Medical Device Courses | Luisa Gutierrez | Activity

Luisa Gutierrez replied to the topic "career path" -

Wed, 15 May 2019 16:56:39 -0400

The clinical research path I know would not be something for me. But I do see it to be a good learning experience and provide a great base knowledge in regards to clinical studies and how the whole documentation process… Read more»

Luisa Gutierrez replied to the topic "Clinical Study Location/cost vs. results" -

Wed, 15 May 2019 16:56:34 -0400

I agree with the statement above that the clinical trials may be conducted depending on partially where the disease may be more prominent but the secondary is also the cost. This cost can be whether the company is directly managing… Read more»

Luisa Gutierrez replied to the topic "Consent and predicted outcome" -

Wed, 15 May 2019 16:56:20 -0400

Both of the cases provided above are great representation of a clinical trial going wrong. Companies before reaching the clinical trial stage, they make sure the pre-clinical trials are successful and the device is effective. Also, the company makes sure… Read more»

Luisa Gutierrez replied to the topic "Management Responsibility" -

Wed, 15 May 2019 16:55:42 -0400

That is an interesting point to bring up. Within my current company, I have seen how teams are not allowed bring in more individuals even though the workload has increased. And it is unfortunate because it puts more burden on… Read more»

Luisa Gutierrez replied to the topic "correction vs corrective action" -

Wed, 15 May 2019 16:55:21 -0400

From my experience, I am actually working on a project that currently deals with both. Due to regulation change in Asia on how the packaging is labeled, we were able to create the new product to reflect the change. However,… Read more»

Luisa Gutierrez replied to the topic "Discussion Topic: When Quality Systems change in the middle of a project" -

Wed, 15 May 2019 16:54:41 -0400

I agree that is a change in the quality system occurs, the projects would have to be evaluated and see if the change will completely change the parameters of the project or allow them to be grandfathered in. If a… Read more»

Luisa Gutierrez replied to the topic "Discussion Topic: Vagueness of GMP's" -

Wed, 15 May 2019 16:54:40 -0400

With the way the GMP requirements are set up, it seems that it is trying to make any start-up companies fail. But as mentioned above, the GMP have general requirements to allow any style of company whether it is in… Read more»

Luisa Gutierrez replied to the topic "No GMPs" -

Wed, 15 May 2019 16:54:39 -0400

That is great input to this discussion so far. To add to the idea, the GMP is definitely required to also ensure that the product being sold is consistent. If the documentation used to make the product didn’t provide the… Read more»

Luisa Gutierrez replied to the topic "Product Life Cycle Curve" -

Wed, 15 May 2019 16:54:09 -0400

For the product life cycle, I do think that the introduction around the launch time frame can be very costly. At this point, the company places all the effort into the marketing and preparing for launch to have the adequate… Read more»

Luisa Gutierrez replied to the topic "product manager role" -

Wed, 15 May 2019 16:54:08 -0400

Gp232, I agree with your call out since sometimes people do use those roles interchangeably and they are actually different. Product Manager is keeping track of the product as it evolved from the development phase to launch. I do believe… Read more»

Luisa Gutierrez replied to the topic "Interpersonal Skills" -

Wed, 15 May 2019 16:54:08 -0400

I do agree that both of the interpersonal skill and business knowledge are important during negotiation. However, interpersonal skill should definitely weight more since that is the drive that provides the trust to the customer of the product you are… Read more»

Luisa Gutierrez replied to the topic "Go or Kill" -

Wed, 15 May 2019 16:53:28 -0400

I agree with the statements above. I have seen, similar to Michelle, how a product is placed in the development stages and had the approval of the company based on the market but towards the middle of the project it… Read more»

Luisa Gutierrez replied to the topic "Product Failure" -

Wed, 15 May 2019 16:53:28 -0400

I personally do not have a direct experience to link a product failure but there are some common reasons for the failure to occur. The device can experience some form of contamination whether it is from a chemical attack or… Read more»

Luisa Gutierrez replied to the topic "Discussion Topic: Managing the Product Life Cycle" -

Wed, 15 May 2019 16:53:27 -0400

I agree with the key aspect of the post-launch product management being having the correct sales team to help push the product into the market and be a helpful resource to better understanding the nature of the product. Another key… Read more»

Luisa Gutierrez replied to the topic "Comparing Knowledge of FDA, EU, etc before and after this course" -

Wed, 15 May 2019 16:52:40 -0400

For my experience, this is the fourth class I have taken with Dr. Simon and the content itself has been very helpful to relate to the industry. For instance, the two series of medical device development definitely helped me understand… Read more»

Luisa Gutierrez replied to the topic "Maintenance & validation" -

Wed, 15 May 2019 16:52:37 -0400

I agree with the posts above. The investigation is definitely a key parts that should occur first to be able to find the answer. Even though sometimes it is a long process to find the issue, there are times that… Read more»

Luisa Gutierrez replied to the topic "Simulation" -

Wed, 15 May 2019 16:52:35 -0400

It is a good point brought up that the setbacks are definitely crucial to be taken into account during any product planning process. And with my experience, I have been in companies that make sure to have a six-month supply… Read more»

