https://medicaldevicecourses.com/members/jad73/activity/ Activity feed for jad73. Fri, 24 Apr 2026 19:34:49 -0400 https://buddypress.org/?v= en-US 30 hourly 2 31e355acbb59cb39b07418b8e21db5e7 https://medicaldevicecourses.com/activity/p/14475/ Wed, 15 May 2019 18:57:17 -0400 I think this class is truly an eye opener because the materials that were covered here weren’t really discussed in the undergraduate level; there were mentions here and there but never really discussed thoroughly. This class has shown me another…   Read more»

]]> 7544c884ec77a0484d618f59deee2c15 https://medicaldevicecourses.com/activity/p/14472/ Wed, 15 May 2019 18:57:15 -0400 I think that its not fair to have a non-compete agreement that will last a long time, e.g. 6+ months, especially for the newly graduated people because its not as if the company is gonna sustain you when you leave…   Read more»

]]> 73b560fc2f21edf88d301f4be20b6c56 https://medicaldevicecourses.com/activity/p/14464/ Wed, 15 May 2019 18:57:12 -0400 Written agreements are definitely much better than verbal agreement. As most of the participants mentioned here, that written agreements are easier to defend in court because you have a document that is legally binding which is easier to use in…   Read more»

]]> 3291a843bbd1ef278f0af24ca0feb2f0 https://medicaldevicecourses.com/activity/p/14306/ Wed, 15 May 2019 18:54:58 -0400 I agree with @tilak‘s post. I think that the matrix organization will allow for a more open communication between staffs of each company which will result in a clearer, defined goals in which everyone involved will be on the same…   Read more»

]]> cbfabd5defc0a9e091ad3ea0f6ba7029 https://medicaldevicecourses.com/activity/p/14293/ Wed, 15 May 2019 18:54:51 -0400 I think I can do both. I’m more suited starting out in a middle management role then transitioning to upper management. It goes in line with what @Scott said where upper managers would be best if they spent some time…   Read more»

]]> 401a7592b03f3b794f69d082b737c08c https://medicaldevicecourses.com/activity/p/14292/ Wed, 15 May 2019 18:54:50 -0400 From personal experience, I think that its better to work with people who you don’t personally know but knowledgeable in the role they’re playing on a project. For Capstone I and II, I worked with people whom I’ve never met…   Read more»

]]> 5c860a64501e98267e4f61107f8c14f6 https://medicaldevicecourses.com/activity/p/14156/ Wed, 15 May 2019 18:52:34 -0400 I think that its only fair that getting a hold of these standards for regulations because these standards are what can possibly save a company from a lawsuit. However, sometimes regulatory standards are not enough measure to prevent injuries. I…   Read more»

]]> d656e05de30e667cbc808a6721d07146 https://medicaldevicecourses.com/activity/p/14153/ Wed, 15 May 2019 18:52:33 -0400 This phrase does pose a difficult situation because gauging “As Far As Possible” is pretty much relative. However, I think that thorough assessment of risks involved ,whether it be severe or minor, and providing solutions to either avoid or mitigate…   Read more»

]]> 5cfde7559c77094a2eb199c59ad8eb15 https://medicaldevicecourses.com/activity/p/14151/ Wed, 15 May 2019 18:52:31 -0400 I completely agree with the notion that risk management documentation should be considered a living document. I think that updating risk management documentation based off of feedback and complaints after its out on the market is important to improve processes…   Read more»

]]> 6c0fc05d67d3aa8fd8ddda16c58eab11 https://medicaldevicecourses.com/activity/p/14019/ Wed, 15 May 2019 17:10:28 -0400 Verification is important because this ensures that the product meets the requirements for the design of the product. This is verified by executing a test plan to verify that it’s within the accepted tolerance described in the requirements document. Verification…   Read more»

]]> c3ba00fa35db7a03af99682adab53e04 https://medicaldevicecourses.com/activity/p/14017/ Wed, 15 May 2019 17:10:27 -0400 These three documents were the backbone of the entire Capstone project. These documents follow the project’s journey from it’s conception to its completion. The requirements document describe the project’s overall characteristic from its physical characteristics to its technical features. These…   Read more»

