Nicolle Cannon

A start-up CEO itinerary: June 13-22 - Wilson Sonsini Medical Device & Digital Health Conf. (San Francisco) - Father’s Day (New Hampshire) - Wells Fargo Private Medtech Symposium (Virtual) - Medtech MVP (Minneapolis) - Board Meeting (Virtual) - Day trip (Minnesota) - Becker’s Spine, Orthopedics and Pain-Mgmt ASC Conf. (Chicago). Top 12 takeaways: - The medtech venture market is warming. Might Josh Baltzell’s playing of Vivaldi’s “Spring” concerto at Medtech MVP mark the market’s turn for the positive? - Some are observing “it’s easier today to raise $50mm than $15mm.” For commercial stage companies, this (directionally at least) seems to ring true. There is capital to deploy, but conservatism still abounds. Thanks to Wells Fargo Corporate & Investment Banking for the invitation and superb meetings. - Jennie Xue has the pulse on digital medtech. Her presentation at WSGR conference received many complements. - One of the most fun and productive conf formats is the Wilson Sonsini Goodrich & Rosati tradition of having VCs host wine tasting stations at the closing reception. It fostered quick, casual hellos and all were good sports (the aprons were a nice touch as well). - Minneapolis is a Medtech star. Great conference and superb showing by the “home team.” Thank you to all. - Scott Becker has built a stellar healthcare franchise. His newsletters are ubiquitous and conference line-up is broad, but I was most impressed with the community of professionals who shared best practices, new strategies and innovative technologies to adopt w peers. Thank you Michael R Redler, MD for the “exciting companies to watch” shoutout to Pristine Surgical. - Ambulatory surgery centers are the unsung heroes of healthcare. What do they want? Not new fangled gadgets, not more expensive capital equipment. They want ways to serve patients better, more efficiently, at a lower cost. “Enough with the AI, give me EI: Efficiency Intelligence. That’s what we need.” We’re on it, Dr Mihir Patel - Summit beer pairs well with appetizers on the run. Thanks for a great day Christopher Cleary and Stephen J. Snyder, MD - Growing up in Minnesota, I’ve crossed the Mississippi hundreds of times. But it’s not til you witness St Anthony Falls up close that you truly appreciate its power. Multiply that 1,000x as it travels to the Gulf. The backbone of America. - For all the career advice on LinkedIn, the best job in the world is being a dad. To the young-ins, have kids. there’s never a “good” time career-wise, but do it anyway. Thanks for making Father’s day special, ladies. #girldad - Community matters. F2F matters. We all are more efficient with Zoom, but the most powerful experiences remain F2F and the most effective conferences recognize that #community is the difference between a functional vs impactful gathering. Kudos to all the organizers who make the effort to make this difference. A great stretch. And to any to whom I still owe a follow-up, more soon!

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⚠️WARNING ⚠️, don't listen to this advice! The architecture is not only the fundamental element for the design but it is the element that allows the manufacturer to be sure of having certified the correct device. Do you know how many customers I have seen who thought they had a regularly certified device and instead had submitted the documentation for a device that they actually never install? If you want to be sure that your documentation is correct, the first thing you need to have is an architecture that exactly represents the device. Not only that, there are also cybersecurity-related issues that you may never find. Be careful, these are serious errors! https://lnkd.in/dQevCyGD

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One of the major challenges of any kind of quality or process improvement effort is deciding where to draw the organizational boundaries around your initiative. There seems to be an inverse relationship between "how much of the apple you try to bite off at once" and "successfully taking a bite without breaking a tooth." It's easier to pull something off just within a single team or department, but far less impactful. On the other hand, enterprise-wide change can have a huge impact but is far more complicated to pull off. For a fantastic and entertaining example of this, take an hour and listen to this podcast episode from #ThisAmericanLife: Episode #561 - NUMMI (2015) "A car plant in Fremont California that might have saved the U.S. car industry. In 1984, General Motors and Toyota opened NUMMI as a joint venture. Toyota showed GM the secrets of its production system: How it made cars of much higher quality and much lower cost than GM achieved. Frank Langfitt explains why GM didn't learn the lessons—until it was too late."

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Finally, something that isn't all about AI! One news report says funding is shrinking, and another says it's expanding. Especially in M&A. Look, if you have a great project, a good team around you and a few takeaways from this article, success is imminent. The future is pulling us forward, lean in! #medtech #innovation #medicaldevices #healthtech #funding

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https://lnkd.in/gBAncryc "Formalized expectations” ain’t that a beauty of government speak. This kind of reminds me of preparation of the government minions getting a pay rise (been there done that) , well boys were going in expect it, but don’t expect much ya hear. Truth be said (don’t expect the agency to say it) not much in general can be done by the agency in any supply chain problem. Kinda reminds you of the pricing gig doesn’t it? Why don’t we stick to good quality drugs from places that still are exploring the definition of good. Yeah there’s the answer formalize a MOU on the expectation of exporting only good drugs to the US. MOU, mou , mou kinda of reminds me of nobody listening to the cows, they still pay the ultimate price regardless of how much MOUing they are doing. Yep this is also just another moooooou.

