Medical Device Courses | pz98 | Activity

pz98 replied to the topic "Poka-Yoke/ Error Proofing" -

Mon, 17 Nov 2025 04:52:01 -0500

Mistake-proofing shouldn’t be intrusive in a way which disrupts workflow. The best types of mistake-proofing are ones which are seamlessly integrated into non-mistake-proofed workflows. Overly rigid solutions for mistake-proofing can backfire. Introducing slots in designs for easy installation is good,… Read more»

pz98 replied to the topic "When Mitigation Becomes Its Own Risk!" -

Mon, 17 Nov 2025 04:37:13 -0500

One thing which I think is also important to consider is the user’s perception of the device if the device is “over-engineered” to mitigate risk. For the actual device, implementing all these features can make a device safer on paper,… Read more»

pz98 replied to the topic "Are We Over-Relying on FMEAs?" -

Mon, 17 Nov 2025 03:21:57 -0500

To build upon what was mentioned in the post before mine, FMEAs are only as effective as the team who constructed it. Relying on checklists can be the result of inexperience and/or the reluctance to challenge the design of a… Read more»

pz98 replied to the topic "Can Verification Cause a Tragedy?" -

Mon, 10 Nov 2025 04:50:16 -0500

What contributed to the Therac-25 incidents was a reliance on old code as mentioned in previous posts. Engineers possibly assumed their code from previous projects was fine as is. With AI entering medical devices now, what is stopping engineers from… Read more»

pz98 replied to the topic "Efficiency or Compliance?" -

Mon, 10 Nov 2025 03:28:37 -0500

Following design controls intentionally is important for efficiency, even if it feels like it’s there just for compliance. A lot of it feels like regulatory checkboxes, but it can benefit a project team if it is followed. In business, there… Read more»

pz98 replied to the topic "Updating documentation or information overload?" -

Mon, 10 Nov 2025 02:50:23 -0500

As briefly mentioned, sectioning off the DDP by “departments” will allow the file to be filtered to view what is relevant to an individual or team. Filtering changes based on the specific sector the change came from allows the document… Read more»

pz98 replied to the topic "Risk Management in Verification & Validation" -

Mon, 03 Nov 2025 04:14:09 -0500

To coordinate between risk and verification validation results, a dynamic risk assessment system can be used to consider the results. Verification and validation can uncover problems with a device relating to its design controls, and being able to update a… Read more»

pz98 replied to the topic "Verification vs. Validation — Do We Really Need Both?" -

Mon, 03 Nov 2025 03:47:52 -0500

FDA and ISO should begin to change their requirements. All of their requirements were written where the submissions were done in concrete steps. Many AI models have algorithms that can change after their initial training and these changes are most… Read more»

pz98 replied to the topic "User Needs vs. Business Goals — Who Wins in Design?" -

Mon, 03 Nov 2025 03:08:35 -0500

Engineers should “fight” for an ideal design in a way which describes their design as a benefit to the business. In design, usually user needs will complement business goals. For example, designing a medical device which takes into account rather… Read more»

pz98 replied to the topic "The Placebo vs. The Nocebo Effect in Blind Clinical Studies" -

Mon, 27 Oct 2025 03:44:55 -0400

There is a conflict when it comes to honest/proper communication and using the nocebo or placebo effect as a therapeutic tool. Patients entering a clinical trial will develop their own expectations for their treatment even prior to receiving a full… Read more»

pz98 replied to the topic "Why Is Clinical Research So Complex?" -

Mon, 27 Oct 2025 03:28:18 -0400

Clinical trials are indeed very long and very expensive because of the ethics, regulatory demands, and demands for solid results which go into each clinical trial. Simplifying clinical trials might not directly be possible, however optimizing clinical trials in a… Read more»

pz98 replied to the topic "The Secret Ingredient in Every Clinical Trial: Trust" -

Mon, 27 Oct 2025 03:12:32 -0400

As mentioned, a blinded study is a bit difficult to have honest conversations with the patient as it could compromise the study integrity. If a patient learns about which treatment they are receiving, it pretty much ruins the study. To… Read more»

pz98 replied to the topic "Medical Device Marketing: Informative or Misleading?" -

