Medical Device Courses | Randa | Activity

Randa replied to the topic "Cost/benefit for risk management" -

Mon, 09 Nov 2026 18:39:47 -0500

I think making changes in the design early would be the most efficient when completing a cost/benefit analysis. Changing the design early on is usually cheap because nothing has been manufactured yet, and it removes the risk instead of just… Read more»

Randa replied to the topic "Risk Acceptance" -

Mon, 09 Nov 2026 18:32:00 -0500

I think that risk acceptance does not really create a higher probability of risk, but it does mean the risk stays the same because nothing is being done to lower it. Usually companies only accept risks that are low in… Read more»

Randa replied to the topic "Risk Management" -

Mon, 09 Nov 2026 18:21:20 -0500

Some benefits of implementing a risk management assessment for a device include finding problems early before the device reaches patients, making the device safer. It also saves the company time and money, since it is cheaper to fix a problem… Read more»

Randa replied to the topic "Why user needs should come before designing a medical device" -

Tue, 03 Nov 2026 20:46:18 -0500

I agree, a surgeon, nurse, and patient can all want different things from the same device. I think one way to make sure everyone is considered is to actually go into the hospital and see how the device would be… Read more»

Randa replied to the topic "Making User Needs Specific Enough" -

Tue, 03 Nov 2026 20:35:12 -0500

I agree, this was something we struggled with too. One way I think about it is that the user need can stay the same, like “easy to operate by surgeons,” but you break it down into something you can actually… Read more»

Randa replied to the topic "Customer Needs and Design Input" -

Tue, 03 Nov 2026 20:02:35 -0500

The good thing about the DID is that it gives an overall description of the device and what the user needs. However, it is not descriptive in detail, so it would be hard to build or test the device from… Read more»

Randa replied to the topic "Validation Study Success Defined" -

Sun, 25 Oct 2026 17:40:21 -0400

To define success criteria, the team must have a plan and a step by step process. First they need to know what the device is supposed to do and the user needs. Then they set criteria that can actually be… Read more»

Randa replied to the topic "The Relationship Between Verification and Validation" -

Sun, 25 Oct 2026 17:29:22 -0400

I think that verification and validation are both equally important. It can be somewhat simultaneous depending on what the design or device is. However, if they are worked on simultaneously, it could potentially overlook the purpose of each one and… Read more»

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

Sun, 25 Oct 2026 16:44:55 -0400

When it comes to design, user needs are the first step. If you do not know user needs, you cannot continue on to the next part. Knowing what the user needs is key to developing a successful design or product…. Read more»

Randa replied to the topic "Clinical research" -

Mon, 19 Oct 2026 19:51:26 -0400

I think the responsibility depends on what went wrong. If the doctors and scientists followed the approved protocol, got proper informed consent, and the patient knew the risks, then it’s not really one person’s fault, since clinical trials always have… Read more»

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

Mon, 19 Oct 2026 19:42:22 -0400

I would not put anything out on the market until I have more information regarding the testing and the pill. If the pill was really a placebo, it shouldn’t have done better than the placebo group, so something probably went… Read more»

Randa replied to the topic "Placebo Effect" -

Mon, 19 Oct 2026 19:27:21 -0400

This question is actually a good point. Clinical trials should be accurate, and the placebo effect can make that harder. If the placebo group shows the same results as the group getting the real drug, that usually means the drug… Read more»

Randa replied to the topic "Brand Coloring" -

Mon, 12 Oct 2026 15:49:14 -0400

Using color for marketing is interesting because different colors represent different meanings. For example, the color green can represent health, wealth, and nature. Nature’s Bounty, a supplement and vitamin company, uses green packaging on its bottles. TD Bank’s logo is… Read more»

Randa replied to the topic "Digital Marketing" -

Mon, 12 Oct 2026 15:15:56 -0400

With the advancement of technology, the way companies market has tremendously changed. Instead of using media like TV or magazines, marketing now uses a lot of digital tools to attract customers. It is also way more cost efficient. Posting on… Read more»

Randa replied to the topic "Importance of building TRUST as a Sales Rep" -

Mon, 12 Oct 2026 15:01:09 -0400

When it comes to sales, especially in the medical device industry, the main thing is building long lasting relationships. To be a successful sales rep, you must know your product as being in a clinical environment and building trust with… Read more»

Randa replied to the topic "Can Companies Invest in Stock Market?" -

Wed, 07 Oct 2026 00:40:03 -0400

Yes, a company can invest its retained earnings in the stock market. It would open a brokerage account in the business’s name using its EIN, so the investments belong to the company, not the owner. Large companies like Apple do… Read more»

Randa replied to the topic "Sole Proprietorship or Partnership?" -

Tue, 06 Oct 2026 22:30:33 -0400

If I were to open my own business, I would lean more towards a sole proprietorship rather than a partnership. Since I would be working as a freelancer on the side with my styling license, I don’t need a partner…. Read more»

