https://medicaldevicecourses.com/members/krp76/activity/ Activity feed for krp76. Fri, 24 Apr 2026 14:09:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 52bf711c1706e397d6eac89f392f4fc0 https://medicaldevicecourses.com/activity/p/14451/ Wed, 15 May 2019 18:57:06 -0400 An NDA is a useful tool when pitching your idea to prospective investors and even when searching for patent attorney’s for your idea. By state and federal law patent attorney’s would have an obligation to not reveal your idea and…   Read more»

]]> acf6fc2c85ef498e68c3912b8f767b7b https://medicaldevicecourses.com/activity/p/14449/ Wed, 15 May 2019 18:57:04 -0400 An example of kickbacks that happened within NJ about a decade ago involved many of the top orthopedic device companies in the area. Zimmer, Biomet, Depuy, Smith & Nephew, and Stryker (although Stryker was not directly fined for kickbacks they…   Read more»

]]> b30a1e0a78b005abcb2591eb89362d7e https://medicaldevicecourses.com/activity/p/14416/ Wed, 15 May 2019 18:55:55 -0400 I do not believe this is an over-restriction in fact the companies do have many loopholes. During undergraduate I worked part time as a clinical research coordinator for a pain management practice and every week at least 3-4 times a…   Read more»

]]> e0ec1b682978341099d45ea942dcac20 https://medicaldevicecourses.com/activity/p/14245/ Wed, 15 May 2019 18:54:23 -0400 Currently I work as a Process Engineer and the organization type I work in is a matrix organization. We have associate directors in our group and a director that oversees several departments and has the strategic outlook for our Manufacturing…   Read more»

]]> 961e1d828993b2988a17dff5e74d5bc2 https://medicaldevicecourses.com/activity/p/14244/ Wed, 15 May 2019 18:54:23 -0400 Organizational type depends on the goals of the company. Larger companies with multiple product lines and established brands would benefit from a matrix organization. In this situation the main advantage is the information flow between departments and knowledge transfer between…   Read more»

]]> 3212d41ea834dcba21614129ca27b101 https://medicaldevicecourses.com/activity/p/14243/ Wed, 15 May 2019 18:54:22 -0400 I agree with Ginger that it would be ideal to work with people are knowledgeable and easy to collaborate with. In my current role as a Process Engineer I work in a matrix organization and have to deal with many…   Read more»

]]> 0176a3a4fd2a886eec374206aee6f765 https://medicaldevicecourses.com/activity/p/14126/ Wed, 15 May 2019 18:52:15 -0400 My current role is that of process engineer at my company, within the manufacturing and science technology division. During this phase of the products life cycle we have to assess risks that arise from global investigations usually related to user…   Read more»

]]> 4ed200ba5ceed3b8414a042e188f3d42 https://medicaldevicecourses.com/activity/p/14125/ Wed, 15 May 2019 18:52:14 -0400 The best strategy in running risk management meetings is to ensure understanding of the device. A basic understanding of the device components, it’s functionality, and how the end user will be utilizing the device are all key in recognizing risks…   Read more»

]]> 86440e4e372090dd1a1482c85088717d https://medicaldevicecourses.com/activity/p/14124/ Wed, 15 May 2019 18:52:13 -0400 I agree with aaq2 in respect to mitigation being the best strategy for countering high severity risk. I do not agree with the fact that risk acceptance is wise option based off cost of acceptance being less than the cost…   Read more»

]]> 36224c50279b7bf5e8fe011e84582518 https://medicaldevicecourses.com/activity/p/14028/ Wed, 15 May 2019 18:51:12 -0400 I agree with dbonanno1 that you can rationalize failures during the verification process. For example, at work we have a new combination product releasing and I was part of the team conducting verification shipping study. As a precautionary action in…   Read more»

]]> 7c640f1a2f1e5302553776ffa3296a0c https://medicaldevicecourses.com/activity/p/14027/ Wed, 15 May 2019 17:10:32 -0400 I agree with dbonanno1 that you can rationalize failures during the verification process. For example, at work we have a new combination product releasing and I was part of the team conducting verification shipping study. As a precautionary action in…   Read more»

]]> 2320ec09f743ef88e338da4f7434974a https://medicaldevicecourses.com/activity/p/14025/ Wed, 15 May 2019 17:10:31 -0400 A successful validation process will ensure that each requirement for a use is fulfilled, essentially end user needs are met. An important aspect of a validation plan is knowing your target customer/end user so that you can confirm that the…   Read more»

