Stanford Biodesign Ethics Case Studies
Stanford Biodesign Ethics Case Studies
1. What are the potential consequences of the product’s malfunction: on patients; on XMed’s
reputation; on your responsibility for the product?
The reputation of XMeds depends on a number of factors, including ensuring that the business delivers on its promises to customers and vendors. Being transparent, trustworthy and responsive are essential to the survival of XMeds. Bad word-of-mouth, lack of response to a crisis, and lack of transparency can rapidly decimate the reputation of any company, so it is essential that XMeds are fully compliant with all the quality and design control systems along with the product specifications laid out within the business case.
XMeds Reputation is a risk and should have been identified within the risk management register along with Operational, Strategic and financial risk. A company’s reputation matters along with the brand there are selling the damaged caused will not just be felt finically the most damaged caused will be lack of trust from the public as there will feel betrayed and once the trust has gone it will be very difficult to regain the public’s trust again, this is what makes the difference to success or failure. The reputation of XMeds could also be affected with the Wholesalers and possible the retail stores.
While the product was identified at low risk, this does not remove the obligation from XMed project team to ensure that the product is fit for purpose and has followed the policies and procedure set out by the FDA design controls. There is still the ethically issue to address before putting a product in the market that may injury a member of the public. XMeds reputation and brand reputation are as important as each other so releasing a brand to the market that XMeds no is not 100% backed by all the safety systems in place could lead to legal issues. Patients that take the product are expecting it to help in any recovery not potential set the recovery back due to the products malfunction.
XMeds have a legal duty of caution and prudence ensuring that the product is safe and does not pose a hazard to the public. Since XMeds could foresee a potential issue with the product they are responsible for attempting to minimize the harm. Failing to warn the patients of a product that has not fully been tested as per the FDA design controls is your duty.
2. What are the potential consequences of your actions on your role/reputation/position in XMed?
There are several potential consequences in XMeds on all staffs including the top and lower management. The release of the product without a final testing may lead to its failure when it is introduced into the market. So, there is a potential threat to the XMeds reputation that can lead to the loss of their potential clients. The Lead Product Development Engineer will be in the spotlight since he is the one coming with the design models and development of the product. As such, all the faults will be levelled against the Lead Product Development Engineer since he was responsible for testing the product until the final touches before releasing to other departments. The advice being given by the Project Manager on ignoring the approval by the company may lead to his firing since he was going to break the sensitive policies of the company. It was unethical to sign the PRA without the approval of the company. Among other possible consequences apart from being fired is that the company can take legal actions including suing the Lead Product Development Engineer for authorizing the release of unfinished product to the market, which may cause harm to the company’s reputation.
3. What would you do? What are your options?
I would work on my own and send an email to the relevant departmental heads requesting more time to complete testing the products. I will put on hold the authorization of the product since it would be unethical to do what is wrong to satisfy the Project Manager. As such, I would put the company’s interest first before any other employee since Keith was carrying out the responsibilities of supervising the project. Another option could be requesting the urgent meeting to brainstorm together instead of confronting other staff members during their busy days.
4. How do you assess the issues you were concerned with at CNA?
I would ask for more time to go through the documentation to be sure there are no pending concerns. Seeking the required resources including more time and energy would help in making a successful assessment. Since other professional staff in the project were busy, I would be personally responsible to seek all the content of the documentation and rectify any potential error.
5. Should you escalate your concerns to Keith’s boss?
Some concerns are so critical that the potential problem it could cause you with your boss is outweighed with the potential risk to the patient. You have an obligation to inform someone of the situation you are facing. In this case all the testing had been completed successfully and there were no glaring omissions, the issues are the final design phase documentation has not correctly been followed as per the quality plan that states “each design review requires approval by XMeds representatives”. After reviewing all the information, test results, reports and discussing the situation with all parties I am confident as I can be that the product is safe for commercial distribution but would like to ensure that the procedures which were put in place to safe guard the public and XMeds should be followed. In this case I don’t feel it necessary to raise this to Keiths boss but I believe it needs to be documented in the daily log and risk register to ensure it is captured and resolved going forward.6. Whom can you turn to for advice?
I would seek advice from the top management using emails and copying the Project Manager in order to avoid any confrontation with Keith for the safety of the project. Seeking advice from the company’s top management would be the best way to solve the issue in order to creating awareness about the problem to the company to avoid future consequences. It would save me from any blame in case the product fails in the market. Moreover, alerting the Keith’s boss about the anomalies may also draw the right path on whether to sign it or not even before the approval of the company’s representative. Therefore, seeking advice from top management team would provide me to solve the pending issues in order to work honestly and professionally as required by the company’s rules and regulations. Lack of assistance from other colleagues also influences the needs to seek advice from the employers to avoid any blame for my position.
Stamford Biodesign. Ethics Case Studies: To Release, or Not to Release: An Engineer’s Perspective. Web. 2010. Accessed April 29, 2015. <http://biodesign.stanford.edu/bdn/ethicscases/EthicsCase21.pdf >
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