https://medicaldevicecourses.com/members/lechichr/activity/ Activity feed for lechichr. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 643c83cea8343af206b16a1280f3c21c https://medicaldevicecourses.com/activity/p/21024/ Mon, 23 Nov 2020 18:08:55 -0500 So I have seen NDAs and CDAs for a long time. My perspective is that folks sign them very quickly to move their business forward but rarely “read” the fine print and leave it to their laywers. This is a…   Read more»

]]> 8bdbfe61a106e1895a86b5d2bba6b05f https://medicaldevicecourses.com/activity/p/21023/ Mon, 23 Nov 2020 17:59:31 -0500 A couple of years ago, I hired a physician to consult on a medical device for a surgical medical device. The device was part of a combination product used in surgeries to control bleeding. The consultant helped to put together…   Read more»

]]> f3c0b04b76f554750e01b8822f7e6e9b https://medicaldevicecourses.com/activity/p/21022/ Mon, 23 Nov 2020 17:54:45 -0500 The non compete seems to have more impact to folks in R&D, senior management and the sales and marketing organization. Clearly individuals that have had access to critical information such as new product innovation and business plans are going to…   Read more»

]]> f84ac0714c5cfa3132bf69c270bb7d8c https://medicaldevicecourses.com/activity/p/20963/ Wed, 18 Nov 2020 11:46:44 -0500 I am the PM on my class project and I would reference the Tuckman team forming model. In our first week we went through the forming and storming phases. The group was trying to get to know each other and…   Read more»

]]> 968fd4ef3f6ff9fc05045a56206462d3 https://medicaldevicecourses.com/activity/p/20962/ Wed, 18 Nov 2020 11:37:46 -0500 I think in order to answer the question, it might be more important to characterize the size, maturity and existing organizational structure of the medical device company. Medical devices are made with a widely different types of organizations. Some a…   Read more»

]]> b42044da4657719adb425fa134e626e0 https://medicaldevicecourses.com/activity/p/20961/ Wed, 18 Nov 2020 11:26:52 -0500 in a previous role, i had a group of supply chain project managers responsible for product launches, so you could say we were a PMO group. We developed a set of processes to manage the projects. Each project manager had…   Read more»

]]> e717de13fa58f350981a52c404a9d94b https://medicaldevicecourses.com/activity/p/20887/ Fri, 13 Nov 2020 12:41:03 -0500 Your comment about product availability reminds me of a potential risk that I have experienced. Many medical devices have components that are outsourced from a supplier. They could be a “simple” as a plastic tube or more complicated as a…   Read more»

]]> 0f3b12b1135efe85335f51ab2eb86451 https://medicaldevicecourses.com/activity/p/20886/ Fri, 13 Nov 2020 12:29:08 -0500 My perspective is that Post Market Surveillance is where the rubber its the road. With all the efforts of design engineering and the design controls, in some situations, it is only when we really have the medical device used in…   Read more»

]]> dae74f93240a59f191e74188c0603269 https://medicaldevicecourses.com/activity/p/20885/ Fri, 13 Nov 2020 12:20:12 -0500 I have used many of the tools mentioned including brainstorming, fish bone diagrams and FMEA. i think it is important to know when to use them in the right situation. For example if you are doing it to resolve a…   Read more»

]]> 0438da0e13a81ccef0ed8c94da3ffde7 https://medicaldevicecourses.com/activity/p/20821/ Fri, 06 Nov 2020 12:05:46 -0500 I know how you feel about incomplete Gantt charts. Having run projects for years, I think that the effort to develop gantt charts seem a little overwhelming. Having a project manager or designated project scheduler responsible for the initial development…   Read more»

]]> b907ac68624d2abd88a78ef3d8b796d6 https://medicaldevicecourses.com/activity/p/20820/ Fri, 06 Nov 2020 11:56:46 -0500 Scope management is definitely an important part of project management of medical devices. Gathering elements from different individuals certainly can bring additional elements potentially incongruent with others, but we need to better understand what the real scope is. The project…   Read more»

]]> 6c3b6ed01544e9379f37e9933448ffc4 https://medicaldevicecourses.com/activity/p/20819/ Fri, 06 Nov 2020 11:48:01 -0500 I agree with the comment that the DID and DSD documents will not guarantee a quality medical device product. The overall process beginning with the voice of the customer (VOC) a term from Operational Excellence is the beginning. The efforts…   Read more»

]]> 1b732269dd413c99692ce2777df28b1d https://medicaldevicecourses.com/activity/p/20749/ Sat, 31 Oct 2020 12:08:48 -0400 My perspective is that the various artifacts such as Design input Document, Design Specification Document and/or Design Output Document are important to document the robust process of gathering information, analysis and decision making. As the Professor indicated each organization may…   Read more»

