Medical Device Courses | cef3 | Activity https://medicaldevicecourses.com/members/cef3/activity/ Activity feed for cef3. Fri, 24 Apr 2026 18:41:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 f48f8979bfbde492569910bb81e9b3d9 cef3 replied to the topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/11346/ Wed, 15 May 2019 16:44:06 -0400 The thing is that what you may be working on (as covered by an NDA) may not be sufficient to be apply for a patent. You may in fact be needing work or studies done by a contractor or collaborator…   Read more»

]]> 5be4900ef709f052f539b4ba8d4d55b2 cef3 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/11340/ Wed, 15 May 2019 16:44:03 -0400 The biggest difference between a written and oral contract is that a written contract can easily be defended in court, while an oral one requires additional evidence that can stand up in court. If there is any risk that legal…   Read more»

]]> 9d90d14ce1b9bafc63633482ef6b6883 cef3 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11321/ Wed, 15 May 2019 16:43:54 -0400 Well, Dr. Simon, when I first signed enrolled in this class, I was expecting it to be really more about medical devices and theory that goes into that. I was kind of caught of guard with how it is really…   Read more»

]]> 27e4087012a15d6a58549e2038a04ee4 cef3 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/11220/ Wed, 15 May 2019 16:43:02 -0400 It’s been my experience that project teams are simply made by allocating personnel from each function that have less responsibilities with other projects. Sometimes, people with some expertise or knowledge necessary for the project are pulled in, regardless of their…   Read more»

]]> 2a28af4b5dab559719f3ac12fdaa6c12 cef3 replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/11143/ Wed, 15 May 2019 16:40:16 -0400 My work setting seems to fit best as a matrix-type of organization. There are functional departments as well as project teams and project managers. However, while there are projects that involve various departments, there are also projects within departments. There…   Read more»

]]> 317954644a7027dec2645a45e495ec38 cef3 replied to the topic "Risk Identification" - https://medicaldevicecourses.com/activity/p/11089/ Wed, 15 May 2019 16:39:48 -0400 The way it was done in my previous job was to use a quality by design matrix. Critical quality attributes (CQAs) were determined based on the design input and then critical development parameters were selected. A risk ranking was then…   Read more»

]]> d4a739a527554b647507e87d8aa95907 cef3 replied to the topic "Risk management methods" - https://medicaldevicecourses.com/activity/p/11074/ Wed, 15 May 2019 16:39:40 -0400 Two other methods are: Hazard Operability Analysis (HAZOP) – Based on a theory that assumes that risk events are caused by deviations from the design or operating intentions. It is a systematic brainstorming technique for identifying hazards using so-called guide…   Read more»

]]> 979dd533fde7c8c2c5fe28a0b75391af cef3 replied to the topic "Expense of Regulations" - https://medicaldevicecourses.com/activity/p/11058/ Wed, 15 May 2019 16:39:31 -0400 I’ve wondered about this as well, especially because in academic research I’ve needed to look at ISO standards and I wasn’t going to pay for them. I found this information given by ANSI: https://ansi.org/help/charge_standards.aspx. It seems it is really just…   Read more»

]]> b687fd7ba14571b3aa152596d26df014 cef3 replied to the topic "Combination Product Phase I clinical Studies" - https://medicaldevicecourses.com/activity/p/10982/ Wed, 15 May 2019 16:38:32 -0400 This is an interesting question, which brings another question to mind: would design transfer activities even have begun at phase I clinical studies? I ask because typically for drugs and biologics, transfer to manufacturing is not done during phase I,…   Read more»

]]> 5ee03bc199ff4d5d3b0d1dc1d27db71d cef3 replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/10952/ Wed, 15 May 2019 16:38:15 -0400 I can only speak to my experience, but generally it’s been as Roberto pointed out. Nobody really pays much attention to the minutes and they are more just for documentation purposes. The team or project leader always sends out revised…   Read more»

