https://medicaldevicecourses.com/members/pdp47/activity/ Activity feed for Parth D. Patel. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 6343f0f11fcca4736dcb151fbe50aded https://medicaldevicecourses.com/activity/p/15999/ Wed, 15 May 2019 19:16:02 -0400 I agree with you, I also feel people here are overworked which is very detrimental to their motivation. There will be times when work will piles up and it has to completed to meet its deadlines. I say this with…   Read more»

]]> 2d7e7a2c1f12add1330cc65b53307421 https://medicaldevicecourses.com/activity/p/15998/ Wed, 15 May 2019 19:16:01 -0400 I also feel like I should work as an engineer for couple of years before moving up to a higher management position. I had always set a goal for myself to move up within a company to higher position, such…   Read more»

]]> dc222fefe2d35cf60301cce80afb5a8c https://medicaldevicecourses.com/activity/p/15997/ Wed, 15 May 2019 19:16:00 -0400 Retaining talented employees is really important not only for the team’s success but also for the company. Having retained employees, you will not waste time retraining new employees. New employees usually have a buffer of two/three months new employees getting…   Read more»

]]> 9c0e33ab6f4623d6f5678b05eeb68cfd https://medicaldevicecourses.com/activity/p/15905/ Wed, 15 May 2019 19:15:08 -0400 I agree with you, working with great people makes your job more enjoyable. I say this with experience, in my opinion if you have a great team environment and everyone gets along then you will enjoy going to work the…   Read more»

]]> bc76414ce2156bd9a684b5115b3eb438 https://medicaldevicecourses.com/activity/p/15903/ Wed, 15 May 2019 19:15:07 -0400 I believe it starts with the culture of the team. If your team has any issues with one another or have no desire of helping one another then it will lead to people either leaving the team to join another…   Read more»

]]> edb6f57cb43cbe6cbf8e006164a32ca1 https://medicaldevicecourses.com/activity/p/15902/ Wed, 15 May 2019 19:15:06 -0400 My motivation is accomplishing your goals. There are many challenges we will all face throughout our career. There will be ups and downs, but reaching your goal is probably the most satisfaction. By this I mean, you’re completing your goal…   Read more»

]]> a0c7df6c579049df83acbc3f27e1a07e https://medicaldevicecourses.com/activity/p/15755/ Wed, 15 May 2019 19:13:35 -0400 WBS does have its pros and cons. However, I feel that the biggest pitfall in this case could be having to do with multiple task all at once.The goal is to break down all tasks so that you can compete…   Read more»

]]> 7e2a0ad4a30427b39f9b6cd9035a33f5 https://medicaldevicecourses.com/activity/p/15754/ Wed, 15 May 2019 19:13:34 -0400 I think HR plays a huge role. This department is responsible for find the correct candidate for the desired position. In terms with medical device, they typically look for someone who as a similarity of the process in the medical…   Read more»

]]> 9c99c2a1326b93d302ff26389f1502fd https://medicaldevicecourses.com/activity/p/15753/ Wed, 15 May 2019 19:13:34 -0400 I’ve also experience something similar with my capstone project. We had multiple components or call them sensors, in order to finish our final project. Our project’s goal was to measure three different biometrics data (blood glucose, blood oxygen, and activity)….   Read more»

]]> b4837ca1d4af335e864ef3e1f8158759 https://medicaldevicecourses.com/activity/p/15615/ Wed, 15 May 2019 19:08:16 -0400 I had the same experience with my capstone project. We were really confused on what class it would be considered. On the other hand we had so many different components, that we had to do research for each one separately….   Read more»

]]> be6681179702de4d2e2b5c2cf6ba6b98 https://medicaldevicecourses.com/activity/p/15614/ Wed, 15 May 2019 19:08:16 -0400 As people have stated the professor mentioned this in the lecture. In my case, during our weekly meetings we go over the weekly metrics. Overall, I believe project management metrics, can help teams especially project managers keep track and have…   Read more»

]]> 589c38627e7c96d45bbfa6bca2972edb https://medicaldevicecourses.com/activity/p/15613/ Wed, 15 May 2019 19:08:15 -0400 Like many, we had to create a gantt chart for our capstone project. There were many couple of times where we missed a great milestone in our project. Our project consisted of using several different sensors, that will be uploaded…   Read more»

]]> a4d31adbedf8fd73af0292eebf21e376 https://medicaldevicecourses.com/activity/p/15500/ Wed, 15 May 2019 19:07:02 -0400 I remember during my internship, I had an opportunity to sit down in a design review meeting. All the head department members were at the meeting. These meeting were taken very seriously and it was mandatory for all member to…   Read more»

