Joe Mullings

60% of development costs are spent in the concept phase. If you're not focusing on the riskiest part of your design first, you'll have a ticking time-bomb You have a hole in your boat, what do you do next? You don't worry about the paddles or rudder. You figure out how to plug the hole. If you're not sure how to identify the riskiest part of your design is: 1. Identify the mechanisms driving your core value propositions 2. Isolate the components most directly driving those mechanisms 3. Quantify required performance: are you hitting it with the current design? The design change required might force a modification to the form factor or material, impacting adjacent components, or maybe the entire product. And that larger change to the product changes the orbit of everything else.

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🔗Standardizing Vendor Credentialing for Medical Device Sales Reps: Enhancing Healthcare Compliance In the healthcare sector, the pivotal role of medical device sales reps can't be overstated—they bridge the gap between manufacturers and healthcare providers, ensuring the effective use of medical technologies. However, the lack of standardized vendor credentialing has posed challenges, affecting patient safety and regulatory compliance. This insightful article sheds light on the critical need for standardized credentialing processes, emphasizing how they can enhance healthcare compliance, streamline operations, and ensure the highest quality of care. 🌟 Key highlights include: - The importance of vetting sales reps to maintain patient safety and compliance. - The challenges of the current fragmented credentialing practices. - The substantial benefits of standardizing these processes, such as improved compliance, reduced administrative burdens, and consistent quality of care across facilities. - Essential components of effective vendor credentialing, including uniform criteria, centralized platforms, and regular monitoring. 👏 Special thanks to Jason Gwilliam of JDG. for sharing his extensive expertise on this vital topic. With 18 years of leadership experience in medical device sales and sales enablement, his insights are invaluable. https://lnkd.in/gDQZjq6S

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Once patients get access to their own reports, it’s impossible to put that genie back in the bottle. Rather than debating whether patients should get radiology reports, the question now should be how radiologists can ensure their reports will be understood without confusion by their ultimate customer – patients. Read more at https://lnkd.in/guDzh-gZ #radiology #medicalimaging

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Are you a medical device manufacturer? What are some of the biggest challenges you've faced? I'd bet they have a lot to do with regulatory changes and new technology advancements; just to name a few. With its brand-new “2024 State of US MedTech Regulation” report, Essenvia has pinpointed eight specific hurdles that many medical device manufacturers will have to jump over in the coming years. Learn what they are and how you can position your product to have a successful path to market. Access the report: https://hubs.ly/Q02tkv5k0 Soumya Mahapatra Dhriti Roy, Ph.D., MBA, RAC Christian Johnson MedTech Impact Partners #medtechregulation #medtechmanufacturing #regulatory #regulatorystrategy #industryinsights #lookahead #innovation

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Tune in to the most recent episode of Funding Medtech Podcast to listen to Jeremy Langsam at Portal Innovations, LLC and Rich Mazzola at Project Medtech discuss the details (the network, investment thesis, check size, etc.) of Portal Innovations. Links to the podcast, monthly newsletter, and website are in the comments below! Follow Project Medtech on LinkedIn for more great content or visit our website #medicaldevices #startup #medtech #projectmedtech #innovation #medicaldevice #podcast #strategy

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What value can CephX AI add to patients and orthodontists? Read this case study to find out. #AI #CephX #CBCT

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On October 10th I'm diving deeper into what makes MedTech startup projects unique and difficult to manage with traditional methodology, as well as sharing my tips for avoiding the most common pitfalls in MedTech product development.

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Combining Medtech company sales meetings with cad’ lab product training ⬇️ BBL (Lexington M.A.), has modern conference facilities and a simulated O.R cad’ lab. This means you can talk sales & business, hold didactic product training and then put everything into practice in the cad' lab. Why aren't all Medtech meetings like this? Well, now they can be. https://lnkd.in/eAK8t-ww