Mon, 20 Oct 2025 03:53:45 -0400

Effective promotion and ethical communication relies heavily on how well the science is communicated. As was mentioned, marketing campaigns should be more closely aligned with the science, however not everyone may be well-versed with the technical or pharmacological aspects of… Read more»

pz98 replied to the topic "Science and Strategy… or Just Storytelling?" -

Mon, 20 Oct 2025 03:22:13 -0400

One factor that hasn’t been really mentioned which is important for medical device marketing is being able to capture the trust of the consumer, whether it be prospective patients or physicians. Storytelling in order to oversimply a product has its… Read more»

pz98 replied to the topic "Consumer Input for Marketing Outputs" -

Mon, 20 Oct 2025 01:30:10 -0400

To answer the question of what should the threshold of misunderstanding be, if you define a misunderstanding to be critical based on a risk that it poses to consumers through misunderstanding marketing content, then yes, that is an appropriate way… Read more»

pz98 replied to the topic "Public or Private: Which Path Builds a Stronger Company?" -

Mon, 13 Oct 2025 03:55:06 -0400

For long-term goals in order to remain an established company, going public is almost a requirement in my mind. A private company when it goes public should hit the ground running. As in, the company should already have some momentum… Read more»

pz98 replied to the topic "Why Is Cash Flow More Important Than Profit for a Business?" -

Mon, 13 Oct 2025 03:35:10 -0400

Negative cash flow is definitely more influential than profit itself when evaluating when companies fail. Getting to a negative cash flow indicates numerous poor financial decisions; it is never the result of one mess-up. A medical device can remain unprofitable,… Read more»

pz98 replied to the topic "Evaluating Medical Device Projects (ROI, NPV, Value)" -

Mon, 13 Oct 2025 02:46:49 -0400

One critical factor which could be overlooked with “extremely” innovative technologies would be the payback period. Payback period is the length of time estimated to break even from the development of a project. Tracking this period of time is important… Read more»

pz98 replied to the topic "Quality Control & Quality Assurance Communication" -

Mon, 06 Oct 2025 03:30:48 -0400

Some of the communication troubles between QA and QC because integration of the two is tricky due to the nature of how they deal with quality. QA focuses on being more proactive, while QC is more reactive. QA is there… Read more»

pz98 replied to the topic "Common challenges faced while auditing a Quality Management System (QMS) in the medical device industry & how can they be dealt with" -

Mon, 06 Oct 2025 03:15:58 -0400

Adding on with a specific example of incomplete documentation missing which leads to a failed audit is the lack of “assumed” process in the documentation. In cases where employees work at a company for a fair amount of time, they… Read more»

pz98 replied to the topic "Quality Control and Assurance: Role in Post Market Surveillance" -

Mon, 06 Oct 2025 03:01:24 -0400

Specifically when comparing QA/QC in the development stages of medical devices versus in the post-market surveillance, companies should adapt their strategies in a way which makes the process quicker without sacrificing effectiveness. The QA/QC in the development stages tend to… Read more»

pz98 replied to the topic "Who Should Be Responsible for Regulatory Basics?" -

Mon, 29 Sep 2025 03:51:28 -0400

I agree that engineers should have a layer of responsibility for regulatory basics. Understanding of FDA regulations is important for proper design of medical devices, but with constantly changing guidelines, having a perfect understanding of regulatory regulations for engineers is… Read more»

pz98 replied to the topic "FDA Classes: Reform needed or fine as is?" -

Mon, 29 Sep 2025 03:41:43 -0400

I do think that if a reform is needed on the classification of medical devices in the FDA, the time to do it should be in the near future before too many problems arise in classifying “in between” medical devices. Less… Read more»

pz98 replied to the topic "Should Engineers Worry About Compliance From the Start?" -

