Medical Device Courses | mmd55 | Activity

mmd55 replied to the topic "Skills Learned in this Class" -

Tue, 26 Apr 2022 01:10:29 -0400

In this class and working in industry, one of the most important things I have learned is the importance of being kind and listening to others. It is very important have soft skills, which is generally something that engineers lack…. Read more»

mmd55 posted a new topic "Understanding Project Management as a Non-Project Manager" -

Tue, 26 Apr 2022 01:02:07 -0400

In this course, we’ve learned about project management as it relates to medical devices. For people interested in becoming project managers, there is a clear benefit to taking this course. However, not every person is going to become a project… Read more»

mmd55 posted a new topic "Lessons Learned Documents: When to look back" -

Tue, 26 Apr 2022 00:50:47 -0400

While at work, I was discussing lessons learned documents with my coworkers. They mentioned it being an incredibly useful tool for transferring project knowledge. They then described that despite it being a useful tool, it’s very difficult for people to… Read more»

mmd55 replied to the topic "How was this class helpful" -

Wed, 20 Apr 2022 19:25:34 -0400

I think this course was useful for several reasons. The biggest help is the discussion of design controls and relevant industry terms/processes and how they link to project management structures. In academia, there is a lack of education on what… Read more»

mmd55 replied to the topic "Quick, Fast, Good? Pick Two" -

Wed, 20 Apr 2022 19:13:32 -0400

In my experience in observing clinical trials where I work, the emphasis usually tends to be on the “Good” and “Fast”. Quality is very important and running an appropriate study is necessary to get a medical device approved, so sacrificing… Read more»

mmd55 replied to the topic "Why do people work?" -

Wed, 20 Apr 2022 19:02:41 -0400

I’m not very surprised by the reasons that motivate people. The factors that are mentioned make a lot of sense to keep people happy and trying their best in the work that they do. For me personally, I work because… Read more»

mmd55 replied to the topic "Potential PM?" -

Mon, 11 Apr 2022 18:47:51 -0400

I think I would make a successful project manager. From what we’ve learned, communication is one of, if not the, most important skill for a successful project manager. I consider communication to be broken down into 2 parts: communication between… Read more»

mmd55 posted a new topic "Time Management" -

Mon, 11 Apr 2022 18:33:48 -0400

As we’ve learned, a main function of a Project Manager is to keep the project on track. However, as in any project, problems will arise and will need to be addressed which may threaten project timelines. Has anyone worked on… Read more»

mmd55 posted a new topic "Most Important Project Management Knowledge Areas" -

Mon, 11 Apr 2022 18:25:17 -0400

Of the Project Management Knowledge Areas (Scope Management, Time Management, Cost Management, Risk Management, Procurement Management, People (HR) Management, Quality Management, Communications Management, Stakeholder Management, and Integration Management), which do you consider to be most important and why?

Thanks,
Matt

mmd55 replied to the topic "Premature approval and rushing products to market" -

Wed, 06 Apr 2022 14:27:47 -0400

In the medical device industry, there is a large push to be first-to-market and minimize project timelines in order to capture/increase market share, increase revenue, and reduce costs. Sometimes, businesses will push the ethical envelope in order to do this…. Read more»

mmd55 posted a new topic "Design Transfer Project Management" -

Wed, 06 Apr 2022 14:09:33 -0400

Design Transfer is a critical step of Design Controls during which product and process designs are transferred to production from R&D. I learned at work recently that there are specific Project Managers and teams dedicated to overseeing this transition. Can… Read more»

mmd55 replied to the topic "Testing" -

Wed, 06 Apr 2022 13:46:03 -0400

From working in a testing group, one common strategy I see for developing fast and low cost testing is by taking advantage of compendial test methods. Compendial test methods are test methods that have been used in the past and… Read more»

mmd55 replied to the topic "Verification Protocols vs. Reports" -

Mon, 21 Mar 2022 18:58:30 -0400

In my opinion, both verification protocols and reports are incredibly important however if I had to choose, I think that verification reports are more important than verification protocols. As @anthonynjit described above, a verification protocol lists what is going to… Read more»

mmd55 replied to the topic "Tendency for project management in medical devices field" -

Mon, 21 Mar 2022 18:11:10 -0400

From my limited experience working within a medical device company, I’ve noticed that my company doesn’t have a defined project management department but rather select engineers that are within different sections of the organization that are designated project managers. These… Read more»

mmd55 replied to the topic "Making connections between people and schools" -

Mon, 21 Mar 2022 16:24:49 -0400

Hi All,
Here is my LinkedIn page.
Matthew DaSilva | LinkedIn ( https://www.linkedin.com/in/matthewmdasilva/ )
I look forward to connecting with you all!
Thanks,
Matt

mmd55 replied to the topic "Career Path to becoming a project manager" -

Tue, 08 Mar 2022 23:26:00 -0500

I think this is an excellent question! Becoming a project manager is something that I can see myself doing in the future and I’ve spoken to several project managers where I currently work about their career paths/experiences. I think it’s… Read more»

mmd55 replied to the topic "Difference in communication when working from home" -

