Medical Device Courses | bsk32 | Activity

bsk32 replied to the topic "Covid 19 Vaccines" -

Mon, 05 May 2025 03:59:28 -0400

The Covid vaccine was shown to be good, cheap, and fast due to several reasons. Under normal circumstances, it would be nearly impossible to fulfill all three. During the pandemic, the government passed an emergency use authorization which took a… Read more»

bsk32 replied to the topic "In case of recall" -

Mon, 05 May 2025 03:50:58 -0400

In the case of a recall, Medical Device Manufacturers should take the following steps on what to do. First, a letter should be sent to clinics, doctors, patients, and all stakeholders of the recalled device describing the reason for recall,… Read more»

bsk32 replied to the topic "Motivation factors" -

Mon, 05 May 2025 03:41:14 -0400

After landing a job that I’m passionate about, I’d be very excited to begin by journey learning from new experiences, and continue growing my skills. In the situation where there’s no long term growth or opportunities in the company, I’d… Read more»

bsk32 replied to the topic "Let's Be Motivated!!!" -

Mon, 28 Apr 2025 03:56:48 -0400

To motivate my team, I would reward small improvements while also providing helpful feedback on how to improve their performance. Overall, each member should be taking on roles and tasks that challenge them technically and interpersonally. I would also find… Read more»

bsk32 replied to the topic "Dealing with Low Performers in Research Teams Without Losing Morale" -

Mon, 28 Apr 2025 03:48:36 -0400

I think that a proper assessment should be made to find the root cause of the delay. Several things can be done to prevent these situations, such as communicating deadlines, and providing feedback on schedules. Another way would be to… Read more»

bsk32 replied to the topic "Engineer vs. Manager" -

Mon, 28 Apr 2025 03:30:47 -0400

I would want to begin as an Engineer, and then move up to a manager role. As an Engineer, I’d begin to gain experience working with others on a team to complete a project. After gaining experience and project management… Read more»

bsk32 replied to the topic "Which factors should be followed while deciding number of alternative vendors ?" -

Mon, 21 Apr 2025 00:39:31 -0400

One factor to take into consideration would be the risk associated with losing your only supplier. If you opt to more suppliers, you reduce the risk associated with procurement, but increase the risk of effectiveness complaints. Therefore, having fewer suppliers… Read more»

bsk32 replied to the topic "Navigating Compressed Schedules" -

Sun, 20 Apr 2025 23:44:59 -0400

It’s never truly safe to use any method that causes an increase to risk or cost. After completing a risk analysis, duration compression should only be used if there’s no safer option. In the case of an emergency authorization from… Read more»

bsk32 replied to the topic "Scope Management Optimization Strategies" -

Sun, 20 Apr 2025 22:58:59 -0400

In order to prevent scope creep from happening, the scope process should begin as soon as possible. During initiation, all information of project history should be compiled when determining what the product can or can’t do. The Work Breakdown Structure… Read more»

bsk32 replied to the topic "Enhancing Quality Assurance: Lessons from the DePuy ASR Hip Recall" -

Mon, 17 Mar 2025 02:16:22 -0400

I have experience as a Quality Engineer. One of my tasks was to manage the equipment maintenance schedule and order calibration services. During production of the devices, my team and I would catch equipment or other processes being done out… Read more»

bsk32 replied to the topic "The Crucial Role of Regulatory Compliance in Medical Device Innovation" -

Mon, 17 Mar 2025 01:34:15 -0400

I think in order create an innovative design that passes all regulatory compliance, it should have an effective Validation Plan. The validation method is required to test the device’s safety and effectiveness, and the results to prove its safety and… Read more»

bsk32 replied to the topic "Planning Techniques" -

Sun, 16 Mar 2025 23:48:44 -0400

Although I worked for a company before with a Team, I don’t have experience Initiating and Managing a Project. I think that as an Engineer becomes more experienced with managing many projects in their career, every process in the project… Read more»

bsk32 replied to the topic "Time vs. Money" -

Mon, 03 Mar 2025 05:37:18 -0500

In order to reduce the time and money needed for a project while also increasing the chance for a successful product is to gather up all previous meeting minutes, schedules, and procedures for previous successful projects. Those can be used… Read more»

bsk32 replied to the topic "Making connections between people and schools" -

Mon, 03 Mar 2025 05:07:17 -0500

Hi everyone. My name is Brandon Klavansky, and I’m a BME MS student at NJIT. I’m looking forward to connecting.

