Neil Thompson

Is #Quality missing out in MedTech? And by "missing out" I mean the opportunity to lead. Most of the time Quality is in the BACK SEAT: 👉 Pushing compliance 👉 Running change orders 👉 Routing paperwork 👉 Chasing signatures 👉 Policing (I know you're tired of that term..) This is all part of the quality function and it's critical work -- don't get me wrong. But, quality needs to shift into the FRONT SEAT: 👉 Aligning teams 👉 Refining processes 👉 Teaching and coaching 👉 Spearheading new initiatives 👉 Pushing "lean" practice into MedTech 👉 Changing culture There's a new quality initiative that most US companies are facing -- the harmonization of #QSR and #ISO13485. And it's called.. (drumroll, please...) #QMSR 😲 😶 🙃 Despite the branding genius, did we need yet another confusing acronym in MedTech? But I digress.. It's an opportunity for Quality Managers to hop into the front seat -- to lead. On Tues (5/21) at 11AM Eastern, I'm part of a webinar focused on this harmonization process and the impact to medtech companies. 🔗 Registration link in comments Kanchana Iyer will be covering the specific changes between QSR and QMSR that you need to know about. Eric Sugalski (that's me) will be talking the practical rollout of quality changes. Including how quality managers can and should be leading more. (Ranting included..) Sean Blackall will be adding best practices on doc control. He'll also be keeping Kanchana and myself in-check as the moderator. What are some key topics that you'd like to hear about during this webinar? Drop them in the comments below 👇 Hope to see you there. Seth Goldenberg, Ph.D. Daniel Henrich Archimedic Halloran Consulting Group, Inc. Veeva MedTech Veeva Systems

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The FDA PR machine is at it again, writing unintentional comedy gold in celebration of a "notable milestone" for their Breakthrough Devices Program. 𝐹𝑟𝑜𝑚 𝑡ℎ𝑒 𝑙𝑎𝑢𝑛𝑐ℎ 𝑜𝑓 𝑡ℎ𝑒 𝐵𝑟𝑒𝑎𝑘𝑡ℎ𝑟𝑜𝑢𝑔ℎ 𝐷𝑒𝑣𝑖𝑐𝑒𝑠 𝑃𝑟𝑜𝑔𝑟𝑎𝑚 𝑡ℎ𝑟𝑜𝑢𝑔ℎ 𝑆𝑒𝑝𝑡𝑒𝑚𝑏𝑒𝑟 30, 2024, 𝑡ℎ𝑒 𝐹𝐷𝐴 ℎ𝑎𝑠 𝑔𝑟𝑎𝑛𝑡𝑒𝑑 1,041 𝑑𝑒𝑣𝑖𝑐𝑒𝑠 𝐵𝑟𝑒𝑎𝑘𝑡ℎ𝑟𝑜𝑢𝑔ℎ 𝐷𝑒𝑣𝑖𝑐𝑒 𝑑𝑒𝑠𝑖𝑔𝑛𝑎𝑡𝑖𝑜𝑛 𝑎𝑛𝑑 𝑎𝑢𝑡ℎ𝑜𝑟𝑖𝑧𝑒𝑑 128 𝐵𝑟𝑒𝑎𝑘𝑡ℎ𝑟𝑜𝑢𝑔ℎ 𝐷𝑒𝑣𝑖𝑐𝑒𝑠 𝑓𝑜𝑟 𝑚𝑎𝑟𝑘𝑒𝑡𝑖𝑛𝑔. Now I'm no math whiz, but that works out to about 12% that made it all the way through. So this program that got everyone so excited, thinking that now their fantastic novel and undoubtedly life-saving device was a shoe-in for speedy market approval has only brought 𝟭𝟮% 𝗼𝗳 𝗱𝗲𝘃𝗶𝗰𝗲𝘀 𝗮𝗹𝗹 𝘁𝗵𝗲 𝘄𝗮𝘆 𝘁𝗼 𝗺𝗮𝗿𝗸𝗲𝘁?! That's a great figure if you're talking about a pay increase or Ponzi scheme - sorry, return on investment, but it's not really impressive as an accomplishment. For those who aren't aware, the Breakthrough Devices Program is intended to provide timely access to certain medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Through the program, manufacturers can interact with the FDA’s experts to receive feedback on device development, receive help navigating the path to the FDA’s marketing authorization, and obtain prioritized review on regulatory submissions. It's kinda like your submission on steroids, and it was intended to boost availability of novel devices. I'm hoping that the bar for this program has been set a tad higher than 12%, but with the FDA, you just never know. I cover the specifics of the Breakthrough Devices program in this video on FDA submission pathways: https://lnkd.in/gsV3xFna And talk about the benefits of an FDA pre-submission here: https://lnkd.in/gNw7Q8Ys Just want to rant to alive person about the myriad ways the FDA is making your life miserable? I'm a certified grief counselor, so just put some time on my calendar and I'll help you get through it: https://leanraqa.com/time #medicaldevice #regulatory #FDA #medtech #biotech #qualitymanagement #compliance