]]> 3896abaceb430f36a8be3711464ecd94 https://medicaldevicecourses.com/activity/p/20748/ Sat, 31 Oct 2020 11:53:59 -0400 Having been a project manager, I can say the Gantt Chart is extremely valuable in the initial stages to better communicate relationships between tasks especially when team members think there are nol dependencies. The ability to create a common view…   Read more»

]]> bff55e99c98e81abb7aec67585a87e8e https://medicaldevicecourses.com/activity/p/20747/ Sat, 31 Oct 2020 11:46:07 -0400 My view of design controls is to provide a complete product lifecycle to medical devices. In the early stages of project definition to the ultimate regulatory approval and post market surveillance, we need to fully understand reasons for change and…   Read more»

]]> f9e483589d2672db9dc85f13f167a54a https://medicaldevicecourses.com/activity/p/20699/ Fri, 23 Oct 2020 17:02:38 -0400 I agree with the different backgrounds addressing different roles such as statistican, regulatory submission expert or a biomedical engineer attached to the clinical study for provide technical support.  I would however state that all folks involved in clinical work be…   Read more»

]]> e77e8fa64be8f0e93978633e8e0503f5 https://medicaldevicecourses.com/activity/p/20698/ Fri, 23 Oct 2020 16:31:01 -0400 The value of clinical studies in my opinion, looks at the larger picture of society. We would all probably agree that if a product, medical device or drug were developed and approved without a definitive plan and set of criteria,…   Read more»

]]> 67878fd614180f9ed122ceaecb06ee71 https://medicaldevicecourses.com/activity/p/20697/ Fri, 23 Oct 2020 16:21:58 -0400 So I agree with your comments regarding that medicine involves situations where values come into conflict. I also think that the regulators such as the FDA have put in place regulations to temper the potential expectations have with clinical studies….   Read more»

]]> f0e52f3f61849536cb829b7bcddf288c https://medicaldevicecourses.com/activity/p/20629/ Fri, 16 Oct 2020 12:54:43 -0400 I think most folks would sense if they are being manipulated during a sales cycle or reading marketing literature. In the healthcare industry, working with professionals such as physicians we need to keep in mind that we should be presenting…   Read more»

]]> 98f536eb52b68e2d5b1e18eb03872143 https://medicaldevicecourses.com/activity/p/20628/ Fri, 16 Oct 2020 12:46:29 -0400 Most companies in the healthcare industry have created mission and vision statements like Stryker, Novartis and Pfizer. They have cascaded that approach down to divisins and departments if the company is rather large also. Training sessions are setup to review…   Read more»

]]> bcb45f3fd0ea256e0a51462f88f88d4b https://medicaldevicecourses.com/activity/p/20627/ Fri, 16 Oct 2020 12:38:27 -0400 I have also seen in the pharmaceutical side similar approaches with physicians giving presentations on the use of the product and results. I personnally think the “word” of physicians gives the product drug or medical device a stronger message and…   Read more»

]]> 45098fe074a3657bb2e14c1c244c15bf https://medicaldevicecourses.com/activity/p/20565/ Wed, 07 Oct 2020 11:35:38 -0400 I understand how you have evaluated BMS. Clearly they have had some rough patches in their history but so has many biopharmaceutical organizations. I think they have made some major changes in the oncological space including the acquisition of Celgene….   Read more»

]]> acc4b9aa0bc7472c50f2fb597c44b3c4 https://medicaldevicecourses.com/activity/p/20564/ Wed, 07 Oct 2020 11:25:06 -0400 Actually this is a great topic. I am currently evaluating options but I probably going to the LLC route. I am providing consulting in the cell and gene therapy industry with another consulting organization who is a LLC also at…   Read more»

]]> cf271cddb4807eceec0e252a84f6b958 https://medicaldevicecourses.com/activity/p/20563/ Wed, 07 Oct 2020 11:17:42 -0400 I understand what you are saying with regards to the company’s mission and vision. Having work for both large and small organizations, currently working for a LLC, I would suggest that size will matter as well as reliability and consistency….   Read more»

]]> a1ff68281c64d5e5d764ecc730983247 https://medicaldevicecourses.com/activity/p/20502/ Thu, 01 Oct 2020 23:48:31 -0400 This reminds of me of another reply I made earlier. Quality should be shared across the organization. While a quality organization is important to ensure testing or auditing is performed, manufacturing, supply chain, marketing, everyone needs to develop and support…   Read more»

]]> b6fcfefda186708a42b4e370692933ce https://medicaldevicecourses.com/activity/p/20501/ Thu, 01 Oct 2020 23:39:12 -0400 I agree with the concept that quality control is not solely a final product testing process. The ability to merge quality control testing in-line, on-line and merge with manufacturing process controls is vital to ensure better quality with real-time communication…   Read more»