]]> 1f8b82314db35ec1bd6c7dc696d6e3f7 https://medicaldevicecourses.com/activity/p/15499/ Wed, 15 May 2019 19:07:01 -0400 I believe having a strong baseline schedule is really important. Scheduling seems to be easy but it is never hundred percent accurate. There will always be unexpected events that can throw a team off schedule. For example, one of my…   Read more»

]]> 2708a4832d3182c25dcea200cfeb4876 https://medicaldevicecourses.com/activity/p/15498/ Wed, 15 May 2019 19:07:01 -0400 Yes the executing phase is very important, this were the project is done. However I don’t think it’s the most important. In my opinion planning phase is the most important. You would have to establish roles and responsibilities, make sure…   Read more»

]]> be95506affcf4259ba6b8c323954822e https://medicaldevicecourses.com/activity/p/15394/ Wed, 15 May 2019 19:05:52 -0400 There are some methods to avoid scope creep. One method is to understand the clients or customers vision of the project. What does the client require? As we learned we need to clarify the goals and objectives in the initial…   Read more»

]]> ad30749550980a3ec1515b552c311bc2 https://medicaldevicecourses.com/activity/p/15393/ Wed, 15 May 2019 19:05:51 -0400 This will definitely delay the project. Both sides can be at fault, Dr. Malekai should have presented his information earlier. This simulation showed that there is miscommunication within the project team. The research was basically condense and gave a higher…   Read more»

]]> 1a4efa13154546d2a1cb433a3a346228 https://medicaldevicecourses.com/activity/p/15392/ Wed, 15 May 2019 19:05:51 -0400 Design Validation is basically, did the project team design the right device? In the medical device industry the design validation used to create device within a specific requirement, like design outputs. The goal is to accomplish all the users needs….   Read more»

]]> 95a67807e6a0e8c682b8a96f27ac626c https://medicaldevicecourses.com/activity/p/15284/ Wed, 15 May 2019 19:04:50 -0400 Anything that is unethical will end up causing problems in the end. I believe any medical device companies will try their best to avoid anything unethical, or they will eventually have to deal with the FDA. PM’s need to set…   Read more»

]]> c14e8f259cd8fdb909c34caece9cebcc https://medicaldevicecourses.com/activity/p/15283/ Wed, 15 May 2019 19:04:49 -0400 The planning phase is the foundation of the entire project. It really is how you will execute. If you don’t plan a head, you are bound to fail at some point during the project. The planning phase will determine how…   Read more»

]]> 9e501b6a33a98b92ee0a0ecf3e8e3a04 https://medicaldevicecourses.com/activity/p/15282/ Wed, 15 May 2019 19:04:48 -0400 During my capstone project unfortunately we had many critical path situations. Our project was a monitoring device, using a blood oxygen sensor, and accelerometer that can transfer data to a secure UI. Our goal was to make this monitoring device…   Read more»

]]> 1eaa113cd5ba11ba81d8aaf1d187a73d https://medicaldevicecourses.com/activity/p/15182/ Wed, 15 May 2019 19:03:46 -0400 A lot of companies use gantt charts, and it is a very useful tool. I believe using gantt charts for medical devices helps see the overall picture from the initiating phase to the end phase. It is helpful tool to…   Read more»

]]> 6b03393d072ab455e9258c0baf81273e https://medicaldevicecourses.com/activity/p/15181/ Wed, 15 May 2019 19:03:45 -0400 Like many have stated, some pitfall will occur. Things like holidays and days off could slow a team down. That is why many teams and companies use gantt charts, to organize their tasks. I believe as a team or an…   Read more»

]]> 5f2e9484ed7be0feb389932c39e916bf https://medicaldevicecourses.com/activity/p/15180/ Wed, 15 May 2019 19:03:45 -0400 I remember during my undergraduate capstone class, we had to create a budget for a grant we received. We list all the materials we needed for this project. The biggest problem was we needed sensors and that came from europe….   Read more»

]]> 76018ca1075b90d5c09f6b3b61919750 https://medicaldevicecourses.com/activity/p/15072/ Wed, 15 May 2019 19:02:47 -0400 I also agree with the others, the capstone class is a great example and experience of monitoring and controlling. During my project, there were many times were we fell behind schedule mainly because of our code and electrical components did…   Read more»

