Pacto Syringe

Telehealth, mobile health applications, and AI-powered diagnostic algorithms can address many needs related to assessing, monitoring, and diagnosing patients with rare diseases. That is far from the end of the patient's experience though - they need to receive and access the physical treatment needed for their complex condition(s). For those with rare diseases, this often means countless and frequent intramuscular injections and/or IVs to receive fluids, antibiotics, other medications, steroids, clotting factors, plasma, and more. This seemingly never-ending stream of injections and infusions is the norm for such patients whether they are hospitalized or not.

To administer these types of care, you need easy-to-use, safe, affordable, precise, sterile, and effective physical healthcare products. One of those frequently needed and used physical healthcare products is a pre-filled syringe. Pre-filled syringes have grown dramatically in demand for the purpose of delivering such treatments - from starting IVs to delivering injectable medications and therapeutics. In fact, over 7 billion pre-filled syringes are used around the world each year and the 8 billion dollar market for them continues to grow by 10% each year. Their popularity is due to their convenience, ease of use, sterility, and safety benefits for patients and providers alike. Pre-filled syringes are especially important and in demand for patients with rare diseases who need precise and sterile injections to appropriately manage their conditions while not leading to healthcare-associated infections.

Unfortunately, the current design for pre-filled syringes is not optimized or designed to have a small environmental footprint. Due to the bulky plungers which are almost fully extended, pre-filled syringes waste significant space, resources, effort, and money in the sterilization, shipping, and storing processes. Especially when supply chains are elongated and complex, this poor design leads to extra resource requirements and carbon emissions at each step. Not only are pre-filled syringes causing unnecessary environmental harm due to their plunger rod design, but these plunger rods - which are outside of the sterile field of these products - are also still made with environmentally harmful and unsustainable plastics, rather than biodegradable and sustainable alternatives. These facts make what is a highly desirable and needed product within the rare disease healthcare space also an environmentally unsustainable and harmful product.

Beyond the environmental impact of pre-filled syringes, their bulky plunger rod design also leads to increased supply chain costs which are passed down to patients. This often results in low-income populations with rare diseases in low-resource and remote settings not having access to these products. The alternative is drawing up solutions from vials, which can lead to cross-contamination, accidental needle sticks, wasted medication, wasted supplies, delayed administration, and/or inaccurate dosing. These challenges put the health and safety of patients and providers at risk. Therefore, the status quo leaves those with rare diseases in low-resource contexts who could benefit the most from fast treatment delivery, reduced healthcare-acquired infections, and even at-home self-treatment, without this beneficial technology. This negatively impacts the rare disease patients' experience, adds financial burdens, and is a critical health equity issue.

We have invented a collapsible and resource-saving pre-filled syringe design with a 40% smaller packaging footprint relative to traditional pre-filled syringes. This was done by redesigning the plunger rod and assembly and nesting it alongside the syringe barrel. During transport, the syringe barrel and plunger rod assembly remain compactly attached to one another. When it is ready for use, the user can easily detach the plunger rod from the syringe barrel and reassemble the plunger rod with a quick and easy quarter-turn or press-fit into where it is traditionally attached. A product demo video of one of our attachment designs is available here: https://youtu.be/DIe2pPA5VQg

Due to our 40% smaller packaging footprint, we can fit 7,000 more pre-filled syringes on each pallet than the current design can. This leads to significant reductions in cost when it comes to sterilization processing, shipping, and storage. We have estimated that our solution results in a reduction in supply chain costs of 35%. In the case of many low-resource areas where the place of manufacturing is often even further away from the point of use, these savings in transport costs are magnified even further. With our design, providers and patients at the end of the supply chains can therefore access the benefits of pre-filled syringe technology for a more affordable and less economically burdensome amount.

Crucially, due to the smaller packaging footprint, our solution also dramatically reduces the carbon footprint of shipping these medical products around the world. To demonstrate this, we can think of the current number of pre-filled syringes used around the world being shipped across the Atlantic Ocean in the current form versus the Pacto Syringe form. In this case, the Pacto Syringe form would use 14,000 fewer 40ft shipping containers and emit far less carbon in the process. In fact, using the Pacto Syringe form for that trip alone would save the equivalent of planting over 5,100 football fields of forests. Options to manufacture the newly redesigned plunger rod and assembly with sustainable and biodegradable materials further magnify the positive impact of the Pacto Syringe. 

