https://medicaldevicecourses.com/members/ec52/activity/ Activity feed for ec52. Fri, 24 Apr 2026 23:19:41 -0400 https://buddypress.org/?v= en-US 30 hourly 2 45cafff5c684f163de2194142c0742b8 https://medicaldevicecourses.com/activity/p/18313/ Wed, 15 May 2019 21:47:12 -0400 This is a good point you bring up, however I do not fully agree with the skepticism disconnect in how the industry rewards motivation. While this is definitely an issue within any industry, based off my experience it is in…   Read more»

]]> db7e0df173c4f9d4cd62ddf6e5af7d99 https://medicaldevicecourses.com/activity/p/18312/ Wed, 15 May 2019 21:47:12 -0400 For many companies, particularly the smaller ones engaged in clinical trials, outsourcing might not be so much a choice, but a necessity. As we know, clinical trials can be often very complex projects and it isn’t often feasible to conduct…   Read more»

]]> 874ba6dc3e1752949284b6b257b7c9ff https://medicaldevicecourses.com/activity/p/18311/ Wed, 15 May 2019 21:47:11 -0400 When identifying project priorities it is important to keep in mind some guidelines that can help balance these priorities within the project scope. Before funding a product design project, priorities must be studied, particularly in the case of medical devices….   Read more»

]]> 0e901855e5c382254ffe1dd932ebd6d9 https://medicaldevicecourses.com/activity/p/18243/ Wed, 15 May 2019 21:46:38 -0400 What motivates me is the desire to make products for those less fortunate and to know that I have made a positive difference in someone’s quality of life. An example is my current job in which I am part of…   Read more»

]]> dce896f96c5897447a3bbc763aab691a https://medicaldevicecourses.com/activity/p/18242/ Wed, 15 May 2019 21:46:37 -0400 Studies show that Americans work longer hours and have more stress-related illness than their European and Japanese counterparts. Some of this is due to stagnant wages and outdated overtime laws, but some of the problem is embedded into, particularly in…   Read more»

]]> 0e4cefc7373bc643e412ee2263bade56 https://medicaldevicecourses.com/activity/p/18241/ Wed, 15 May 2019 21:46:37 -0400 In order to prepare a schedule and budget for a clinical trial there are several factors to consider. The schedule of clinical trials is basically an outline that contains all the activities that will be performed during the clinical trial….   Read more»

]]> d264860618ac03761b4f42e648c15349 https://medicaldevicecourses.com/activity/p/18168/ Wed, 15 May 2019 21:45:58 -0400 QA/QC is the combination of quality assurance, the process or set of processes used to measure and assure the quality of a product, and quality control, the process of ensuring products and services meet consumer expectations. Quality assurance is process…   Read more»

]]> e7f3551a65637947f471c7031f16dfec https://medicaldevicecourses.com/activity/p/18167/ Wed, 15 May 2019 21:45:57 -0400 The Six Sigma methodology offers a structured and disciplined process for solving business problems and ensuring product/processes are within acceptable margins of error. Six Sigma uses tools designed to identify root causes for the defects in processes that keep an…   Read more»

]]> 91f625142c94707fe472daa440bf2dd1 https://medicaldevicecourses.com/activity/p/18166/ Wed, 15 May 2019 21:45:57 -0400 Adding to previous posts, one other factor to consider are the regulations about supplier selection and management in 21 CFR 830.50. FDA scrutiny on supplier selection, criteria used, and more importantly how sponsors control their supplier has increased in the…   Read more»

]]> dba790756dc80ea479ad3e63acbee0b9 https://medicaldevicecourses.com/activity/p/18113/ Wed, 15 May 2019 21:45:30 -0400 Design verification means confirming by objective evidence (i.e. testing) that the design outputs meet design inputs. Design Verification is one of the most important activities in the development phase of a medical device. It is a rigid rule as there…   Read more»

]]> 2d20963908797d7052d279d59ba6cbd9 https://medicaldevicecourses.com/activity/p/18112/ Wed, 15 May 2019 21:45:30 -0400 I agree with previous posts to contact the vendor to identify the problem and a solution. However, this is not an unusual issue and typically the way that companies control these problems is by establishing specifications for which the vendor…   Read more»

]]> c9f215abdcc8257c80c70d25f6196f39 https://medicaldevicecourses.com/activity/p/18111/ Wed, 15 May 2019 21:45:30 -0400 There are many factors that can affect schedule variance (SV) such change requests, issues with suppliers of materials/ components to mention a couple. These factors can impact in the timeline of a project and increase project spending. For all problems…   Read more»