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✨ Great review from Richard Rose! ✨ At Basic Jane, we recently introduced *CBG/CBD chews* designed for pain relief, but the initial feedback from our R&D batch surprised us. Instead of solely addressing pain, people shared a different kind of experience: "I feel better." It took some digging to understand what “better” meant—it wasn’t just pain relief. After deeper conversations, we discovered people felt *refreshed*, more energized, and better able to handle daily life especially the seasonal lethargy. This aligns with the endorphin connection we’re now exploring further. With that insight, we named them *Refresh Chews*. 🌿 Learn more about how they can support your wellness journey here: https://lnkd.in/g_9SdCkv

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How to developers 21CFR case Defanging the dogs Yesterday I posted a short post in 21CFR litigation instead of a fools case, commercial trade secret litigation, defendant or plaintiff. So how do you developers 21CFR case? Use discovery to explore all FDA files for the devices you are the plaintiff or defendant in the suit. Start out with the initial and all supplemental FDA filings. As was found in the Philips Texas case according to the FDA Philips filed all 3663 information in Philips 510k filings, initial reports. Sure enough there were references to all requirements of the 3663 for the Ingenia MRI. So where’s the commercial trade secrets Philips claims? Subpoena, MAUDE, 483 inspections, recalls, corrective actions, enforcement reports, 510k, PMA, CAPA, foreign agencies filings similar to the FDA’s correspondence and all other FDA correspondence. Subpoena consent decrees, DOJ, State investigations other lawsuits involving the devices you are being sued for or suing on. Foreign standards, VA, DOD, other Federal and State bids or contract awards including sales bids (this sets it up for debarment in government contracting). FCC, OSHA, HHS, HIPPA files, NIST correspondence and other non FDA correspondence related to the device. Depose the registered agent, the person on the 510k filing and the executive in charge of compliance. Depose outside consultants who performed audits and CAPA’s. Forget FDA officials. They have a shield law to protect them. This has never been done in ISO litigation. Why? A number of tactics are used including the tacit threats by big companies that dissuade lawyers from exposing their firms to big company dogs. Going after FDA issues as a plaintiff or defendant levels the field and gets to the truth in litigation. Exposing an OEM’s FDA patterns and practices makes OEM’s threats like this “tell Quinn to get the FDA off our ass or we’ll be in his face the rest of his life” Picker lawyer James Ditmar made that threat to me through my attorney. That threat didn’t work out to well for Picker. 21CFR cases not only get to the truth in litigation patient safety is protected when the truth prevails. Unlike commercial trade secrets, 21CFR trade secrets on medical devices cannot begin until adequate information instructions are provided by the OEM’s and any disputes are resolved by the FDA, as the Philips letter from the FDA states in the TEC litigation. So what does a lay person need under 21CFR? As the saying goes TBD, to be determined in each lay persons adequate request. That’s why commercial trade secret cases fail to get to the heart of litigation and why OEM’s will run from 21CFR litigation. The simple words adequate and lay persons or owners, or others as 21CFR states . Is there any OEM crazy enough to risk the liability in 21CFR litigation just to sue, settle and seal? Well maybe a few. Try it if needed as a defendant or plaintiff and hire good lawyers.

