Medical Device Courses | Annie | Activity

Annie replied to the topic "User Training in Risk Management" -

Fri, 13 Nov 2026 04:27:11 -0500

I think user training can also help manufacturers identify weaknesses in their product before it reaches the market. Manufacturers can see how users during training struggle with a device, one of its steps, misunderstand instructions, or not understand certain features… Read more»

Annie replied to the topic "Designing Out Risks vs. Warning Labels" -

Fri, 13 Nov 2026 04:18:11 -0500

I think manufacturers should decide after conducting a thorough risk assessment and determining whether future design changes would work or introduce other risks. For example, adding a safety feature to a medical device might make it more complicated to operate,… Read more»

Annie replied to the topic "Should Medical Devices Be Updated Like Smartphones ?" -

Fri, 13 Nov 2026 04:09:08 -0500

I believe that medical devices should be able to implement certain software updates and improvements without obtaining FDA approval if they provide minimal risk. Requiring FDA approval for each update can slow down advancement and prevent patients from benefiting from… Read more»

Annie replied to the topic "Why Packaging and Labeling Matter in Medical Devices" -

Tue, 03 Nov 2026 13:25:30 -0500

I think packaging is very important because different medical devices are stored and transported differently, so packaging is important in making sure everything is still safe. For example, certain medications or medical products need to be refrigerated or kept without… Read more»

Annie replied to the topic "The Role of Different Users in Device Development" -

Tue, 03 Nov 2026 13:14:25 -0500

I think it is also important to consider whether a medical device will be used outside of a hospital or clinical setting. If a product is intended for both hospital and home use, the design needs to be accommodate patients… Read more»

Annie posted a new topic "Making User Needs Specific Enough" -

Tue, 03 Nov 2026 13:03:44 -0500

During capstone this semester, we had to create user needs as well for our project. One issue and feedback that we got was making our user needs measurable. We would put needs like “easy to operate by surgeons” or “be… Read more»

Annie replied to the topic "User Needs vs. Business Goals — Who Wins in Design?" -

Fri, 30 Oct 2026 20:13:27 -0400

I think one challenge companies face is designing for the average user while overlooking patients who have different needs or limitations. For example, a medical device might be designed around the typical patient, but there are differences in age, mobility,… Read more»

Annie replied to the topic "When Design Controls Fail — The DePuy Hip Recall" -

Fri, 30 Oct 2026 20:03:04 -0400

A factor that should be considered is how design controls should consider the entire lifespan of an implanted device, not just focus on how it performs when it is first implanted. Hip implants are expected to last for many years,… Read more»

Annie replied to the topic "Environment of use as a design input: the Philips CPAP recall" -

Fri, 30 Oct 2026 19:57:23 -0400

I think foreseeable misuse should be considered part of a device’s design inputs. A big medical device with experience such as Philips should have anticipated that some users would purchase cleaning products, especially since people using it at home might… Read more»

Annie replied to the topic "Benefits for Patients in Clinical Research" -

Tue, 20 Oct 2026 18:06:32 -0400

I think compensation should also consider the scenario that a participant cannot complete a trial. For example, a participant might experience severe side effects and decide to withdraw, or the doctor might conclude that it is not safe for a… Read more»

Annie replied to the topic "The Secret Ingredient in Every Clinical Trial: Trust" -

Tue, 20 Oct 2026 17:42:12 -0400

I think an important factor in building trust is letting participants know that they can withdraw from the study without feeling guilty or worried that there will be consequences. Some people might feel pressured to continue a study even when… Read more»

Annie replied to the topic "What if I told you..." -

Tue, 20 Oct 2026 16:45:26 -0400

One thing to consider is if people will actually buy the placebo when there is the cost-free option of recovering. If people know its a placebo, they might not buy it because it will be a waste of money. Even… Read more»

Annie replied to the topic "When Does a Surgeon Become a Brand Ambassador Ethically?" -

Mon, 12 Oct 2026 20:37:20 -0400

I think it depends on what the physician is being paid for. I think that physicians should be paid for their expertise when they are helping develop a device or are providing their facilities for testing. This is because they… Read more»

Annie replied to the topic "Understanding Customer Needs in Medical Device Marketing" -

Mon, 12 Oct 2026 20:20:31 -0400

One thing I have learned from capstone this semester is that creating customer needs is an important aspect in addressing the actual needs of physicians and patients. These are creating by interviewing surgeons and other involved healthcare professionals, observing procedures,… Read more»

Annie replied to the topic "The Four Ps of Marketing for Medical Devices" -

Mon, 12 Oct 2026 19:49:47 -0400

I think product has the greatest influence on whether a hospital adopts a new medical device because the product in general and the benefits it provides in improving patient care is very important. The reason someone would buy this depends… Read more»

Annie replied to the topic "Should the corporate veil protect medical device executives?" -

Mon, 05 Oct 2026 03:32:15 -0400

I think you brought up a good point of having a good balance between protecting people who start businesses and also holding leaders accountable when their decisions put patients at risk. I think that leaders should be held to a… Read more»

Annie replied to the topic "Public or Private: Which Path Builds a Stronger Company?" -

