Activity | Anthony | Medical Device Courses

Anthony replied to the topic "Medical Device Companies and the Labs That Use Their Devices." – 5 years, 10 months ago

“High Complexity Tests This category includes those tests that are modified by the laboratory, developed by a laboratory, or a test classified as high complexity under CLIA. Laboratories under CLIA and COLA also must comply with Section §493.1201 (general QC):… Read more»
Anthony replied to the topic "Possibility of Global Regulation of Medical Devices?" – 5 years, 10 months ago

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Anthony replied to the topic "Determining project priority" – 5 years, 10 months ago

In an ideal world a company would fully fund projects large and small, but I think priority will ultimately come down to a risk reward analysis, how much money a company is willing to put into a project versus how… Read more»
Anthony replied to the topic "Design Review Meeting" – 5 years, 10 months ago

In addition to giving ample time for members of the project team to review documents before their approval, I think that it would be beneficial to have frequent short meetings in between official design review document approval meetings. I think… Read more»
Anthony replied to the topic "Design Control Process" – 5 years, 10 months ago

I haven’t had the opportunity to work in industry yet, but if I could choose one of the nine parts of design controls to focus on I would choose design validation. Having a product that is ready for a clinical… Read more»
Anthony replied to the topic "Possibility of Global Regulation of Medical Devices?" – 5 years, 10 months ago

I do not think that the medical device community as a whole is moving towards a globalization of regulatory procedures because as we have learned in lecture, the approach to regulation regarding drugs and medical devices has been a reactive… Read more»
Anthony replied to the topic "Update to Classification System" – 5 years, 10 months ago

Over a medical device’s lifetime the amount of information regarding its safety and effectiveness will increase and can possibly reduce the risk associated with the device. If this happens there is a reclassification process that can be used to update… Read more»
Anthony replied to the topic "FDA Approves First Digital Pill in USA" – 5 years, 10 months ago

With the standard pill, not containing the event marker, there were 6 clinical trials done to get the drug approved. With the addition of the marker the new combination product required new clinical trials using the prior 6 trial data… Read more»
Anthony replied to the topic "''Quality Plan'' meaning ?" – 5 years, 10 months ago

In my experience working in clinical diagnostic laboratories I have had to adhere to many quality control standards and guidelines. When a new device is being validated for clinical use it must have a clear quality control procedure and tracking… Read more»
Anthony replied to the topic "Funding in Medical Devices Industry" – 5 years, 10 months ago

As someone who has never worked in industry, I’m curious to know what happens when a project does get scrapped. I’m sure the repercussions would be determined by the size of the company, but if a project loses funding or… Read more»
Anthony replied to the topic "Discussion Topic: State of your Organization" – 5 years, 10 months ago

I am not currently working in the medical device industry, but throughout my career as a Medical Technologist I have experienced what it is like to work in a strictly functional organization. Previously I worked for a company called BioReference… Read more»
Anthony replied to the topic "Should Interpersonal skills be more valuable than technical skills?" – 5 years, 10 months ago

In response to vcf3, ih37, and jl959, I feel there has been a misunderstanding of what the 70:30 ratio actually represents. When it is said that an individual’s success relies 70% on interpersonal skill and 30% technical knowledge, I do… Read more»
Anthony posted a new topic "Choosing a CRO" – 5 years, 10 months ago

Does partnering with a CRO reduce project risk? If you do choose to partner with a CRO how do you go about choosing the CRO? My initial thought was that hiring a CRO does indeed reduce risk, but then I… Read more»
Anthony posted a new topic "Medical Device Companies and the Labs That Use Their Devices." – 5 years, 10 months ago

The lab I work for purchased a new automated diagnostic machine about a year ago and I had the luxury of validating the device for use. It is called nanoString DX digital analyzer and prep station, the test is called… Read more»
Anthony replied to the topic Choosing a CRO in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

ec52 and Sk90, thank you for your responses. The answers you’ve provided about CRO selection criteria, questions to ask when inquiring about them, and selecting at least three to evaluate are valuable insights. Sk90, the data exporting point you bring up is becoming more and more important as technology evolves, will the data be stored onsite or…[Read more]
Anthony started the topic Choosing a CRO in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

Does partnering with a CRO reduce project risk?
If you do choose to partner with a CRO how do you go about choosing the CRO?

My initial thought was that hiring a CRO does indeed reduce risk, but then I got stuck with the questions: How do I pick the right CRO to partner with? and do I pick the cheapest or the most reputable?

In the following…[Read more]
Anthony replied to the topic Discussion Topic: Outsource vs. Insource the clinical trial in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

I think outsourcing a clinical trial is the most efficient option for a medical device company. In my opinion I think that outsourcing will free up human resources for working on additional projects and ensure that the trial is completed by professionals as fast as possible while maintaining compliance with all the clinical trial rules and…[Read more]
Anthony replied to the topic Avoiding Tunnel Vision in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

Tunnel vision can lead to the downfall of a project because you may miss valuable information or indicators while focusing on a single task. I think the best way to avoid tunnel vision is to have an experienced project team that has open communication and are willing to voice their opinion when they think tunnel vision is occurring or if they feel…[Read more]
Anthony replied to the topic How was this class helpful in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

I have gotten the most out of the simulations from this course. They teach you to not only think about a scientific or technical solution to a problem that may arise during a project, but to also think about other factors such as interpersonal relations and business strategy. After receiving feedback from the previous simulation and finding out…[Read more]
Anthony replied to the topic Changining staff in the forum Project Management Knowledge Areas 5 years, 11 months ago

If you are in a weak matrix organization then the functional heads may have more power than the project managers and may dictate who is allowed to be on your project team and for how long. These employees will still have to answer to their functional heads who may pull them off of a project entirely for whatever reason. If all parties are taking…[Read more]
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