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Understandings what you are under 21CFR 21CFR 820 definitions If you perform any of the functions below you are a manufacturer. I know the push back from this statement is coming but you are manufacturers in the eyes of the FDA. Period end of discussion. Have you installed any medical device? You’re a manufacturer Same for the other requirements to be classified as a manufacturer which is what you want your be. Understanding 21CFR and the benefits of 21CFR will improve patient safety, increase your business profile, decrease your litigation liability and much more. CDRH has made the definition of a manufacturer in many policy documents. Most of you in the installation, service, resale and other duties could be manufacturers, assemblers, servicers, owners, users, installers, or others. All require access to manuals and software upon request and require you to provide these documents and software to the owner upon resale. 21CFR 820 definitions (o) Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.

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It's ironic that politicians contend that #doctors and #surgeons should not receive safe harbor protections similar to those enjoyed by large entities like GPOs and PBMs, citing the potential for corruption linked to kickbacks. This concern ultimately led to the establishment of Stark Laws. Here’s the reason why: When rules are established for physicians, breaking them leads to accountability—not just from a conflict of interest standpoint, but also due to their fiduciary care responsibility toward patients. This framework ensures that care providers are held responsible for their actions, and their measured outcomes. Those who offend almost always get caught, but this doesn’t happen with the protected class. Did you know that meals provided by vendors and compensated speaking engagements are publicly disclosed under the Centers for Medicare & Medicaid Services’ Open Payments program? Yet, there is a troubling lack of transparency regarding GPOs and PBMs contracts for the public. Required reports to CMS detailing each line item related to administrative costs or vendor rebates are incredibly hard to find and are rarely audited. This is concerning, as the cost of care is directly tied to the products, pharmaceuticals, and services governed by GPO contracts. Moreover, GPO employees often infiltrate supply chains and national "Value Analysis" groups, further complicating the landscape. The current corporate practices for those who have “Safe Harbor” protections foster the emergence of monopsonies, oligarchies, and even monopolies through the protectionism of select vendors, all while restricting choice and delaying the timely adoption of innovations essential for improving care and outcomes. As a result, we find ourselves ranked 11th in global healthcare innovation, consistently lagging 10 to 20 years behind other countries, despite spending more than many nations, combined. “In 2021, the U.S. spent 17.8 percent of gross domestic product (GDP) on health care, nearly twice as much as the average OECD country.” “Health spending per person in the U.S. was nearly two times higher than in the closest country, Germany, and four times higher than in South Korea.” “The U.S. spends three to four times more on health care than South Korea, New Zealand, and Japan.” https://lnkd.in/edrCUWQJ. What is truly troubling is that the companies currently benefiting from these safe harbors operate without accountability. They are shielded from scrutiny, often due to the influence of their lobbying efforts, while others bear the consequences. Caregivers endure yearly reductions in their reimbursements and are frequently treated like serfs, despite being the essential providers of hands-on care and patient outcomes. Meanwhile, those who offer no direct care continue to secure their kickbacks, profits, and bonuses, and increasingly get reimbursed for their collusions at pay levels that currently exceed many practitioners. The incentives are all wrong.

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Are AI programs denying dental practice insurance claims? As you probably know, I'm a huge proponent of the power and potential of #AI -- that is, of effective AI. But when AI makes mistakes like this, it's time for an upgrade. Just another reminder that AI has incredible potential, but human oversight will always be necessary. #artificialintelligence #humanintelligence

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Check out this excellent video on ‘What is Tinnitus?’ by Patrick A. Lynch, Esq., MBA and his brilliant team at the American Tinnitus Association. #tinnitus #awareness #raisingawareness #tinnitusawareness #audpeeps

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Lately, I have been catching up on regulations that might have slipped by: the FDA impact of the Chevron case with the Supreme Court or the changing of classification for wound care products (and the subsequent CMS reimbursement changes). I was just looking at the EU battery regulation (Regulation (EU) 2023/1542) changes that take effect on August 2024 (next month for those of you keeping track). Many of the new regulations are pretty much already common practice if your device has access to the battery (replaceable or externally rechargeable): - battery has clear, understandable, legible instructions and safety information - the name of the battery (and address if applicable) has to be on the battery - the battery has to have a CE mark AND there has to be an EU declaration of Conformity for the battery. Now the kicker - in 2027 (yes again far away but...) you have to have a waste program EVEN for devices where the battery is typically not accessible by the user. To do this the regulations say (Article 11) that the battery MUST BE“readily removable and replaceable” by the end user. There is a 'slight' out, the law allows for some batteries to be replaced by independent professionals but its a pretty limited. For those of you keeping score this could be a "significant change" according to MDR and must be resubmitted to the NB. This could cause HUGE issues with surgical power tools, ultrasounds, pacemakers, robotic systems, infusion pumps, let alone wearable medical devices. These will have to be redesigned because commonly the battery is not-accessible to the user. One last point as with a lot of EU regulations; there is an exemption but it might be tough for most medical devices to qualify. If your interested in discussing or need an internal assessment to see how this will impact you - contact me or MEDIcept Inc. and we can help