Overall, our design saves supply chain costs, reduces environmental impact, and makes it easier to get more pre-filled syringes to more rare disease patients around the world. This is especially the case in low-resource, fragile, complex, and emergency settings where supply chain challenges, costs, and bottlenecks are abundant and resources such as transport, staff, and funds are low.

Patient: These are patients with rare diseases, especially those living in rural and/or low-resource settings where access to physical healthcare products and services is extremely limited, expensive, and unreliable. Expensive healthcare costs are a burden for them, they need their treatment to be delivered safely and quickly, and cannot afford to deal with the costs or challenges associated with HCAIs. For these patients, the Pacto Syringe offers high-quality pre-filled syringes and products often needed for their treatment at a reduced cost. These pre-filled syringes are also available more often due to their reduced cost for the procuring groups and because each box now carries far more doses so there are fewer supply chain backlogs and bottlenecks. These pre-filled syringes also deliver these patients safer and more sterile treatment compared to the alternative of a healthcare provider drawing up doses of medication or solution from a vial outside of a sterile manufacturing plant. This means the patient will experience fewer HCAIs. In many cases, patients may be trained to take extra injections home so they can administer their treatment at home. This is because injecting with a pre-filled syringe is easier and does not require much training. For the patient, this would mean less time spent in healthcare settings and more time in the comfort of their own home.

Healthcare professionals: These professionals' time, health, and safety is of high importance. The Pacto Syringe allows them to have improved access to pre-filled syringes. Such syringes make delivering treatments faster, easier, and more convenient, saving them time and frustration when compared to the vial method. In addition, as pre-filled syringes avoid the step of drawing up solution from a vial, there is reduced interaction with needles per medication administration, which reduces the chance of accidental needle sticks and occupational injuries for these providers. With the Pacto Syringe, these providers can deliver better quality care that is faster, easier, more convenient, more precise, and safer for all involved.

Payer: These funding and procuring organizations are varied in type, but all have finite budgets and are working to provide the most and best care for the least amount of money. The Pacto Syringe allows them to stretch their budgets further while offering them access to pre-filled syringe technology and improved associated care and patient outcomes.

Planet: This group encompasses everyone living on our planet, but especially those living in low-resource settings who are disproportionately negatively impacted by climate change. For them, we offer a solution that allows healthcare delivery to improve and continue, but with a significantly reduced environmental footprint.

Current syringe manufacturers and suppliers are not incentivized to optimize products to have the lowest possible environmental impact. This is because this R&D work is challenging, time-consuming, and needs to be done hand-in-hand with the product user communities. As the design for commercially available pre-filled syringes has remained stagnant for far too long, it is clear that a passionate and grounded team from outside of the commercial sector is needed to create and propel a feasible solution for these challenges.

Our background includes medical logistics, supply chain management, public health, direct patient care, product management, human-centered design, and engineering. One of our founders and CEO has spent over 10 years physically delivering healthcare in a variety of settings around the world. He has also spent over five years working in medical logistics, supply chain system strengthening, and public health management in these settings. During his career, he has lived and worked closely with communities and professionals impacted by the challenges we have discussed in our application, including in Liberia, Tanzania, and the Bahamas. Throughout his education, including his Master of Public Health, he has concentrated on ethics, human rights, technological innovation, and the decolonization of healthcare. He is joined by two other founders who have extensive experience in human-centered design, user interviewing, and product co-designing.

