Medical Device Courses | jbh8 | Activity

jbh8 replied to the topic "Time Management in Medical Devices" -

Mon, 15 Apr 2024 01:09:56 -0400

One way to mange time effectively when developing biomedical devices is to determine the critical path. This method involves identifying the longest sequence of dependent tasks that needs to be completed in order to finish the project. Managers and team… Read more»

jbh8 replied to the topic "Which factors should be followed while deciding number of alternative vendors ?" -

Sun, 14 Apr 2024 21:09:15 -0400

The decision on the number of alternative vendors likely uses the same criteria used for solicitation planning. The evaluation criteria of price, understanding of need by seller, overall/life cycle cost, technical capability, management approach, and financial capacity was likely used…. Read more»

jbh8 replied to the topic "Benefits associated with Work Breakdown Structure" -

Mon, 08 Apr 2024 03:46:43 -0400

A WBS facilitates better project planning because it requires the project manager and other team members to have a clear understanding of what must be undertaken to reach the intended project goal. Essentially it transitions the project from being a… Read more»

jbh8 replied to the topic "Project Management Knowledge Areas" -

Mon, 08 Apr 2024 03:20:27 -0400

To ensure all elements of the project are properly coordinated among the 10 knowledge groups, planning meetings should be conducted to ensure every element is appropriately managed. Such meetings during the planning phase allow for the initialization of open communication… Read more»

jbh8 replied to the topic "Collaborative Research in Academia and Industry" -

Mon, 08 Apr 2024 03:06:04 -0400

One strategy I think that could be implemented is tier-based data sharing. While working as an intern, I noted in Outlook there were sensitivity labels for emails: General, Public, Non-Business, Confidential, and Highly Confidential. Applying a similar labeling approach is… Read more»

jbh8 replied to the topic "Verification & Validation NDAs" -

Mon, 25 Mar 2024 03:41:10 -0400

NDAs are ways to ensure a company’s confidential information about their product stays within their personnel and necessary external parties such as the FDA. As the previous user had stated, their use and what information they seek to prevent disclosure… Read more»

jbh8 replied to the topic "Transference of Risk in Medical Device Companies" -

Mon, 25 Mar 2024 03:00:43 -0400

Typically in the medical device industry, avoidance, mitigation, and acceptance are used as risk management approaches. Transference is uncommon. If used, as others have stated before, insurance is used as a means of transferring risk to another party. Another way… Read more»

jbh8 posted a new topic "Monitoring and Controlling in a Project" -

Mon, 25 Mar 2024 01:57:31 -0400

This week, we learned about what would need monitoring and controlling in a project such as the schedule, budget, resources, performance, and scope. For example, the schedule can change when a part doesn’t arrive by its planned date. Thus, the… Read more»

jbh8 replied to the topic "Success Rate of Projects" -

Mon, 11 Mar 2024 03:39:12 -0400

A majority of users defined success as the successful completion of the project; they focused more on the internal industry team’s perspective of success. From a business perspective, factors such as adoption of use, investment return, market share, and customer… Read more»

jbh8 posted a new topic "Examples of when Design Validation is Not Required" -

Mon, 11 Mar 2024 02:58:27 -0400

Design validation checks if the product’s inputs are equal to the product’s user needs or intended use. This types of testing studies the product under its intended environment/conditions. However, it is not always needed. It is essentially shows whether the… Read more»

jbh8 posted a new topic "Email Communication" -

Mon, 11 Mar 2024 01:24:00 -0400

Information distribution is essential during the executing process. Being up to date regarding emails and voice messages helps project managers remain informed regarding the current status of the project. Whether an individual is in academia or industry, their inbox is… Read more»

jbh8 replied to the topic "EF and LF in Medical Device Development" -

Mon, 04 Mar 2024 02:13:04 -0500

After reading through the replies to my original post (the topic starter), I noticed a trend in medical devices suggested by previous posts that is likely to have a late finish and early finish. As the complexity and newness of… Read more»

jbh8 replied to the topic "Difficulty of a Project" -

Mon, 04 Mar 2024 00:22:37 -0500

I agree with a previous user that stated management of project scope is the most difficult part of a project. This previous user focused more on the scheduling and planning aspect of scope management. Another aspect of project scope management… Read more»