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🇪🇺 𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐭𝐡𝐞 𝐁𝐨𝐫𝐝𝐞𝐫𝐥𝐢𝐧𝐞: 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 𝐯𝐬. 𝐌𝐞𝐝𝐢𝐜𝐢𝐧𝐚𝐥 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐬! The 𝐌𝐃𝐂𝐆 𝟐𝟎𝟐𝟐-𝟓 𝐠𝐮𝐢𝐝𝐚𝐧𝐜𝐞 just received an 𝐮𝐩𝐝𝐚𝐭𝐞, bringing greater clarity to the 𝐛𝐨𝐫𝐝𝐞𝐫𝐥𝐢𝐧𝐞 𝐛𝐞𝐭𝐰𝐞𝐞𝐧 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞𝐬 𝐚𝐧𝐝 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐚𝐥 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐬 under 𝐄𝐔 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 𝟐𝟎𝟏𝟕/𝟕𝟒𝟓. Here’s what’s new and noteworthy! 🆕 𝐖𝐡𝐚𝐭’𝐬 𝐂𝐡𝐚𝐧𝐠𝐞𝐝? • 𝐄𝐱𝐩𝐚𝐧𝐝𝐞𝐝 𝐄𝐱𝐚𝐦𝐩𝐥𝐞𝐬: New product examples have been added to illustrate 𝐛𝐨𝐫𝐝𝐞𝐫𝐥𝐢𝐧𝐞 𝐜𝐚𝐬𝐞𝐬, especially for 𝐬𝐮𝐛𝐬𝐭𝐚𝐧𝐜𝐞-𝐛𝐚𝐬𝐞𝐝 and 𝐜𝐨𝐦𝐛𝐢𝐧𝐚𝐭𝐢𝐨𝐧 𝐝𝐞𝐯𝐢𝐜𝐞𝐬. • 𝐑𝐞𝐟𝐢𝐧𝐞𝐝 𝐃𝐞𝐟𝐢𝐧𝐢𝐭𝐢𝐨𝐧𝐬: Key terms like 𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐨𝐥𝐨𝐠𝐢𝐜𝐚𝐥, 𝐢𝐦𝐦𝐮𝐧𝐨𝐥𝐨𝐠𝐢𝐜𝐚𝐥, 𝐚𝐧𝐝 𝐦𝐞𝐭𝐚𝐛𝐨𝐥𝐢𝐜 𝐚𝐜𝐭𝐢𝐨𝐧 are more precisely defined, helping clarify when a product is regulated as a device vs. a medicinal product. • 𝐔𝐩𝐝𝐚𝐭𝐞𝐝 𝐂𝐫𝐢𝐭𝐞𝐫𝐢𝐚: New criteria now specify how to handle products combining device and medicinal actions, making it easier to assess 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐫𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬. 