]]> c2ddab6a0ee8db4e00bef58bb6223c52 cef3 replied to the topic "Making up tests for design verification and validation" - https://medicaldevicecourses.com/activity/p/10950/ Wed, 15 May 2019 16:38:14 -0400 If quality by design is used in the development of the product, a simple way to come up with tests for verification/validation is to just use characterization techniques that have been used to measure the critical quality attributes all through…   Read more»

]]> d5737ee2211da508c98bc516b1175f7a cef3 replied to the topic "Design Transfer" - https://medicaldevicecourses.com/activity/p/10945/ Wed, 15 May 2019 16:38:11 -0400 I disagree. For a smaller company, it is usually more cost effective to outsource manufacturing because they rarely have the infrastructure required for production. It is usually larger companies that are producing many products that can justify and afford the…   Read more»

]]> 9e481f658241b51e5bbd18253383ceca cef3 replied to the topic "Design Transfer and Challenges" - https://medicaldevicecourses.com/activity/p/10929/ Wed, 15 May 2019 16:38:02 -0400 Many things can go wrong during transfer. For example, if the design specs heretofore have all been for a product made through a different process and/or scale than what will be used in manufacturing, the release specs may have to…   Read more»

]]> 1ba40c6724be44b69b433c8db69bb435 cef3 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" - https://medicaldevicecourses.com/activity/p/10857/ Wed, 15 May 2019 16:37:13 -0400 It seems that the DHF is superior to the Design Dossier or Tech File in it’s thoroughness and documentation and that is why there seems to be a move in the EU toward the use of a DHF instead. From…   Read more»

]]> 45c538f49cbe28527a0d2139bccdd9a8 cef3 replied to the topic "Design Controls for Legacy Combination Products" - https://medicaldevicecourses.com/activity/p/10846/ Wed, 15 May 2019 16:37:07 -0400 I found a presentation that was put together by BioTechLogic to address this issue (http://c.ymcdn.com/sites/www.casss.org/resource/resmgr/2016_CMCS_TreDenickTracy.pdf). It seems like it is a very involved process and I’ve just listed the major steps below: 1. Quality System Gap Assessment 2. CAPA 3….   Read more»

]]> 420acb6fce3e18704b73451c4cf89367 cef3 replied to the topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/10839/ Wed, 15 May 2019 16:37:03 -0400 It’s important to add that when revisions are made to the design controls, change control procedures must be followed and documented. The FDA is very strict on this, since good documentation practices require that everything be documented or else it…   Read more»

]]> a56c4edb2e4b549699728db88676daf3 cef3 replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/10838/ Wed, 15 May 2019 16:37:02 -0400 I assume that sources of design input would be marketing studies on what type of product is needed, key opinion leaders, and scientific experts. In the lecture, Dr. Simon commented that marketing puts this together through customer opinions and development…   Read more»

]]> e58154849a02342d736fb667bb48f9fa cef3 posted a new topic "Organization types of medical devices?" - https://medicaldevicecourses.com/activity/p/10408/ Wed, 15 May 2019 16:33:20 -0400 So there may be more than just the 3 main organization types that Dr. Simon presented in the lecture: http://blog.hubspot.com/marketing/team-structure-diagrams. Say you were to start up a medical device company that will function worldwide. What type of organization would you…   Read more»

]]> a0dcb729fdbd1a807ce829b540de3250 cef3 replied to the topic NDA vs Patents in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/830/ Thu, 01 Dec 2016 17:43:38 -0500 The thing is that what you may be working on (as covered by an NDA) may not be sufficient to be apply for a patent. You may in fact be needing work or studies done by a contractor or collaborator to have sufficient data or evidence to make the idea patentable or defendable before a patent agency. Thus, an NDA is almost always necessary prior to…[Read more]