]]> eedad6643ff32f8d98d5a05234469449 https://medicaldevicecourses.com/activity/p/14015/ Wed, 15 May 2019 17:10:26 -0400 In Capstone I and II, I participate in my team’s weekly design review meeting along with our advisor. During design review meetings, my team and I would start it off by discussing the milestones we’ve accomplished and missed; These milestones…   Read more»

]]> 895d08eb5459eec98d8109f5ec3f7bc2 https://medicaldevicecourses.com/activity/p/13901/ Wed, 15 May 2019 17:09:14 -0400 Meeting minutes is good to keep track of because this also helps you keep in track of what phase you are in in a project. For Capstone, I have weekly meetings with my group members and advisor, and everything that…   Read more»

]]> 74c0127994fe182b4076177c6771c8e5 https://medicaldevicecourses.com/activity/p/13894/ Wed, 15 May 2019 17:09:10 -0400 For Capstone II, I had to make up a test method to validate the product. I don’t remember having to use a specific set of criteria for validation. When I had to do it along with my team, we thought…   Read more»

]]> 0d950562b920cc7c47fe4b283dd7504a https://medicaldevicecourses.com/activity/p/13890/ Wed, 15 May 2019 17:09:09 -0400 Having completed Capstone I and II, the requirements and test plan documents are the most important documentation you have for your product. These documents describe the product’s mechanical properties, electrical properties, biocompatibility and the likes. These documents are also considered…   Read more»

]]> 1fe648ffc7be44a8fb4e56ac65568709 https://medicaldevicecourses.com/activity/p/13763/ Wed, 15 May 2019 17:08:00 -0400 I agree with your stand regarding clinical trials. It is necessary for discovery but comes with greater risk in the form of a negative impact on the well-being of the subject when the experiment goes awry. I think that human…   Read more»

]]> 56173310569b546057081070a5e43ea6 https://medicaldevicecourses.com/activity/p/13762/ Wed, 15 May 2019 17:07:59 -0400 I agree with the consensus here. Double blind study will produce a more reliable/unbiased result because the data that will be collected is based solely on observations by the investigators. I think that if the investigator has prior knowledge as…   Read more»

]]> 254a485cff7945b918c00e57d4bc166e https://medicaldevicecourses.com/activity/p/13759/ Wed, 15 May 2019 17:07:58 -0400 I think that informed consent is an important aspect in a clinical trial or hospitals because this protects clinics/hospitals/laboratories/organizations from liabilities when things go awry. In the case of Henrietta Lacks, her cells were cultured and used for research without…   Read more»

]]> 1d7de42abc08cd0e7391e320e80fe5ce https://medicaldevicecourses.com/activity/p/13490/ Wed, 15 May 2019 17:05:20 -0400 You’re definitely right about the financial burden being less in partnerships as oppose to sole proprietorship. Also, you are right about the great risk in choosing the right partner. I think that entering a partnership is something that will only…   Read more»

]]> c068528dd9f65f9ddd0dd0d158e3dfcd https://medicaldevicecourses.com/activity/p/13468/ Wed, 15 May 2019 17:05:08 -0400 I agree with what gaberuiz13 says. In this time and age, it is really challenging to land a first job offer as a recent graduate especially not having any industry experience from internships or co-ops; especially true in engineering. Even…   Read more»

]]> f2b0d4ca73b70f1ef2f42096b53f35f6 https://medicaldevicecourses.com/activity/p/13466/ Wed, 15 May 2019 17:05:07 -0400 If I were to be an owner of a business, I would want to own a piece of an LLC. A LLC can have multiple owners including corporations. Therefore, the possibilities are endless in addition to being able to sell…   Read more»