🧪 𝐊𝐞𝐲 𝐏𝐨𝐢𝐧𝐭𝐬 𝐑𝐞𝐜𝐚𝐩: • 𝐌𝐨𝐝𝐞 𝐨𝐟 𝐀𝐜𝐭𝐢𝐨𝐧: If the principal action is pharmacological, immunological, or metabolic, it’s likely classified as a medicinal product. • 𝐍𝐚𝐭𝐮𝐫𝐚𝐥 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐬: Herbal and other natural substance-based products can be classified as medical devices, but only if their primary action isn’t medicinal. • 𝐂𝐨𝐦𝐛𝐢𝐧𝐚𝐭𝐢𝐨𝐧 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: For products incorporating medicinal substances as an 𝐢𝐧𝐭𝐞𝐠𝐫𝐚𝐥 𝐩𝐚𝐫𝐭, the primary vs. ancillary action is crucial. This 𝐠𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐮𝐩𝐝𝐚𝐭𝐞 is essential for 𝐑&𝐃 𝐭𝐞𝐚𝐦𝐬, 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐩𝐫𝐨𝐟𝐞𝐬𝐬𝐢𝐨𝐧𝐚𝐥𝐬, and anyone involved in healthcare product development to ensure their innovations align with EU standards. 🔗 Link in the comments 💕 Enjoy ———————————— 𝘐 𝘢𝘮 𝘎𝘶𝘪𝘭𝘭𝘢𝘶𝘮𝘦 𝘝𝘢𝘭𝘦𝘯𝘻𝘶𝘦𝘭𝘢, 𝘰𝘸𝘯𝘦𝘳 𝘰𝘧 𝘊𝘚𝘋𝘮𝘦𝘥 𝘊𝘰𝘯𝘴𝘶𝘭𝘵𝘪𝘯𝘨. 𝘞𝘦 𝘢𝘴𝘴𝘪𝘴𝘵 𝘪𝘯 𝘙&𝘋, 𝘘𝘶𝘢𝘭𝘪𝘵𝘺, 𝘢𝘯𝘥 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘤𝘩𝘢𝘭𝘭𝘦𝘯𝘨𝘦𝘴 𝘸𝘪𝘵𝘩 𝘢 𝘧𝘰𝘤𝘶𝘴 𝘰𝘯 𝘪𝘯𝘵𝘦𝘨𝘳𝘪𝘵𝘺 𝘢𝘯𝘥 𝘱𝘢𝘵𝘪𝘦𝘯𝘵-𝘤𝘦𝘯𝘵𝘳𝘪𝘤 𝘴𝘰𝘭𝘶𝘵𝘪𝘰𝘯𝘴. 𝘞𝘩𝘢𝘵 𝘴𝘦𝘵𝘴 𝘶𝘴 𝘢𝘱𝘢𝘳𝘵? 𝘈 𝘤𝘰𝘭𝘭𝘢𝘣𝘰𝘳𝘢𝘵𝘪𝘷𝘦 𝘴𝘱𝘪𝘳𝘪𝘵, 𝘧𝘰𝘤𝘶𝘴𝘦𝘥 𝘰𝘯 𝘥𝘦𝘭𝘪𝘷𝘦𝘳𝘪𝘯𝘨 𝘪𝘮𝘱𝘢𝘤𝘵𝘧𝘶𝘭 𝘴𝘰𝘭𝘶𝘵𝘪𝘰𝘯𝘴 𝘸𝘪𝘵𝘩 𝘢 𝘱𝘰𝘴𝘪𝘵𝘪𝘷𝘦 𝘰𝘶𝘵𝘭𝘰𝘰𝘬. 𝘊𝘰𝘯𝘵𝘢𝘤𝘵 𝘶𝘴 𝘵𝘰 𝘥𝘪𝘴𝘤𝘰𝘷𝘦𝘳 𝘰𝘶𝘳 𝘢𝘱𝘱𝘳𝘰𝘢𝘤𝘩 𝘢𝘯𝘥 𝘷𝘢𝘭𝘶𝘦𝘴. 🔍#csdmed #medtech #medicaldevices #regulatoryaffairs

