cup.
Packaging & Delivery Technologies
Improving the safety, acceptability, and effectiveness of immunization and drug delivery. We identify and advance primary packaging and delivery innovations for vaccines and pharmaceuticals that have the potential to maximize efficacy, increase access, and reduce costs.
•SoloShot™ syringe—the first commercially available autodisable syringe catalyzed a global policy shift in safe injection, and now more than 7 billion have been produced by BD.
•PharmaJet Tropis®—5 million needle-free syringes (and thousands of reusable jet injectors) and more than 4 million West Pharmaceutical Services, Inc., Intradermal Adapters have been procured by the World Health Organization for use for fractional dose inactivated poliovirus vaccine delivery.
•BD Uniject™ injection system—the system contains a small plastic bubble (reservoir), prefilled with a single dose of vaccine or pharmaceutical to effectively administer the drug without reusing the needle; more than 194 million have been distributed for use around the world.
Supply Systems & Equipment
Building stronger immunization supply and logistics systems to reach every child. We advance supply systems and equipment, policies, and programs to help to store, monitor, and transport vaccines at appropriate temperatures across the supply chain.
•Vaccine vial monitor (VVM)—a small sticker on a vaccine vial that changes color when exposed to heat over time, helping health workers know in a glance if a temperature-sensitive vaccine can be used. Temptime has produced 10 billion VVMs that are the standard for all UNICEF procured vaccines.
•Freeze-Safe vaccine carrier—the first vaccine carrier approved by the World Health Organization to prevent vaccine freezing during transport; the carrier's innovation protects vaccine potency and reduces health worker burden.
Our end-to-end product development: services from technology ideation to impact:
The Medical Devices and Health Technologies Program (MDHT) is a multidisciplinary group of approximately 60 public health researchers, clinicians, scientists, engineers, designers, health economists, project managers, and business strategists. We collaborate with innovators and can provide support at each stage of product development, and create incentives to lower the risk of entering developing markets for our private-sector partners.
Assessment: With country and global partners, we assess public health needs and identify strategies and technologies that can fill these gaps. MDHT teams have years of experience in conducting innovation landscaping, market, and technological assessments of cost-effective technologies appropriate for use in low-resource settings. We also use these assessments to build strategies and partnerships for further evaluation, manufacturing, commercialization, and introduction.
Technical research and development of products and product categories: Medical Device and Health Technologies staff develop, adapt, and advance innovations in-country and in-house at our state-of-the-art product development shop and laboratory. Our end-to-end development, from an idea to impact, uses our honed multidisciplinary approach and stays focused on solutions for the end user, and includes:
- Needs assessments, field testing, and clinical trials.
- Product design and development, using a holistic user-centered design process informed by human factors engineering standards and best practices.
- Market assessments, commercialization, program introduction, and regulatory strategies.
We conduct landmark research onsite in our Product Development Workshop and Research and Development Biotechnology Laboratory. PATH’s 5,000-square-foot Product Development Shop is divided into a machine shop, model shop, product and environmental testing bay, and a usability and focus group study room where our staff employ rapid prototyping techniques such as 3-D printing, fabrication, machining, and developmental and quality assurance. Our technical bench teams conduct in-house pharmaceutical sciences in our custom-built 5,000 square-foot, multipurpose biosafety level-2 isolation facility which is equipped to produce liquid, lyophilized, and spray-dried vaccine and pharmaceutical products at preclinical and pilot scale.
In multiple countries, PATH’s Living Labs Initiative accelerates the pace of health innovation by co-creating with users in a human-centered design process to rapidly design, test and scale solutions to their long-standing challenges.
Product accelerator: Our multidisciplinary teams provide tailored technical assistance at any stage of the value chain to social entrepreneurs and small-scale innovators wanting to accelerate the development, introduction, and scale-up of their high-impact health innovations. We have more than 40 years’ of experience in working side by side with partners and innovators in LMICs, building the expertise and local capacity needed to develop and introduce sustainable products.
Gap-filling technical support: For high-potential innovations being developed by industry, we can also fill the gap and provide technical support across the value chain, including user-centered product design, development, in-house and in-country testing, commercialization, and introduction.
Procurement and supply technical assistance: For more than two decades, PATH’s procurement and supply technical assistance team has worked with country governments and multilateral organizations to improve the quality, reduce the cost, and speed the delivery of essential health care supplies. Our efforts focus on strengthening human resources and systems, adhering to procurement policies and procedures, and fostering coordination of efforts so countries can more efficiently conduct future procurements and manage supplies. Additionally, PATH supports development of internationally-recognized technical specifications for medical devices. Our extensive experience in strengthening procurement and supply systems has helped countries ensure that health commodities are safe, effective, and available at an affordable price, enabling countries to get the maximum value from scarce health care dollars.
Strengthening innovation ecosystems: We work to create and enable a policy and regulatory environment that encourages the use of lifesaving technologies for low-resources settings. We do this through supporting effective innovation pathways at national and global levels; building capacity through guidance and trainings; and convening stakeholders for peer learning, alignment, and collaboration. By leading working groups, acting as secretariat, participating in technical advisory groups, and presenting at global health technology conferences, we help foster strong political champions and evidence-based policies that are critical to ensuring that health is within reach for everyone.
*Soloshot and Uniject are trademarks of BD. Tropis is a registered trademark of PharmaJet. Caya is a registered trademark of Kessel medintim GmbH. MSR SE200 is a trademark of Mountain Safety Research, a Division of Cascade Designs, Inc.
Leaders in Medical Devices and Health Technologies
Acting Program Leader & Portfolio Leader: Supply Systems & Equipment
Director of Finance and Administration
Dr. Patricia Coffey
Portfolio Leader: Health Technologies for Women and Children
Portfolio Leader: Packaging & Delivery Technologies
Dr. Manjari Lal
Portfolio Leader: Formulation Technologies
Product Development Engineering Lead
Functional Lead: Communications
Functional Lead: Commercialization
Dr. Mercy Mvundura
Technical Advisor Health Economics
MDHT Country Coordinator
Global Director, Living Labs, Center of Digital and Data Excellence
Dr. Jessica White
Functional Lead: Laboratory Science
Functional Lead: Procurement and Supply Chain Technical Assistance