https://medicaldevicecourses.com/members/jwashin3/activity/ Activity feed for jwashin3. Fri, 24 Apr 2026 15:46:02 -0400 https://buddypress.org/?v= en-US 30 hourly 2 4172ec80d23c65530f270adad64e9791 https://medicaldevicecourses.com/activity/p/20155/ Fri, 21 Aug 2020 04:51:37 -0400 I would not even consider a verbal agreement related to medical device development.  I have already been burned going down that track.  A verbal agreement can only be clearly validated if there are witnesses to the agreement, especially good if…   Read more»

]]> a167d04b55756b3c7e37b6b836ec4779 https://medicaldevicecourses.com/activity/p/20154/ Fri, 21 Aug 2020 04:31:19 -0400 Actually, I do feel like NOT paying for the physician’s spouse, if the vendor is taking the physician out for dinner does rank a “petty” in my opinion.  However, I don’t believe that the rule will change, due to the…   Read more»

]]> 1d4782cf5f5ace5f4c51c28ecd45870e https://medicaldevicecourses.com/activity/p/20153/ Fri, 21 Aug 2020 04:11:52 -0400 Protection of trade secrets can be nearly as impactful as an actual patent, and much less expensive.  Trade secrets create a “mystic” around a product.  Products that grow in popularity can thus build their brand around a secret sauce or…   Read more»

]]> d4197aca181e4329b9354ee06170bc1c https://medicaldevicecourses.com/activity/p/20152/ Fri, 21 Aug 2020 03:52:24 -0400 Upper management is ultimately responsible for operations, but more important, upper management must create or articulate the company’s vision for middle management and all employees.  Upper management sets the tone for the company culture, in terms of its expressed values. …   Read more»

]]> b55d91f9a9e7e0f4655cd5a56ee4faeb https://medicaldevicecourses.com/activity/p/20151/ Fri, 21 Aug 2020 03:36:23 -0400 By the nature of most medical device companies being small, I think initially my company structure would start out as project-based, then evolve into a matrix structure as we grew in size and complexity.  I believe that some core administrative…   Read more»

]]> 1f186b47aadcbac0a1a6ec14f83b2e74 https://medicaldevicecourses.com/activity/p/20150/ Fri, 21 Aug 2020 03:21:10 -0400 My current job utilizes a matrix organization. Our non-clinical departments (e.g. Marketing, Public Safety, Marketing, Finance) fit the functional scheme, and their leadership reports directly to the Dean/President. In addition, we have a trio of IT employees, certified as PMPs,…   Read more»

]]> cd6005078c5b8630a39f95293b0bb7a7 https://medicaldevicecourses.com/activity/p/20145/ Mon, 17 Aug 2020 04:36:43 -0400 Besides the already stated benefits of lower complaint costs, better product reliability and higher customer satisfaction, post-market surveillance (PMS) is a process that drives long-term product sustainability, from both a manufacturing and customer relationship standpoint.  In many ways, sustainability is…   Read more»

]]> a8b15b4f0ca9bf3559a1fe6f6090569f https://medicaldevicecourses.com/activity/p/20144/ Mon, 17 Aug 2020 04:20:58 -0400 Risk management for medical devices is set for by ISO 14971 as the consensus standard of the U.S. Food and Drug Administration (FDA), but is also indirectly bolstered by ISO 13485, which is followed by the European Medical Device Regulation…   Read more»

]]> c5b48c67393548520e88c263f1959769 https://medicaldevicecourses.com/activity/p/20143/ Fri, 14 Aug 2020 05:01:38 -0400 Yes, the risk management file is a dynamic and living document.  It is also a reminder of the level of detail and diligence that must go into the creation and eventual commercialization of a medical device.  Risk management is an…   Read more»

]]> 08395cd22b4089f4742084e6a3477cf4 https://medicaldevicecourses.com/activity/p/20142/ Fri, 14 Aug 2020 04:39:36 -0400 From a purely manufacturing or engineering perspective, insufficient design controls can pose dire consequences for medical device development.  The FDA even cites that poor design controls are consistently the number one reason for Form 483 inspections for non-compliance or deficiencies. …   Read more»

]]> 20db3741ed2417ce362f3005eec1d68d https://medicaldevicecourses.com/activity/p/20141/ Fri, 14 Aug 2020 03:57:29 -0400 In my opinion, to say that the Design Input Document (DID) and Design Specification Document (DSD) both have disadvantages is the wrong way to describe them, since each intentionally created for a different purpose.  The DID is built around the…   Read more»

]]> b6ea554623e22a245d14a665ec66ee98 https://medicaldevicecourses.com/activity/p/20140/ Fri, 14 Aug 2020 03:31:36 -0400 The design control regulations implemented by the Food & Drug Administration (FDA) provide a cogent process for the myriad of components that go into medical device development.  It is a godsend to both novice and experienced entrepreneur.  The steps involved…   Read more»