]]> 72a314e6a9e920b76a36e6ffb4bee1af https://medicaldevicecourses.com/activity/p/14024/ Wed, 15 May 2019 17:10:31 -0400 As mentioned in previous posts design verification is an important step in design control process to ensure that the inputs are equal to the design outputs. Verification is an important step as the testing done during verification can satisfy both…   Read more»

]]> c707a667637f138e9e608208a2b11174 https://medicaldevicecourses.com/activity/p/13969/ Wed, 15 May 2019 17:09:59 -0400 Ensuring that your DHF is constantly updated is the best practice in ensuring that it will have all the necessary documents during an audit. As discussed in the past 2 weeks of class the DHF is a living document and…   Read more»

]]> 4d02003e27a162e99fee59c5bb9d1c65 https://medicaldevicecourses.com/activity/p/13865/ Wed, 15 May 2019 17:08:56 -0400 Insufficient design controls will result in a loss for the company. The loss will occur first off by the product not making it to market and this will result in a trickle down effect. As the time, money, and energy…   Read more»

]]> 44a0653ab735e909f821af3737b0cbc5 https://medicaldevicecourses.com/activity/p/13864/ Wed, 15 May 2019 17:08:55 -0400 Since the DHF is important for both informative purposes and audit it is essential that the file maintain accurate information as a “living document”. The best step towards this is having a dedicated team in the product development phase assigned…   Read more»

]]> 583021362796e22b019c91b20e245aa7 https://medicaldevicecourses.com/activity/p/13863/ Wed, 15 May 2019 17:08:55 -0400 Design controls are mandated by the FDA according to 21 CFR (Code of Federal Regulations) towards medical device manufacturers. They are guidelines that help to ensure a proper quality device is created and provide checks and balances for the manufacturer….   Read more»

]]> 0a1c88efac2c578d229d6962e18c1c4c https://medicaldevicecourses.com/activity/p/13714/ Wed, 15 May 2019 17:07:29 -0400 Placebos have been viewed as a necessary process in bolstering scientific proof on the effectiveness of products and evidence that one product is superior to another, within many industries. Personally I believe that placebos are necessary in order to gain…   Read more»

]]> fc67ed05744205b722b6aa6a9d359ea5 https://medicaldevicecourses.com/activity/p/13713/ Wed, 15 May 2019 17:07:28 -0400 In my opinion double blind studies are more accurate as it sets a reliable baseline for the trial. As an example from the lecture would be the double blind multi-center study. In this example Dr. Simon shows that a doctor’s…   Read more»

]]> 59d4f1a3b7c13f2817df819e5633db42 https://medicaldevicecourses.com/activity/p/13711/ Wed, 15 May 2019 17:07:27 -0400 Having clinical trial experience is definitely advantageous in the medical device field as you encounter problems that may not have been thought about during the design of the product, and gives good insight into human factors of the product. After…   Read more»

]]> 32e2d438496d01d742aa8b49cee2aeb8 https://medicaldevicecourses.com/activity/p/13600/ Wed, 15 May 2019 17:06:24 -0400 There are multiple strategies that medical device companies utilize to roll out their devices. Medical device companies utilize strategies that are focused on marketing products towards medical professionals and utilizing academic and medical conferences in order to spread the word…   Read more»

]]> b988f309ef6cdc5a2e27110841905301 https://medicaldevicecourses.com/activity/p/13597/ Wed, 15 May 2019 17:06:23 -0400 One grand strategy that is frequently used in medical devices and technology companies is product development. Product development deals with the company investing heavily in research and development in order to launch new and innovative products to market. The overall…   Read more»

]]> 0e7249f049113d948625ea5d811e888d https://medicaldevicecourses.com/activity/p/13595/ Wed, 15 May 2019 17:06:22 -0400 Interesting video with of course an exaggerated view but definitely touches on a lot of the concepts discussed in this weeks topic. Due to the lack of technical expertise each department was not able to focus in on the problem…   Read more»

]]> ce36c4142f7f4124fecf4a150a5ccc08 https://medicaldevicecourses.com/activity/p/13451/ Wed, 15 May 2019 17:04:59 -0400 Netflix financials and state of company. P/E ratio: 244.39 Gross Margin: 31.72 Operating Margin: 4.3 ROI: 3.49 Revenue: 8.83 Billion Market Cap: 86.13 Billion Share Price: $199.49 EPS: 0.15 vs 0.16 expected (July 2017) From these financials it is clear…   Read more»

]]> b1d812f9fe9f6dd058e6ff635ae575a8 https://medicaldevicecourses.com/activity/p/13445/ Wed, 15 May 2019 17:04:57 -0400 Public vs Private companies, the largest difference between the two is that private companies are not publicly traded, while public companies have shares traded on exchange funds available to the public. The main reason a company chooses to go public…   Read more»

