https://medicaldevicecourses.com/members/mmejia91/activity/ Activity feed for mmejia. Sat, 16 May 2026 08:28:56 -0400 https://buddypress.org/?v= en-US 30 hourly 2 edee669b7c8df309be06301029350f92 https://medicaldevicecourses.com/activity/p/19217/ Sat, 30 Nov 2019 04:48:29 -0500 @ajm73A PA physician pleaded guilty to accepting kickbacks from Insys in exchange for prescribing Subsys, a form of fentanyl. Insys labeled the payments as educational seminars that turned out to be falsely labeled. These seminars were held but were not…   Read more»

]]> e1d482713c6475a4ac433e0f296d6030 https://medicaldevicecourses.com/activity/p/19216/ Sat, 30 Nov 2019 04:13:49 -0500 This course left me with the idea that medical devices are not just devices; they are essentially entire departments made up of people of different backgrounds working on a project to make this device possible. A company is thought to…   Read more»

]]> 8836c85d548c08d4bac46b17121b749d https://medicaldevicecourses.com/activity/p/19215/ Sat, 30 Nov 2019 03:58:19 -0500 While I have never been involved in meetings with outside consultants, I have had supervisors hire senior level physical therapists (PT) affiliated with our organization. I say affiliated as a researcher working with volunteers on one wing of our campus…   Read more»

]]> dbca9f049f7b059d8f5d7726b9451e65 https://medicaldevicecourses.com/activity/p/19156/ Sun, 24 Nov 2019 00:46:28 -0500 I think it is natural to believe that it takes a gradual rise from entry level to middle management to upper management. An entry level employee is given a very specific set of tasks based on his specific role within…   Read more»

]]> eea2fce7745b41e8de0783f8eab773b6 https://medicaldevicecourses.com/activity/p/19155/ Sun, 24 Nov 2019 00:36:40 -0500 It is important to to have a blend of positive personality and relevant experience among all project members. Managers generally have the option to choose their subordinates through an interview process, but depending on the company other employees may or…   Read more»

]]> 13481e8a825b6e89141b9b4757a77a2c https://medicaldevicecourses.com/activity/p/19154/ Sun, 24 Nov 2019 00:12:43 -0500 At this point we are at the stage where our roles are set. We’re researching our roles more closely and outlining the best way to present the most quality information. We submit in each of our corresponding forms the information…   Read more»

]]> d2fd46e33cbcf603552f2a1bf2640634 https://medicaldevicecourses.com/activity/p/19083/ Sat, 16 Nov 2019 03:52:19 -0500 I agree with your assertion that there needs to be a line that sets the amount of risk associated with the device that can be managed. However, “as far as possible” may not be thought of as where the line…   Read more»

]]> ba454b9ccd070a48bc13988f0bbd4420 https://medicaldevicecourses.com/activity/p/19082/ Sat, 16 Nov 2019 03:41:06 -0500 I believe at this point labels are a formality for companies to avoid litigation. The example of a coffee cup with a WARNING HOT label is always one that comes to mind. Everyone knows coffee is hot, but one person…   Read more»

]]> 7abe154a97aa86fb406d991182ed54c1 https://medicaldevicecourses.com/activity/p/19081/ Sat, 16 Nov 2019 03:09:28 -0500 All drugs contain a level of risk to the user. Many of these chemicals are labeled safe by the FDA only in instances where a licensed physician may see fit for their patient. However, in devices that require drug delivery,…   Read more»

]]> a768843b06137d9a9e7a60f632bba898 https://medicaldevicecourses.com/activity/p/19030/ Sat, 09 Nov 2019 17:35:51 -0500 @traceymrawI believe this article explains the expanding role academia now has on the medical device development process, as shown in this picture below. This “paradigm shift” explains that the role of academia in recent years has taken on more responsibility…   Read more»

]]> ffe269fdc0480880a34b5ea56e230223 https://medicaldevicecourses.com/activity/p/19029/ Sat, 09 Nov 2019 17:19:37 -0500 Verification is a constant process for devices such as computer-assisted surgical systems (CASS). Initially CASSs were approved for use in minimally-invasive surgery such as hysterectomy and prostatectomy. As the market grew for CASSs, the case to use these devices in…   Read more»

]]> 704bcd5d361b0d5f74f76f1fe68ad091 https://medicaldevicecourses.com/activity/p/19028/ Sat, 09 Nov 2019 16:53:40 -0500 @as934This is a good idea to consider for future studies, especially ones that incorporates physical activity. With the growing smart wearable market upon us this is becoming increasingly affordable over time. For a project that includes an ECG in their…   Read more»

]]> d848b51a70b7f2075c69066b4786025b https://medicaldevicecourses.com/activity/p/18988/ Sun, 03 Nov 2019 19:50:48 -0500 The main difference between verification and validation is the end user. Verification is more or less a premarket step that distinguishes between the design inputs and outputs. This looks to answer the question of how closely the current design matches…   Read more»