]]> 7de3fbcdd632e2351cd244b292524b17 https://medicaldevicecourses.com/activity/p/20135/ Sun, 09 Aug 2020 16:33:51 -0400 This example still is a point of outrage to me, because it demonstrates what systemic racism in healthcare looks like.  Henrietta Lacks is essentially a guinea pig to be profited from.  Neither she nor her family have been treated like…   Read more»

]]> 6def5079024f02e0d26a4875c9a94936 https://medicaldevicecourses.com/activity/p/20132/ Fri, 07 Aug 2020 05:30:01 -0400 The purpose of blinding and randomization is to eliminate any potential bias and oversampling of a particular subject group, respectively.  Theoretically, the double-blinded and triple-blinded studies are supposed to be the gold standard in achieving evidence-based results.  I often wonder…   Read more»

]]> c498f420863865e69f4a0ea54c61365a https://medicaldevicecourses.com/activity/p/20131/ Fri, 07 Aug 2020 05:11:37 -0400 The ethical implementation of clinical studies is extremely important me.  The prerequisite of pre-clinical research with animal subjects diffuses some of my concerns about the safety of human in clinical studies or trials.  Every study must have a plan for…   Read more»

]]> 4143142821755b66d68153bb58e74a3c https://medicaldevicecourses.com/activity/p/20130/ Fri, 07 Aug 2020 05:00:07 -0400 To make the QA process more efficient for newly developing technologies, my approach would not be different, even though some of the tools I would use might be upgraded.  One of my first steps would be ensuring that I hired…   Read more»

]]> 2be9a11d799297c86559d1d72e92afac https://medicaldevicecourses.com/activity/p/20129/ Fri, 07 Aug 2020 04:41:48 -0400 Oh, how I wish an investment in QA/QC infrastructure was a part of this nation’s strategy in addressing and abating the spread of COVID-19.  Having quality systems and professionals in place to mitigate risk and liability to the company, as…   Read more»

]]> 45abaeafe8c3dbcae8370be391522c55 https://medicaldevicecourses.com/activity/p/20128/ Fri, 07 Aug 2020 04:02:22 -0400 Quality Assurance (QA) is more about preventive measures, having the right systems and processes in place, and complying with industry regulations and standards.  Quality Control (QC), however, focuses on performance and outcomes compared to acceptable standards or stated expectations.  Early…   Read more»

]]> f027c9d8a82f04af8b6d2dd0ecaec795 https://medicaldevicecourses.com/activity/p/20124/ Sun, 02 Aug 2020 15:07:59 -0400 I think the FDA heard your complaint, because beginning in 2019, FDA began making significant revisions to its 510(K) process to simplify the procedural steps and acknowledge that with the rapid advancement of technology, it makes more sense for new…   Read more»

]]> 5b66c8e2235a1cac2cc2170a0244a1fd https://medicaldevicecourses.com/activity/p/20123/ Sun, 02 Aug 2020 13:48:59 -0400 Having already lived this experience, while being outside of the academic health setting, there are several things that I know now, but didn’t know then.  One of my first moves would be to gather an advisory board of experts, consisting…   Read more»

]]> 840da00c2a107394c08755abc92d6d73 https://medicaldevicecourses.com/activity/p/20122/ Sun, 02 Aug 2020 13:30:36 -0400 My concern here is not drugs banned in the US but used in other countries.  Instead, it’s drugs banned in other countries but in wide-use here, like Ritalin and several opioids.  In terms of restrictions and safety protocols, the FDA…   Read more»

]]> bbb2de49705198185ba893df3e43f8e0 https://medicaldevicecourses.com/activity/p/20121/ Sun, 02 Aug 2020 12:58:26 -0400 I was glad to have a lecture that distinguished between product development and product management.  In small operations there is a tendency to blend the two together.  Having spent most of my career in academic settings, when I first conceived…   Read more»

]]> 8345982bf81879e6081da8cfdc017390 https://medicaldevicecourses.com/activity/p/20120/ Sun, 02 Aug 2020 12:27:49 -0400 As others have noted, it seems that social media marketing strategies have become the predominant tactic for marketing to consumers, even those in the medical device and biotechnology industries.  The algorithms that follow my internet activity and inserts ads from…   Read more»

]]> cda576bcf896dca8e4d316c96de8d3f0 https://medicaldevicecourses.com/activity/p/20119/ Sun, 02 Aug 2020 05:48:29 -0400 In my opinion, emotional intelligence (EI) does not just encompass the ability to discern behaviors, emotional responses, and impluses of prospective client; it is the absolute key to fostering and sustaining both business and personal relationships.  EI implores us to…   Read more»

]]> 829c9a860d82331913cbbacfd9b6372d https://medicaldevicecourses.com/activity/p/20118/ Sat, 01 Aug 2020 08:27:23 -0400 There are a couple of advantages that I see pertaining to having a DBA or trade name.  The first one was already mentioned, where a company is acquired by a new owner.  The new owners will likely have a new…   Read more»