http://www.linkedin.com/in/brandon-klavansky-b66479208

bsk32 replied to the topic "Email Communication" -

Mon, 03 Mar 2025 05:04:35 -0500

I think that email communication is used for official information that includes meeting invites, task delegations, and announcements from the manager. Most companies will use a VPN with a private email server in order to protect sensitive information. Microsoft Teams… Read more»

bsk32 replied to the topic "Project Slack Time" -

Mon, 24 Feb 2025 00:56:21 -0500

I think it depends on what you mean by Slack Time. Unexpected delays can happen and extra time should be given for cases such as failure in Validation or Verification phases. Although it’s initially costly, the time given is valuable… Read more»

bsk32 replied to the topic "Value of Design Controls" -

Mon, 24 Feb 2025 00:41:13 -0500

I agree that feasibility studies will improve the chances of success in the Design Control process and help a project lifetime. Innovative projects are often higher in risk, an can result in the scenario described above, where they discovered a… Read more»

bsk32 replied to the topic "Effective Scheduling in Medical Device Development" -

Mon, 24 Feb 2025 00:12:10 -0500

Using ES, EF, LS, and LF is very helpful for planning for any contingencies. Many factors can cause delay in a schedule such as not thoroughly examining Project or Design Inputs. A device may have required more feasibility data, and… Read more»

bsk32 replied to the topic "Should procedures or standards for verification and validation tests be approved by the FDA?" -

Mon, 17 Feb 2025 05:08:25 -0500

I agree with @gdecarvalho22 above that the FDA indirectly approves the tests as long as the final design and design process shows to comply with FDA standards. If the test parameters are not within what the company claims for either… Read more»

bsk32 replied to the topic "A Hypothetical Perspective about the First Simulation" -

Mon, 17 Feb 2025 04:55:03 -0500

Hypothetically, if the bottles are meant to be stored in 37C due to its contents, then we can’t change the testing parameters. The bottles’ labels must be able to stay adhered to the bottle at 37C. In this case, we’d… Read more»

bsk32 replied to the topic "Verification Failures and Adjusting Test Conditions" -

Mon, 17 Feb 2025 04:43:37 -0500

When Verification tests fail, I think that the best approach is to first evaluate whether the model still fills the need of the customer. The testing parameters could’ve been set incorrectly because they excluded a large amount of customers. In… Read more»

bsk32 replied to the topic "Project Management for Non-PM Positions" -

Mon, 10 Feb 2025 04:47:45 -0500

In my personal experience, I had to jump into a role working with a team in a functional organization, not yet knowing how organizations worked and the meaning of the tasks I was doing. Know that I know how projects… Read more»

bsk32 replied to the topic "Test Method Validation" -

Mon, 10 Feb 2025 04:36:37 -0500

The Design verification and Validation test the design of your product. In an experiment, there are always statistical analysis to determine the significance of the results to prove or disprove the hypothesis. The Test Method Validation is to predict the… Read more»

bsk32 replied to the topic "Determining Spec" -

Mon, 10 Feb 2025 04:24:13 -0500

Determining the spec with tolerances is the most important part in the effectiveness of the design. It really depends on the application and market in my opinion. If it is an orthopedic implant, there should be a plan included to… Read more»

bsk32 replied to the topic "Misclassification of a Device?" -

Mon, 03 Feb 2025 03:37:00 -0500

I agree that those devices may need to be regulated by all three sub-agencies. If the design contains any drug or biologic components, the other agencies might come after us if we don’t get those components approved by them. I… Read more»

