Medical Device Courses | AndrewG | Activity

AndrewG posted a new topic "User Training in Risk Management" -

Mon, 09 Nov 2026 14:14:01 -0500

In this weeks lecture, we learned about 4 different forms of risk management: Avoidance Mitigation Acceptance Transference Where do you think user training falls in the above list, and how strong of a role should it play in risk management?… Read more»

AndrewG replied to the topic "Risk Management in the Manufacturing Process" -

Mon, 09 Nov 2026 14:07:54 -0500

I agree that risk avoidance is the most ideal path to manage risk, followed by mitigation. If you make a device so it can’t cause harm, then your are eve protected from improper use. [quote data-userid=”22596″ data-postid=”18764″] How is… Read more»

AndrewG replied to the topic "Risk Management Team =/= Project Team" -

Mon, 09 Nov 2026 13:50:13 -0500

There are definitely some pro’s and con’s… Read more»

AndrewG replied to the topic "When Should Engineers Stop Improving a Medical Device ?" -

Mon, 09 Nov 2026 02:36:22 -0500

[quote data-userid=”55586″ data-postid=”24606″] It is common for the manufacturers of medical devices to upgrade their products after they are already developed and released. Each alteration, however, can create new dangers, as well as add to the costs of development and… Read more»

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

Mon, 09 Nov 2026 02:19:11 -0500

Labelling should absolutely be taken seriously for medical devices. As much as they inform what is inside the packaging, they can also indicate notable hazards, who should/shouldn’t use the product, and other information that increases the likelihood of successful usage… Read more»

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

Mon, 09 Nov 2026 01:38:19 -0500

[quote data-userid=”55511″ data-postid=”24587″] 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… Read more»

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

Thu, 29 Oct 2026 22:38:17 -0400

[quote data-userid=”1481″ data-postid=”434″] In design controls, there is the DID and DSD documents. DID is design input and gives a broad description of the product (ex, “red knob”), whereas the DSD is design specification and gives a very specific description(ex,… Read more»

AndrewG replied to the topic "Validation vs Verification" -

Thu, 29 Oct 2026 22:28:48 -0400

[quote data-userid=”17937″ data-postid=”13282″] In lecture, it was mentioned that the two terms are different from each other. Validation is when we are comparing our products to the customers’ needs while verification is comparing the physical properties of the product to… Read more»

AndrewG replied to the topic "Minutes for meetings" -

Thu, 29 Oct 2026 22:16:23 -0400

As mentioned in prior comments, meeting minutes direct functional importance can be minimized by meeting summaries, gannt charts/schedules, and other deliverables that can render many aspects of the meeting minutes redundant. Additionally, the taking and reviewing of detailed minutes can… Read more»

AndrewG replied to the topic "Minutes for meetings" -

Thu, 29 Oct 2026 22:15:57 -0400

AndrewG replied to the topic "Placebo Effect" -

Mon, 26 Oct 2026 22:34:30 -0400

Placebo effects certainly can have an impact on clinical data, and is why clinical studies should be intentionally designed to minimize its impact where possible. As discussed in class, this can often be remedied using placebo-controlled, randomized, and/or blinded prospective… Read more»

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

Mon, 26 Oct 2026 22:17:00 -0400

I think that there is a line of how a patient should be compensated for a clinical trial. From one perspective, patients are exposing themselves to increased risk, potentially incurring additional medical expenses and time commitments, missed work and wages,… Read more»

AndrewG replied to the topic "Can AI Replace Human Participants in Clinical Trials ?" -

Mon, 26 Oct 2026 21:51:02 -0400

I do not think AI should be used as a replacement for Clinical Trials, nor any virtual medium. While AI and technology is growing in capability, anything it could produce would just be a model that does not represent, but… Read more»

AndrewG replied to the topic "Manipulation or no?" -

Thu, 15 Oct 2026 22:00:58 -0400

I would argue that effective sales persuasion crosses the line into manipulation once the strategy stops considering they best interests of the customer. Of course the salesperson always has the goal of closing as many deals as possible. However, since… Read more»

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

Thu, 15 Oct 2026 21:37:38 -0400

I think that physicians should be able… Read more»

AndrewG replied to the topic "Is the Best Medical Device Always the Best Selling Product ?" -

Thu, 15 Oct 2026 21:05:06 -0400

The way a company sells, brands,… Read more»

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

Sat, 10 Oct 2026 22:28:11 -0400

Personally, I believe that privately owned companies (with the exception of those acquired by private-equity) are the most likely to stay aligned with their initial vision and goal for the company. While a goal for every for-profit business is to… Read more»

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

Sat, 10 Oct 2026 22:14:35 -0400

AndrewG replied to the topic "In-House or Outsource: What’s Best for a Growing Business ?" -