]]> ffbd9d155fbbb6f8a894b161e16e63c6 https://medicaldevicecourses.com/activity/p/20117/ Sat, 01 Aug 2020 08:12:10 -0400 Ratios are very important in establishing industry financial standards and norms.  Generally, it is important to note what industry your company is residing in.  Some industries just are not high margin businesses, such as grocery stores, auto dealerships and gas…   Read more»

]]> e3f6db5e2fd10d157b1f7b1a9dfc4e62 https://medicaldevicecourses.com/activity/p/20116/ Sat, 01 Aug 2020 07:44:52 -0400 I find that nearly 3/4ths of the people I run into who are start-up companies are gravitating towards the LLC corporate structure, pointing out that they want to avoid double taxes.  This is logic is fine if you’re running a…   Read more»

]]> 09425a084a8ad44a9550fd4bbcbbf580 https://medicaldevicecourses.com/activity/p/20115/ Sat, 01 Aug 2020 07:05:44 -0400 The financial incentives that drive industry, without question, account for the different pace than academia.  What I have noticed is that partnerships with the private sector “quicken” the normal pace of our research work, especially when they tie additional levels…   Read more»

]]> 992a2e31562f9a96ec90089cf4de683b https://medicaldevicecourses.com/activity/p/20111/ Sat, 01 Aug 2020 06:21:05 -0400 Initially, I leaned towards calling the Initiation or the Planning phases as the most crucial phases, but after a taste of real-life projects, I’m more convinced that the Monitoring phase is the most important.  Reason being, with the development of…   Read more»

]]> ac29b2fc39211932c6864606e037cecb https://medicaldevicecourses.com/activity/p/20104/ Sun, 19 Jul 2020 06:49:54 -0400 I haven’t had to directly participate in pre-clinical research involving animals.  However, as the research administrator for my area, I have had more than one experience of test mice and rats dying unexpectedly through human error.  In one case, it…   Read more»

]]> 082e343b14e63010b162b2140a2ce435 https://medicaldevicecourses.com/activity/p/20099/ Thu, 16 Jul 2020 19:48:27 -0400 Other respondents have already emphasized how biocompatibility is cover by ISO 10993, so I will dig right into how I evaluate new biomaterial in my previously failed dialysis product from five years ago.  There is an inventor that I met…   Read more»

]]> 5053b42ecb541785e408215ae2b5384b https://medicaldevicecourses.com/activity/p/20098/ Thu, 16 Jul 2020 17:32:05 -0400 I have not been involved in building a new school or skyscraper per se, but I have been involved in building new hospitals and expansion of hospital campuses.  The project management for architectural structures have much greater certainty than project…   Read more»

]]> 2f3e4b5b44db2d4d1835b96615ae54e4 https://medicaldevicecourses.com/activity/p/20096/ Thu, 16 Jul 2020 04:45:53 -0400 My preference would be a project manager who was a stickler for following and implementing projects according to PMI guidelines.  I figure that I can just roll with what ever personality that they have.  In my work experience, the organization’s…   Read more»

]]> ea49e44f0b96cfaa85f3fc9ae43069c1 https://medicaldevicecourses.com/activity/p/20095/ Thu, 16 Jul 2020 04:05:51 -0400 I have very mixed emotions about the COVID-19 crisis, because it has begun to adversely affect people that I know personally. However, from a research and biotech standpoint, I hope that we don’t miss out on a historic opportunity.  Crises…   Read more»

]]> 9a31c0f278bc10fd2a9c40c7bbd77ee3 https://medicaldevicecourses.com/activity/p/20094/ Wed, 15 Jul 2020 19:06:31 -0400 @prateekch18 I agree with you about more emphasis on practical coursework.  Moreover, specifically in the Information Technology field, there are plethora of programs where even with just a high school diploma or GED, an individual with untapped talent can enroll…   Read more»

]]> 8ca1ee4532928891353b0ee8abec4013 https://medicaldevicecourses.com/activity/p/20093/ Wed, 15 Jul 2020 18:31:51 -0400 d39af9241cd711af8db6256b3317f6fe https://medicaldevicecourses.com/activity/p/20092/ Wed, 15 Jul 2020 13:23:06 -0400 Personally, I tend to agree with the respondents who advocate for close to a 50-50 split in practical vs. informational courses.  Academically, most of the Master’s coursework repeats science that was studied at the undergraduate level.  These courses are very…   Read more»

]]> c5e730c5886e3e49c21a8dc9dae9a3b6 https://medicaldevicecourses.com/activity/p/20091/ Wed, 15 Jul 2020 13:08:06 -0400 0ac4d0cc61c5c74855885e7b8ea10bc4 https://medicaldevicecourses.com/activity/p/20090/ Wed, 15 Jul 2020 12:58:49 -0400 @amandaally1029 Having spent most of my career in the academic medical center setting, where pace and business activity more closely resemble industry, as well as the academic research setting, I would concur that the academic research side does provide much…   Read more»

]]> 3759aade492de4e21ce73c9b6595741b https://medicaldevicecourses.com/activity/p/20088/ Mon, 13 Jul 2020 01:00:21 -0400 0