bsk32 replied to the topic "Pre-market Approval (PMA) vs. 510(k)" -

Mon, 03 Feb 2025 03:26:31 -0500

A 510(k) is used for class II devices which rely on a predicate device for its design and purpose. If the device is the same category as a long existing device, this form can use the older device as a… Read more»

bsk32 replied to the topic "Handling Conflicts Among Team Members Effectively" -

Mon, 03 Feb 2025 03:21:39 -0500

In order to handle conflicts effectively, we should have open communication from the beginning of the project. Managers need to share what is expected of their employees before the start of the project. One way to handle conflicts is to… Read more»

bsk32 replied to the topic "Design Verification Failures" -

Thu, 23 Jan 2025 01:36:30 -0500

If the cause of failure was with the device design, then verification will take longer, and the timeline should be anticipated to be pushed back. As a project manager, I would confer with the Engineering team to conduct a root… Read more»

bsk32 replied to the topic "Balancing Stakeholder and Customer Values" -

Thu, 23 Jan 2025 01:24:30 -0500

I think where the value goes depends case-by-case. Those decisions are often made before creating a project, and involves outlining the strategy and analyzing the market and economy. If the market and economy favor the needs of customers that aren’t… Read more»

bsk32 replied to the topic "Transitioning to New Technologies During an Ongoing Project" -

Thu, 23 Jan 2025 01:05:24 -0500

Incorporating newer technology will affect the project’s lifetime. Therefore, to determine the effect that newer technology will have, it should first be determined whether the new technology will help the team achieve their goal. Then, it should be determined whether… Read more»

bsk32 replied to the topic "Confidentiality and Transparency in Consulting Agreements" -

Mon, 02 Dec 2024 02:34:39 -0500

Upholding NDAs can build a contractor’s reputation as trustworthy, and help them build relationships with companies. A good contract should be made so that sensitive information should only be shared within the scope of the project. One way to balance… Read more»

bsk32 replied to the topic "Advice before signing an NDA" -

Mon, 02 Dec 2024 02:17:55 -0500

Before signing an NDA, one must read through the entirety of the document and understand every part of it. If there is any discrepancy, all questions must be answered and understood. You should know to what extent the information is… Read more»

bsk32 replied to the topic "Verbal Contracts" -

Mon, 02 Dec 2024 02:11:59 -0500

Written and Verbal contracts are both effective, however, for different purposes. A written contract is much more commonly used because its written agreement can be kept recorded for extended periods of time. An example is a non-disclosure agreement where someone… Read more»

bsk32 replied to the topic "Desicion made by one person" -

Mon, 02 Dec 2024 00:56:26 -0500

I think a solution to this problem could be creating surveys on staff satisfaction with the managers, as well as creating meetings to discuss and align team values and goals. When the manager hears out the opinions from the staff,… Read more»

bsk32 replied to the topic "Forming a Project Team" -

Mon, 02 Dec 2024 00:52:44 -0500

I think each member in a team should be a good fit with the role they take in a team. Relationships can be a challenge, so there should be a balance between have good relationships and knowledge. If someone has… Read more»

bsk32 replied to the topic "Impact of Covid-19 pandemic on organizational behavior" -

Mon, 02 Dec 2024 00:43:19 -0500

During the Covid pandemic, communication between individuals and teams were very impacted. For functional organizations, a clear, hierarchical system must be maintained. Virtual work disrupted this because it prevented in-person supervision on staff members, and ultimately can cause delays in… Read more»

bsk32 replied to the topic "Risk Management Tools" -

Mon, 18 Nov 2024 00:01:46 -0500

The FMEA is most valuable when determining the risks on a device. It can detect additional failure modes that add to the list of possible risks. It determines the risk something can go wrong, and under what criteria a failure… Read more»

bsk32 replied to the topic "Risk Management in the Manufacturing Process" -

Sun, 17 Nov 2024 23:51:27 -0500

I agree that risk avoidance is the best way to deal with any level of risk, especially in manufacturing. However, mitigation tools and acceptance criteria are also important to use in risk avoidance. Certain tools can be used such as… Read more»

