Students: Cate Adams, Emma Clopton, Isabelle Spirk, Julie Wright (Southside Permaculture Park), Ava DeLauro, Zelalem Ayalew (ImmesED)

Ethical Decision-Making Methodology 

Case Study: While trying to develop a low-cost syringe for the developing world context, you (the designer) hit a crossroads. 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 – obtain all of the unbiased facts possible. Clearly state  the ethical issue. 

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

• Hospitals/clinicians, patients, regulatory bodies (FDA), insurance companies, manufacturers, the designer

• Patients & their family members because they are directly affected 
• Healthcare workers because they are directly involved in the administration of the drug
• Hospitals/clinicians because they are involved in the offering and admin of the drug 

Secondary Stakeholders: 

Step 3: Assess the motivations of the Stakeholders 

• Patient: Get better
• Hospitals/clinicians: Provide quality care safely 
• Regulatory bodies: Ensure safety and legality  
• Insurance companies: Ensure safety of patients; reduce liability on the company
• Manufacturers: Provide quality devices for user-friendly administration 

Step 4: Formulate (at least three) alternative solutions – based on information available, using basic ethical core values as guide 

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

• Ethical Principle or code: Legal

• Pros: No need for an auto-disable feature, therefore removing the added expense
• Cons: Can be confusing; you have to learn the proper way to manage post administration of the drug prior; can be time consuming; cannot ensure that steps will be fully followed; could be costly

Solution 2: Revise the design to be more affordable, collaborate with other manufacturers and explore other prototypes 

• Ethical Principle or Code: Consequence- based thinking
• Pros: Finding an affordable solution; will be easier for stakeholders to access the drug
• Cons: Could delay time in releasing the drug for public use

Solution 3: Add a user warning label that explicitly states that the drug device is single-use and must be properly discarded

• Ethical Principle or Code
• Pros: Does not substantially increase cost of production, lifts liability off the company’s shoulders
• Cons: Can be easily ignored, therefore increasing the chance of the syringes being reused. If syringes are reused, a disease could spread in communities that could have been avoided. 

Step 5: Seek additional assistance, as appropriate – engineering codes of ethics, previous cases,  peers, reliance on personal experience, inner reflection 

– Previous designs of other medical technologies that were made with safety features cost-effectively

– Insight from other designers 

– Insight from hospital staff regarding staff training 

– Ethics codes in healthcare administration 

– Insight to how the patients feel using the design 

Step 6: Select the best course of action – that which satisfies the highest core ethical values.  Explain reasoning and justify. Discuss your stance vis-a-vis other approaches discussed in the class

Solution 3 – Add a user warning label 

This solution makes it so that users would know that this is a one-time device. While it does not remove the threat of spread of disease, it decreases the likelihood. This solution also would be relatively cheap and quick to implement, meaning it would not affect the rollout of the product.

Step 7: (If applicable) What are the implications of your solution on the venture. Explain the  impact of your proposed solution on the venture’s technology, economic, social and environmental  aspects. 

-Would allow for syringe to be distributed faster

-Still poses a risk for spread of disease