Multiple Perspectives
Watch the following videos from the perspectives of various stakeholders in order to obtain a more complete understanding of the situation.
The Perspective of the President of the Company
1) As the owner of a medical device company, what do you believe needs to be considered in this situation?
2) How do you set priorities for each of the stakeholders involved in the decision?
3) How much influence do stockholders and investors have on your decision?
4) Who are the key people that help you make your decisions?
5) Do you have consultants or attorneys that support the company when legal issues are involved, and how are they involved in the decision-making process?
6) Are there guidelines or protocols in your decision process for initiating an investigation on a device and how do guidelines vary for smaller companies versus larger companies?
7) Are there guidelines or protocols in your decision making process for initiating production of a device at a particular point in time?
8) What FDA regulations do you have to consider and how much does the FDA affect the outcomes of production?
9) What are the possible repercussions of your decision? Is your job security a factor in any of your decisions to market a product?
The Perspective of the Lead Engineer
1) What is the protocol for manufacturing a new drug or device?
2) What are the main regulations you must follow in order to conduct clinical trials?
3) What are the steps to get approval on initiating the developmental process of a product?
4) What circumstances would prevent you from developing the drug or device you have been researching?
5) If something goes wrong along the development process, who must you collaborate with?
6) If something goes wrong before production begins, what are your options?
7) If an anomaly at the last minute occurs, what are some possible explanations?
8) Where do your priorities lie as far as saving lives versus production of a completely safe product?
9) Is cost ever an issue in developing a device, and if so, what are the factors involved?
10) Is cost ever an issue in researching possible adverse effects?
The Perspective of the Doctor
1) Who decides what products will be in the stocking room of a hospital?
2) For general products, what is the range of brand choice?
3) What is the protocol in choosing one product over another? Are there specific rules and regulations you need to follow? How explicit are these rules?
4) Do you interact with the company representatives or the FDA?
5) Are company representatives usually aware of the risks associated with their product, and if so, are they revealed?
6) When a product can potentially save a patient’s life, how do you know when the risks associated with that product outweigh the benefit of saving a patient’s life?
7) Do other doctors and hospitals affect your choice of which product or brand to use?
8) Do you seek advice on product selection and use?
9) Do you have any influence on whether a company markets a product?
10) How much blame do you get for device or product failure?
The Perspective of the Lawyer
1) What kind of lawyer would be involved in a situation like this?
2) What is your main role in handling this case?
3) Are you hired on a long term basis or as needed in special situations?
4) What rules and regulations are involved in marketing a product?
5) How explicit are the rules and regulations?
6) How do your personal and professional ethics play in your advice to the company?
7) What influence do you have on the company’s final decision?
8) What are the possible repercussions that can stem from the advice that you give the company?
The Perspective of the Ethicist
1) What are some possible stakeholders involved in this situation?
2) Is there any protection offered to those that are against production of an unsafe product?
3) What steps should be taken when extending research on a medical device before production begins?
Continue to #4 'Research & Revise'
 |
 |
 |
 |
 |
 |