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This is a *really cool* initiative announced today! The FDA is working with an architecture firm to develop an #AugmentedReality / #VirtualReality home environment to facilitate development of #MedicalDevices that are intended for use in the home. The "Home as a Health Care Hub" initiative "will serve as an idea lab, not only to connect with populations most affected by health inequity, but also for medical #device developers, policy makers, and providers to begin developing home-based solutions that advance health equity." The initiative is going to start with a focus on rural and economically-disadvantaged home environments. Such a great idea...well done #FDA!! Hopefully once this is operational, the developers will be able to leverage the Hub as a tool for regulatory purposes. It would also be great if, in time, the Hub is applied more broadly. #AR #VR #DeviceInnovation #HealthcareInnovation #AI #RegulatoryAffairs

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In one of the posts (https://t.ly/7q5x_), we examined how the FDA has included software (often referred to as 𝐂𝐃𝐒 𝐬𝐨𝐟𝐭𝐰𝐚𝐫𝐞) that is meant to 𝒔𝒖𝒑𝒑𝒐𝒓𝒕 𝒅𝒆𝒄𝒊𝒔𝒊𝒐𝒏-𝒎𝒂𝒌𝒊𝒏𝒈 𝒇𝒐𝒓 𝒉𝒆𝒂𝒍𝒕𝒉𝒄𝒂𝒓𝒆 𝒑𝒓𝒐𝒗𝒊𝒅𝒆𝒓𝒔, 𝒑𝒂𝒕𝒊𝒆𝒏𝒕𝒔, 𝒐𝒓 𝒄𝒂𝒓𝒆𝒈𝒊𝒗𝒆𝒓𝒔 𝒇𝒐𝒓 𝒕𝒉𝒆 𝒅𝒊𝒂𝒈𝒏𝒐𝒔𝒊𝒔, 𝒕𝒓𝒆𝒂𝒕𝒎𝒆𝒏𝒕, 𝒑𝒓𝒆𝒗𝒆𝒏𝒕𝒊𝒐𝒏, 𝒄𝒖𝒓𝒆, 𝒐𝒓 𝒎𝒊𝒕𝒊𝒈𝒂𝒕𝒊𝒐𝒏 𝒐𝒇 𝒅𝒊𝒔𝒆𝒂𝒔𝒆𝒔 𝒐𝒓 𝒐𝒕𝒉𝒆𝒓 𝒄𝒐𝒏𝒅𝒊𝒕𝒊𝒐𝒏𝒔 in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as how Section 3060(a) of the Cures Act amended the Food, Drug, and Cosmetic Act and under the section 520(o), certain software functions were excluded from the definition of the medical device. Prior to discussing the types of "𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐝𝐞𝐜𝐢𝐬𝐢𝐨𝐧 𝐬𝐮𝐩𝐩𝐨𝐫𝐭" (𝐂𝐃𝐒) software functions that are not regarded as being a part of the definition of the device under section 520(o)(1)(E).  Let’s comprehend who is referred to as a 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐏𝐫𝐨𝐟𝐞𝐬𝐬𝐢𝐨𝐧𝐚𝐥 (𝐇𝐂𝐏). The term "HCP" as used by the FDA refers to a person who is authorized to administer health care and who has been granted a license, registration, or certification by a State or other regulatory body. This includes, but is not limited to, 𝑛𝑢𝑟𝑠𝑒 𝑝𝑟𝑎𝑐𝑡𝑖𝑡𝑖𝑜𝑛𝑒𝑟𝑠, 𝑟𝑒𝑔𝑖𝑠𝑡𝑒𝑟𝑒𝑑 𝑛𝑢𝑟𝑠𝑒𝑠, 𝑙𝑖𝑐𝑒𝑛𝑠𝑒𝑑 𝑝𝑟𝑎𝑐𝑡𝑖𝑐𝑎𝑙 𝑛𝑢𝑟𝑠𝑒𝑠, 𝑐𝑙𝑖𝑛𝑖𝑐𝑎𝑙 𝑠𝑜𝑐𝑖𝑎𝑙 𝑤𝑜𝑟𝑘𝑒𝑟𝑠, 𝑑𝑒𝑛𝑡𝑖𝑠𝑡𝑠, 𝑜𝑐𝑐𝑢𝑝𝑎𝑡𝑖𝑜𝑛𝑎𝑙 𝑡ℎ𝑒𝑟𝑎𝑝𝑖𝑠𝑡𝑠, 𝑝ℎ𝑎𝑟𝑚𝑎𝑐𝑖𝑠𝑡𝑠, 𝑝ℎ𝑦𝑠𝑖𝑐𝑎𝑙 𝑡ℎ𝑒𝑟𝑎𝑝𝑖𝑠𝑡𝑠, 𝑝ℎ𝑦𝑠𝑖𝑐𝑖𝑎𝑛𝑠, 𝑝ℎ𝑦𝑠𝑖𝑐𝑖𝑎𝑛 𝑎𝑠𝑠𝑖𝑠𝑡𝑎𝑛𝑡𝑠, 𝑝𝑠𝑦𝑐ℎ𝑜𝑙𝑜𝑔𝑖𝑠𝑡𝑠, 𝑟𝑒𝑠𝑝𝑖𝑟𝑎𝑡𝑜𝑟𝑦 𝑡ℎ𝑒𝑟𝑎𝑝𝑖𝑠𝑡𝑠, 𝑎𝑛𝑑 𝑠𝑝𝑒𝑒𝑐ℎ-𝑙𝑎𝑛𝑔𝑢𝑎𝑔𝑒 𝑝𝑎𝑡ℎ𝑜𝑙𝑜𝑔𝑖𝑠𝑡𝑠, 𝑡𝑒𝑐ℎ𝑛𝑜𝑙𝑜𝑔𝑖𝑠𝑡. #FDA #HCP #HealthcareProfessional #software #CDS #medicaldevice #clinical #decision