Luisa Gutierrez replied to the topic "Discussion Topic: Differences between ISO and FDA" -

Wed, 15 May 2019 16:51:46 -0400

I agree with the posts above. The ISO standard provides the flexibility needed to accommodate the needs of the companies but still providing the necessary regulation to process output. But from the FDA side, it provides the monitoring through the… Read more»

Luisa Gutierrez replied to the topic "Process Revalidation" -

Wed, 15 May 2019 16:51:36 -0400

When encountering the movement of equipment in production, I believe that a re-validation is a necessary step. However, as some have mentioned above, it must be identified if a full Validation process is required in order to utilize equipment. This… Read more»

Luisa Gutierrez replied to the topic "Holistic Qualification" -

Wed, 15 May 2019 16:51:34 -0400

Chris, This is a type of qualification that I have not encountered within my daily work but it is interesting to read about it. I found a few details that show how it can expedite the process a product to… Read more»

Luisa Gutierrez replied to the topic "DHF vs. DHR" -

Wed, 15 May 2019 16:50:53 -0400

This link definitely provides a great representation of the difference between the two. Some key aspects of the DHF that are mentioned are that all the activities during the design and development process should be properly collected and should be… Read more»

Luisa Gutierrez replied to the topic "SOP: how much detail before too much detail?" -

Wed, 15 May 2019 16:50:50 -0400

I agree with the comments above that an SOP is a step by step process that provides guidance to the person reading the procedures. In addition, the type of detail that goes into the SOP is crucial to accommodate any… Read more»

Luisa Gutierrez replied to the topic "Quality Management System Documentation Hierarchy" -

Wed, 15 May 2019 16:50:48 -0400

I definitely agree with the QMS system in a small company can start off with various obstacles. But in a sense, it is a necessary rite of passage to get the base standards in place. The tough part is beginning… Read more»

Luisa Gutierrez replied to the topic "Discussion Topic: ECO's" -

Wed, 15 May 2019 16:49:51 -0400

As mentioned above and within Dr. Simon’s video, the ECO is required when the design controls are finished and the device needs a change. With this, it may create more modifications within the regulatory aspect such as SOP changes, additional… Read more»

Luisa Gutierrez replied to the topic "Discussion Topic: Post-market surveillance" -

Wed, 15 May 2019 16:49:47 -0400

I agree with the comments provided so far. The importance of post-market surveillance is to provide the necessary information on the product being used by patients and confirming that is maintaining the safety and efficacy of the product. Also, it… Read more»

Luisa Gutierrez replied to the topic "Regression Verification and Validation" -

Wed, 15 May 2019 16:48:44 -0400

This is an interesting question. In my opinion, it may depend on the type of changed specifications and how that may affect the device. If it is a change in a minor detail of the aesthetics of the device, it… Read more»

Luisa Gutierrez replied to the topic "Discussion Topic: Verification vs. Validation" -

Wed, 15 May 2019 16:48:27 -0400

The verification is when the tests are created for each specification in the DSD to confirm that the design input equals the design output. For instance, if the device is design to be coated black and it was incorrectly coated,… Read more»

Luisa Gutierrez replied to the topic "Discussion Topic: Is the DHF a living document?" -

Wed, 15 May 2019 16:48:24 -0400

I would agree that the DHF is considered a living document due to its importance in holding all the required information during the design controls. However, after the design transfer process is completed, the DHF should be utilized as a… Read more»

Luisa Gutierrez replied to the topic "Combination Products in EU" -

Wed, 15 May 2019 16:48:16 -0400

This is an interesting article. It also points out that a medical device is actually faster and less expensive than a medicinal product. But if the combination product has both a medical device and a medicinal component, that it is… Read more»

Luisa Gutierrez replied to the topic "Guidance Documents" -

Wed, 15 May 2019 16:48:15 -0400

I agree with previous posts in regards to NB-MED Guidance Documents being one of the most useful documents. Since it is written by the notified bodies, it is very useful that they do have the authority to assess and verify… Read more»

Luisa Gutierrez replied to the topic "Discussion Topic: Easier regulatory in EU?" -

Wed, 15 May 2019 16:48:11 -0400

I do agree that the EU has an easier system to approve the medical devices than the FDA approval. Initially all the countries in Europe had their respective rules and they all had to give up their individual rights for… Read more»

Luisa Gutierrez replied to the topic "Legal Contracts" -

Wed, 15 May 2019 16:45:32 -0400

Hello Andrew, I actually do work in a space that deals contracts do perform either research tasks or even with the later stages of the clinical trials and it is tough to get a contract pushed especially if it deals… Read more»

Luisa Gutierrez replied to the topic "Primary Mode of Action (PMOA)" -

Wed, 15 May 2019 16:45:31 -0400

I personally have no experience working with PMOA for combination devices. But the best way to understand what is the PMOA is by seeign the two possible designation. And then evaluate if it were to go through the FDA process… Read more»

Luisa Gutierrez replied to the topic "Multi-Center Clinical Studies" -

Wed, 15 May 2019 16:45:31 -0400

Fady, I do agree with your statement that with multi-center studies, there is a greater chance for variability within the studies. In order to reduce variability, it is important to have the same internal staff throughout the study with proper… Read more»

