If the project management team also handles risk management, there will be no room for miscommunication that can occur between two separate departments. Also, the project management team may set more realistic deadlines and put more research into the risks of implementation at the very start. If there is a strict project boundary, the project…[Read more]

Other aspects to consider during the planning phase include the meeting stakeholders’ expectations, incorporating inputs from customer surveys, and allotting time for any changes that may be made to the original design. The planning team should outline how they can meet the requirements of the stakeholders within their desired time frame.…[Read more]

The design input should be a collaborative effort between the initiating process team, customer support, and stakeholders. Input from the customer support department is required to state the needs of potential users, in order to fix any shortcomings of the previous products and prevent commercial failure. The stakeholders will set their…[Read more]

While I have yet to work in industry, I am most interested in the initial product design/planning phase that includes determining spec and coming up with a new design that combats the problems of existing products. However, I think I would need to have experience working in the verification stage first, in order to fully understand what it takes…[Read more]

If the labels kept falling off to the point where customers were filing complaints, the products should definitely be recalled. Even if the product had no other defect and was in perfect working order, the instructions and warnings on the labels are crucial especially when dealing with materials that may cause harm. For example, in a lab setting,…[Read more]

I believe it depends on the resources available and the size of the company. Larger companies like Stryker typically have the resources to hire more employees on lower priority projects. This will increase the expenditure, but wasting resources on lower priority projects that ultimately yield no results due to lack of proper funding contributes to…[Read more]

Verification should be considered continuously during the design process, especially since successful verification often takes more than one attempt. It includes designing the set of experiments to physically test the product, and making sure the output matches the input(ex: in spec). Validation can only come after verification (if validation is…[Read more]

After determining the main problem that needs to be addressed, or the new product the team wants to create, team members should do more research on solutions/options already available to the public. They should discuss the shortcomings of those existing options and why their proposed product will be more effective. Then the costs (time and money)…[Read more]

Building a proper team is crucial since projects require the cooperation of each member in order to facilitate and expediate completion. If one member refuses to communicate any obstacles, or open up to different solutions offered by the group, there will be a lot of time wasted on disputes that yield no results. The group should comprise of…[Read more]

The classification system for medical devices, according to the FDA, is based on risk of failure when used or implemented. Class 1 being the least invasive or safest(such as tongue depressors), class 2 having moderate risk(or having a similar FDA approved product on the market already), and class 3 having the highest risk with a novel approach.

The company will have to weigh out the risks and benefits of continuing the project. If the idea is completely novel and backed up with successful clinical trials, the project should not be dropped and further research should be conducted since the potential for commercial success is great. The company should then expend some resources to look for…[Read more]

I believe the keys to being a successful project manager is strong communication and problem solving skills. The ability to empathize with different team members while standing firm on what is required of them is also crucial. He/she should be open to new suggestions and criticisms meant to improve and expediate the progress of the project. Though…[Read more]

While I do agree with the importance of interpersonal skills, I think the 70% ratio is too great (especially if applied to all job fields). For example, a BME scientist who’s primary task is to create and run experiments in a lab setting will require more technical skill. While he/she may need to relay the results to a peer or committee, it will…[Read more]

I have not worked in industry before, but I believe a project-based organization would suite me most. For my senior design project, I got to work with a great team with different strengths and ideas of how to tackle obstacles. We worked together to make up for any setbacks (like the Instron being out of service), while sharing ways to reduce the…[Read more]