Mon, 29 Sep 2025 02:34:52 -0400

I agree with the opinion that smaller startups should focus more on innovation than compliance since it can give them a good product to stand out. This lets them develop opportunities for receiving funding, which can allow for an easier… Read more»

pz98 replied to the topic "Pitching Research in Industry vs. Academia" -

Mon, 22 Sep 2025 03:59:13 -0400

Starting research on time in industry is realistic, but fully completing research on time is less realistic. The deadlines in industry are often there to demonstrate that progress is being made to shareholders. Having shareholders that are happy with the… Read more»

pz98 replied to the topic "Why Is Pre-clinical Research So Important Before Testing on Humans?" -

Mon, 22 Sep 2025 03:36:34 -0400

I do agree with the next step for pre-clinical research before testing on humans is the substitution of animal testing with computer simulations, but in reality I don’t think this will be happening any time in the near future (hopefully… Read more»

pz98 replied to the topic "Should Companies Use Safer Materials or Take Risks With New Ones?" -

Mon, 22 Sep 2025 03:14:34 -0400

The choice between novel and tested materials ultimately comes down to balancing the benefits versus the risks a company is willing to take to gain from a market. Materials that are already proven are most likely mass-produced in some capacity,… Read more»

pz98 replied to the topic "Why is project planning important?" -

Mon, 15 Sep 2025 03:55:15 -0400

Over-planning sounds like it would lead to a more straight-forward project, however it could complicate risk management processes. While meticulous planning could account for many risks, there is always a chance something is overlooked. What if the alternative for a… Read more»

pz98 replied to the topic "What Makes a Good Project Manager?" -

Mon, 15 Sep 2025 02:42:04 -0400

As you mentioned, projects may not go exactly as planned, especially in medical device projects. A lack of organization can mean that a project fails to pivot quickly enough to address issues, delays, or regulatory problems. An organized project manager… Read more»

pz98 replied to the topic "Teamwork in Projects" -

Mon, 15 Sep 2025 02:28:28 -0400

I would say that the biggest obstacle in projects is making sure everyone does their fair share of work. Disagreements can be solved through discussion, and more than likely a solution will arise. When individuals have a disagreement about the… Read more»

pz98 replied to the topic "Academia vs. Industry: Why I Prefer Industry" -

Mon, 08 Sep 2025 03:56:14 -0400

For transitioning between careers within BME, I would think that it is harder to transition from academia to industry, than from industry to academia. This makes me lean more towards industry. Academia and industry are two completely different working environments;… Read more»

pz98 replied to the topic "How to be a successful professor ?" -

Mon, 08 Sep 2025 03:46:34 -0400

I believe that a successful professor should have some experience in industry, however successful can be defined by different definitions. For a professor who puts measures success by their teaching effectiveness, gaining industry experience prior to becoming a professor can… Read more»

pz98 replied to the topic "Medical Device News" -

Mon, 08 Sep 2025 02:48:32 -0400

For an improvement in the industry, I think the use of AI is showing signs that is is helping accelerate progress in medicine. On the news, I read about a medical device company which developed AI-based software for identifying ovarian… Read more»

pz98 replied to the topic "In case of recall" -

Mon, 05 May 2025 03:10:15 -0400

As mentioned previously, there are different stages to recalls; each one being more severe than the other. The FDA can inform the company on a strategy on how to proceed with the recall, either through public announcements or coordinating return… Read more»

pz98 replied to the topic "Covid 19 Vaccines" -

Mon, 05 May 2025 01:55:14 -0400

The cheap aspect of fast-good-cheap is one topic that may be up for discussion. More specifically, much of the financial aspects of developing a vaccine was subsidized by the government and FDA instead of the pharmaceutical companies. The financial planning… Read more»

pz98 replied to the topic "Clinical trials when exporting medical devices to other countries." -

Mon, 05 May 2025 00:32:21 -0400

Certain jurisdictions allow for streamlined product approval by using clinical data obtained from other jurisdictions. This is called a data-reliance pathway. For example, Canada and the US have a mutual agreement which essentially help approve new medical devices in both… Read more»

pz98 replied to the topic "How to manage contracts with external clinical trial management teams?" -

Mon, 28 Apr 2025 01:50:35 -0400

Assuming that once a smaller companies has identified a suitable clinical trial management company to contract with, payment could become a key part in managing the contract between the two companies. With smaller companies, monetary resources may not be so… Read more»

pz98 replied to the topic "Role of Communication Plans in Clinical Trial Execution" -