Tue, 08 Mar 2022 23:12:50 -0500

In my brief experience working since the pandemic has started, I’ve found that it is really on you (the employee) to set the work-life balance boundaries. As you said, the line between home-life and work-life has become ever blurred and… Read more»

mmd55 replied to the topic "Verification Test" -

Tue, 08 Mar 2022 22:59:49 -0500

I agree with @anthonynjit its impossible to design a design verification test that is guaranteed not to fail. The purpose of design verification is to make sure that your inputs = outputs. It’s an important part of the design control… Read more»

mmd55 posted a new topic "Unique Project Risks for Medical Device Companies" -

Mon, 28 Feb 2022 00:08:52 -0500

Medical Device companies face unique challenges when running/developing projects due to high risk and complexity that may not exist in every industry. Can anyone thing of any unique challenges that may exist for Medical Device/Healthcare Project management? For example, Medical… Read more»

mmd55 replied to the topic "Importance of Stakeholders" -

Sun, 27 Feb 2022 23:55:25 -0500

I agree with @anthonynjit in that both are very important with the project manager edging out the stakeholder for importance. @anthonynjit raises a really great point about “No amount of funding can override the decisions of poor management.” Since the… Read more»

mmd55 replied to the topic "Project Slack Time" -

Sun, 27 Feb 2022 23:45:48 -0500

Incorporating slack into a project timeline/schedule is critically important. I’ve learned in school and at work that in any project, anything that can go wrong will go wrong (A little something called Murphy’s Law). Slack is something to help prevent… Read more»

mmd55 posted a new topic "Project Manager Changes" -

Tue, 22 Feb 2022 19:56:03 -0500

Due to the lifetime of projects, there may not always be one project manager for the entire duration of a project. What are some difficulties that can arise when a project manager change occurs? What are some challenges that someone… Read more»

mmd55 replied to the topic "Time vs. Money" -

Tue, 22 Feb 2022 19:45:35 -0500

I completely agree with @ridmehta , I would also argue that time is more valuable. @ridmehta raises a great point by discussing how cutting corners and getting a project done quickly can ultimately become more costly in the long term… Read more»

mmd55 replied to the topic "Project Management Tools" -

Tue, 22 Feb 2022 19:34:48 -0500

In my experiences working in projects, I have found Gantt charts to be very useful in helping to visualize timelines and tasks, and for identifying critical path items that need to be completed. I’ve worked on several projects where the… Read more»

mmd55 posted a new topic "Supply Chain and Project Management" -

Fri, 18 Feb 2022 21:13:23 -0500

The optimization of supply chains has had a tremendous impact on every industry. With this constant push to make processes faster and more efficient, how do you think this has impacted the project management processes? How has supply chain optimization… Read more»

mmd55 replied to the topic "Risk Management" -

Thu, 17 Feb 2022 23:02:31 -0500

I agree with pv223, transference is not a feasible risk management strategy in the medical device/pharmaceutical field. Like pv223 mentioned, avoidance and mitigation are the two primarily used strategies with mitigation being preferred. In Dr. Simon’s medical device development course,… Read more»

mmd55 replied to the topic "Different Types of Teams for Different Size Companies" -

Thu, 17 Feb 2022 22:43:04 -0500

In my career so far, I’ve only ever worked at a large company. Since the company is very big, there are teams dedicated to very specific things (Exactly like you and Dr. Simon mentioned). To me, this question boils down… Read more»

mmd55 posted a new topic "Test Method Validation" -

Tue, 08 Feb 2022 00:27:40 -0500

In my current role, I often hear a lot of discussion about Test Method Validation and how it relates to design controls. I’ve also noticed there tends to be confusion around how TMV’s relate to Design Verification and Design Validation…. Read more»

mmd55 replied to the topic "Types of organizations" -

Tue, 08 Feb 2022 00:17:11 -0500

I don’t have too much experience working or knowledge in medical device companies to say which organization approach is most common. However, from my experiences I have noticed Matrix-based organizations to appear more frequently in major medical device companies. I… Read more»

mmd55 replied to the topic "Different Project Manger Approaches" -

Tue, 08 Feb 2022 00:06:00 -0500

I prefer to work for bosses/project managers that take a more hands-off approach. Personally, I think this allows project team members more autonomy in their work and reduces pressure. As long as the project team members are able to accomplish… Read more»

mmd55 posted a new topic "Career Decisions: Managerial Vs. Technical Tracks" -

Sun, 06 Feb 2022 01:24:17 -0500

After working for a company for several years, many engineers are eventually faced with making a decision about their careers: Do they want to pursue a Managerial or Technical track. Often times, a managerial track can mean project or people… Read more»

mmd55 replied to the topic "Design Controls" -

Sun, 06 Feb 2022 01:10:44 -0500

I don’t think there is one “essential” design control. Design control is an essential process that guidelines how to create a safe and effective medical device, so each step in the process is essential in achieving that. Each of the… Read more»

mmd55 replied to the topic "Sizes of Project Teams" -

Sun, 06 Feb 2022 00:56:19 -0500

Personally, I enjoy working in a larger project team. As you’ve said, “people can have different backgrounds and areas of expertise” and I think that really adds value when working in a project-setting. The biggest advantage is that these different… Read more»