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

Wed, 15 May 2019 16:44:15 -0400

Dr. Simon, As most have mentioned above, what is really great about these courses is how it provides a glimpse of student with no work experience with a preview of what are some of the engineering aspects to expect in… Read more»

Luisa Gutierrez replied to the topic "Consultants NDAs and CDAs" -

Wed, 15 May 2019 16:44:14 -0400

Fady, This is a great discussion point. From the example you provided, it is definitely violating the NDA or CDA agreement that the consultant and previous company. Not only are they disclosing that company’s name, they are also indirectly exposing… Read more»

Luisa Gutierrez replied to the topic "Restrictions for physician's gifts" -

Wed, 15 May 2019 16:44:14 -0400

Roberto, Fady provides a great example. In my case, whenever dealing with business meetings, it is only the person that is part of the project itself would be eligible to receive the set gifts. Within the industry, these are aspects… Read more»

Luisa Gutierrez replied to the topic "Discussion Topic: Your organizational type" -

Wed, 15 May 2019 16:43:09 -0400

My current work environment is a matrix organization. Within the procurement department, I have had the opportunity to be involved in different projects and collaborate with different SME’s throughout J&J in the medical device and pharma sector. It is an… Read more»

Luisa Gutierrez replied to the topic "Forming a Project Team" -

Wed, 15 May 2019 16:43:07 -0400

It is interesting that in my line of work, there are times that teams are formed due to what projects the team members were involved. And using that experience that can be leveraged for another style of projects. And that… Read more»

Luisa Gutierrez replied to the topic "Project Management Preferences" -

Wed, 15 May 2019 16:43:07 -0400

That is an interesting question Lamiaa. I believe that for a Matrix Organization, even though it is ideal, could pose more challenges to a project manager. One of the main reasons is due to sharing resources that sometimes need to… Read more»

Luisa Gutierrez replied to the topic "The change from ALARP to AFAP" -

Wed, 15 May 2019 16:40:11 -0400

Risk cannot always be eliminated by design solutions. This is why medical devices use protective measures (i.e., – alarms) and inform users of residual risks (i.e., – warnings and contraindications in an Instructions For Use (IFU). The “ALARP” concept has… Read more»

Luisa Gutierrez replied to the topic "Manage Risk" -

Wed, 15 May 2019 16:40:08 -0400

I agree with the comments above. The acceptance leads to a high severity of risk due to the company not any additional steps to deal with the risk. As Dr. Simon has mentioned, sometimes it is cheaper for the company… Read more»

Luisa Gutierrez replied to the topic "Risk Management Mistakes" -

Wed, 15 May 2019 16:40:07 -0400

This is an interesting discussion. The main one that I believe is overlooked is the lifecycle process of risk management. Most companies, as expressed by article, only work with this portion during product development. But is it important to also… Read more»

Luisa Gutierrez replied to the topic "Combination Product Phase I clinical Studies" -

Wed, 15 May 2019 16:38:39 -0400

Good discussion topic. I found this interesting link that provides a helpful visual on page 3 to understand where Phase I Clinical Studies would occur. As per the source, it shows that as part of the design validation, the clinical… Read more»

Luisa Gutierrez replied to the topic "Design Transfer" -

Wed, 15 May 2019 16:38:39 -0400

The benefits to outsourcing the design transfer into manufacturing process are leveraging multidisciplinary expertise have breakthrough ideas from other industries and technologies and be able to expand without needing to maintain the technology in-house. Expand internal engineering capabilities helps to… Read more»

Luisa Gutierrez replied to the topic "When is validation is not required?" -

Wed, 15 May 2019 16:38:38 -0400

In general, validation is an important part of getting a product to market because it verifies that the user needs are met. Even though it may take up to a few years to complete, it can improve the launch success… Read more»

Luisa Gutierrez replied to the topic "What are Design Controls?" -

Wed, 15 May 2019 16:37:17 -0400

I agree with the responses so far. One of the aspects that I think design controls help to bring out in the product development process is risk management. This is a way to take the policies, procedures, and practices to… Read more»

Luisa Gutierrez replied to the topic "Design input sources" -

Wed, 15 May 2019 16:37:11 -0400

I agree with what has been said so far. The design input is the document that provides the basic requirements of the product. It takes the input from different sources like marketing, sales, direct team, customers in order to obtain… Read more»

Luisa Gutierrez replied to the topic "Design Controls for Legacy Combination Products" -

Wed, 15 May 2019 16:37:10 -0400

Fady, That is an interesting point to bring up. With combination products, if I understand correctly, the company must identify first the necessary center for the primary use of the product. Once it is designated into CDER, CBER, or CDRH… Read more»

Luisa Gutierrez posted a new topic "Non-Conformity" -

Wed, 15 May 2019 16:34:05 -0400

In this week’s lecture, Dr. Simon discussed about nonconforming product and how action must be taken to make sure the DMR requirements are met. In addition, any rework must be completed before releasing the product into market. Does anyone have… Read more»