https://medicaldevicecourses.com/members/savery115/activity/ Activity feed for Scott. Fri, 24 Apr 2026 17:34:39 -0400 https://buddypress.org/?v= en-US 30 hourly 2 2b136f461a97e74ce9bec1f14b4fc5f6 https://medicaldevicecourses.com/activity/p/16003/ Wed, 15 May 2019 19:16:04 -0400 I agree with a lot of the post above in regards to the amount of paperwork that potentially needs to be done within this field. I don’t have experience in working within Clinical Trials, however, as I have found just…   Read more»

]]> e3e9ddb51726f686caad218a5c881cbe https://medicaldevicecourses.com/activity/p/16002/ Wed, 15 May 2019 19:16:03 -0400 The simulations were very helpful because it teaches you different ways to think outside the box in terms of resolving different issues from a very basic and high level approach. The simulations were very practical and are very real situations…   Read more»

]]> d3c3da549712757048eb8ded901f143b https://medicaldevicecourses.com/activity/p/16001/ Wed, 15 May 2019 19:16:03 -0400 MDD and AMDD are very good classes to get your feet wet in understanding the different aspects of medical devices and what can lie ahead in your engineering career. As expansion to these type of courses, I would like to…   Read more»

]]> 3802430f2c0fae6483fff3257df81bae https://medicaldevicecourses.com/activity/p/15938/ Wed, 15 May 2019 19:15:25 -0400 In agreement with this. You can have two similar functioning products but have different risk. An implantable suture that biodegrades into the body would have significant risk as these sutures are used to sustain life. However, you can also have…   Read more»

]]> 48822fbc91766603b60e93e18180abaa https://medicaldevicecourses.com/activity/p/15926/ Wed, 15 May 2019 19:15:19 -0400 I agree with this point. Failed clinical trials is bad press for a company. Articles usually pop up when a company’s clinical trials fail for a medical device or drug. The same issue occurs, when an FDA doesn’t allow a…   Read more»

]]> 4f0735f9c6ec849057d8d54c073e25ad https://medicaldevicecourses.com/activity/p/15920/ Wed, 15 May 2019 19:15:16 -0400 Outside of the budget and resource issues that others above have pointed out, it would be interesting to consider conducting a clinical study depending on where the issue you are tackling is most prevalent. For example, if you are conducting…   Read more»

]]> 98c3c3dff481aa42160b466ef21b8ac8 https://medicaldevicecourses.com/activity/p/15809/ Wed, 15 May 2019 19:14:06 -0400 I don’t necessarily agree that having zero GMP will lead to lower cost in anything. I’m not sure what type of buyer would want to purchase any product, let alone a medical device or drug, that didn’t follow a certain…   Read more»

]]> fc73635413d1f429a9d7c9279e8f2074 https://medicaldevicecourses.com/activity/p/15807/ Wed, 15 May 2019 19:14:05 -0400 This is a very good observation. Contracting employees has long been a solution for big medical device companies to control budget constraints. The way this usually works is a big project comes along for a specific department. The department director…   Read more»

]]> b3031f01a3c94cb9a03edad8454af001 https://medicaldevicecourses.com/activity/p/15805/ Wed, 15 May 2019 19:14:03 -0400 I agree with this. CAPAs are meant to self correcting actions that a quality system intakes to ensure products and processes are in conformance. I would like to add some of the minor cons that may occur with opening CAPAs….   Read more»

]]> e1936775db53541be61b08651b2be80c https://medicaldevicecourses.com/activity/p/15685/ Wed, 15 May 2019 19:12:52 -0400 In agreement with this. The ambiguity for GMPs established within a start-up opens itself for improvement and new policies that will, in turn, reduce vagueness. At the start of production, this helps as you can keep production going forward. In…   Read more»

]]> 71865a824b17f4f5651b127ddcba493b https://medicaldevicecourses.com/activity/p/15684/ Wed, 15 May 2019 19:12:52 -0400 At my company most non-conforming issues usually stem from either operator mistakes or product not conforming to QC testing. When non-conforming issue occurs due to operator error an investigation is initiated. The investigation report usually entails a 6M (Man, Method,…   Read more»

]]> b1e9c5602783b2b9d95f1c80671be468 https://medicaldevicecourses.com/activity/p/15683/ Wed, 15 May 2019 19:12:51 -0400 Grandfathering a project due to changes in a quality system usually consider the following components: project scope (ex. changes to processes, documentation, drawings, validations) + area of grandfathering (document control, quality, engineering) + Date. The date aspect is key because…   Read more»