jbh8 replied to the topic "PMI Talent triangle" -

Sun, 03 Mar 2024 23:53:54 -0500

The importance of strategic and business management proficiency in a project manager’s skill set should not be undervalued. Having an understanding of the business context is important when working in the medical device industry. Project managers are able to make… Read more»

jbh8 replied to the topic "It's the Right Thing To Do" -

Fri, 23 Feb 2024 19:03:23 -0500

One ISO standard I think would always be followed if ISO requirements did not exist is: ISO 10993, the standards for biocompatibility. This standard calls for evaluation of all data from materials, prior use, clinical data, and testing performed. Its… Read more»

jbh8 posted a new topic "EF and LF in Medical Device Development" -

Thu, 22 Feb 2024 05:03:14 -0500

Task scheduling has four important date types: early start (ES), early finish (EF), late start (LS), and late finish (LF). Projects that can achieve project initiation on the early start date and completion on the early finish date are preferable…. Read more»

jbh8 replied to the topic "FS and SF in Gantt Chart Relationships" -

Thu, 22 Feb 2024 04:51:41 -0500

I’ll be providing a start-to-finish relationship example that occurred a few semesters ago on campus. The implementation of the new parking tapping card access system must be completed before the old swiping card access system is removed represents a SF… Read more»

jbh8 posted a new topic "Feasibility Research vs Marketing Research" -

Sun, 18 Feb 2024 23:04:18 -0500

In addition to enterprise environmental factors, organizational process assets, and project initiator/sponsor, the initiating process group requires pre-feasibility/feasibility data and business case/business assessment model (BAM). The research department can spend significant time, potentially years, collecting pre-feasibility/feasibility data.…[Read more]

jbh8 replied to the topic "Post-project lessons learned" -

Fri, 16 Feb 2024 03:36:05 -0500

During my internship, I reviewed lengthy documentation as part of my summer-long project and recorded my findings in an Excel workbook. I was not aware of all of the shortcuts and tools offered in Excel. As a result, organizing my… Read more»

jbh8 posted a new topic "Avoidance in each Project Area" -

Wed, 14 Feb 2024 22:08:41 -0500

In the medical device industry, there are 3 ways to manage risk: avoidance, mitigation, and acceptance. Risk management does not occur on only the product design, but also on the product itself and its manufacturing process. Avoidance is the most… Read more»

jbh8 posted a new topic "Remote or In-Person PM" -

Fri, 09 Feb 2024 21:11:55 -0500

Following the Covid-19 pandemic quarantine, remote work has become a more common option. However this in turn effects team dynamics, especially teams formed during or after lockdown. Would you prefer to work under a project manager that primarily communicates online… Read more»

jbh8 replied to the topic "Project Management for Non-PM Positions" -

Fri, 09 Feb 2024 20:56:03 -0500

A basic understanding of project management is critical because there are many benefits associated with the skills and abilities acquired through project management. The skillset is invaluable in a medical device field. Such skills can help in being more successful…. Read more»

jbh8 replied to the topic "How to ensure the project is on schedule to meet deadline" -

Mon, 05 Feb 2024 23:20:07 -0500

One method to ensure the project remains on schedule to meet deadlines is identification of the critical path. The critical path is the longest sequence of dependent activities (in time) that are required to complete the project. Identification ensures the… Read more»

jbh8 replied to the topic "Leaders: Nature or Nurture?" -

Mon, 05 Feb 2024 04:57:27 -0500

I agree with previous replies that have stated although leadership is a mixture of nurture and nature, it is ultimately nurture that influences the leadership qualities of an individual. Although we have “inherited” leadership qualities from our parents, in reality,… Read more»

jbh8 replied to the topic "Strategies for Conducting Effective Design Review Meetings" -