]]> 8c9608e2bd399b40e14df77ee16181c9 https://medicaldevicecourses.com/activity/p/15071/ Wed, 15 May 2019 19:02:47 -0400 Risk analysis is crucial for medical device companies. Medical device companies has to be safe and service efficiently. I do not think there is a specific ratio, because the less risk companies have or more awareness the companies know about…   Read more»

]]> 1af0c1fbcfd1da689db7cb48b4c1a56c https://medicaldevicecourses.com/activity/p/15070/ Wed, 15 May 2019 19:02:46 -0400 If I was running a risk management meeting, the first thing I would do is ask the team to review IS0 14971, because it is basically the bread and butter for risk analysis for medical devices. I would have a…   Read more»

]]> 83921bd09efac1440586fd8acbb10150 https://medicaldevicecourses.com/activity/p/14960/ Wed, 15 May 2019 19:01:44 -0400 There are many risk management plans for different backgrounds. In the medical device industry we base our risk management plans on ISO 14971. Every time we mention risk management I think of ISO 14971, because the medical devices companies have…   Read more»

]]> 405b776485a42cbd1c558e9f84542277 https://medicaldevicecourses.com/activity/p/14958/ Wed, 15 May 2019 19:01:43 -0400 In my current company it all depends on which department you work for. The department I work for is a functional organization. I know most engineers in other departments are assigned to a project. In other departments they have engineers…   Read more»

]]> cc64dd874dac8d33ef1ffcf5e1255665 https://medicaldevicecourses.com/activity/p/14957/ Wed, 15 May 2019 19:01:43 -0400 That’s really interesting, because I believe it all depends on the company. The question can arise, why should customers and funders buy and fund your products? In my opinion, if the company has a product that they believe can make…   Read more»

]]> da1d162710b047699859405f8cbea42e https://medicaldevicecourses.com/activity/p/14819/ Wed, 15 May 2019 19:00:23 -0400 During my undergraduate I did an internship over the summer at a medical device company that developed knee and hip replacements. The company’s customers were mainly doctors. I remember we use to get feedback from surgeons around the country on…   Read more»

]]> 4fc5748bf61e085181e208cb77b939e8 https://medicaldevicecourses.com/activity/p/14818/ Wed, 15 May 2019 19:00:22 -0400 In my recent experience I worked for both matrix and functional organization structures. I found that functional organizational structures much more efficient than matrix organization structure. I am not saying matrix structures do not work, but communication was very difficult….   Read more»

]]> 25dd58147d1054880d43bd2d3594c6f1 https://medicaldevicecourses.com/activity/p/14817/ Wed, 15 May 2019 19:00:22 -0400 I also prefer the functional organization structure. This structure seems like an overall structure of many companies. The employees are managed by a manager with experience in the same specialty who can understand and review the staffs work. If you’re…   Read more»

]]> fda20c879d25d090bfbe8d3cc2c1812c https://medicaldevicecourses.com/activity/p/14687/ Wed, 15 May 2019 18:59:12 -0400 Those are two really big issues you brought up. How safe is the data being transmitted? What happens if the sensor is not capable of working? There are cases where sensors do not transmit correct data or do not transmit…   Read more»

]]> 69b1d8961835f4eff80e5eacce317a41 https://medicaldevicecourses.com/activity/p/14685/ Wed, 15 May 2019 18:59:11 -0400 In my opinion I feel that this is more of a drug then a device. The purpose of this drug used for schizophrenia and act as a sensor second. Patients who are taking the drug are using the sensor to…   Read more»

]]> 809389ff2ef8b184eccbd2f363b7b5e5 https://medicaldevicecourses.com/activity/p/14683/ Wed, 15 May 2019 18:59:10 -0400 I completely agree with you. This does have a restriction on engineers, creating new innovative ideas. Medical devices basically have to be pre-existing. This week in the lecture we learned about CDRH. The goal of CDRH is to bring innovative…   Read more»

]]> 6e6cca0e6e550c8c241bca57553157bf https://medicaldevicecourses.com/activity/p/14526/ Wed, 15 May 2019 18:57:40 -0400 I consider that a mobile “medical” app as a medical device. If you are using that device to collect clinical data it should be considered a medical device. During my capstone project, we programmed an accelerometer and medical monitoring device….   Read more»

]]> 281c6f96e614a08d7e3ef024a65e0a53 https://medicaldevicecourses.com/activity/p/14525/ Wed, 15 May 2019 18:57:39 -0400 According to the FDA the fitbit is classified as class II. It’s funny, something so small such as a fitbit runs on algorithm has to be regulated and considered to be a class II. During my capstone project we also…   Read more»