]]> aaa3609f0b92dba95e6002fecaf40faf https://medicaldevicecourses.com/activity/p/15647/ Wed, 15 May 2019 19:12:28 -0400 From my experience if sales numbers are lagging, there needs to be a way to compensate that by finding ways to SAVE money. Usually if sales at my company are falling behind for the year I have noticed the engineering…   Read more»

]]> fe73f9f74df32bf41daada463d902b39 https://medicaldevicecourses.com/activity/p/15646/ Wed, 15 May 2019 19:12:27 -0400 Emotional intelligence is highly important in negotiations. I believe this is one of the few things that is difficult to teach as emotional intelligence can vary greatly person to person and is almost a subjective idea depending on who you…   Read more»

]]> 2aa227d4bb689140cc3fdc066a82bbdc https://medicaldevicecourses.com/activity/p/15645/ Wed, 15 May 2019 19:12:27 -0400 I believe I can relate to this. I have noticed that engineers in a leadership role for an extended period of time within a company, can at times, get complacent with innovation and more resistant to change. And to your…   Read more»

]]> e7075f50f97d6b07c4d09c266e2d2c42 https://medicaldevicecourses.com/activity/p/15462/ Wed, 15 May 2019 19:06:37 -0400 Like many have said I have also been involved in root cause analysis to examine the reasoning behind something failing. In many cases, most of the root cause analysis I have done involves a lot for a product failing. From…   Read more»

]]> f1853e32c602c1c3185caf713842395c https://medicaldevicecourses.com/activity/p/15449/ Wed, 15 May 2019 19:06:30 -0400 I have experience with evaluating legacy products and obsoleting products. It is usually a bigger undertaking then one would think. To your point, it is very important that companies continuously evaluate the portfolio of the products to see what is…   Read more»

]]> b773aa4069611f92f59b5600185f6bfd https://medicaldevicecourses.com/activity/p/15211/ Wed, 15 May 2019 19:04:00 -0400 I agree with this that the thought process in technical writing in industry is always “if a random person picked up this document, could they understand how it works.” However, undergraduate doesn’t teach much technical industry writing because I believe,…   Read more»

]]> e9aea7d3b66135046650278efbe11267 https://medicaldevicecourses.com/activity/p/15207/ Wed, 15 May 2019 19:03:58 -0400 From a business standpoint, you would want to open less CAPAs. In manufacturing of medical devices most CAPAs tend to be reactive since they are usually opened after an Event, Non Conformance, SCAR (Supplier Issue), or Customer Compliant. CAPAs, to…   Read more»

]]> 9f933105c0fb3eb20e6bb7f7d5d1a145 https://medicaldevicecourses.com/activity/p/15204/ Wed, 15 May 2019 19:03:57 -0400 Ideally in manufacturing it is best practice to have spare equipment in the instance that a machine fails. Therefore, it is a simple task to bring it in and replace it. If the machine is the same make and model,…   Read more»

]]> 047c39475ea54168adfa94f4b8da83fa https://medicaldevicecourses.com/activity/p/14931/ Wed, 15 May 2019 19:01:28 -0400 I would like to point out that post market surveillance can also be conducted on clinical studies. The importance of Post Market Clinical Follow Up (PMCF) studies is to try to identify and investigate any enduring risks that are associated…   Read more»

]]> b8a13c04ae6a17cdb500d3398442a38b https://medicaldevicecourses.com/activity/p/14929/ Wed, 15 May 2019 19:01:27 -0400 Yes, SOPs should be used in research phase. If you are looking to produce a new product to market or making changes to current products in your product line, SOPs should be strictly followed. During the research phase, chances are…   Read more»

]]> e5b6b6bd7413241f4dc12e0af1e782fa https://medicaldevicecourses.com/activity/p/14928/ Wed, 15 May 2019 19:01:27 -0400 The company I currently work for generates ECOs to make specific changes to products or manufacturing processes. Our ECOs are generated in a Product Management System, we currently use Agile but there are others such as OTIS or ADAPTIV. Basically,…   Read more»

]]> ad588916318b68cc2a1285efabc9fcd5 https://medicaldevicecourses.com/activity/p/14845/ Wed, 15 May 2019 19:00:43 -0400 In agreement that acceptance criteria needs to be re-evaluated. Before that, a deviation should be opened to address the failure of a validation and why the deviation occurred and how it will be addressed. I would re-evaluate what additional testing…   Read more»

]]> ec281f895515fae50cea832fea0e2494 https://medicaldevicecourses.com/activity/p/14815/ Wed, 15 May 2019 19:00:20 -0400 It depends what you are looking for. The DHF would be more useful all around for people in Quality, Regulatory, Supply Chain, and even Product Development. This is because this will provide more then enough information for all the departments…   Read more»