Mon, 28 Apr 2025 01:41:51 -0400

One factor which can make or break communication within a clinical trial and project is communication latency. The time from delivery to acknowledgement of a message can be critical when it comes to completing stages of a clinical trial and… Read more»

pz98 replied to the topic "Outsourcing Clinical Trials" -

Mon, 28 Apr 2025 01:33:30 -0400

One reason that a company may want to outsource their clinical trials is for scalability reasons. With small companies, a limiting factor for clinical trials may be the quantity of patients a company may be able to find. For medical… Read more»

pz98 replied to the topic "Scope Management in Biomedical Devices" -

Mon, 21 Apr 2025 03:49:01 -0400

Adding on to the others, COVID is a prime example of where agile scope management was applied. As more information came out, project scopes most likely increased. One example of this is a company called Inovio. They were developing a… Read more»

pz98 replied to the topic "Scope Management and the Role of the WBS in Project Clarity" -

Mon, 21 Apr 2025 03:39:04 -0400

WBS should be closely aligned with a company’s risk management planning. Different deliverables like the change history are effective in a WBS, but incorporating a risk-perspective into the WBS as well can make areas with more uncertainty more visible to… Read more»

pz98 replied to the topic "Critical Path, PERT, and Managing Time Under Uncertainty" -

Mon, 21 Apr 2025 00:08:56 -0400

Adding on to what was said, an effective way to manage time compression while mitigating risk if employing a scenario-based method that can evaluate the trade-offs faced when pressed for time. A project manager can approach the stakeholders or executives… Read more»

pz98 replied to the topic "The Impact of Earned Value Management (EVM) on Project Budgeting" -

Mon, 14 Apr 2025 03:38:27 -0400

As you mentioned, EVM is a good tool for identifying if a project is behind schedule by using EV and PV. One additional benefit of EVM is its ability to detect scope creep before it happens. Projects that have requirements… Read more»

pz98 replied to the topic "Why Capturing Lessons Learned Matters" -

Mon, 14 Apr 2025 02:39:14 -0400

Capturing lessons learned by using a slideshow presentation or using software like sharepoint is a good idea, but making these efforts to capture the project lessons without working off of them could defeat the purpose of doing so in the… Read more»

pz98 replied to the topic "Making Design Reviews Work in Medical Devices" -

Mon, 14 Apr 2025 01:02:54 -0400

The main key aspects of the preparation for a design review were covered previously, however one critical step for preparation is engaging with stakeholders prior to the design review meetings. Stakeholders can provide valuable insights that may have been overlooked… Read more»

pz98 replied to the topic "How do the FDA manage" -

Mon, 31 Mar 2025 03:53:11 -0400

For many products, companies are required to follow GLP and other good practices as mentioned previously. These good practice rules give companies an outline on standard protocols to follow when it comes to the study itself and record keeping of… Read more»

pz98 replied to the topic "Project Initiation" -

Mon, 31 Mar 2025 02:54:12 -0400

One way to prepare for challenges in the product development process early is to organize review meetings with team leaders from cross-functional teams. When project members from different teams, for example engineering and compliance, are able to express their uncertainties… Read more»

pz98 replied to the topic "Managing Challenges in Metrics" -

Sun, 30 Mar 2025 21:22:32 -0400

Making sure that relevant metrics are collected efficiently and correctly are indeed an important step in the project process. One way to make sure the metrics that are collected are relevant with the goals of the current project objective. Revising… Read more»

pz98 replied to the topic "Sequence of the PM Process" -

Mon, 17 Mar 2025 03:37:49 -0400

Cross-functional teams are essential to many projects, and omitting a sequence of activities can significantly impact their purpose. The purpose of these teams is to allocate project resource effectively and distribute project tasks efficiently. When a project’s schedule is being… Read more»

pz98 replied to the topic "Execution phase" -

Mon, 17 Mar 2025 02:52:59 -0400

One way to make sure that all project documents remain accurate and update is by maintaining and utilizing version control software, along with access control. As mentioned, suppliers and manufacturers can run into issues with their schedule, which can impact… Read more»