]]> a5ec958a2d6fad9c5a40b188a5856d5c https://medicaldevicecourses.com/activity/p/14524/ Wed, 15 May 2019 18:57:39 -0400 Interpersonal skills are crucial when it comes to working in the industry. We all work as teams and sometimes your peers will not agree with on another. That is why interpersonal skill are really important. In my opinion verbal communication…   Read more»

]]> 6e796ca4eff3ee6e675096bf02e40367 https://medicaldevicecourses.com/activity/p/11421/ Wed, 15 May 2019 16:44:49 -0400 There is a clear difference between a patent and a NDA. First of all a patent is a legal document that gives you or a company a legal binding of ownership that is reinforced by penalties. The NDA is a…   Read more»

]]> 40edd2cd2d13aacd98bedef0bbe66db4 https://medicaldevicecourses.com/activity/p/11420/ Wed, 15 May 2019 16:44:49 -0400 I agree with you, lets say a company is getting sued, no verbal agreement will be taken into account in court. There is no proof that will back your claims. Only written agreements are known to be reinforce your case….   Read more»

]]> 78f3cb9c04d08fcedcd9236ceb50883d https://medicaldevicecourses.com/activity/p/11418/ Wed, 15 May 2019 16:44:48 -0400 Verbal agreement and Written agreement are totally different. One is more important than the other. First of all verbal agreement nothing is guaranteed. Verbal is all talk, and most of the time it is just discussion on what ideas they…   Read more»

]]> 95cea4c42bc67566004a9eedf7a8f8a2 https://medicaldevicecourses.com/activity/p/11311/ Wed, 15 May 2019 16:43:49 -0400 I agree with you, I also prefer the Functional organization if you are starting up a company. Yes matrix organization seems a lot more helpful, let’s say some is stuck and needs help there are many people who can help…   Read more»

]]> 2e2c33ae56afe81b2d6f548cc2f4d0e3 https://medicaldevicecourses.com/activity/p/11303/ Wed, 15 May 2019 16:43:45 -0400 I agree with you that communication is a major key in team work. Communicating as a team makes the work a lot easier and working as a team. If their is no communication this can lead to group conflict and…   Read more»

]]> 983d36e6eba80a63384229c5f6897b30 https://medicaldevicecourses.com/activity/p/11302/ Wed, 15 May 2019 16:43:45 -0400 I believe this can go either way. In a company people build relationships with other people and they work as a team. In my opinion it is better to work with a team of individuals who are more knowledgeable in…   Read more»

]]> 1dfbb2fb0a9da9460b3b111c7deee1c9 https://medicaldevicecourses.com/activity/p/11166/ Wed, 15 May 2019 16:40:28 -0400 As we all learned in risk management, Failure Modes and Effects Analysis (FMEA) and fault tree analysis (FTA) is a valuable tool used to evaluate errors in medical device designs. In my opinion if risk analysis evaluated earlier there is…   Read more»

]]> 962f1222ae7270f594345265f882d401 https://medicaldevicecourses.com/activity/p/11164/ Wed, 15 May 2019 16:40:27 -0400 I agree with you, analyzing the device as team at all angles is really important. There are times when other may catch mistakes that you have missed. This goes for all departments or areas. As a company, employees need to…   Read more»

]]> 0a1bc9ef5612a6e5535633468caefc97 https://medicaldevicecourses.com/activity/p/11163/ Wed, 15 May 2019 16:40:26 -0400 It is kind of shocking that many companies basically do not follow through after the production of a product. In a business standpoint, customers would want a product that will not have any flaws. To ensure a product is safe…   Read more»

]]> 2cc2856dd8703198c2d94aac8cd09a99 https://medicaldevicecourses.com/activity/p/11003/ Wed, 15 May 2019 16:38:43 -0400 Meeting minutes is basically important protocols discussed at a meeting. Basically meeting minutes covers all the topics discussed during a meeting, such as the current status of the project, any issues with the project, and schedule of and what has…   Read more»

]]> 9e7d94ce6b7e0216945f33d63e44b28f https://medicaldevicecourses.com/activity/p/11002/ Wed, 15 May 2019 16:38:42 -0400 I agree with you that larger companies would benefit the outsource the design transfer. The goal is if all specifications are completed efficiently, the companies would save a lot of money and time to do other work. Larger companies have…   Read more»

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