]]> f349548c45494e1eff1914f0c3aee304 https://medicaldevicecourses.com/activity/p/13348/ Wed, 15 May 2019 17:04:11 -0400 Sounding off to the previous posts. I think that R&D and Quality Assurance/Compliance conflicts in most cases due to the differences in the role they play and the overall objective they need to meet. Quality assurance/compliance dictates whether each or…   Read more»

]]> 7db63e47d4f71e005e63c80a2d56ad78 https://medicaldevicecourses.com/activity/p/13345/ Wed, 15 May 2019 17:04:09 -0400 Echoing on what dh239 posted; This is what happened in the Ford Pinto case. The company knew that there was a flaw in the design and they did the risk analysis and calculated the amount that would be needed to…   Read more»

]]> 0f10e39827c6768630e52e2f138c0d4c https://medicaldevicecourses.com/activity/p/13332/ Wed, 15 May 2019 17:04:03 -0400 Although quality can be burdensome due to several factors mentioned in majority of the posts here; I think that its worthwhile for companies to implement it, especially for companies in the medical/healthcare space. Quality Assurance/Control makes sure that the processes…   Read more»

]]> 3d52a2902e1a501fbafc2b7f8b4952ce https://medicaldevicecourses.com/activity/p/13041/ Wed, 15 May 2019 17:01:28 -0400 As of now, animal testing is the closest we can get when it comes to testing new medicines, vaccines or medical devices on a living subject before moving on to actual human subjects. This is due to the limitations in…   Read more»

]]> bbd1ca8a7c122d8e26eb74656deb36bf https://medicaldevicecourses.com/activity/p/12988/ Wed, 15 May 2019 17:01:02 -0400 In the industry research is done by scientists or engineers as oppose to grad-students or post-docs in academia. I think that researchers in the industry setting is a better approach since you have a wider selection of candidates that will…   Read more»

]]> cab1a10cae262f2fdda46b1a24aabcaf https://medicaldevicecourses.com/activity/p/12987/ Wed, 15 May 2019 17:01:01 -0400 I think research that will yield results to be used for now can lead to research ideas that can be improved upon; which will then pave the way to a research study that will be used for future generation or…   Read more»

]]> d6578a5e310b9f519a8f17afaa029b46 https://medicaldevicecourses.com/activity/p/12887/ Wed, 15 May 2019 16:59:59 -0400 In Capstone I and II, there are several milestones set to ensure completion of the project at the end of the 2 semester course. Here, if milestones were met its marked completed but if it is missed; a team must…   Read more»

]]> 25701849f3e740271a24ba41f771d88a https://medicaldevicecourses.com/activity/p/12882/ Wed, 15 May 2019 16:59:56 -0400 Managers and engineers play completely different roles in projects, which can cause ethical dilemmas that has no clear answer(s). Managers are mostly concerned with the end results where they must meet certain deadlines, budget and etc. to make a profit…   Read more»

]]> 96526cac8f67520bab486415a821efad https://medicaldevicecourses.com/activity/p/12879/ Wed, 15 May 2019 16:59:55 -0400 I think that the main challenge project management for medical devices face is the lengthy time of certain projects. This is mainly due to the rigorous protocols and strict regulations enforced by the FDA or other regulatory agencies alike. Since…   Read more»

]]> 1f35ecbbda80f42f1f4731f72973219b https://medicaldevicecourses.com/activity/p/5528/ Mon, 04 Dec 2017 02:52:41 -0500 I think this class is truly an eye opener because the materials that were covered here weren’t really discussed in the undergraduate level; there were mentions here and there but never really discussed thoroughly. This class has shown me another aspect of device development, outside of R&D and theory; which also showed me more career options…[Read more]

]]> 0 4829ef44a8ceb552ee8e2b731e9e70cc https://medicaldevicecourses.com/activity/p/5525/ Mon, 04 Dec 2017 02:37:35 -0500 I think that its not fair to have a non-compete agreement that will last a long time, e.g. 6+ months, especially for the newly graduated people because its not as if the company is gonna sustain you when you leave or get fired. You are basically on your own and not having a job for that long can be rough. It’ll also affect one’s chances of getting…[Read more]

