Medical Device Courses | lmedina21 | Activity

lmedina21 replied to the topic "Optimizing Information Distribution" -

Sun, 30 Mar 2025 19:03:14 -0400

Balancing communication methods is very important practice to be able to keep projects running smoothly without wasting valuable time. Some good strategies are to tailor communication to the type of information being shared. For simple updates or information that doesn’t… Read more»

lmedina21 replied to the topic "Change Control in Project Management" -

Sun, 30 Mar 2025 18:56:26 -0400

Organizations are able to maintain balance between control and flexibility through setting clear guidelines and actually structuring how to make project changes. Defining the scope of creativity and encouraging cross-functional collaboration helps teams approach problems with innovative solutions while staying… Read more»

lmedina21 replied to the topic "Significance of Team Development in Project Execution" -

Mon, 17 Mar 2025 00:47:52 -0400

Project execution is rarely static, especially in fields like medical device development where shifting regulations, sudden roadblocks, and changing priorities are the norm. Adaptability isn’t just a nice to have it’s essential. Teams need the flexibility to shift roles, rebalance… Read more»

lmedina21 replied to the topic "Planning Techniques" -

Mon, 17 Mar 2025 00:39:53 -0400

Effective planning can be very essential for the managing of various complex demands in medical device development. This can include but not be limited to including meeting deadlines, staying within budget of the project, as well as tending to regulatory… Read more»

lmedina21 replied to the topic "Different Types of Risks in a Project" -

Mon, 03 Mar 2025 02:23:04 -0500

From my experience project risks come in various forms which include financial, schedule, resource, and quality risks which can all impact a projects success differently in their own way. One common form of risk is the schedule risk in which… Read more»

lmedina21 replied to the topic "Value of Design Controls" -

Mon, 24 Feb 2025 02:40:06 -0500

Balancing rigorous design controls with the flexibility that is needed for innovation is crucial in various regulated industries like medical devices. While strict design controls ensure safety, accountability, and regulatory compliance, as well as proper documentation and formal review processes,… Read more»

lmedina21 replied to the topic "Avoiding Pitfalls in Project Initiation: The Importance of Clear Proposals and Feasibility Studies" -

Mon, 24 Feb 2025 02:18:44 -0500

If you were to start a project without a clear proposal and a feasibility study in can lead to scope creep, resource misallocation and unexpected challenges. A well-structured proposal will align stakeholders on objectives, timelines, and other expected outcomes, while… Read more»

lmedina21 replied to the topic "Project Slack Time" -

Mon, 24 Feb 2025 02:11:47 -0500

Slack is a very crucial element in project planning because it helps accommodate for the unexpected, like delays, vacations, holidays or various emergency closures. Including slack in your schedule also allows for increased flexibility which will prevent the project from… Read more»

lmedina21 replied to the topic "Pre-market Approval (PMA) vs. 510(k)" -

Sun, 02 Feb 2025 23:02:24 -0500

As far as I know PMA and 510K’s are two pathways to get FDA approval to sell their product to the US. For a 510K the company is saying that their device is similar to a device that is already… Read more»

lmedina21 replied to the topic "Difference between drug and medical device?" -

Sat, 25 Jan 2025 19:20:03 -0500

A drug is a treatment that works through a chemical or biological interaction with the body which can impact various cellular pathways or physiological functions to treat, prevent or diagnose diseases. Though a medical device is different because it achieves… Read more»

lmedina21 replied to the topic "Sizes of Project Teams" -

Sat, 25 Jan 2025 19:11:53 -0500

Personally in my field, team size depends on the types of projects you’re working on. Since I work in the development of In-vitro models the kind of research we do can really only be done by one person at a… Read more»

lmedina21 replied to the topic "Leaders: Nature or Nurture?" -

Sat, 25 Jan 2025 19:02:44 -0500

In my opinion, good leaders are born with emotional intelligence, and learn how to manage projects logistically in the company. A good leader takes into account both the logistics of the team, their skills, their work, and what they need… Read more»

lmedina21 replied to the topic "Advice before signing an NDA" -

Mon, 02 Dec 2024 02:09:04 -0500

When someone signs an NDA it is very crucial to review and understand the agreement as best as possible, some key considerations is the definition of confidential information, the level of confidentiality as well as the duration of the agreement… Read more»

lmedina21 replied to the topic "Discussion Topic: Course conclusion and impressions" -

Mon, 02 Dec 2024 01:53:14 -0500

I found that this course ended up focusing on the practical aspects of the medical device industry rather just the theoretical knowledge which was very interesting, there were a lot of insights into the real world application and processes. I… Read more»

lmedina21 replied to the topic "Written Agreement v/s Verbal Agreement" -

Mon, 02 Dec 2024 01:41:12 -0500

In my field written agreement is a very important aspect of our work. When we share research outside of the company we have to come up with agreement documents to outline what information is to be shared or not, who… Read more»

lmedina21 replied to the topic "Hazard, Hazardous, Harm" -

Mon, 18 Nov 2024 02:42:57 -0500

Since i mainly have worked in many lab setting there are a lot of hazards we come into in the biological sense, where at times we need to work with harsh chemical like paraformaldehyde or even other cases where we… Read more»

lmedina21 replied to the topic "Ways to deal with risks" -

Mon, 18 Nov 2024 01:45:50 -0500

In medical device companies there are a lot of ways to implement risk avoidance, mitigation and acceptance from what I learned in the field there are design changes in the medical device as a way to use biocompatible materials as… Read more»