Mon, 05 Oct 2026 03:22:21 -0400

Another factor to consider when debating whether to stay private or go public depends on how the company values their employees. A growing company can use its stock to give to employees as mentioned in the lecture as a reward… Read more»

Annie replied to the topic "Which Type of Business Structure Is Best for a Startup?" -

Mon, 05 Oct 2026 03:09:41 -0400

I think the best approach is to pick the structure that fits with the company’s needs. It is important to consider the funding and what type of investors will be involved. It is probably best for a small company to… Read more»

Annie replied to the topic "Most effective ways to manage risk in the context of Quality Assurance for high-risk medical devices (Class III)" -

Mon, 28 Sep 2026 03:06:10 -0400

I think QA can help ensure the safety of a Class III device by providing requirements on the components and materials that are used to create that device. QA can help provide requirements regarding supplier and supplier quality to make… Read more»

Annie replied to the topic "Unified Quality System?" -

Mon, 28 Sep 2026 02:56:13 -0400

Another aspect of having a unified quality system across all regions is that it would allow it provides a standard system on recording issues, conducting investigations, and other important details that is uniform across all sites. This allows it to… Read more»

Annie replied to the topic "Who Should Be Responsible for Quality: Engineers or Dedicated QA/QC Teams?" -

Mon, 28 Sep 2026 01:48:19 -0400

I think that the priorities and goals of QC/QA are different enough that they should be separated, but both teams should work with each other. Both teams can bring their knowledge and expertise to the table when designing a product…. Read more»

Annie replied to the topic "Disease Outbreaks" -

Mon, 21 Sep 2026 19:42:37 -0400

@justinwilliams On the topic of Johnson and Johnson during COVID-19, a conflict I remember arising during the pandemic was J7J’s vaccine for COVID. This vaccine did not go through the normal FDA process of approval and instead went through the… Read more»

Annie replied to the topic "Are Regulations Helping Innovation or Slowing It Down?" -

Mon, 21 Sep 2026 19:23:55 -0400

I think often, regulatory is often viewed in a negative light, because the engineers who are creating these medical devices probably don’t like hearing numerous rules that restrict their ideas. It might feel like regulatory just comes in to control… Read more»

Annie replied to the topic "Why Product Claims Matter in Medical Device Regulation" -

Mon, 21 Sep 2026 19:09:20 -0400

I think that regulatory professionals should be involved from the very beginning of the design process. By being involved early, engineers who are designing the medical device can get a clear understanding on what the regulations are and adjust their… Read more»

Annie replied to the topic "Balancing Medical Advancements and Ethical Concerns" -

Tue, 15 Sep 2026 01:00:31 -0400

A negative consequence that comes with animal studies for pre-clinical testing that hasn’t been discussed is the cost. As seen in the 2 animal study protocols posted on Canvas, getting animals for the study are very expensive. Additionally, many animals… Read more»

Annie replied to the topic "Pre-Clinical Device Development" -

Tue, 15 Sep 2026 00:39:57 -0400

From your discussion, I was able to learn about NAMSA, which I previously had no knowledge about before. According to their website, they help with “market research, preclinical studies, clinical trials, biological safety testing, regulatory submissions, and much more”. I… Read more»

Annie replied to the topic "Should Companies Use Safer Materials or Take Risks With New Ones?" -

Mon, 14 Sep 2026 20:28:54 -0400

I agree with the points mentioned above about why it is financially safer, since using materials already in the market have a stable supply, reduces costs and times, and prevents financial downfall in the future. However, I think it is… Read more»

Annie replied to the topic "Why is project planning important?" -

Wed, 09 Sep 2026 16:57:40 -0400

I think it is very important to spend time planning details of a project before getting started. I don’t think a lot of time should be spend on it and not every detail can be planned out, but there should… Read more»

Annie replied to the topic "Project on time and within budget: What should be the strategies of a project manager?" -

Wed, 09 Sep 2026 15:39:53 -0400

I think one way to effectively strategize is mentioned in this week’s lecture about earned value (EV), planned value (PV), and actual cost (AC). Earned value is the value of the work that has been completed, planned value is the… Read more»

Annie replied to the topic "What Makes a Good Project Manager?" -

Wed, 09 Sep 2026 15:03:21 -0400

I agree that organization, communication, staying calm, motivation, and being a team player are all important traits that make up a good project manager. Another trait that I think is important for a project manager is delegation. A good project… Read more»

Annie replied to the topic "Medical Device News" -

Wed, 02 Sep 2026 19:19:10 -0400

This summer, I was made aware of how a large medical device company is actually being financially hit due to tariffs as released in their Q3 report. Also another reason for their financial loss was because their second biggest market,… Read more»

Annie replied to the topic "How to be a successful professor ?" -

Wed, 02 Sep 2026 19:19:08 -0400

In order to be a good professor, I think there are a few different traits that a person might need. As someone who is a student in the biomedical engineering department, I noticed that a common issue in a lot… Read more»

Annie replied to the topic "Making a Difference in Academia vs Industry" -

Wed, 02 Sep 2026 01:10:43 -0400

Hey Raina, In regards to your question about which one is more fulfilling, I think that academia and industry work can have an equal impact in different ways. I agree with your point about how academia is important because the… Read more»