]]> 0 ab280e91d54b1b33fa855d450fcd8458 https://medicaldevicecourses.com/activity/p/5517/ Mon, 04 Dec 2017 02:19:53 -0500 Written agreements are definitely much better than verbal agreement. As most of the participants mentioned here, that written agreements are easier to defend in court because you have a document that is legally binding which is easier to use in court if things went awry. This is also the main reason why documentation is stressed a lot not just in…[Read more]

]]> 0 0d3294ab7a2dc55da5ecfb7d71ffc334 https://medicaldevicecourses.com/activity/p/5347/ Mon, 27 Nov 2017 01:33:16 -0500 I agree with @tilak‘s post. I think that the matrix organization will allow for a more open communication between staffs of each company which will result in a clearer, defined goals in which everyone involved will be on the same page all throughout the completion of the project. I also agree that there will be an indirect system of checks and…[Read more]

]]> 0 1bf3e0682f95aa4ceb82da885e61a7b9 https://medicaldevicecourses.com/activity/p/5333/ Mon, 27 Nov 2017 00:29:57 -0500 I think I can do both. I’m more suited starting out in a middle management role then transitioning to upper management. It goes in line with what @Scott said where upper managers would be best if they spent some time with the company as a middle manager. I think that being able to complete/fulfill a task on a daily/weekly basis is a fulfilling…[Read more]

]]> 0 fecac8e9cbb957127ab4237b2ace68fd https://medicaldevicecourses.com/activity/p/5332/ Mon, 27 Nov 2017 00:09:52 -0500 From personal experience, I think that its better to work with people who you don’t personally know but knowledgeable in the role they’re playing on a project. For Capstone I and II, I worked with people whom I’ve never met from previous classes but they were knowledgeable of the things that they’re supposed to do. The team dynamics were somewhat…[Read more]

]]> 0 cdcb1ebb9d7142921797b457ec564696 https://medicaldevicecourses.com/activity/p/5190/ Mon, 20 Nov 2017 00:35:22 -0500 I think that its only fair that getting a hold of these standards for regulations because these standards are what can possibly save a company from a lawsuit. However, sometimes regulatory standards are not enough measure to prevent injuries. I remember from one of my classes where the issues with the design on the Ford Pinto had caused the car to…[Read more]

]]> 0 e6be978b4f4e86ed9a849257e583c26a https://medicaldevicecourses.com/activity/p/5187/ Mon, 20 Nov 2017 00:10:12 -0500 This phrase does pose a difficult situation because gauging “As Far As Possible” is pretty much relative. However, I think that thorough assessment of risks involved ,whether it be severe or minor, and providing solutions to either avoid or mitigate these risks is best. This would also tie into another discussion topic regarding risk management…[Read more]

]]> 0 72d79d7f4fdda2e8714046f197b3f9fd https://medicaldevicecourses.com/activity/p/5185/ Mon, 20 Nov 2017 00:01:28 -0500 I completely agree with the notion that risk management documentation should be considered a living document. I think that updating risk management documentation based off of feedback and complaints after its out on the market is important to improve processes as well as the quality of the product. This can also help identify products that needs…[Read more]

]]> 0 ed6574819afc50c9e079adf022f7b9b0 https://medicaldevicecourses.com/activity/p/5042/ Sun, 12 Nov 2017 23:49:31 -0500 Verification is important because this ensures that the product meets the requirements for the design of the product. This is verified by executing a test plan to verify that it’s within the accepted tolerance described in the requirements document. Verification makes sure that the product would not cause any harmful side effects due to a faulty…[Read more]

]]> 0 8c7b94edb7e87f1682352005cdecb9dc https://medicaldevicecourses.com/activity/p/5040/ Sun, 12 Nov 2017 23:31:28 -0500 These three documents were the backbone of the entire Capstone project. These documents follow the project’s journey from it’s conception to its completion. The requirements document describe the project’s overall characteristic from its physical characteristics to its technical features. These requirements were all based off of the customer needs…[Read more]