]]> aed0bc4c4a3835901b0b8e3abefaa1e3 https://medicaldevicecourses.com/activity/p/14814/ Wed, 15 May 2019 19:00:20 -0400 The DHF is a living document. Logically to me it doesn’t even make sense why it wouldn’t be. What is the point of documenting just the original process if you are going to open a 2nd DHF if the product…   Read more»

]]> a003d9569d1ea02d646887e3d022acca https://medicaldevicecourses.com/activity/p/14757/ Wed, 15 May 2019 18:59:47 -0400 In the US, nonabsorbable sutures can be classified as Class II with moderate risk of injury. In addition, absorbable sutures can be classified as Class II. In EU it is considered Class IIb medium to high risk if it is…   Read more»

]]> 3506a42e078b3ea27e0364ea955cde29 https://medicaldevicecourses.com/activity/p/14751/ Wed, 15 May 2019 18:59:44 -0400 Absolutely. The revisions that have taken place under the Medical Device Directives are meant to be on par or if not more stringent then the US FDA. Notified bodies showing up unannounced and greater scrutiny, which wasn’t existent at this…   Read more»

]]> 951facd229d32e0999d4aad9e9a9b17f https://medicaldevicecourses.com/activity/p/14595/ Wed, 15 May 2019 18:58:20 -0400 I don’t believe there should be a defined limit of center or subjects because that should depend fully on what the study is. However, when choosing multi centers or shouldn’t be random centers that chosen just because they are close…   Read more»

]]> 381c24f8f81db69e72931536f95093f8 https://medicaldevicecourses.com/activity/p/14594/ Wed, 15 May 2019 18:58:20 -0400 At the medical device company I work at, our marketing team focuses on actively following the customers who continue to buy our products. They stay on top of any issues the customer has in terms of malfunctioning devices, questions, or…   Read more»

]]> 074fe88dd6fd47200107133b852b3235 https://medicaldevicecourses.com/activity/p/14590/ Wed, 15 May 2019 18:58:18 -0400 As an engineer that currently uses 3D printing, most 3D printing applications have been used toward manufacturing equipment and fixing parts as opposed to 3D printing actual devices. Most items I am 3D printing are used to help fix a…   Read more»

]]> 212b3a96756cd8a6eb2852fc30a1ba70 https://medicaldevicecourses.com/activity/p/14377/ Wed, 15 May 2019 18:55:35 -0400 I believe when you move from one medical device company to another, as part of the application or on-boarding process they ask “Have you worked for a company in which you are legally non-competing or restricting you from applying”. It…   Read more»

]]> 26bc3ef82b08d104093ead57078b6a20 https://medicaldevicecourses.com/activity/p/14376/ Wed, 15 May 2019 18:55:34 -0400 This course was excellent in giving a high overview of how the medical device industry functions. The lectures were really informative and gave me a better understanding about departments that I work with directly. It also helped me weed out…   Read more»

]]> c634924ace26990c9cc7b40c4523a548 https://medicaldevicecourses.com/activity/p/14267/ Wed, 15 May 2019 18:54:36 -0400 Agree with this. Competition is always good to keep people motivated to bring their best each and everyday. However, if its taken to the point where one is stepping on someone else to move up or get a promotion, then…   Read more»

]]> 1c92f8aac96ffae1422c015fd807a60f https://medicaldevicecourses.com/activity/p/14263/ Wed, 15 May 2019 18:54:33 -0400 I work in an organization that is both Functional and a Matrix organization. We essentially use project managers within departments that lead the projects with a staff beneath them. Most of the project managers pertain to Engineering. There is definitely…   Read more»

]]> 3dd556efbc95953fdeafd00bac723452 https://medicaldevicecourses.com/activity/p/14172/ Wed, 15 May 2019 18:52:43 -0400 A lot of companies and regulators such as BSI, put a lot of time and effort to ensure that the IFUs and graphic labels on the product match. I can see both sides why this is important and why this…   Read more»

]]> 5d496c71ee4afad9172445940c876a6d https://medicaldevicecourses.com/activity/p/14170/ Wed, 15 May 2019 18:52:42 -0400 It helps if a similar product is already approved in whatever country the company is trying to release their product. If it is a whole new product that is being brought to market most of the cost are going to…   Read more»

]]> 915f2f6d5587939a1f93fe617e202f2b https://medicaldevicecourses.com/activity/p/14155/ Wed, 15 May 2019 18:52:34 -0400 Point #4 – Risk Management is not a lifecycle process is one of the most common errors that occurs for most companies when they assess risk management. Risk management is done at the beginning stages of product development and theoretically…   Read more»