Mon, 05 Feb 2024 04:48:27 -0500

One strategy that can be undertaken to ensure smooth document approval is establishing early on team expectations of the documentation. The author should be informed of what standards they must be fulfilling when generating the documentation. This will lead to… Read more»

jbh8 replied to the topic "Different Project Manger Approaches" -

Wed, 31 Jan 2024 22:27:59 -0500

Within teams, I prefer a boss who is more hands off. However, I think it is still dependent on whether this boss is willing to have a regular progress meeting. Based on my academic and professional experience, I have seen… Read more»

jbh8 replied to the topic "Ambiguity in Medical Device Classification" -

Mon, 29 Jan 2024 04:46:30 -0500

I both agree and disagree with the benefits of “overclassifying” a device as mentioned in a previous reply. On one hand, reclassifying a device from Class III to Class II is preferable to the opposite case in terms of not… Read more»

jbh8 posted a new topic "Combination Product Project Management" -

Mon, 29 Jan 2024 04:20:30 -0500

Combination products are devices that have two or more regulated components such as drug/device, biologic/device, etc. Companies are typically focused on producing one type of product, either biologics, drugs, or devices. Therefore, they are likely to create a combination product… Read more»

jbh8 posted a new topic "Project Manager Experience" -

Mon, 29 Jan 2024 01:55:48 -0500

In the medical device industry, managers will usually have some background in a science related field either academically or professionally. In the academic case, at minimum they usually have a basic science degree; at the other end, they can have… Read more»

jbh8 replied to the topic "How to increase emotional intelligence" -

Mon, 22 Jan 2024 04:56:13 -0500

Although I am unsure this would be considered a pure objective way to increase emotional intelligence, I think journalling is an acceptable first step. The key with journaling is to be completely honest to oneself when writing down their experiences…. Read more»

jbh8 replied to the topic "More Influence or Less?" -

Mon, 22 Jan 2024 04:38:50 -0500

As previous replies had mentioned, each contribution of a team member may not be equal based on the nature of the project. Some projects may require more expertise from certain individuals compared to others on the team. An individual may… Read more»

jbh8 replied to the topic "Emotional Intelligence" -

Mon, 22 Jan 2024 04:26:34 -0500

Emotional intelligence is extremely important to project success is 70% due to interpersonal skills compared to 30% due to technical knowledge. Typically projects are run by teams. In order to successfully collaborate, interpersonal skills, specifically emotional intelligence is essential. Reflecting… Read more»

jbh8 posted a new topic "International Contract Law" -

Fri, 01 Dec 2023 15:14:33 -0500

Contract law is the basis for business. Without contract law, business would not occur. Trust is established through contract law. Societies function due to the respect for law and order. Therefore, contract law strength is indicative of company strength. However,… Read more»

jbh8 replied to the topic "Discussion Topic: Course conclusion and impressions" -

Fri, 01 Dec 2023 14:54:29 -0500

Overall, I found this course very informative and interesting. I believe much of what I learned will be helpful when I make the transition from graduate school to industry. I enjoyed the discussion forum because it gave students a platform… Read more»

jbh8 posted a new topic "Benefits of Consulting Experience as a Recent Graduate" -

Fri, 01 Dec 2023 14:43:35 -0500

Consulting offers both obvious advantages and disadvantages as a job for a recent college graduate. With the current job market, the probability of being hired for a permanent position in industry immediately after graduation is likely lower. Thus, consulting presents… Read more»

jbh8 posted a new topic "Impact of Covid-19 pandemic on organizational behavior" -

Sat, 25 Nov 2023 04:48:02 -0500

This past week, we learned about the 3 types of organizations: functional, project-based, and matrix. These are the typical ways a company organizes its workforce to engage in project activities. However the Covid-19 pandemic lockdown forced the workforce to accept… Read more»

jbh8 replied to the topic "Seniority and Old Habits Vs. Newbies and New Techniques" -