]]> 7a966c8c6ea9eedd65180ffb89ff1482 https://medicaldevicecourses.com/activity/p/18026/ Wed, 15 May 2019 21:44:47 -0400 The different kinds of changes, as mentioned in previous posts, are Non-Essential Design Change (NDC), Design Change Number, and Engineering Change Order. Each one of these carry a workload in order to implement the change. All of them require following…   Read more»

]]> 67384c32e050cc580e441b99118e956e https://medicaldevicecourses.com/activity/p/18025/ Wed, 15 May 2019 21:44:46 -0400 It will be prudent to include buffers in the project plan to account to the unexpected. This is a practice in two companies I have worked for developing medical devices and combination products. I always include buffers in my timeline…   Read more»

]]> 5064cc89cf5f2501ad83cc395ce75b38 https://medicaldevicecourses.com/activity/p/18024/ Wed, 15 May 2019 21:44:46 -0400 Change control is another well-know concept that focuses on managing change to prevent unintended consequences. The regulations provide for change control primarily through the assigned responsibilities of the quality control unit. Certain major manufacturing changes (e.g., changes that alter specifications,…   Read more»

]]> a31043f7578cf41837fd86e61b89379a https://medicaldevicecourses.com/activity/p/17951/ Wed, 15 May 2019 21:44:07 -0400 Echoing several responses above, the PM has many important responsibilities. However, I believe that these responsibilities would not be as challenging as communicating effectively amongst all department/ functional areas working together on the project. There needs to be a great…   Read more»

]]> 0b7deacd434d07dfcaba18dd5a27c23f https://medicaldevicecourses.com/activity/p/17950/ Wed, 15 May 2019 21:44:06 -0400 This type of scenario was part of the mini-sim this week in which we were asked to deal with delays in timeline which happened due to incorrect task duration. Creation of WBS and task duration is a critical activity that…   Read more»

]]> 0e435567672e655154a23a1832aabdff https://medicaldevicecourses.com/activity/p/17949/ Wed, 15 May 2019 21:44:06 -0400 One of approaches to take would be to look “easy” fixes first (e.g. improve packaging configuration first, then propose modifications to the device, then propose modifications to the combination product) so we can try to identify the root cause, followed…   Read more»

]]> e4097805edef11314baee5290fa2ebf2 https://medicaldevicecourses.com/activity/p/17815/ Wed, 15 May 2019 21:42:52 -0400 Risk/ Benefit Ratio is an assessment of the risks against their benefit. Ideally the benefit has to outweigh risks in order for the company to accept the risk. Typically, risk analysis has a qualitative component and the result feeds into…   Read more»

]]> 0c031ad6b45812bc71503d493ae167b0 https://medicaldevicecourses.com/activity/p/17814/ Wed, 15 May 2019 21:42:52 -0400 A successful project will include risk management as part of planning phase. As stated by the professor, “if you fail to plan, plan to fail”. Risk management will help the company anticipate issues/ problems and identify mitigations ahead of time…   Read more»

]]> ebd9e371ecca7ac4f4c200a605d7bd9a https://medicaldevicecourses.com/activity/p/17785/ Wed, 15 May 2019 21:42:37 -0400 It seems the company has a lot to worry about and updating the Gantt Chart may be the last of their worries. The balloon pops immediately instead of lasting for days could be a catastrophic issue and could result in…   Read more»

]]> 9828d741b2ced73aeed7c6f72be7df5f https://medicaldevicecourses.com/activity/p/17724/ Wed, 15 May 2019 21:42:06 -0400 I think another great example of process group within medical device are product complaints and change control that fall under monitoring and controlling process group. This continuous monitoring provides the project team insight into the heath of the project and…   Read more»

]]> bdacefed43690cbc668a7d56806e28db https://medicaldevicecourses.com/activity/p/17723/ Wed, 15 May 2019 21:42:06 -0400 As mentioned in today’s lecture, often companies disregard project management with design controls thinking they are one and the same. This leaves gaps that can implicate the success of the project. The PM would ensure the planning phase of a…   Read more»

]]> 39b21a7a90a68a3a1b053f823b5ac490 https://medicaldevicecourses.com/activity/p/17722/ Wed, 15 May 2019 21:42:05 -0400 The marketing team typically identifies the need based on market evaluation for a new product to be developed and often provides design inputs mostly from VOC (voice of customer). However from my experience if the project depends solely on marketing…   Read more»

]]> 30f66c38964ee3da29c1b02f15915017 https://medicaldevicecourses.com/activity/p/17667/ Wed, 15 May 2019 21:41:35 -0400 Selection of the members of the project team is extremely important in several ways. Obviously you desire the project team to be composed of people a high level technical knowledge/ skills from all functional areas that will support the program…   Read more»