Randa replied to the topic "Family Businesses" -

Tue, 06 Oct 2026 18:00:15 -0400

A sole proprietorship is a business where one person owns everything, and it’s tied to their personal finances. Because of that, if the business becomes successful and the owner wants to pass it on to his two sons, he can’t… Read more»

Randa replied to the topic "Regulations with quality" -

Fri, 25 Sep 2026 16:12:32 -0400

I think regulations can definitely be a barrier to improving product quality. When it comes to the FDA, there are huge amounts of paperwork and processes needed to approve an improved product. Because of this, some companies may choose not… Read more»

Randa replied to the topic "Can Too Much Quality Control Slow Down Innovation?" -

Fri, 25 Sep 2026 15:51:48 -0400

This is an interesting way to think about quality control and innovation. When it comes to medical devices, patient safety has to come first, but I don’t think that means innovation has to suffer. I do think QC can feel… Read more»

Randa replied to the topic "Form 483" -

Thu, 24 Sep 2026 22:45:37 -0400

I think that even though companies know the risks that come with not following the rules, problems still happen within the companies themselves. This can come from poor management, pressure to meet deadlines, cutting costs, or steps not being double… Read more»

Randa replied to the topic "FDA biased?" -

Thu, 24 Sep 2026 20:47:21 -0400

I agree that the user fee system raises real concerns about bias. Even though the fees are set by Congress and paid whether or not a drug is approved, relying on industry for so much funding can still create pressure… Read more»

Randa replied to the topic "Punishment for Failing FDA Audits" -

Thu, 24 Sep 2026 18:16:17 -0400

During FDA inspections, the consequences depend on how serious the problem is. Serious issues can lead to warning letters, recalls, delayed approval of new products, or even fines and legal action. For smaller issues, it depends on what the problem… Read more»

Randa replied to the topic "Punishment for Failing FDA Audits" -

Thu, 24 Sep 2026 18:16:05 -0400

Randa replied to the topic "Precision and Accuracy" -

Thu, 24 Sep 2026 01:08:33 -0400

Precision and accuracy play an important role in medical devices. The small mistakes can be life threatening when it comes to medical devices. Accuracy is how close the device gets to the right value and precision is if it gives… Read more»

Randa replied to the topic "Precision and Accuracy" -

Thu, 24 Sep 2026 01:08:23 -0400

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

Sat, 19 Sep 2026 23:35:31 -0400

When it comes to taking risks, it’s about a 50/50 chance of success. Companies can stick to the materials they know are safe, which keeps the business running, just not as fast as it could go if they took more… Read more»

Randa replied to the topic "Difference in Biocompatibility testing" -

Sat, 19 Sep 2026 23:18:48 -0400

Medical devices must be biocompatible before any further steps. To test the biocompatibility, it must undergo in vivo and in vitro experiments. One technique is a cytotoxicity test, which is in vitro. The purpose of this is to test how… Read more»

Randa replied to the topic "Why Is Pre-clinical Research So Important Before Testing on Humans?" -

Sat, 19 Sep 2026 21:56:52 -0400

Before clinical trials, it is important for companies to test the device. I think the way they should do these tests depends on what it is they are testing and which one would be more efficient. For example, replicating an… Read more»

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

Tue, 08 Sep 2026 23:22:28 -0400

When planning a project, no one should just dive in and figure things out as they go, but spending an excessive amount of time planning every detail is not the answer either. It is about finding the right balance. Starting… Read more»

Randa replied to the topic "Project Planning: How Much Detail is Enough?" -

Tue, 08 Sep 2026 23:05:49 -0400

This is a great question. I would say setting a project plan depends on preference and how well it works for the person executing it. There may be two amazing but different plans, and one might simply work better for… Read more»

Randa replied to the topic "Teamwork in Projects" -

Tue, 08 Sep 2026 22:41:11 -0400

Personally, working with teammates can be a great thing, yet also tough. Having a group that works together and communicates efficiently can make the team stronger and lead to more progress. On the other hand, having teammates who rely on… Read more»

Randa replied to the topic "Thoughts on BME degree, "a little of everything"" -

Mon, 07 Sep 2026 00:09:28 -0400

I certainly agree that Biomedical Engineering is a mix of different types of engineering, such as electrical, chemical, and mechanical, as well as biology. However, I do not believe that knowing a little bit of everything prevents someone from eventually… Read more»

Randa replied to the topic "Is AI going to control the medical Industry ?" -

Sun, 06 Sep 2026 19:03:36 -0400

As technology continues to develop quickly, I can see how AI is changing biomedical companies, as well as specific roles within them. For example, medical companies are using AI-powered robots to assist surgeons in the operating room. I do not… Read more»

Randa replied to the topic "Redesigning Medical Devices" -

Sun, 06 Sep 2026 18:21:52 -0400

There are many medical devices that can always be improved in some way to make healthcare better for patients. One medical device I would improve is the glucose monitor for diabetic patients. Currently, there are two ways to test the… Read more»