]]> b9609715df37a4d72a72ebe43e7b5326 https://medicaldevicecourses.com/activity/p/13443/ Wed, 15 May 2019 17:04:56 -0400 For positions out of school I believe it is more important in determining the type of experience you will receive from the company and the depth of your role, rather than the type of company. Initially you want to gain…   Read more»

]]> d6385735eb971df5186418132954459d https://medicaldevicecourses.com/activity/p/13346/ Wed, 15 May 2019 17:04:10 -0400 My current role dealing with engineering change controls involved document control and properly maintaining records of changes in manufacturing of medical device and pharmaceutical products. This information is used for regulatory filings, quality control, health authority filings, and audits. The…   Read more»

]]> 1be0ce5e30560daf656f820c6d452502 https://medicaldevicecourses.com/activity/p/13325/ Wed, 15 May 2019 17:03:55 -0400 The dynamic is interesting and I have a middle ground perspective between the two fields. As a Process Engineer in my companies manufacturing and science technology group my role deals in bridging the gap between R&D and manufacturing, therefore I…   Read more»

]]> 31b91977a08f0f21d420bcf73b3a89e2 https://medicaldevicecourses.com/activity/p/13324/ Wed, 15 May 2019 17:03:54 -0400 Quality can definitely burdensome for medical and pharmaceutical companies and is a key driving factor in the high cost of delivering good products to the consumers. For a portion of my role as a Process Engineer we have teams dedicate…   Read more»

]]> a0c66fc0874bd2cce7fd00d510b4a909 https://medicaldevicecourses.com/activity/p/13128/ Wed, 15 May 2019 17:02:10 -0400 The user fees increase could be a benefit for the industry as it has the potential to increase the regulatory timeline for FDA. This can allow for drugs and medical devices to reach market quicker and aide thousands of patients…   Read more»

]]> 1560ca64496b479216cead39385d98d1 https://medicaldevicecourses.com/activity/p/13126/ Wed, 15 May 2019 17:02:09 -0400 A recent prominent recall that happened was part of Johnson & Johnson’s orthopedic subdivision Depuy Synthes. In this situation J&J was found negligent in properly informing consumers that their metal on metal hip implant (Pinnacle Hip implant) had a design…   Read more»

]]> 2be9b8397c821df3ea218be000848eb7 https://medicaldevicecourses.com/activity/p/13125/ Wed, 15 May 2019 17:02:08 -0400 An antibiotic hip stem would be considered a combination product “as defined by 21 CFR 3.2 (e)”. The primary mode of action of this hip stem would be to provide similar functionality and support of a hip and the antibiotic…   Read more»

]]> ef72d2878550775888524f403d01802a https://medicaldevicecourses.com/activity/p/12958/ Wed, 15 May 2019 17:00:44 -0400 Within industry research the main advantage is the resource and workflow that is in place to deliver finished products. For example, currently my role is that of a Process Engineer and the main task of my group is working in…   Read more»

]]> c04333257fd2012c8c269b804f353be2 https://medicaldevicecourses.com/activity/p/12957/ Wed, 15 May 2019 17:00:43 -0400 While working in industry I did come across a situation very similar to this, in which our company was conducting animal studies for a product under development. The constraint that we had was we had to conduct the trial at…   Read more»

]]> c4a7638cfda8160f39d567963b0612b6 https://medicaldevicecourses.com/activity/p/12956/ Wed, 15 May 2019 17:00:43 -0400 Personally I am more interested in doing research that can be developed into product in a useful time frame. I do not agree that the hard line is between academic doing long term research and industry doing short term research….   Read more»

]]> 0787030c09047eb2e6b1c18964ade1bf https://medicaldevicecourses.com/activity/p/12847/ Wed, 15 May 2019 16:59:38 -0400 A milestone failure within the medical device industry can be viewed as a learning opportunity and improvement area no matter what stage of the project planning phase it occurs in. With that being said if the failure is to occur…   Read more»

]]> 8a4b4b67954da892b72d08c198197980 https://medicaldevicecourses.com/activity/p/12845/ Wed, 15 May 2019 16:59:37 -0400 Personally within industry I have used Microsoft Project for creating project timelines. Microsoft Project’s functionality to integrate with different functional teams is crucial for project planning and execution. One recent project I was working on dealt with lab validation and…   Read more»