Community and user input and co-design is at the center of our process and solution. We have co-designed, tested, and validated each iteration of our design with healthcare, supply chain, logistics, and humanitarian experts from around the world. The communities and experts engaged live and work in countries including Nigeria, Argentina, South Africa, Liberia, Kenya, Tanzania, Ghana, the US, Germany, Canada, the UK, & Australia. We consistently work with these users, communities, and stakeholders and they have been engaged with from the initial concept through 3D-printed model testing. We intend to continue to speak and work with other communities, users, and experts from around the world and have launched a survey to gather a larger and broader set of input and opinions on our idea and design. With sufficient funding, we will also complete test tooling and test product runs to then use in user focus groups and interviews. It is our priority to not be extractive of such communities and user experiences and knowledge, so having funding to appropriately compensate such stakeholders and communities for their time and contributions is crucial.

We have 3D-printed models of our design and have tested them with users and stakeholders in the relevant supply chains and care networks. We have also completed renderings and space-saving calculations using CAD software. While our product is not yet serving people and is not commercially available, we are beyond the concept and idea stage.

Funding is our key constraint at present and the $150,000 grant would propel us through the remaining key steps of our pre-market journey and ensure we can develop and deliver a ready-for-market product to fit the needs of those in the rare disease healthcare space. With sufficient funding, we will 1) complete test tooling and test product runs to then use in user focus groups and interviews; 2) secure our US utility patent; 3) submit our PCT patent application; 3) map and complete our regulatory journey, including 510(k) approval; and 4) launch a pilot test manufacturing run with a strategic manufacturing and distribution partner. 

It is our priority to not be extractive of communities and user experiences and knowledge throughout this R&D process, so having funding to appropriately compensate such stakeholders and communities for their time and contributions is crucial.

In addition to the funding support, we hope and anticipate that being a part of the MIT Solve community and presenting in front of distinguished judges and thought leaders in this space will also provide us with access to:

Monitoring and evaluation support: As we continue and expand our user testing and focus group work, we would highly value monitoring and evaluation support so we can track, document, and analyze the results of this work.

Legal support: We are looking for support as we secure our IP portfolio with a US utility and PCT patent application. We are also looking for legal and regulatory advice regarding our best pathway to regulatory approval as a class 2 medical device.

Strategic support from peers and experts: We are looking for strategic support and advice navigating the SBIR process to help fund test tooling and manufacturing runs. We have a lot to learn and gain from connecting and speaking with other MIT Solve teams and experts so we can avoid potential pitfalls and keep moving forward.

Marketing and exposure: Visibility and exposure to potential users, manufacturers, and investors is crucial to help us continue to grow and stay on an impactful and fast track for our solution.

Our team lead's background includes medical logistics, supply chain management, public health, direct patient care, and medical device R&D. Ian has spent over 10 years as an EMT physically delivering healthcare in a variety of settings around the world, including in partnership with patients impacted by rare diseases. Much of this work has occurred in humanitarian and disaster settings during which patients with rare diseases are particularly vulnerable and at risk. He has also spent over five years working in medical logistics, supply chain system strengthening, and public health management in these settings. During his career, he has lived and worked closely with communities and professionals impacted by the challenges we have discussed in our application, including in Liberia, Tanzania, and the Bahamas. Throughout his education, including his Master of Public Health, he has concentrated on ethics, human rights, child protection, technological innovation, and the decolonization of healthcare. He is joined by two other founders who have extensive experience in human-centered design, user interviewing, and product co-designing.

We have a novel and patent pending design for a compact pre-filled syringe with dramatic and documented space-saving features. We have had the time, space, and sector-relevant expertise to design and pilot this invention in an unconstrained start-up environment where we can think and act outside of the corporate box and structure these companies are burdened with.

We aim for our invention to push the large players in the existing pre-filled syringe market into needing to think about and act on the environmental, patient, supply chain, and health equity challenges we have described in our solution. If we or others in the market begin offering the same type of product at a reduced cost and environmental impact for consumers and open up new markets that were previously inaccessible due to supply chain and cost constraints, existing players will start to lose market share. When they experience this, they will either need to come on board and license or buy our solution which solves the challenges we have outlined. 

At a larger scale, this space-saving innovation should light other fires in the heads of other innovators and medical device and supply manufacturers so they bring this similar mindset to other products. Our product is just one of many medical devices and supplies that could be optimized to save space, be cheaper, more sustainable, and more accessible for patients and providers. Hopefully, this innovation will be the start of other changes in the medical product space, which will amplify our impact.