Sat, 25 Nov 2023 04:09:05 -0500

Similar to previous replies, I also believe that contacting upper management is a last resort. Involving upper management in this type of situation reflects poorly on the communication skills within teams. This issue can be resolved through better interpersonal communication… Read more»

jbh8 posted a new topic "Matrix Strength" -

Fri, 24 Nov 2023 22:54:37 -0500

In matrix organizations, the power of project managers and functional heads varies. Temporary project teams are formed from each department and may be led by a project manager to complete a project. The dynamics and workflow of the team is… Read more»

jbh8 posted a new topic "Risk Management in the Manufacturing Process" -

Mon, 20 Nov 2023 03:33:17 -0500

Risk management is not exclusive to one area of the project, but rather it is applied to multiple areas: the product, product design, and the manufacturing design. All areas apply the same process and principles with different groups. In this… Read more»

jbh8 replied to the topic "Risk Acceptance" -

Mon, 20 Nov 2023 00:58:49 -0500

Risk acceptance essentially is acknowledging but taking no action towards a risk based on certain criteria. Risk acceptance may create a higher probability of risk, but it will not guarantee the risk will occur. Rather, there are factors taken into… Read more»

jbh8 replied to the topic "Hazard, Hazardous, Harm" -

Sun, 19 Nov 2023 23:39:57 -0500

A patient is fitted for their first back brace following a scoliosis diagnosis. However during that fitting, the prosthetist/orthotist had incorrectly written the waist measurement to be significantly smaller than the patient’s true waist size. The back brace now poses… Read more»

jbh8 posted a new topic "Design Matrix Content" -

Sun, 12 Nov 2023 18:28:07 -0500

The Design Matrix is an extremely useful tool to get a fuller picture of the design process. It compiles inputs, specifications, validation, and verification information. It is a spreadsheet with each information type in its respective column. Do you think… Read more»

jbh8 posted a new topic "Validation Study Success Defined" -

Sun, 12 Nov 2023 16:15:50 -0500

Validation is how companies confirm there is objective evidence demonstrating that their processes consistently produce either a result or product that fulfills its predetermined specifications. A successful study must be clearly defined and fixed to avoid moving target success criteria…. Read more»

jbh8 posted a new topic "Benefits of Software Validation" -

Fri, 10 Nov 2023 21:02:08 -0500

Software validation is an important tool in ensuring the device software and software operations are of desired quality. There are several long-term benefits such as decreased failure rates, less recalls and needed corrections, and lowered risk. There are many more… Read more»

jbh8 replied to the topic "Different Standards for Design Controls" -

Sun, 05 Nov 2023 02:13:18 -0500

I think one factor that influences how a company interprets these guidelines are previous product documentation that were used in successful products (products that were approved and performed well in the market). This previous documentation could serve as reference to… Read more»

jbh8 replied to the topic "Design Controls Component" -

Fri, 03 Nov 2023 18:30:39 -0400

Of the nine components, the three most interesting ones are: inputs, design history file, and planning. Inputs are essential to the overall success of a product. This phase pushes manufacturers to address the product as an attainable device that fulfills… Read more»

jbh8 posted a new topic "Design Input Requirement Categories" -

Wed, 01 Nov 2023 23:37:51 -0400

Design input requirements typically can be sorted into 3 categories. These requirement categories are: functional, performance, and interface. Functional requirements specify what the device does, which includes its operational characteristics, and input processing and resulting outputs. Performance requirements specify use… Read more»

jbh8 posted a new topic "Clinical Trial Participation" -

Mon, 30 Oct 2023 03:04:30 -0400

Clinical trials enable improved and/or emerging medicines and medical devices to be developed and later available to a wide consumer population. Patient participation makes clinical trials possible. Without them, clinical trials cannot be conducted to fulfill regulatory requirements and knowledge… Read more»

jbh8 replied to the topic "Balancing Scientific Rigor and Ethical Considerations in Clinical Trials" -

Mon, 30 Oct 2023 02:34:14 -0400

One consideration taken should be the benefit-risk ratio. Researchers should determine whether the benefits outweigh the risks by asking whether risks have been minimized and benefits maximized to their full potential. Have all the possible steps been taken to ensure… Read more»

jbh8 posted a new topic "Diversity and Inclusion in Clinical Trials" -

Mon, 30 Oct 2023 01:13:04 -0400

Clinical trials are an important step in evaluating product performance to determine its appropriateness as a commercially available product to the wider population. It’s essential to understand all of the potential effects the product can have on humans. Therefore, it… Read more»