]]> d684dfb85e5518ed549efd37a0a89791 https://medicaldevicecourses.com/activity/p/17666/ Wed, 15 May 2019 21:41:35 -0400 Based on the PMBOK, there are five phases of project management. Phase 1; Project Initiation – This is the start of the project, and the goal of this phase is to define the project at a broad level. This phase…   Read more»

]]> fb9f103296ebad809bbce9ccc3575084 https://medicaldevicecourses.com/activity/p/17665/ Wed, 15 May 2019 21:41:34 -0400 In my opinion, it is very important that projects are properly prioritized and that every member of the team understands the details around priority that the project holds. Ultimately, successfully prioritizing tasks in each project will impact the success of…   Read more»

]]> 2b20fc7e32b6bf6af11151ebddaa9081 https://medicaldevicecourses.com/activity/p/17578/ Wed, 15 May 2019 21:40:47 -0400 In agreement with some of what was described in previous posts, if the manufacturer is not the one claiming that the TJA total joint arthroplasty can be used while performing high intensity or extreme sports then it would not fall…   Read more»

]]> eef452293e7d784174917c0e641d9219 https://medicaldevicecourses.com/activity/p/17577/ Wed, 15 May 2019 21:40:46 -0400 I believe no matter how flawless a medical device design and manufacturing process is, there is still potential for users to be harmed (e.g. use error). That said, the manufacturer is responsible for understanding all risks related to the medical…   Read more»

]]> b7fa2f936f42efc77dc0ba1724b59c54 https://medicaldevicecourses.com/activity/p/17574/ Wed, 15 May 2019 21:40:45 -0400 Verification and validation are distinct, but related activities that combined demonstrate through objective evidence that the medical device meets the design requirements defined and the medical device meets user needs and intended use. Before talking about timing of V&V, it…   Read more»

]]> ad6b17b02d6dabe2443b72fd87bf573b https://medicaldevicecourses.com/activity/p/17532/ Wed, 15 May 2019 21:40:19 -0400 I agree with what was said in previous posts about regulatory compliance challenges, but I also think these challenges will only increase at least for the next 10-20 years. Given the EU Medical Device Regulations (MDR) 2017/745 that will take…   Read more»

]]> fac9b71778295a183df318273734835e https://medicaldevicecourses.com/activity/p/17531/ Wed, 15 May 2019 21:40:19 -0400 The beginning of a project can be the calm before the storm or an insane rush to get things sorted and ready for the main project team work to start. As per PMBOK, the project is composed of five process…   Read more»

]]> 752c5689560888b11ba4bc59b85b60f4 https://medicaldevicecourses.com/activity/p/17493/ Wed, 15 May 2019 21:39:59 -0400 Using a similar but different example, birth control implants are also combination products. The implant is a tiny, thin rod about the size of a matchstick. A doctor inserts the implant under the skin of the user’s upper arm. It…   Read more»

]]> 94b3534b30c688311ecf76f4da1163e4 https://medicaldevicecourses.com/activity/p/17454/ Wed, 15 May 2019 21:39:39 -0400 A project manager requires many skills in order to succeed. There is no one sole skill that will allow the project manager to be successful. As emphasized in the PMBOK, effective project managers require a balance of technical, interpersonal, and…   Read more»

]]> 62891bc2a2f2c46b28d6b644110637bd https://medicaldevicecourses.com/activity/p/17452/ Wed, 15 May 2019 21:39:38 -0400 The experience I have comes from working within a device development group in a big pharma company organized in a project based environment. The organization structure is based on teams with specific goals. Main business goals for big pharm companies…   Read more»

]]> aa1c2ed33e21401d0abd3fa0f39a42e6 https://medicaldevicecourses.com/activity/p/17450/ Wed, 15 May 2019 21:39:37 -0400 The beginning of a project is critical to the program as it is when objectives, scope, purpose, and deliverables to be produced are defined. Early in the program there can be a lot of unknowns especially if the project involves…   Read more»

]]> 299b9a241ab1ee6b46fa5b4e3a63963d https://medicaldevicecourses.com/activity/p/14392/ Wed, 15 May 2019 18:55:43 -0400 The NDA is a great mechanism to protect the company during partner ventures, but not a substitute for a patent. For example, you find out that company ABC (to whom you never told your idea), has put out the same…   Read more»

]]> 4acfd658db9075f7431c16518edbe105 https://medicaldevicecourses.com/activity/p/14391/ Wed, 15 May 2019 18:55:42 -0400 The gift restrictions are established by the Sunshine Act that came into effect in 2010 and it required companies such as pharmaceutical and medical device, including durable medical equipment suppliers, to report gifts above $25. While I understand the perspective…   Read more»