]]> 0 7490ab61951c9cd7c0b51bf7bc02ee5e cef3 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/823/ Wed, 30 Nov 2016 22:59:00 -0500 The biggest difference between a written and oral contract is that a written contract can easily be defended in court, while an oral one requires additional evidence that can stand up in court. If there is any risk that legal action can result from the contract, it is probably best to put the agreement in writing. However, if it is not important…[Read more]

]]> 0 0db86e0a6cb81ed1537a8e2d476412aa cef3 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/797/ Mon, 28 Nov 2016 18:11:57 -0500 Well, Dr. Simon, when I first signed enrolled in this class, I was expecting it to be really more about medical devices and theory that goes into that. I was kind of caught of guard with how it is really more about how the medical device industry works. That being said, the class is very useful, even for someone like me who has seen some of these…[Read more]

]]> 0 d8af486e884d82eadb2241107456ee13 cef3 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/678/ Wed, 23 Nov 2016 20:28:41 -0500 It’s been my experience that project teams are simply made by allocating personnel from each function that have less responsibilities with other projects. Sometimes, people with some expertise or knowledge necessary for the project are pulled in, regardless of their schedules/responsibilities, but generally I have never seen teams being formed…[Read more]

]]> 0 5a61d46dbe0fabe44cd3127d4f1f60fa cef3 started the topic Organization types of medical devices? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/593/ Sun, 20 Nov 2016 22:53:09 -0500 So there may be more than just the 3 main organization types that Dr. Simon presented in the lecture: http://blog.hubspot.com/marketing/team-structure-diagrams. Say you were to start up a medical device company that will function worldwide. What type of organization would you choose to instate in your company and why?

]]> 0 46dedba08d59f3659a327d13d4fbe176 cef3 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/585/ Sun, 20 Nov 2016 21:19:13 -0500 My work setting seems to fit best as a matrix-type of organization. There are functional departments as well as project teams and project managers. However, while there are projects that involve various departments, there are also projects within departments. There are also projects within department sub-groups. Because of this complexity, project…[Read more]

]]> 0 6c3e3c57932c36ab62885293e4b8d6a0 cef3 replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/506/ Wed, 16 Nov 2016 19:53:15 -0500 The way it was done in my previous job was to use a quality by design matrix. Critical quality attributes (CQAs) were determined based on the design input and then critical development parameters were selected. A risk ranking was then assigned to each parameter based on the theoretical knowledge of how the parameter could affect each of the CQAs.…[Read more]

]]> 0 351f00d50832d693655a63a96620bff4 cef3 replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/484/ Tue, 15 Nov 2016 17:20:06 -0500 Two other methods are:

Hazard Operability Analysis (HAZOP) – Based on a theory that assumes that risk events are caused by deviations from the design or operating intentions. It is a systematic brainstorming technique for identifying hazards using so-called guide words. Guide words (e.g., No, More, Other Than, Part of) are applied to relevant…[Read more]

]]> 0 76e405b8558f28ecf23660b257f59779 cef3 replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/483/ Tue, 15 Nov 2016 17:20:06 -0500 Two other methods are:
Hazard Operability Analysis (HAZOP) – Based on a theory that assumes that risk events are caused by deviations from the design or operating intentions. It is a systematic brainstorming technique for identifying hazards using so-called guide words. Guide words (e.g., No, More, Other Than, Part of) are applied to relevant…[Read more]

]]> 0 5176d4a36e178c07e07d9829d7166236 cef3 replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/462/ Mon, 14 Nov 2016 15:03:21 -0500 I’ve wondered about this as well, especially because in academic research I’ve needed to look at ISO standards and I wasn’t going to pay for them. I found this information given by ANSI: https://ansi.org/help/charge_standards.aspx. It seems it is really just about the costs associated for the organizations to write, administer, and supply the…[Read more]

]]> 0 8ee22cee020c651e1954d3c6a6f5c397 cef3 replied to the topic Combination Product Phase I clinical Studies in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/370/ Sat, 12 Nov 2016 19:29:38 -0500 This is an interesting question, which brings another question to mind: would design transfer activities even have begun at phase I clinical studies? I ask because typically for drugs and biologics, transfer to manufacturing is not done during phase I, since low volumes are needed. Phase I studies are run with very small number of patients, which…[Read more]