lmedina21 replied to the topic "To risk manage or not to risk manage?" -

Mon, 18 Nov 2024 01:41:39 -0500

I believe risk management is an important aspect of risk management because it ensures patient safety because any malfunction or failure can lead to significant harm. There is also requirements in the FDA and other health bodies that require risk… Read more»

lmedina21 replied to the topic "Project Proposal" -

Sun, 03 Nov 2024 23:25:01 -0500

As someone who works in a research field the project proposals created in my field may be different as our work tends to also focus on publications and research based goals. Overall they tend to formulate in similar ways. Background… Read more»

lmedina21 replied to the topic "Minutes for meetings" -

Sun, 03 Nov 2024 23:20:14 -0500

At work I have implemented the use of meeting minutes as a way to highlight project progress and highlight team member achievements. In the minute meetings we all highlight the main progress in our projects which can then be easily… Read more»

lmedina21 replied to the topic "Validation vs Verification" -

Sun, 03 Nov 2024 23:16:57 -0500

In industry, I had experience with method validation and verification as part of the work I did on our machines. The main differences between the two is mainly how validation involves ensuring that the product meets our customers’ or laboratory’s… Read more»

lmedina21 replied to the topic "Non for profits" -

Thu, 10 Oct 2024 23:42:55 -0400

Having worked at a non-profit tissue bank in research and development, I found it quite shocking that the business model was more profit focused than I expected. The tissue bank I had worked for sold its products to other hospitals… Read more»

lmedina21 replied to the topic "First Job: What type of company to choose?" -

Thu, 10 Oct 2024 23:27:45 -0400

Since I have been in school continuously and went straight into my PhD I don’t have the most insight in choosing the right first job, but I do have experience at both small and big companies in terms of internships… Read more»

lmedina21 replied to the topic "Examples and ways to improve quality assurance" -

Mon, 07 Oct 2024 02:00:33 -0400

One of the key ways to ensure manufacturing safety is by having a clean and organized workspace. This helps locate the necessary materials easily and prevents the loose or misplaced items that could cause injuries. Regular machinery inspections are also… Read more»

lmedina21 replied to the topic "What are some ways Document Control can improve?" -

Mon, 07 Oct 2024 01:57:07 -0400

While document control will be more manageable for the QA and R&D departments if documents are completed without errors, missing information, or false data. Balancing research and documentation simultaneously is one of the most challenging aspects of the job, since… Read more»

lmedina21 replied to the topic "Perception of QA/QC" -

Mon, 07 Oct 2024 01:13:11 -0400

I see that Quality is very crucial in todays market where it is a key differentiator for various products and services. Both QA and QC are essential for businesses to meet customer expectations. QA focuses on proactive measures in the… Read more»

lmedina21 replied to the topic "Animal Diversity in Pre-clinical Research" -

Sun, 22 Sep 2024 23:03:37 -0400

Animal diversity is important and definitely played a big role in my previous research doing biofabrication for Vocal Fold Fibrosis models, in the decision making process for what animals we wanted to use there was a lot of previous work… Read more»

lmedina21 replied to the topic "Discussion Topic: Biomaterial Selection" -

Sun, 22 Sep 2024 22:57:07 -0400

Biomaterial selection is big in my line of work. This can play a big role into what fabrication method is used for creation of our various models and mechanical characterization of these samples are a very big issue, especially in… Read more»

lmedina21 replied to the topic "Animals used for research and for food" -

Sun, 22 Sep 2024 22:38:22 -0400

While I understand the moral issues behind animal studies, at the current moment our technology is not fit for doing only in-vitro work to get through pre-clinical studies. As someone who is working in biofabrication right now, it is the… Read more»

lmedina21 replied to the topic "Which feature is the most important for a project manager?" -

Sun, 15 Sep 2024 21:49:21 -0400

Project management in my opinion is more about managing a project but about managing people and their workflows to get something done. A good project manager must be flexible to change, creative, and easy to work with. There are a… Read more»

lmedina21 replied to the topic "People in a Project" -

Sun, 15 Sep 2024 21:18:00 -0400

In my opinion, teamwork is a very important aspect of getting a project done, but despite that not always will you be placed in an ideal team, I believe part of being a project manager means also understanding how people… Read more»

lmedina21 replied to the topic "Project on time and within budget: What should be the strategies of a project manager?" -

Sun, 15 Sep 2024 19:40:01 -0400

I’m not a project manager but when I was still doing internship I had interned at a place that made me do some hardware project management at a start up. Most of the work I was doing was focused on… Read more»

lmedina21 replied to the topic "Academia or Industry Preference?" -

Sun, 08 Sep 2024 12:47:45 -0400

Starting off, I’m willing to admit I am a lot more biased towards industry. I have had many working experiences in industry and the style of workflow matches to what I want out of MY career. That being said, I… Read more»

lmedina21 replied to the topic "Grades and GPA's in graduate education" -

Sun, 08 Sep 2024 12:19:00 -0400

So me personally, during undergrad whenever I would search for jobs or internships I would always see GPA requirements associated with the position and as an okay student there would be time that my grades would not always match up… Read more»

lmedina21 replied to the topic "Thoughts on BS, MS, and PhD in BME" -

Wed, 04 Sep 2024 17:29:58 -0400

As a first year PhD with about 2 years of industry experience I have been witness to the paper ceiling in industry. All my colleagues are in senior roles and all have PhD’s. I have seen people who have been… Read more»

lmedina21 became a registered member

Tue, 03 Sep 2024 14:16:09 -0400