]]> faf165d7ac37ca5431b524e15924a81d https://medicaldevicecourses.com/activity/p/14390/ Wed, 15 May 2019 18:55:42 -0400 I really enjoyed this course. The course is well structured and provides pretty good insight of the device development process and design controls. As a professional with multiple years in the pharma-med dev. industry I have learned from this course…   Read more»

]]> 21d0e599b10179b95b674ab0cdd286b7 https://medicaldevicecourses.com/activity/p/14389/ Wed, 15 May 2019 18:55:41 -0400 In addition to the examples mentioned in previous posts, Olympus Corp. of Americas (OCA), the United States’s largest distributor of endoscopes and related medical equipment, will pay 623.2 million to resolve criminal charges and civil claims relating to a scheme…   Read more»

]]> 48fa6f96725886f3d6466f8846c16c06 https://medicaldevicecourses.com/activity/p/14227/ Wed, 15 May 2019 18:53:11 -0400 I believe that teams should be empowered to make decisions and this is critical for product development to be effective and efficient. I agree with the previous post from srg36 that interdepartmental team building events can help. From my experience,…   Read more»

]]> f9aeb80ff608eb6a2ebee06d114e1ae8 https://medicaldevicecourses.com/activity/p/14220/ Wed, 15 May 2019 18:53:08 -0400 I agree with all previous responses that pointed out best practices to form a good project team. From my experience, we do not get to choose who we will work with so we have to be professionals and learn to…   Read more»

]]> 128b98d12d3d9e81a07d461b30ff87b4 https://medicaldevicecourses.com/activity/p/14219/ Wed, 15 May 2019 18:53:07 -0400 Companies structured based on functional, project, and matrix organization have their individual advantages and disadvantages, as discussed during this week’s lecture. I work in a hybrid organization that utilizes functional and matrix structure. The hybrid organizational approach uses project managers…   Read more»

]]> 418e61bc96a441a4b0a158cd8102d733 https://medicaldevicecourses.com/activity/p/14119/ Wed, 15 May 2019 18:52:08 -0400 ISO 14971 is the standard well recognized by FDA and other regulatory agencies around the world for Risk Management. Some of the key aspects required to comply with ISO 14971 and therefore to be considered to have a risk management…   Read more»

]]> 48c5275677cf9af103fefc2ddc8d4aad https://medicaldevicecourses.com/activity/p/14116/ Wed, 15 May 2019 18:52:05 -0400 To add to previous posts on this forum, an approach I have seen is to breakdown risk analysis in three parts; design, manufacturing, and use of finished product. These analyses may involve experts from each area of focus, for example;…   Read more»

]]> 284a18165e899aa3f2faffc2543fc4cc https://medicaldevicecourses.com/activity/p/14114/ Wed, 15 May 2019 18:52:03 -0400 To add to other posts on this forum, another factor to consider during benefit-risk analysis is patient perspectives. If the risks are identifiable and definable, risk tolerance will vary among patients, and this will affect individual patient decisions as to…   Read more»

]]> 8811bf4e45c2906b0bea34e493bcc06d https://medicaldevicecourses.com/activity/p/13996/ Wed, 15 May 2019 17:10:16 -0400 Just to clarify, the term audit is used when an internal company department performs evaluation of the company procedures, processes, facilities, etc. whereas inspection is when a regulatory agency visits a company to review the company documents, processes, procedures, facilities,…   Read more»

]]> 78e5327698c5a125a5aa771ac304987d https://medicaldevicecourses.com/activity/p/13820/ Wed, 15 May 2019 17:08:30 -0400 Appropriate procedures for design controls is a critical requirement of 21 CFR 820.30 to ensure the product development follows a systematic approach while documenting the decisions made along the way. Insufficient/ Inappropriate design control procedures will result in inconsistency developing…   Read more»

]]> 8b7877996abf067d0c353e0ba6e76e47 https://medicaldevicecourses.com/activity/p/13818/ Wed, 15 May 2019 17:08:29 -0400 Design validation ensures that the device conforms to defined user needs and intended use(s). While some design validation can be done through “bench testing” most likely if the device requires user interface it will be essential to perform human factors…   Read more»

]]> 5ff465e7152183b541c4ba157ac62aa7 https://medicaldevicecourses.com/activity/p/13815/ Wed, 15 May 2019 17:08:28 -0400 Risk analysis is part of Design Control System and one of the aspects regulatory agencies look for is the integration of risk management to complaint handling. Establishing a risk management file is critical and more importantly is establishing a feedback…   Read more»

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