]]> 0 e4417784d8919b666a109ac27472a515 cef3 replied to the topic Minutes for meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/326/ Thu, 10 Nov 2016 13:03:45 -0500 I can only speak to my experience, but generally it’s been as Roberto pointed out. Nobody really pays much attention to the minutes and they are more just for documentation purposes. The team or project leader always sends out revised timelines with deliverables after every meeting, followed by the minutes. Since we always operate based on what…[Read more]

]]> 0 ed78fc5302fb93e93e36f95206651925 cef3 replied to the topic Making up tests for design verification and validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/323/ Thu, 10 Nov 2016 12:50:48 -0500 If quality by design is used in the development of the product, a simple way to come up with tests for verification/validation is to just use characterization techniques that have been used to measure the critical quality attributes all through development. As long as the testing technique is reproducible, scientifically sound, and not complicated…[Read more]

]]> 0 0f8a2bf0bbe6faadc6d045b0ac644e4d cef3 replied to the topic Design Transfer in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/316/ Wed, 09 Nov 2016 23:33:22 -0500 I disagree. For a smaller company, it is usually more cost effective to outsource manufacturing because they rarely have the infrastructure required for production. It is usually larger companies that are producing many products that can justify and afford the facilities, equipment, personnel, expertise, etc. for in-house manufacturing.

However,…[Read more]

]]> 0 8568cc5b8f456bc8fb302861ed674df7 cef3 replied to the topic Design Transfer and Challenges in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/289/ Tue, 08 Nov 2016 18:04:12 -0500 Many things can go wrong during transfer. For example, if the design specs heretofore have all been for a product made through a different process and/or scale than what will be used in manufacturing, the release specs may have to be modified. Testing protocols for specs have to be properly documented and quality control personnel must be properly…[Read more]

]]> 0 4b5e97cacb48ce0b2ca7f23bfef2aafe cef3 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/190/ Sun, 06 Nov 2016 15:27:17 -0500 It seems that the DHF is superior to the Design Dossier or Tech File in it’s thoroughness and documentation and that is why there seems to be a move in the EU toward the use of a DHF instead.
From the same link that pt58 posted: “Newer EU regulatory guidance documents are moving the TF/DD more in the direction of the DHF. However, a review of both…[Read more]

]]> 0 2e877bc2cb4b1261c1d2df31e8842200 cef3 replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/172/ Sat, 05 Nov 2016 19:15:25 -0400 I found a presentation that was put together by BioTechLogic to address this issue (http://c.ymcdn.com/sites/www.casss.org/resource/resmgr/2016_CMCS_TreDenickTracy.pdf). It seems like it is a very involved process and I’ve just listed the major steps below:
1. Quality System Gap Assessment
2. CAPA
3. Form Cross Functional Team
4. Develop “Device F…[Read more]

]]> 0 8667a8c2ad97c052a9d1e467d2bf2118 cef3 replied to the topic What are Design Controls? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/160/ Sat, 05 Nov 2016 15:29:06 -0400 It’s important to add that when revisions are made to the design controls, change control procedures must be followed and documented. The FDA is very strict on this, since good documentation practices require that everything be documented or else it didn’t happen. Furthermore, change controls require valid justification and cannot just be executed…[Read more]

]]> 0 4fca7ecb4d8e3f789e97babd45be14b4 cef3 replied to the topic Design input sources in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/159/ Sat, 05 Nov 2016 15:20:41 -0400 I assume that sources of design input would be marketing studies on what type of product is needed, key opinion leaders, and scientific experts. In the lecture, Dr. Simon commented that marketing puts this together through customer opinions and development team input. Design inputs can be such things as how the device should function, how long it…[Read more]

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