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Spine Deshittification (Thank you Mitch Johnson for coining the phrase) In 30+ years in this crazy business, I have never worked in spine.  Some customers are actually brain surgeons – and the surgical technology reflects it – VR, robotics, navigation. Yet “workhorse” devices, upon which outcomes often depend, have had little recent R&D investment. This hasn’t gone unnoticed. A prominent spine surgeon told me, “There are a shed-load of interbody cages with no evidence that any one product or approach is superior to another. In our health system, we will move to a ‘generic’ platform because we can’t justify increased expense for ‘proprietary” devices. In 2-3 years, devices will be off the market unless they clearly demonstrate a value proposition.” In the last 5 years, better battery chemistry and low power sensors have allowed Canary to significantly shrink our CHIRP implant. We can now create a “cartridge” suitable for insertion into interbody cages in a manner similar to cementless knee, hip and shoulder products under development with Zimmer Biomet. ALL of these devices have received FDA breakthrough designation. Heel strike during walking sends a shockwave through the skeleton. Accelerometers, gyroscopes and step counters implanted in the disc space can measure and quantify activity (step count, cadence, walking speed, stride length, distance); at high fidelity (3200 observations/second) they can detect subvisual spinal segment movement (range of motion, gait, vibration). The object is to confirm lack of spinal segment movement (fusion), as opposed to increased movement (ROM) for Persona IQ knee patients. Algorithms can be developed to quantify and stratify (5th to 95th percentile) normal/abnormal patient activity and interbody kinematic metrics obtained daily during recovery; sort and filter algorithms can identify “outliers” and alert care teams to individuals needing enhanced, personalized care. Individualized physiotherapy, exercise programs, and therapy guided by objective data can help patients recover better and faster – at home remotely. Machine learning applied to the generated data set can search for potential complications (subsidence, infection, painful gait, DVT, etc). Rich, objective, post-operative data can be combined with rich, interoperative data to inform everything from patient selection and surgical technique to implant design. (Apologies if you have heard this before) Spine surgeons are anxious to have objective data: 87% would use this technology if it was available; only 6% were “somewhat” negative; the best acceptance rates I have seen for a novel device concept. Canary plans to make this technology widely available, either by making a “generic” interbody cage to deliver CHIRP-lc, or by working with existing manufacturers to modify their devices to accept a “smart” cartridge. If any company is willing to go first and invest, let me know - you can get a couple of years’ head start!

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Creating a MedTech ecosystem is something I want to develop over time. It is an extremely difficult task because the amount of moving parts are "infinite" in a sense. Putting that vision into a realistic structure starts somewhere though. The team around me is helping tremendously to make that vision a reality. These people believe in me as much as I believe in them because it is a harmony and we have fun with it. A bunch of my clients are on board into this vision too! First off, they love the results/delivery of any engagement. Why wouldn't they be interested in being part of a world where their brand+mission is being elevated? We elevate one another. Think about Apple and Tim Cook/Steve Jobs. Customer experience is such a valuable asset. Positive or negative feedback helps in ways I never imagined because I give my customers the freedom to say what is on their mind and I do the same in a professional sense - this is exactly how you build and develop a STRONG relationship for the long run. Apple's ecosystem is untouchable for a variety of reasons (many of you know this because you use their products and systems like I do). At the end of the day, if you are obsessed with your customers and their values, a karmic energy comes back to you in a cascade, and it resonates throughout your ecosystem. 🙏 svatantrya #blessed #letsfindout #devanfamlovesanalogies

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Want some in depth reading on Surgical Robotics ? Insights - hints - what’s coming - technology - selling tips - and more. Tons of in depth articles here 👉 https://lnkd.in/eKgWe-qX #roboticsurgery #surgicalrobotics #ai #imaging #stapling #surgery #intuitive #medtronic #cmrsurgical #medicaroid #distalmotion #moonsurgical #laparoscopy

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While investments in cutting-edge robotic surgical systems surge, #SterileProcessing departments often find themselves without resources. Explore how strategic provisioning of tools and equipment can invigorate reprocessing departments. #TheReprocessingReport: https://hubs.ly/Q02DCZXc0 #PureProcessing #SPD #CentralProcessing #MDR

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With the rapid expansion of digital workflows into the dental laboratory, continued advancements in restoration and appliance processing are crucial for success. Investments in technology just for the sake of technology are bad investments. Critical to a laboratory’s success when purchasing and implementing new fabrication technology is not only about delivering consistent quality, but doing so with an acceptable ROI. With that said, I would recommend dental laboratories take a look at what PostProcess Technologies has developed specifically for the dental laboratory to finish and clean their 3D Printed restorations, dentures and appliances. It’s not only “smart technology” it’s truly game changing.