bsk32 replied to the topic "Residual risk during device development" -

Sun, 17 Nov 2024 23:43:40 -0500

To determine the acceptable level of risk, it’s important to follow the Risk Management Process. First, do a Risk Analysis and Estimation to list the possible risks of the device for the analysis, and estimate their possibilities and severity for… Read more»

bsk32 replied to the topic "Feeling Safer?" -

Mon, 11 Nov 2024 04:15:33 -0500

Hi elm33, After this week’s lecture, I feel a lot safer knowing about Verification/Validation. These steps are there to catch flaws early on, and if the device will perform its intended function. Verification is there to test if the design… Read more»

bsk32 replied to the topic "Validation vs Verification" -

Mon, 11 Nov 2024 04:08:42 -0500

Verification tests whether design outputs match design inputs. Validation tests whether design outputs satisfies user needs. In my previous job as a Quality Engineer, I took part in the verification tests and validation activities. During the verification tests, we had… Read more»

bsk32 replied to the topic "Effective Use of Design Transfer in Streamlining Production for Medical Devices" -

Mon, 11 Nov 2024 02:20:53 -0500

One way to improve design transfer is to implement the use of CAD drawings so manufacturing can better understand how to make the product. This can include a Bill of Materials, and what to include and not include in the… Read more»

bsk32 replied to the topic "Design Output" -

Mon, 04 Nov 2024 03:48:23 -0500

Companies will have Design Input and Design Specification documents in their DHF. They might not have a Design output because the Design specification might already outline the outputs. In some cases, the device output might not be available until after… Read more»

bsk32 replied to the topic "Benefits of Software Validation" -

Mon, 04 Nov 2024 03:35:01 -0500

Software Validation has many advantages. Software validation ensures that the device meets regulatory standards. This makes for quicker regulatory approval, and market access. If the software is used in a hospital to store patient data, and track their medical history,… Read more»

bsk32 replied to the topic "Validation's Role in Quality Product Development: Insights and Challenges?" -

Mon, 04 Nov 2024 03:22:05 -0500

Validation is very important to ensure that the costumer needs are met. This may involve using Human Clinical Trials. This is a step further that Design Verification, which only checks if the Design specifications are met. In a case where… Read more»

bsk32 replied to the topic "Placebo Effect" -

Mon, 28 Oct 2024 03:45:38 -0400

Placebo affects do not negatively impact a clinical trial. The Placebo group if compared with itself before comparing with the treatment group. Over many subjects, placebos results generally show insignificant data, with varying responses. Even in the case where some… Read more»

bsk32 replied to the topic "Benefits for Patients in Clinical Research" -

Mon, 28 Oct 2024 03:34:41 -0400

I believe that in some cases it’s ok, where in other cases it’s not. In the case of a drug that required an IDE, it might be a good incentive just in case the patient may require additional treatments from… Read more»

bsk32 replied to the topic "Double Blind Vs Single blind Study" -

Mon, 28 Oct 2024 03:28:09 -0400

In a double-blind study, both the Investigator and Patient don’t know whether they’re being given the placebo or actual results. In a single-blind study, only the patient doesn’t know what’s being given to them. A double-blind study is better in… Read more»

bsk32 replied to the topic "Building marketing trust in medical devices: healthcare providers vs patients" -

Mon, 21 Oct 2024 02:34:51 -0400

I agree that providing clear evidence based data on safety and effectiveness is important for doctor’s and patients. I think that patients want to feel that the product is safe and effective regardless on how the company claims that the… Read more»

bsk32 replied to the topic "Difference between Product Development and Product Management" -

Mon, 21 Oct 2024 02:24:17 -0400

Product development is mainly responsible for research and development of devices. They are preoccupied with testing prototypes and designs for either improving current devices, or designing a new one. Product management looks over a project or product life cycle from… Read more»