1 year: Test tooling and initial test manufacturing run of Pacto Syringes completed. Further testing with stakeholders, users, and communities that will be impacted and served by this solution also completed. US utility patent and PCT patent applications filed. The top plunger rod and assembly designs are finalized. The top sustainable and biodegradable material for the plunger rod and assembly design is finalized.

5 years: Solidified partnerships with pre-filled syringe manufacturers and regular manufacturing runs of Pacto Syringe components for integration into at least 500,000 pre-filled syringes each year.

Our solution addresses the following UN SDGs: 1. No poverty. 3. Good health and well-being. 9. Industry, innovation, and infrastructure. 10. Reduced inequalities. 13. Climate action

We are measuring our progress toward our impact goals in the following ways:

1) Percent of funding raised to enable test tooling and initial test manufacturing run of Pacto Syringe (%). Goal: 100%. Current progress: 25%.

2) Number of individual potential users, community members, and stakeholders engaged and meaningfully consulted and interviewed (#). Goal: 100 by year 1. Current progress: 45.

3) Solidified partnerships with pre-filled syringe manufacturers (#). Goal: 2. Current progress: 0.

4) US utility and PCT patents filed and accepted (yes/no). Goal: Yes. Current progress: no (US provisional patent submitted).

5) Number of Pacto Syringe components manufactured each year (#). Goal: 500,000 by year 5. Current progress: 0.

Activities: 

Work with and listen to relevant communities, users, and stakeholders about their experiences (focus groups, observation, interviews, and quantitative data collection). 

Join accelerators, venture programs, and take part in networking opportunities with other social impact innovators and entrepreneurs.

Co-design prototypes and 3D printed designs of Pacto Syringe for testing.

Solidify intellectual property portfolio by obtaining US utility and PCT patents.

Outputs: 

Identify challenges, needs, and wants relating to the challenge of accessing physical healthcare treatment components (specifically pre-filled syringes) for rare disease patients and providers, especially those in low-resource settings.

Obtain funding to support test tooling and test manufacturing runs, as well as to compensate interviewees appropriately. 

Learn from experienced innovators and entrepreneurs to document and avoid potential pitfalls, issues, and mistakes.

Establish networks and make connections with key players in industry, healthcare organizations, and humanitarian groups who are potential partners.

Refine prototypes and 3D printed designs of Pacto Syringe with stakeholders.

Intellectual property protected.

Conduct pilot testing with one manufacturer and a limited number of health facility sites for proof of concept and further feedback.

Short-Term Outcomes: 

High-fidelity prototype and tooling established that meets the needs and wants of the communities, stakeholders, and users this solution aims to serve.

The financial runway to continue to develop and launch the Pacto Syringe is secured.

Pre-filled syringe manufacturers want and need to establish relationships with Pacto Medical to roll out and make this solution commercially available.

Pacto Syringe is commercially available for purchase at a reduced price compared to current designs.

Long-Term Outcomes:

Expanded access to safe, effective, convenient, fast, and easy-to-use pre-filled syringe technology at a reduced price.

Pre-filled syringes are more readily available to those in the rare disease space, especially those in rural and low-resource settings around the world.

Reduced environmental impact and footprint within the pre-filled syringe and rare disease healthcare space.

Reduced healthcare-acquired infections during rare disease healthcare treatment, especially in low-resource settings around the world.

High-Level Goal:

Improved equitable access to morbidity and mortality-reducing pre-filled syringe products for rare disease patients, all at a significantly reduced environmental impact.

The core technology of the Pacto Syringe is a cleverly designed plunger rod and assembly that has geometry that allows it to store and ship securely on the side of the syringe, contains a permanent locking mechanism, and features a thumb depression area. The plunger rod and assembly can also be constructed with sustainable and biodegradable materials instead of traditional plastics.

Our packaged product contains a plunger that is attached to the syringe body in two different places. At the syringe tip, the plunger wraps around the Luer Lock area and snaps securely to provide a strong connection that prevents damage in transport. The shape of this snap-fit has been designed to also be a thumb depression surface for when the syringe is being used. The opposite end of the plunger has been designed to be inserted into the stopper component and permanently lock into place. This end is also designed with a locating feature at the tail end of the syringe to hold it in place during transit.