]]> 3b7613b976885cf46efd9ed0f817fb6e https://medicaldevicecourses.com/activity/p/18985/ Sun, 03 Nov 2019 19:36:04 -0500 I was the secretary in my undergraduate BMES and among my roles was writing minutes for all our meetings. This was an important task as it gave us in charge the ability to check back and corroborate any future decisions…   Read more»

]]> b572963e9a374e8b68c3d98c6b3b869c https://medicaldevicecourses.com/activity/p/18915/ Sat, 26 Oct 2019 04:34:14 -0400 Without naming any names, has anyone ever experienced an AE during a clinical trial, either as an investigator or patient?I have never had one happen during an experiment, but I have had several patients report AEs that occurred during their…   Read more»

]]> 00e93b949fd39b4e13920c4e7eedd22a https://medicaldevicecourses.com/activity/p/18914/ Sat, 26 Oct 2019 04:04:32 -0400 It is important to find the root cause of death before making any initial assessments on what to blame. The responsibility will depend on the language in the informed consent regarding risks and adverse events. I have not been involved…   Read more»

]]> a1a2b49bc36143a9f250c9ce0652a34c https://medicaldevicecourses.com/activity/p/18913/ Sat, 26 Oct 2019 03:54:18 -0400 I would like to work in a position where I’m involved with data collection and processing, so either a CRA or investigator. However, I also would consider a position such as a monitor where I’m looking over the protocol and…   Read more»

]]> 44d9a7189d713b2174a8597257243c7a https://medicaldevicecourses.com/activity/p/18847/ Sat, 19 Oct 2019 18:05:06 -0400 Cardinal Health, Inc. (CAH) general SWOT analysis:StrengthsLarge and growing revenue stream ($136.8 billion in 2018 and up about 190% since 2005)Large audience (over 100,000 product locations)Large share of hospital market (over 75% US hospitals with CAH equipment)Largest share of nuclear…   Read more»

]]> 700b27c52387010d72610e5e7166481f https://medicaldevicecourses.com/activity/p/18846/ Sat, 19 Oct 2019 17:44:23 -0400 Cardinal Health, Inc. (CAH)StrengthsLarge revenue stream ($136.8 billion in 2018)Large audience (over 100,000 product locations)Large share of hospital market (over 75% hospitals with CAH equipment)

]]> ad0b0a52c0990466adbe6be93688f3ce https://medicaldevicecourses.com/activity/p/18845/ Sat, 19 Oct 2019 17:42:20 -0400 Cardinal Health, Inc.StrengthsLarge revenue stream ($136.8 billion in 2018)

]]> be614c866dcf3f4471c9526b612aeeeb https://medicaldevicecourses.com/activity/p/18844/ Sat, 19 Oct 2019 17:41:06 -0400 I choose to perform a SWOT analysis on Cardinal Health:Strengths: Incredibly large stream of revenue, generating over $136 billion in 2018

]]> 9b30c5934e59ca7c209ed008f31f7c37 https://medicaldevicecourses.com/activity/p/18843/ Sat, 19 Oct 2019 17:25:03 -0400 Marketing is spreading a brand to the world. People, such as celebrities or athletes, market themselves as the product, and spread their brand through their respective media, either on TV or with their own tangible products that spin-off from your…   Read more»

]]> 8ae3200deda67be73351aa717fc8a3c0 https://medicaldevicecourses.com/activity/p/18841/ Sat, 19 Oct 2019 16:46:11 -0400 GEICO is the first company I think of when I think of consistently memorable marketing strategy. A promotional letter was sent from GEICO to my dad once during their promotions featuring a camel who loves Wednesdays, or “hump day”. My…   Read more»

]]> c5d18e437c90d368bfe376866cf4edf3 https://medicaldevicecourses.com/activity/p/18789/ Sat, 12 Oct 2019 01:41:09 -0400 LLPs are generally left for a few professionals that may all co-manage their partnership, while LLCs can be managed by a small number of owners relative to total ownership. LLCs have the option to be further taxed as either an…   Read more»

]]> ad54e5e13319ce1cf6a76c16e8255705 https://medicaldevicecourses.com/activity/p/18788/ Sat, 12 Oct 2019 01:13:38 -0400 Public companies are owned by stockholders that participate in a stock exchange where anyone can pitch in, while private companies are owned by stockholders that may sell, buy, or trade stock with anyone of their choice. Private companies have more…   Read more»

]]> 0d55b1fbd8248de43f5127dee7391c01 https://medicaldevicecourses.com/activity/p/18787/ Sat, 12 Oct 2019 00:53:24 -0400 In the case of many companies, their ownership decides whether they will require to make business as an S-Corp or C-Corp from where they primarily make business. A domestically based corporation with international negotiations may still apply as an S-Corp….   Read more»

]]> 1b6959366867041c158c38c85b861afa https://medicaldevicecourses.com/activity/p/18743/ Mon, 07 Oct 2019 01:28:54 -0400 @traceymrawTo go along with your research suggestion, specifically human research is vital to understand the effect of these new technologies on society. Companies in charge of IP within these new technologies must have a robust customer service department that will…   Read more»