]]> 0 c123a464991a8dee914d1f620644f225 https://medicaldevicecourses.com/activity/p/5038/ Sun, 12 Nov 2017 23:14:08 -0500 In Capstone I and II, I participate in my team’s weekly design review meeting along with our advisor. During design review meetings, my team and I would start it off by discussing the milestones we’ve accomplished and missed; These milestones were set at the beginning of the project. During these meetings we give and get inputs from everyone about…[Read more]

]]> 0 75b3d5a5a840fa9499263054f14c3e07 https://medicaldevicecourses.com/activity/p/4911/ Mon, 06 Nov 2017 01:58:29 -0500 Meeting minutes is good to keep track of because this also helps you keep in track of what phase you are in in a project. For Capstone, I have weekly meetings with my group members and advisor, and everything that was discussed in the meeting is logged; we also discuss where we currently stand regarding the project which tells us what we need to…[Read more]

]]> 0 0eb59202e5af277e4dc3eea159894324 https://medicaldevicecourses.com/activity/p/4904/ Mon, 06 Nov 2017 01:26:54 -0500 For Capstone II, I had to make up a test method to validate the product. I don’t remember having to use a specific set of criteria for validation. When I had to do it along with my team, we thought of what could be done by ourselves to validate our design. For example, I was responsible for the mechanical properties of the product. So what I did…[Read more]

]]> 0 62951397b89c921ca593c6763caa3e87 https://medicaldevicecourses.com/activity/p/4899/ Mon, 06 Nov 2017 00:39:56 -0500 Having completed Capstone I and II, the requirements and test plan documents are the most important documentation you have for your product. These documents describe the product’s mechanical properties, electrical properties, biocompatibility and the likes. These documents are also considered living documents because if there are any additions to…[Read more]

]]> 0 58ee2bb6c8406740a1352e16a7d001fb https://medicaldevicecourses.com/activity/p/4627/ Mon, 30 Oct 2017 00:14:11 -0400 I agree with your stand regarding clinical trials. It is necessary for discovery but comes with greater risk in the form of a negative impact on the well-being of the subject when the experiment goes awry. I think that human subjects are necessary in clinical trials however its still ways a way before we can completely eliminate this method…[Read more]

]]> 0 393df148f0292dc5f708b870103bb113 https://medicaldevicecourses.com/activity/p/4626/ Sun, 29 Oct 2017 23:53:51 -0400 I agree with the consensus here. Double blind study will produce a more reliable/unbiased result because the data that will be collected is based solely on observations by the investigators. I think that if the investigator has prior knowledge as to who got placebo or the actual drug can affect their judgment when recording results; because in a…[Read more]

]]> 0 00bfef8824d957b1180c972fcae4cf5e https://medicaldevicecourses.com/activity/p/4623/ Sun, 29 Oct 2017 23:36:50 -0400 I think that informed consent is an important aspect in a clinical trial or hospitals because this protects clinics/hospitals/laboratories/organizations from liabilities when things go awry. In the case of Henrietta Lacks, her cells were cultured and used for research without her consent. I think that Johns Hopkins should’ve done their due…[Read more]

]]> 0 4abaed8f0fc38647ce8f0262eb738a04 https://medicaldevicecourses.com/activity/p/4172/ Mon, 16 Oct 2017 02:56:47 -0400 You’re definitely right about the financial burden being less in partnerships as oppose to sole proprietorship. Also, you are right about the great risk in choosing the right partner. I think that entering a partnership is something that will only work with someone who you fully trust. Someone who is really close to you where you both share the…[Read more]

]]> 0 35aeb1ffd37f6580496c5e0c2b3e9245 https://medicaldevicecourses.com/activity/p/4150/ Mon, 16 Oct 2017 00:42:12 -0400 I agree with what gaberuiz13 says. In this time and age, it is really challenging to land a first job offer as a recent graduate especially not having any industry experience from internships or co-ops; especially true in engineering. Even having average to good credentials/grades right out of college is challenging in landing that first job that…[Read more]

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