By Noah Weaver

1. Facts:

• single-use feature is incredibly important to preventing further spread of disease
• auto-disable feature significantly adds costs to producing the syringe
• without the auto-disable feature, it is a near-certainty that the problem will be made worse compared to doing nothing at all
• if the auto-disable feature is made without any other caveats, the target market the syringe was meant to help will never reach them

2. Stakeholders:

• Investors
• Company
• Designer (myself)
• Hospitals, clinics, PHUs
• Healthcare workers (e.g. doctors, nurses, CHWs)
• patients

3. Motivations of stakeholders:

• Investors have two relevant motivations: the first is that they get a return on investment (financially). They want to know that they are contributing to a venture that they can also succeed from. The second motivation is a reasonable return of investment from a social/health perspective. Considering that they are investing in a technology for an LMIC, it is highly likely that they also care about the impact of the syringe itself on the health crisis. They also would like to broaden their impact by making such an investment, and would hope to continue making world-changing investments going forward.
• The company producing the syringes also have it in their best interest to produce high-quality syringes at an affordable price. They are motivated to do this most likely because they would like to stay in business, keep their employees employed, and potentially expand operations so they can sustain themselves. If the product is not successful, they will all be out of jobs (this is an especially powerful motivator).
• As the product designer, my primary motivation is to solve a complex issue to the extent possible because of the immense responsibility associated with my design. My product design will literally influence whether millions of people live or die. Knowing just how many people’s lives depend on my decision-making/design, I must do the best job possible within the context of an LMIC (that is, if I want to sleep at night considering that I have a conscience).
• The hospital, clinics, and PHUs and healthcare workers want to have a successful syringe because they are the ones who directly treat patients in their communities. They each have a powerful incentive to use an affordable, high-quality syringe because of the need to maintain their reputations, provide a welcoming environment for their patients to receive treatment, and, perhaps most importantly, because they must live with the consequences of the disease. If the disease becomes to rampant, then they will suffer with their patients, become overwhelmed, and risk exposure to the disease to themselves and their loved ones in the process.
• The patients have their health to motivate them to receive treatment. The syringe must be low-cost enough for the common person to afford its use, but quality enough for them to maintain their health.

4. Solution A: Allow the syringe to go to market without the auto-disable feature. This solution makes the syringe affordable for LMICs, and it puts accessibility at the forefront of the decision-making process. Accessibility to healthcare is especially important, because I believe that healthcare should be a basic human right, not a privilege. For example, I see many patients at the hospital I work at that bring up their primary concern for treatment as “how am I going to afford this ER visit?” This is a valid concern because people are often left choosing between food, medicine, and shelter. However, the decision to let the syringe go to market without the auto-disable feature is potentially more dangerous than not allowing the distribution of the syringe to begin with. It is well-documented in the literature that syringes are reused in LMICs. As a result, the disease may spread more rapidly. This option is incredibly unethical because it breaks the basic principle that all medical practitioners need to adhere to: do no harm.

Pros of Solution A:

• accessible
• low-cost

Cons of Solution A:

• very dangerous/near certainty for the spread of the disease
• unethical

Solution B: Allow the syringe to go to market with the auto-disable feature. This puts patient safety as the highest priority, which should (generally) always be the primary concern in a healthcare setting. However, the problem with this option is that the communities the syringe is aimed at helping will never see the syringe, to begin with. As a result, it is pointless to make the syringe. If the syringe cannot be used by the target market, is there really much of a need to produce the product? The answer is no. Although this option aligns with the statement of “do no harm”, it is also not helpful for the problem we are attempting to solve.

Pros of Solution B:

• safety is at the forefront of the design
• makes it impossible to reuse syringes, thus avoiding further spread of the disease (inadvertently)

Cons of Solution B:

• too expensive to reach LMIC target market
• syringe is useless before it is even sold: if the target population can’t afford to use it, then it won’t be used at all
  • this is as if nothing was done to control the virus to begin with

Solution C: Find a middle ground by producing the syringe with the auto-disable feature and providing financial incentive for the return of used syringes to the manufacturer. This option would likely accomplish our goal while meeting the needs of all stakeholders: we can produce a syringe that does not sacrifice quality, that is safe for patients (and guarantees this), and is affordable/accessible by LMICs and those in the target market. By choosing this option, we acknowledge that no solution is perfect, but this is likely the best way forward within the constraints of the setting we are working in. The primary con associated with this option is that the syringe is still more expensive than it would have been without the auto-disable feature, but producing the syringe without such a feature is highly unethical and unsafe.

Pros of Solution C:

• sustainable/cradle-to-cradle design
• safe
• low-cost
• accessible

Cons of Solution C:

• more labor/logistically-intensive to incorporate a syringe return program
• will likely still be more financially expensive than the syringe without an auto-disable feature at all
• although it will likely be much more accessible than distributing the syringe with only the auto-disable feature, it could still be too expensive for some PHUs to afford

5. As mentioned above, the literature provides an abundance of evidence showing that syringes without an auto-disable feature are reused inappropriately in LMICs. In order to make the best decision, it is imperative that we put patient safety at the top of our priority list while simultaneously considering what is practical in the context of an LMIC. Again, healthcare should be a basic human right, not a privilege. Making the syringe affordable is essential to making the product accessible by all and leaving the greatest impact.

6. The best option is Solution C. This satisfies the highest set of ethical values because we do not sacrifice accessibility, patient safety, affordability, or product quality. Another option my group discussed was distributing the syringe without the auto-disable feature AND investing in education for both healthcare providers and patients. However, we felt that this option was not appropriate because it cannot guarantee that the syringes will not be reused. As mentioned above, Solution C is far from perfect/ideal, but it is likely the most realistic option that will satisfy the needs of all stakeholders and our ethical principles. This minimizes the financial burden on the target market without it being at the expense of patient safety. Please see Solution C above for the detailed pros/cons showing the maximization of benefits and minimization of risks.

For further evidence, please see this article at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3567947/

-the article at the link above discusses the (mixed) but generally positive impact of needle/syringe return programs in LMICs.

7. The solution chosen will provide an affordable syringe that does not harshly burden the economic needs of its target market. It will allow for the containment of the disease with a high-quality technology that is both safe and effective. From an environmental standpoint, this is also ideal because it significantly heightens the ability of the manufacture to recycle used syringes and dispose of any materials that cannot be reused in an appropriate manner. Otherwise, there is a very real chance that the syringes will end up in landfills and other areas that are harmful to the environment. Above all else, this is a socially valid way to contain the disease because it is the right thing to do. This solution does not allow for harm to patients and allows people to maintain their health simultaneously.