mmd55 posted a new topic "Regulatory Project Management" -

Wed, 26 Jan 2022 01:08:59 -0500

As we’ve learned, the regulatory role is crucial in the development of medical devices in order to meet all requirements set forth by the FDA. That being said, how important is project management for people with Regulatory roles? Has anyone… Read more»

mmd55 replied to the topic "Importance of management skills" -

Wed, 26 Jan 2022 00:56:14 -0500

I think the most important management skill to grasp is understanding conflict. There are 2 types of conflict: Relationship-based and Task-based. Relationship-based conflict is when a person is disagreeing with another person, for example personal attacks, “People vs. People”. Task-based… Read more»

mmd55 replied to the topic "Roles of the Regulatory Department" -

Wed, 26 Jan 2022 00:47:55 -0500

Posted by: @ajy6 Product development and post-market management are the two major functions of the regulatory department. Out of the two, which one would you want to work for and why? Also, which one seems to be the most important. … Read more»

mmd55 replied to the topic "Projects and Programs" -

Sun, 23 Jan 2022 03:37:35 -0500

Some major advantages of grouping projects under a program include sharing/leveraging resources, personnel, and project capital, as others have mentioned. Another major advantage that I have noticed from the programs where I work is that similar projects can allow a… Read more»

mmd55 replied to the topic "Does Organizational Structure change how you prioritize ?" -

Sun, 23 Jan 2022 03:20:24 -0500

One particular skill that helps me keep projects on track is strict time management. Not only is it important to have the timeline set and agreed upon early in the project initiation & planning phases, but it is also critical… Read more»

mmd55 replied to the topic "What kind of projects interest you the most?" -

Sun, 23 Jan 2022 02:49:58 -0500

I agree with @cassiem , I think that the projects that interest me the most are difficult and complex projects. Difficult projects allow you to push outside your comfort zone and achieve things you may have thought you were not… Read more»

mmd55 replied to the topic "Consultants in the Medical Device Industry" -

Tue, 23 Nov 2021 02:05:36 -0500

I, personally, have never worked with consultants in the Medical Device industry. However, I do think consultants can be a very useful tool. One area I think that consultants can be of use, in particular, is the supply chain. Specifically,… Read more»

mmd55 replied to the topic "Discussion Topic: Course conclusion and impressions" -

Tue, 23 Nov 2021 01:49:31 -0500

Hi Dr. Simon, At the start of the semester, in one of your very first lectures you said that this course will get you a job. At the time, I didn’t think that could be true. As the class continued… Read more»

mmd55 posted a new topic "Non-compete agreements" -

Tue, 23 Nov 2021 01:28:50 -0500

I recently received a job offer and while reviewing my offer I noticed I would have to sign a non-compete agreement, which is an industry standard. I asked the recruiter if I would be able to read the non-compete before… Read more»

mmd55 replied to the topic "Forming a Project Team" -

Tue, 16 Nov 2021 01:13:17 -0500

Posted by: @fo3 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project according to their expertise/role. How would… Read more»

mmd55 replied to the topic "Organization types of medical devices?" -

Tue, 16 Nov 2021 01:00:38 -0500

Posted by: @cef3 So there may be more than just the 3 main organization types that Dr. Simon presented in the lecture: http://blog.hubspot.com/marketing/team-structure-diagrams. Say you were to start up a medical device company that will function worldwide. What type of… Read more»

mmd55 replied to the topic "Your Organizational prference; but why?" -

Tue, 16 Nov 2021 00:46:48 -0500

Personally, I have only worked in a Matrix-based organization and really enjoy this organization structure. Out of the three options, I think the Matrix-based would be my preference because of the sharing of departmental knowledge between colleagues. I think this… Read more»

mmd55 replied to the topic "To risk manage or not to risk manage?" -

Tue, 09 Nov 2021 23:00:12 -0500

Posted by: @jaf22 In the world of medical devices, there is no such thing as a waste of money for risk assessment. When a device deals with aiding in human function with direct contact to user, then there is a… Read more»

mmd55 replied to the topic "Benefits of post-market surveillance" -

Tue, 09 Nov 2021 22:37:32 -0500

Posted by: @tulikadasp To make sure medical devices remain safe and effective once it’s on the market – medical post-market surveillance (PMS) is done. It a system that provides continuous feedback about a device on the market in order to… Read more»

mmd55 replied to the topic "Dealing with risk" -

Tue, 09 Nov 2021 22:26:01 -0500

Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting? I think that risk in medical device development is incredibly different than many other… Read more»

mmd55 replied to the topic "Customer Needs, Business Requirements, Test Plan" -

Tue, 02 Nov 2021 22:05:29 -0400

Posted by: @jtl27 This week’s discussion reminds me a lot of what we had to learn in our capstone design class senior year. The three biggest deliverables for that class other than our powerpoint presentations were the two documents that… Read more»

mmd55 replied to the topic "Customer Needs and Design Input" -

Tue, 02 Nov 2021 21:48:54 -0400

Posted by: @rv347 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»