One full-time and three part-time staff.

1.5 years.

Our founding team started off as a homogenous group of white cis-gendered men with existing connections to one another through school and business. As the venture has grown into a full-fledged venture, we have focused on becoming a more diverse, equitable, representative, and inclusive team. 

As part of this, we have connected with and established various advisors from across the world that we work with, keep in touch with, and learn from and with. These advisors bring a wide variety of backgrounds and are from different countries, have different experiences, and educational backgrounds. This group is also made up of a variety of different races, ethnicities, cultures, religious groups, sexes, genders, and sexual identities.

At the same time, we have intentionally and regularly co-designed with, interviewed, and worked with stakeholders, users, and communities from across the world. They also come from a broad variety of backgrounds and have a wide range of social, cultural, and identity-based human attributes. It is our priority to not be extractive of such communities and user experiences and knowledge, so having funding to appropriately compensate such stakeholders and communities for their time and contributions is crucial.

We are also welcoming in part-time fellows moving forward to work with us and we are aiming to compensate them appropriately, as allowed by our funding. These fellows will bring more diversity and different experiences and backgrounds into our venture on a regular basis.

Finally, we are also working with a DE&I advisor and expert consultant at Harvard University who is supporting us in our mission and goal to become a more diverse, equitable, representative, and inclusive team. 

Our key customers and beneficiaries include patients, healthcare providers, payers/procuring entities, and the planet.

We provide them with equitable access to high-quality, effective, safe, affordable, convenient, fast, easy-to-use pre-filled syringe solutions. These solutions hold the ability to provide morbidity and mortality-reducing medical treatment in less time, for less money, at a reduced environmental impact, and with improved patient and provider safety.

We will do this by establishing and protecting our unique Pacto Syringe and then manufacturing and selling the components to existing pre-filled syringe makers and manufacturers. They will then integrate these components into their different pre-filled syringe solutions. Given the reduced packaging footprint of these solutions, payers, procurers, and consumers will then be able to access these at a reduced transport cost and receive more per box, thus reducing supply chain hurdles and bottlenecks.

For our initial startup and prototyping expenses we are using non-dilutive grant funding from venture programs, accelerators, and pitch competitions.

For our test tooling, test manufacturing runs, and pilot testing, we plan to continue to use such non-dilutive funding opportunities as well as apply for an SBIR grant.

For initial full manufacturing runs, we plan to open up to angel investors and venture capital for funding in exchange for a small percentage of our equity. We are also open to and exploring opportunities to do further pilots with NGOs and charitable groups, if funding allows.

After the initial full manufacturing runs, we plan to use the revenue to continue manufacturing runs with outsourced manufacturers. As we have not taken on debt, we will be able to continue to turn profits around into increased manufacturing runs without taking money out of the business.

As the global market for pre-filled syringes is massive and growing, we anticipate being able to capture enough of it to start with our initial manufacturing runs and get our foot into the door of this market. For perspective, there are an estimated seven billion pre-filled syringes manufactured globally each year, and this number is growing rapidly. The global prefilled syringe market is projected to grow from $7.51 billion USD in 2022 to $15.20 billion USD by 2029, at a compound annual growth rate of 10.6% during this period.

So far, we have not taken on debt and are cash positive, though we are working part-time on this project as we have not raised enough money to step away from our full-time jobs yet. We have not given away any equity in our company so far.

So far we have secured non-dilutive funding from:

Harvard T.H. Chan School of Public Health - Public Health Innovation Award: $1,000

Harvard Innovation Labs - Spark Grant 1 of 2: $250

Harvard President's Innovation Challenge - Ingenuity Award: $2,700

Dartmouth College Entrepreneurs Forum - 2nd place and People's Choice Award: $12,500

UMass Lowell Innovation Hub/Clean Green Challenge - 1st place and Best Business Plan Award: $4,000

Harvard Innovation Labs - Spark Grant 2 of 2: $2,000