]]> e0f7c17aaf9f2fb0dbac02d6dae711bc https://medicaldevicecourses.com/activity/p/20500/ Thu, 01 Oct 2020 23:33:15 -0400 The value of digital transformation with the various technologies such as IIOT, Artificial Intelligence, etc. to the “Quality” of medical devices would have similar impact to other technologies over the last forty years. The ability to communicate and share information…   Read more»

]]> eb7fc73f9c32aab3c89150d703492849 https://medicaldevicecourses.com/activity/p/20426/ Fri, 25 Sep 2020 14:38:01 -0400 I think innovation can be conducted especially with physicians and health care providers, but thinking of the product life cycle of a medical device, starting with the idea generation all the way to support of an on market product, is…   Read more»

]]> 87a6dbfe22581e65d2d3ee5b0a50c848 https://medicaldevicecourses.com/activity/p/20425/ Fri, 25 Sep 2020 14:30:36 -0400 So my perspective is that FDA seems to be harder on larger firms than smaller ones. Having worked with big companies such as Roche, Merck and Pfizer, the kind of questions and challenges we receive is more than what I…   Read more»

]]> 39db62d8a87738d23e4fc57a69cf411f https://medicaldevicecourses.com/activity/p/20424/ Fri, 25 Sep 2020 14:23:49 -0400 I worked on a combination product a few years ago for Pfizer. it was Xyntha a drug for Hemophilia A patients. The key to the product was to make a simplified dosage for home use with a dual chamber syringe….   Read more»

]]> f370a26e58fdbc266d235541cd51bef0 https://medicaldevicecourses.com/activity/p/20322/ Tue, 15 Sep 2020 16:06:23 -0400 I do not think the concept of animal testing is unethical in general. However, it could become unethical if we treat the animals inappropriately by not designing the experiments correctly. For example, reducing the number of animals for testing by…   Read more»

]]> 86efc478b6708cbe9d969c01687933b3 https://medicaldevicecourses.com/activity/p/20321/ Tue, 15 Sep 2020 15:47:30 -0400 Very interesting debate. As others have stated both are necessary. Short term and long term research is needed for the patients and stakeholders of medical devices. As long as academia and industry both participate in medical device development both will…   Read more»

]]> de67dc58456e0a6e7bba8a5ae451feff https://medicaldevicecourses.com/activity/p/20320/ Tue, 15 Sep 2020 11:36:02 -0400 So as far as biomaterials go, the selection process has both a technical perspective but from a project management perspective needs to align marketing/sales, cost, scheduling. regulatory and risk. The project manager needs to develop a collaborative process to evaluate…   Read more»

]]> 55af862069284ac34526f5d373fa289f https://medicaldevicecourses.com/activity/p/20259/ Fri, 11 Sep 2020 20:07:30 -0400 I agree but I also think a good project manager needs a few critical characteristics. One would be able to organize the scope, cost, schedule and resources. Being able to create a plan of the critical project elements and be…   Read more»

]]> b93208f64bf12a62d0cf6a12cf20efc9 https://medicaldevicecourses.com/activity/p/20258/ Fri, 11 Sep 2020 20:01:30 -0400 I think project management of medical devices has some few unique aspects in relation to other types of projects. i would like to discuss three areas; product complexity, uncertainty and risk/product liability. Medical devices are becoming more complex with regards…   Read more»

]]> 9ac22124ccb1e89e0ed5d3db58ba5fb1 https://medicaldevicecourses.com/activity/p/20240/ Thu, 10 Sep 2020 16:46:00 -0400 I have been involved in several combination products and what I find interesting is that the pharma drug development and the device development seem to be treated as separate projects. An example is the drug product formulation is done first…   Read more»

]]> 1e6869e64457bc8e5ac073d27cde170a https://medicaldevicecourses.com/activity/p/20211/ Sat, 05 Sep 2020 22:24:32 -0400 Most of my work experience has been in industry with several pharmaceutical companies and now cell and gene. I can understand how many students feel comfortable with the academic world and for some this is the right decision. I think…   Read more»

]]> 8b4254409dab179f8aea718615207aa2 https://medicaldevicecourses.com/activity/p/20210/ Sat, 05 Sep 2020 22:16:31 -0400 Okay let me bring in a different way of looking at this. Generalists versus specialists. Due to creating new knowledge whether in BME or in any field, there will always be a tendency to want to initiate specialization. I would…   Read more»

]]> 2cdd3317a01f28d5c294e94cecaf87fb https://medicaldevicecourses.com/activity/p/20189/ Thu, 03 Sep 2020 23:58:20 -0400 I think one of the biggest impacts is the limited supply of components to manufacturing especially from Asia. The crisis has impacted organizations to underproduce with plant shutdowns. Supply chains will need to deal with more inventory and multiple suppliers…   Read more»

]]> 48500807d3c0c9f900b8b76eb8e1d367 https://medicaldevicecourses.com/activity/p/20187/ Thu, 03 Sep 2020 23:26:59 -0400 0