]]> f05bc49969db96287b861dc5d94540d3 https://medicaldevicecourses.com/activity/p/18742/ Mon, 07 Oct 2019 01:21:57 -0400 QA is “part of quality management focused on providing confidence that quality requirements will be fulfilled”, according to ISO-9000. QA is crucial in the medical field because it helps to identify the standards of medical equipment and services. The Research…   Read more»

]]> 1bf1501f9c60572c4d38c4b83777d274 https://medicaldevicecourses.com/activity/p/18730/ Sun, 06 Oct 2019 20:09:59 -0400 I have been audited by the IRB and the process is very bureaucratic. The quality system of all studies contain several forms and standards such as subject consent and HIPAA forms, but also case report forms and researcher notes, that…   Read more»

]]> 053a510ea6c41ca3abad1c3d484023ae https://medicaldevicecourses.com/activity/p/18670/ Mon, 30 Sep 2019 00:26:00 -0400 Levamisole is a medication used to treat parasitic worm infections, and more recently, colon cancer. While it is on the World Health Organization’s List of Essential Medicines, it has been discontinued in the US since 1999 for unknown reasons. One…   Read more»

]]> ad0f531c5eaa5349a07013cc21dd88c0 https://medicaldevicecourses.com/activity/p/18666/ Sun, 29 Sep 2019 23:44:36 -0400 Senseonics, makers of the first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes, recently recalled their devices approximately 1 year after FDA approval. The recall was a result of a…   Read more»

]]> 00585b7c1471c2234ee79e4710b58009 https://medicaldevicecourses.com/activity/p/18661/ Sun, 29 Sep 2019 18:45:47 -0400 I believe some recalls are as a result of a new technology brought up too quickly to realize its unfortunate side effects. For example, take lead paint or asbestos, materials that for a long time were accepted in mainstream use…   Read more»

]]> 98cba310e6ecf0cec9860a503dd7f511 https://medicaldevicecourses.com/activity/p/18604/ Sun, 22 Sep 2019 00:47:14 -0400 Any study that involves multiple partners from a distance, the laws, regulations, and practices of the partners’ corresponding agencies and governments must be enforced. The situation becomes tougher in this regard with international partnerships. However, even for domestic studies, a…   Read more»

]]> 4ba2e4deeb57c08092b1aa43a09a5193 https://medicaldevicecourses.com/activity/p/18603/ Sun, 22 Sep 2019 00:14:07 -0400 Humans are animals, so the entire world of medicine revolves around animal testing. Pre-clinical research allows us to test our devices on animals that aren’t human. The unfortunate risks and consequences of research testing must be strictly understood and enforced…   Read more»

]]> 87fe8e50d4aa2fedc778fbb50d4763ed https://medicaldevicecourses.com/activity/p/18602/ Sat, 21 Sep 2019 23:36:18 -0400 All research is vital for the progression of science and knowledge. Academia and industry have allowed us the ability to prioritize solutions to the biggest problems. There tends to be a larger urgency for industrial research because of the closer…   Read more»

]]> 6c163503c55250453c0a5779f6638565 https://medicaldevicecourses.com/activity/p/18528/ Sun, 15 Sep 2019 04:05:44 -0400 I think the type of industry is not the deciding factor of how project management is structured. I believe whether it is a medical device company or any other industry, the professional hierarchy of the company is what determines the…   Read more»

]]> 44f4c78753bce4fee6ec9df2a989f864 https://medicaldevicecourses.com/activity/p/18527/ Sun, 15 Sep 2019 03:38:32 -0400 During our planning stage my team realized part of our existing equipment was not generating reliable data. A customer service engineer was able to locate an error in the software and while 2/4 components ended up rectifying, the rest of…   Read more»

]]> b6bb3d3521e201e084a813446259ab8d https://medicaldevicecourses.com/activity/p/18526/ Sun, 15 Sep 2019 03:13:13 -0400 Combination devices would need to follow the sum of the rules and regulations required for each separate aspect, in addition to rules and regulations required for combination devices. This makes combination devices more resource heavy as far as time and…   Read more»

]]> 6069dda275a2dd6d374a542347bb515b https://medicaldevicecourses.com/activity/p/18455/ Sat, 07 Sep 2019 19:33:18 -0400 No one will truly know how they feel about academia or industry until one has experience in both. Unless you are dead set on the academic or industry lifestyle, you will have to try both and decide from there. I…   Read more»

]]> df67b6b587cae4d46e24e8ac12a2c162 https://medicaldevicecourses.com/activity/p/18450/ Sat, 07 Sep 2019 18:51:58 -0400 As for the jack of all trades discussion, I agree that students who have yet to decide on a career path have a vast sea of opportunities in front of them. A master of none is simply one who has…   Read more»

]]> dd9faa257a933136f4d5c5588b6e639e https://medicaldevicecourses.com/activity/p/18449/ Sat, 07 Sep 2019 18:45:32 -0400 @eh76You raise an excellent point on the connection between the work of a BME as it relates to direct human involvement. As BMEs we are the largest engineering based profession that directly obverses the human body as the main body…   Read more»

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