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Enjoyed a great conversation with Mamdouh "Mondo" Mikhail, Lead Architect at ADLINK Technology and Joe Speed, Head of Edge at Ampere Computing about the future of healthcare research from medical imaging to scientific discovery during the EdgeOpen Consortium meeting. #neurology #pathology #radiology #medicalresearch #ai #inference #biology #computationalbiology #syntheticbiology #digitalbiology #spatialbiology #omics #multiomics

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The true adoption of AI in medtech will face a series of decisions by some of the its leaders in the next few years. Let’s look at the original digital native company that dominates surgical robotics, the most complex of medtech platforms, and has one of the largest market caps ($148B) in the industry. Intuitive. Intuitive continues to operate like a street savvy startup allowing them to remain agile and dominant. The D5 platform is another proof point of their prowess in the surgical robotics space. But without the decision to make massive investments in the current software architecture and AI-based infrastructure, the true incorporation of Data & AI will face challenges. “What else is under the hood?” on the recent release of the D5, have not yet been revealed, perhaps for several reasons, which likely is based on FDA regulations, as well as its limited capability of the delivery of data driven AI-based advisement in its current state. Imaging is at the heart of data and AI.  The recent release of chips by Samsung and Nvidia tied and multi-spectral imaging technologies being incorporated into surgical robotics platforms is advancing at a rate that could not have been forecasted and producing data in orders of magnitude beyond what the systems were foundationally built upon. Leadership wrestle on a regular basis with how far ahead do you let a platform technology go in the absence of recurring revenues to rationalize the investment that is going to be required to bring the true value of all the “data” that can eventually be monetized?      - The original open-source code that got them foundationally started and still resides at the base of some aspects of their system needs to replaced in order to unlock the real data from their platforms. - Investments required will easily be in the range of $100’s of millions to realize the capabilities of software, firmware, and hardware to process these LLM’s that can unlock incredible advisement, learning, and training. These massive investments will be required at the expense of near-term profit margins for the higher value of data & AI to be realized and eventually demanded by their users. It is much easier to have Boards, the C-Suite driven by incentives, and investors for share price, to sign off on building more capable manufacturing facilities, additional installation of capex, and expansion of company footprints on other continents than pull the trigger on this decision. Currently, Intuitive is not being pushed by anyone in the market of surgical robotics. An opportunity to expand their already massive moat with data & AI is likely wrestled with regularly. When is the distance between you and your competition enough? It will be of great interest to see how Intuitive decides to pave the way with the decisions they will make in the ongoing pursuit of Data & AI as they navigate the current state of the FDA, investors, profits, patients, and surgeons. See you at #SRS2024 in next week.

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Lower valuations in Medtech are shifting the landscape for investors and startups alike. With funding harder to secure, the focus has shifted to achieving key milestones that validate the business and drive growth. Deals are increasingly being structured around phased funding, ensuring that companies not only extend their runway but also build tangible value along the way. This approach means showing investors exactly where their capital will make a difference and laying out a clear path to the next round. This market rewards those who can pivot quickly and execute with precision. Companies need to reassess priorities, double down on what works, and cut back on what's less essential. Be prepared to adjust strategies and embrace creative deal structures to attract the right backers. Make sure you’re ready to seize the opportunity, demonstrating the ability to drive meaningful progress in uncertain times.

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📝 This PSG Guide is designed to evaluate critical aspects like the impact on current workflow and patient comfort, software capabilities, and future readiness of the chosen PSG. It includes a comparison chart showcasing the technical features of the Nox Medical A1s PSG system and space to compare competitor products. #psg #sleepdiagnostics #polysomnography #hsat https://hubs.li/Q02tmbTP0

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Another good medtech strategy article. A centralized, searchable resource for global medtech regulations is a game-changer. Here are two key benefits: 1. Easier access to documents streamlines the approval process, potentially accelerating time to market for critical devices. 2. A clearer understanding of global regulations can fuel innovation in underserved markets, improving access to healthcare technologies. #MedTech #Policy #GlobalHealth https://lnkd.in/gJWTMQPb

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One of the advantages of the newer emerging companies in the digital surgery domain is that there is not a business to “defend” as they attempt to transition and shift owned market share to a likely shift in workflow, care team training, pricing models, and most probably competing with others who also are bringing digital surgery to the markets. Steve Bell and I discussed SS Innovations at the recent LSI event in Portugal and the opportunities for these newer players in the space. The organizations that have the opportunity to look beyond a single market solution, and create a company that brings digital solution platforms first to the market may have a slower uptake but longer term may have competitive benefits. Creating a culture is easier than changing one.

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