Students: Zelalem Ayalew, Cate Adams, Emma Clopton, Ava DeLauro, Isabelle Spirk, & Julie Wright

Case Study #1 On Ethical Decision-Making

Case prompt: While trying to develop a low-cost syringe for the developing world context, you (the designer) hit a cross-roads. Constructing the syringe to auto-disable after a single use, an important safety feature, significantly adds to the cost of the design – making it potentially unaffordable for some hospitals and clinics. However, if you don’t add the safety feature, you are enabling the potential for the spread of disease. How do you as a designer proceed?

Step 1: Determine the facts in the situation 

1. The auto-disable safety feature is important for minimizing the spread of disease 
2. The safety feature makes the product less affordable for primary stakeholders
3. Sometimes, syringes may be reused without a sterilization process
4. In developing nations, the likelihood of clinics having abundant access to syringes is less than in the developed world, increasing the chances of spreading diseases through reusing unsterilized needles. 
5. Some form of safety feature/indicator is needed to reduce disease spread and handle the drug properly.

Step 2: Define the Stakeholders – those with a vested interest in the outcome

1. Hospitals/clinics
2. Healthcare workers
3. Patients & their family members
4. Insurance companies
5. Designer & manufacturer
6. Regulatory bodies (FDA)

Step 3: Assess the motivations of the Stakeholders

1. Hospitals/clinics: provide quality care safely to the patient(s) that is still at an affordable cost to maintain operation of the facility. They are in need of an affordable device that delivers the medicine to the patient safely without compromising the budget & patients need to be able to afford the drug. 
2. Healthcare workers: Want to be able to provide the medication without running the risk of infecting patients through the reusing of needles.
3. Patients & their family members: The motive for both patients and their family members is simple: to get better and to see their loved one get better. Additionally, to be able to receive the medication without facing the risk of getting a new disease or worrying about a highly unaffordable cost.
4. Insurance companies: Ensure safety of the patients and also reduce liability on the company
5. Designer: Designer is looking to invest a lot of time and effort into the product to be as safe as possible to reduce any liability. However, if the cost of the medical device is too costly, the target market will be narrowed if people are less able to afford the medication.
6. Manufacturer: Maximize profit while ensuring that they are producing a safe option for people. Also, to minimize cost of production so margins are larger.
7. Regulatory bodies (FDA): Ensure that the approved drug is being correctly administered so there is no concern of new diseases spreading.

Step 4: Formulate (at least three) alternative solutions

Solution 1: Provide a how-to user guide for sterilization and/or disposal of the device

• Ethical Principle or code: care-based thinking, consequence-based thinking  
• Pros:
  • no need for an auto-disable feature, therefore removing the added expense
  • with no added expense, more patients will be able to access the medication
  • If just a sterilization process, needles can be reused which will create less waste

• Cons:
  • Instructions can be confusing;
  • You have to learn the proper way to manage post administration of the drug prior and have the tools to do so;
  • can be time consuming if patient urgently needs the medication;
  • Cannot ensure that steps will be fully followed

Solution 2: Add a user warning label that explicitly states that the drug device is single-use and must be properly discarded

• Ethical Principle or code: care-based thinking, consequence-based thinking  
• Pros:
  • no need for an auto-disable feature, therefore removing the added expense
  • with no added expense, more patients will be able to access the medication
  • reduce risk of disease spreading
  • no liability, discourages reuse

• Cons:
  • Can be easily ignored
  • Does not combat waste issue
  • still no disable feature if someone went to reuse the needle by accident
  • People still may be unsure as to how to properly administer/ handle after care of using the medication device

Solution 3: Develop the auto-disable feature

• Ethical Principle or code: duty-based thinking
• Pros:
  • Auto-disable to prevent reuse of needle
  • Lowers rates of disease spreading
  • Keeps patient safe and no liability on company
• Cons:
  • Expensive, making it difficult for some people to afford
  • Does not combat waste issue
  • Reduces target market
  • Some hospitals and clinics in developing nations will be unable to purchase the medication due to the expense, therefore not being able to treat patients properly
  • Additional training may be needed to learn how to handle to device — an added expense (both time and money).

Step 5: Seek additional assistance, as appropriate

As a designer who is responsible for developing a medical product that can either save or kill a patient in need comes  significant responsibility. You would want to create the best solution possible to meet the needs of as many people as possible without compromising their safety. By adding a warning label, you are able to keep costs low which allows more people and facilities to have access to the medication. Additionally, it is a seal that strongly encourages to immediately dispose of the needle after administration, reducing the risk of spreading other unwanted diseases. You cannot fully control what someone does, but putting a physical barrier in front of them to educate about the uncleanliness of reusing needles, it will greatly help communities and keep people alive.

Step 6: Select the best course of action

The best course of action is to create a physical indicator, such as an explicit warning label. This will reduce the cost of production substantially and while there is no disabling device on the syringe, it is strongly encouraged to not reuse the device. This will reduce the risk of diseases spreading and will allow more people to receive the medication worldwide. Still, because there is no training on the administration, there is still obvious risk that the syringe may be reused. However, it would not be the designer’s fault since the physical indicator would explicitly mention to only use the device once and to dispose of it.

Step 7: (If applicable) What are the implications of your solution on the venture.

The implications of the solution is that there is still an absolute chance of someone neglecting the warning label and reusing the needle, therefore increasing the risk of spreading disease. Additionally, only adding a physical warning label still does not address the waste issue at hand. Single-use medical devices create significant waste and can harm our environments. Lastly, there is no “training” of how to properly operate the syringe both during administration and after.