]]> f614e7b5a18b9190640f8b178a40a40d https://medicaldevicecourses.com/activity/p/12844/ Wed, 15 May 2019 16:59:37 -0400 For a medical device project I agree that the manager must provide the balance of executive deadlines and taken into consideration the overall safety of the users. However, the role of the manager should not be limited to a business…   Read more»

]]> ac83babd340880aecf1de4e1e3843395 https://medicaldevicecourses.com/activity/p/12714/ Wed, 15 May 2019 16:58:28 -0400 I was recently made aware of this ratio as I was attempting to create a schedule so that I would be able to take all 4 courses that you provide in my curriculum. I would disagree with the 3 to…   Read more»

]]> c0fd2db9f4eadb56e55a4e0962fe60b1 https://medicaldevicecourses.com/activity/p/12713/ Wed, 15 May 2019 16:58:27 -0400 The biggest difference that I see for academia and industry is the structured projects present within industry and the unstructured projects you can choose within academia. Within industry for the most part the projects you are assigned are limited in…   Read more»

]]> 263045835d98d2bd870ed7bfad838df9 https://medicaldevicecourses.com/activity/p/12712/ Wed, 15 May 2019 16:58:27 -0400 Currently I am working at Bristol Myers Squibb on a process characterization team focused on bridging the gap between R&D and manufacturing for commercial medical devices. I also have previous industry experience at Ethicon, where I worked mainly on design…   Read more»

]]> 97f40e5565b5d7d47d23431783bec6e6 https://medicaldevicecourses.com/activity/p/12562/ Wed, 15 May 2019 16:57:09 -0400 I don’t fully agree with the skepticism on lack of upper management willing to listen. While this is definitely an issue within any industry based off my experience it is in the minority of cases where these situations occur. This…   Read more»

]]> a132fb6f58c2533e58872249bb1cef53 https://medicaldevicecourses.com/activity/p/12561/ Wed, 15 May 2019 16:57:09 -0400 There can be many reasons to leave work, one of which as you stated would be limited praise/recognition. Many times people also feel that they would be better off in a different division if there is stagnation within their own…   Read more»

]]> 34716aa53585ce70b879a0d6572ea942 https://medicaldevicecourses.com/activity/p/12560/ Wed, 15 May 2019 16:57:08 -0400 Six Sigma certifications are intended to demonstrate that you have the capability of handling complex projects and the problems that may arise while working on them. Through my company I recently registered for lean six sigma yellow belt course, and…   Read more»

]]> c381e910b693346e6fdae7f16463aeb2 https://medicaldevicecourses.com/activity/p/12399/ Wed, 15 May 2019 16:55:38 -0400 I was not part of a team that had a team member removed to work on another project completely. In my experience it usually isn’t a complete removal but the individual that is chosen to work on another project has…   Read more»

]]> 72637796c989aa5d8848cf671695ae3e https://medicaldevicecourses.com/activity/p/12398/ Wed, 15 May 2019 16:55:37 -0400 For a project we were working on it was a smaller part of a whole, which was analyzing viral clearance for a legacy product process. At first we did the initial research and looked through historical information within the company…   Read more»

]]> d53b0597d8def8d78888a42d43b1b902 https://medicaldevicecourses.com/activity/p/12397/ Wed, 15 May 2019 16:55:37 -0400 I have had several instances where I’ve had to deal with vendors and our project team has had to work on choosing the appropriate vendor. The initial steps in dealing with the situation are setting up meetings with different vendors….   Read more»

]]> 31071fc6a44737abfbb51dd61a54c476 https://medicaldevicecourses.com/activity/p/12314/ Wed, 15 May 2019 16:54:47 -0400 Similar to Davids’s situation I was in the same class and our final project was a novel prosthetic arm. Our proposal was the development of new types of soft robotic structures, especially materials/methods for the fabrication of such robots, involving…   Read more»

]]> 0695adc4f36526ab96e279772738f5a6 https://medicaldevicecourses.com/activity/p/12273/ Wed, 15 May 2019 16:54:24 -0400 An example of a combination product would be Stryker’s Vitagel Hemostat (http://www.stryker.com/en-us/products/Orthobiologicals/SoftTissue/Vitagel/index.htm). The delivery system for this product is a syringe and the primary mode of providing a therapeutic effect comes from the contents of the syringe which is the…   Read more»

]]> 21659ce8ee345afdbcb30e9b8c5804e6 https://medicaldevicecourses.com/activity/p/12272/ Wed, 15 May 2019 16:54:23 -0400 An example that I dealt with on a team at work was on a hemostatic agent that we were releasing. The testing that we conducted with the contract lab suggested that there would be potential risk associated with the endotoxin…   Read more»

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