Sat, 10 Oct 2026 21:46:18 -0400

I agree there are many tradeoffs made when deciding whether to outsource aspects of a business or complete them in house. These decisions are situation specific, so it is difficult to say one way is better than the other. Some… Read more»

AndrewG replied to the topic "Quality Control & Quality Assurance Communication" -

Sun, 04 Oct 2026 22:12:15 -0400

[quote data-userid=”24139″ data-postid=”22176″] Looking at the lecture, I can see that Quality Assurance builds the methods, rules, acceptance criteria, and systems that prevent errors in medical device development. On the other hand, Quality Control executes the rules, measures results, and… Read more»

AndrewG replied to the topic "AI vs Human Judgment in QA : Who Makes the Final Decision ?" -

Sun, 04 Oct 2026 21:57:18 -0400

In this context, I believe the QA professional should make… Read more»

AndrewG replied to the topic "Discussion Topic: The cost of Quality" -

Sun, 04 Oct 2026 21:50:12 -0400

I believe “The Cost of Quality” is an especially relevant topic in todays engineering atmosphere. One of the most influential figures in engineering and tech today is Elon Musk, who – among many notable companies – founded the biotech company… Read more»

AndrewG replied to the topic "Role of Regulatory Affairs" -

Sun, 27 Sep 2026 16:50:53 -0400

I would argue that the regulatory affairs department does not set out to protect the patients,… Read more»

AndrewG replied to the topic "Predicate Devices and the 510(k) Process" -

Sun, 27 Sep 2026 16:36:44 -0400

I believe the 501(k) process does limit innovation. From the perspective of the medical device company, if I can make a device that is equivalent to a predicate device, why would I invest resources into developing a novel device that… Read more»

AndrewG posted a new topic "Regulatory Classification of Novel Devices" -

Sun, 27 Sep 2026 14:34:04 -0400

As we learned in this weeks lecture, all new products that are not substantially equivalent to a predicate device are categorized in Class 3 until proven to belong to a lower class. From a safety perspective this is an understandable… Read more»

AndrewG replied to the topic "Pre-Clinical Research: Academia(Passion) or Industry(Money)?" -

Sat, 19 Sep 2026 02:10:27 -0400

I tend to agree that industry is more set up to push ideas into executed research trials. Although the pressures to work within a budget and timeline can compromise some aspects the study, those same pressures also ensure that the… Read more»

AndrewG posted a new topic "Deciding How to Perform Research in Industry" -

Sat, 19 Sep 2026 01:53:27 -0400

In this weeks presentation, Professor Simon listen 3 different ways to handle performing pre-clinical research: In-house, in an academic lab, in a contract lab As with all engineering decisions, there exists tradeoffs between the features of each option. In this… Read more»

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

Sat, 19 Sep 2026 01:12:26 -0400

When determining whether a company should use an established material… Read more»

AndrewG replied to the topic "Manager Vs Engineering" -

Fri, 11 Sep 2026 21:00:56 -0400

As many have discussed previously, the relationship between the manager and engineer is paramount to the success of the project. A manager that is knowledgeable, respectful, and open in communication with their engineers can lead to an environment and dynamic… Read more»

AndrewG replied to the topic "Can a Strong Initiating Phase Prevent Most Project Problems Later?" -

Fri, 11 Sep 2026 20:34:08 -0400

I agree many companies and project teams can rush through the initiating phase, which certainly can lead to problems later in the project execution phase. As presented in lecture, consequences can include scope creep, underbudgeting, and unachievable deadlines. A thorough… Read more»

AndrewG replied to the topic "Pressure vs. Safety: A Project Manager’s Toughest Decision" -

Fri, 11 Sep 2026 19:57:19 -0400

[quote data-userid=”55586″ data-postid=”23978″] When a technical or regulatory problem arises in medical device development, how should project managers weigh the importance of deadlines for a project’s completion against patient safety? While some industries may put pressure on project managers to… Read more»

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

Tue, 08 Sep 2026 00:11:44 -0400

For many posts on this thread the common consensus seem to be that due to the multidisciplinary nature of biomedical engineering, students often feel like generalists. While the coursework may be broad and touch a variety of subjects, I don’t… Read more»

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

Tue, 08 Sep 2026 00:11:30 -0400

I think there are limitations to the control AI will have in the medical device industry, especially in highest regulated class of devices. Many of these devices are implantable and stay with patients their entire lives since they only go… Read more»

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

Fri, 04 Sep 2026 22:43:37 -0400

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

Fri, 04 Sep 2026 22:11:49 -0400

When comparing academia and industry, I believe fulfillment comes down to the timescale on which you see your impact. For instance in academia you may spend months doing research and writing a paper that may not directly cause a notable… Read more»