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The Rise and Fall of Exactech: From Orthopedic Pioneer to Chapter 11 Bankruptcy So, how does a successful 40-year orthopedic company get into so much trouble? Simple answer is: Packaging recall + aggressive US attorneys = bankruptcy. BTW, this is why many EU companies avoid the US market altogether. Litigation risk can drain $1B of value quickly. Read the whole story here - https://lnkd.in/eQCMmEUa

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You might be surprised by how early you can start conducting formative evaluations. The earlier, the better for ROI! With the FDA increasingly focusing on human factors and usability work, you can also help align with the required processes. #FDA #IEC62366 #QMS

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Sectors of the medical device industry are experiencing an incredible ramping of complexity that is not native to the market. We are in an early transition period that is showing signals of liability and entrenched thinking that are creating technology and financial liabilities for organizations. Imaging, Navigation, Artificial Intelligence, Robotics, AR / VR. The few organizations that are natively digital and their existence has been spent in hundreds of thousands of hours immersed in asking the questions, gaining the experiences, and acquiring the certainty of the knowledge giving them a head start that may be insurmountable. Being first is important. Being fast is also important. Being first and fast is devastating to the competition. To those that are not digitally native and are seeking to enter these markets, acquisitions of these technologies is certainly a beginning. Beware. Acquisitions are the purchase of product and information. Information is not knowledge. In acquisitions, those with the knowledge often flee. And the acquirer is left with only information and often mistakes it for knowledge. Bring information to a knowledge fight, and you lose. During this period of digital transition and acquisitions, the legacy device firms should consider… -             Starting stand-alone divisions that are independent of the mothership -             Acquisitions should be left alone and aggressively invested in and tribal knowledge should be massively economically rewarded with cash and tools to keep doing what they are doing. -             Stop creating compensation bands around the internal equity of your current structure. Choosing to prioritize salaries to be equitable no longer prioritizes excellence.

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We have all observed the changes that Tiger Buford describes. He offers some insightful reasoning about the "why." I am finding that more and more exhibitors are reducing their support of the big conferences, by not attending, reducing booth size, etc. The NASS exhibit floor was a great place to meet with company representatives - but not surgeons. The surgeons mostly attended the sessions, visited the city with family, or simply stayed home to practice. I've attended NASS for years, and really appreciate the meeting, but I think that the exhibit floor there and at other big meetings is due for a rethink. The exhibits structure is from an earlier and more engaged era, where the innovations were bigger each year -- rather than the more mature markets we have now. Read the Tiger Buford article and see what you think.....

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Leadership is vital to the success of every organization. Mission and Vision must be driven from the top down and lived daily. It can be “lip service” if you want to attract and keep top talent. Similar to the design history file or master validation plan, the #MissionStatememt has to be a living document. The Sea of Galilee and the Dead Sea both receive their source of water from the Jordan River and yet they provide a sharp contrast and lesson for all of us. One, the Sea of Galilee, is teaming with life and the other supports no life. Why? The Sea of Galilee takes and then it also has an outlet and gives while the Dead Sea only takes as it has no outlet to give. The reasons why companies succeed or fail is clear over decades of data across all industries and leadership relevant to Mission/Vision, company misalignment, and hiring top talent for culture are always key factors. #ServantLeaders are able to hire and keep talent at a higher level- consider John Maxwell’s The Law of the Lid. They focus on each individual as a person versus only the work, empower their team, and set clear expectations. Poor leaders aren’t able to attract top talent or retain those that they inherit which directly impacts annual voluntary turnover. Let’s partner on your critical leadership positions to avoid the cost of mishires and hire for culture so you have higher employee engagement, less wasted resources, and improve the retention rates of your #paretoprinciple amplifiers! #medtech #leadershipmatters #giving #lawofthelid ##qualitymatters #hireforculture

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5 ways to ruin your research: 1. Only talk to your advisors 2. Let the inventor do the talking 3. Point out all the benefits 4. Correct users on proper use 5. Ask how much they'd pay If you do these things, you may succeed in convincing a customer why your device is great. But you missed the whole point. Research isn't to pre-sell. Research is to figure out how users and customers think when salespeople are NOT in the room. A better approach to research: 1. Talk to naive customers 2. Use 3rd party to collect data 3. Observe existing workflow 4. Hunt for confusions 5. Benchmark similar devices in use Done well, #research is the best way to understand how users and customers think. But if you treat it as a sales activity, you are just wasting everyone's time.

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There are 6 expired products and 2 recalled items in this cabinet. If it was your cabinet, would you know? Could you easily locate them? The truth is that product safety is a major issue for healthcare providers, and unsafe items are often lurking in stock. These products are a ticking timebomb and need to be identified and removed before they can cause any patient harm, or compromise the organization's regulatory compliance. But luckily for our customer, this isn't any cabinet, it's TotalSense. Our RFID smart cabinet has built-in safety features, including expiry and recall alerts that signpost staff to unsafe items, so they can be swiftly removed. But our technology doesn't just react to 'already-expired' items, it flags up items due to expire in the coming months, so they can be prioritized for use before they expire - lowering patient risk and reducing wastage costs. If you're battling with expiry management and need an automated inventory management solution that proactively manages your high value inventory, it's time to talk. Contact me: LinkedIn: DM me Email: [email protected] Web: https://lnkd.in/diAGnqgW #ExpiryManagement #HealthcareInventoryManagement #HealthcareTransformation

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