]]> da7ca0cae4bb1198d26765b29e2fda1c https://medicaldevicecourses.com/activity/p/14154/ Wed, 15 May 2019 18:52:33 -0400 In agreement with this post. AQL levels for most companies are the guideline for identifying what the sample size should be depending on the risk. However, further analysis such as power level, significance level, confidence intervals, etc can be applied…   Read more»

]]> d237c97a6feacae3f9334bb5664228de https://medicaldevicecourses.com/activity/p/13971/ Wed, 15 May 2019 17:10:01 -0400 Agree with this in terms of having an established amount of lots, units, and time for running the validation. If you are conducting a validation you would want to prove that a set amount of lots or units is sufficient…   Read more»

]]> 36cd500bbd9e442e418fee38b52677b0 https://medicaldevicecourses.com/activity/p/13898/ Wed, 15 May 2019 17:09:12 -0400 From my experiences determining the duration of each task is highly important. Through past projects within industry, I have found that project managers are sometimes over optimistic about how long a task takes. Finally, when that task exceeds the amount…   Read more»

]]> 4f0e4da3c09891a8eb49beaa8b38eabf https://medicaldevicecourses.com/activity/p/13895/ Wed, 15 May 2019 17:09:11 -0400 I fully agree with this. There are various test that can be done to physically test a device. Instron testing to test mechanical properties, environmental testing to test how a product reacts in certain temperature conditions and for shelf life,…   Read more»

]]> 701337903fed55513f48e90456e78557 https://medicaldevicecourses.com/activity/p/13804/ Wed, 15 May 2019 17:08:21 -0400 To have an adequate Design Control System – one that will pass audits at the minimum, you must have Design Inputs, Design Outputs, Verification, Validation, Design Transfers, Risk Analysis, the DHF. For Design Input this includes physical appearance of the…   Read more»

]]> b65122f7055ecc94ed31a48f633ff6d4 https://medicaldevicecourses.com/activity/p/13803/ Wed, 15 May 2019 17:08:21 -0400 I recently went through an internal audit in which we reviewed the DHF of one of our product lines. There was heavy debate on information within the Design Specification Document (DID). The DID contains specific specifications and tolerances for drawings…   Read more»

]]> bec942bde1320e5eff2ec4c1036905ff https://medicaldevicecourses.com/activity/p/13743/ Wed, 15 May 2019 17:07:50 -0400 I don’t believe it is completely necessary to have a clinical background to work in this field. To say you need have a clinical background for a role is highly limiting the talent pool that would potentially be interested in…   Read more»

]]> 65242f7cf70acab441cfb1bf1220ffb8 https://medicaldevicecourses.com/activity/p/13740/ Wed, 15 May 2019 17:07:49 -0400 From a Big Pharma standpoint in terms of clinical research, it is very money driven and results driven. For example, for a double blind test, the intent is to remove as much bias from the test subject and investigator as…   Read more»

]]> f694944860cd6e524e30374e650cd66a https://medicaldevicecourses.com/activity/p/13609/ Wed, 15 May 2019 17:06:28 -0400 SWOT Analysis for Boston Scientific – Boston Scientific is a global developer of interventional medical devices that target cardiac rhythm management, cardiac and vascular surgery, electrophysiology, tumor reduction, cancer treatments, hearing reduction; and pain management Strengths: Broad Product Portfolio in…   Read more»

]]> ed0138c675292b091484f50f75c110b3 https://medicaldevicecourses.com/activity/p/13604/ Wed, 15 May 2019 17:06:26 -0400 I feel this video clearly depicts that there tends to be disconnect from the customer and the supplier. I believe most of this can either be attributed to lack of communication – the customer doesn’t clearly communicate what they desire…   Read more»

]]> fda4f2f0d473ead44ffddb8630daf7d7 https://medicaldevicecourses.com/activity/p/13450/ Wed, 15 May 2019 17:04:59 -0400 In China, the country offers Wholly Foreign Owned Enterprises. This is the most popular form of incorporation of foreign companies in China. WFOE allows an LLC company that is owned by foreign to open their company in China, usually for…   Read more»

]]> cfa6e737fe0ec3f6d8959eb784821ae8 https://medicaldevicecourses.com/activity/p/13439/ Wed, 15 May 2019 17:04:54 -0400 Depends. If you are looking to work in medical devices and it is a well established company such as a conglomerate like Johnson and Johnson, then you don’t need to worry about their stability or financial history since it is…   Read more»

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