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𝐈𝐧 𝐂𝐚𝐬𝐞 𝐘𝐨𝐮 𝐌𝐢𝐬𝐬𝐞𝐝 𝐈𝐭: If you're a startup or small company looking to bring a new device to market, dealing with the FDA can be overwhelming. The list of questions can seem endless - What product code do I need? What's the best submission pathway for my device? Where can I find information about predicate devices? What is ISO 10993 and why does it matter? What is QMSR and how does it apply? Where do you even start? 😳 I've been in your shoes, and I feel your pain. After accepting my first job as a regulatory specialist for a medical device company, I found myself in a big pile of regulatory doo doo with no idea where to begin. I knew less than NOTHING, and would have loved having a resource like this to help get ne through it. As it was, I had to endure a lot of confusion, poor documentation, many late nights, a lot of coffee, and a few gray hairs while reading regulations until my head throbbed and my eyes bled. This video walks you through the FDA, clarifying the various processes and laying the foundation for your interactions with FDA. And when you're ready to learn more about FDA submissions, we've got a video on that, too (link in the comments below). You're welcome. 😆 😉 #medicaldevices #regulatoryaffairs #compliance #qualitymanagement #medtech #biotech #startups #FDA #510k

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Fascinating advancements in wearable-enabled biomarker research! The future of health monitoring is here, and I am honored to work alongside the hardworking team at rce.ai. Imagine the impact this could have on early disease detection and prevention.. lets keep striving!!! #HealthTech #Innovation #cardiovascular #WearableTech #Healthcare #BiomarkerResearch #Innovation #HealthInnovation #TechProgress #HealthcareRevolution #ArtificialIntelligence

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This article misses two critical points. If you have all the money in the world what are the two things you need? Agree? 1) People 2) Execution www.vitatek.io Medical Device Development Manufacturing Everything In House RD/Rapid Prototyping/Weekly in house Hydrophilic Coating in house Regulatory in house Die Mold Tooling in house Contract Manufacturing in house Sterilization in house #prototyping #rapidprototyping #contractmanufacturing #manufacturing #medical #medicaldevices #sterilization #medicaldevicemanufacturing #researchanddevelopment #researchdevelopment #equity #privateequity #capital #hydrophilic #coatings #diemolds #meddevice #doctors https://lnkd.in/guZV6Khp

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🚀 Embarking on creating a new Medical Device or launching a startup around your new idea? Consider This First... In the exciting world of new product development and medical device startups, it's easy to adopt the "if we build it, they will come" mentality. However, the landscape is filled with landmines, and understanding the various critical factors beyond technical risk is crucial for success. Many of my new R&D and enthusiastic entrepreneurial clients I come across are primarily focused on the technical aspects of their products. While this is undoubtedly important, it's just one piece of a much larger puzzle. Here are the key areas you must consider thoroughly to avoid pitfalls and steer your innovation to success: 1️⃣ Regulatory Compliance: Understanding the regulatory requirements early on can make or break your entry into the market. 2️⃣ Clinical Adoption: It's not just about creating a functional product but one that clinicians are willing to adopt and use regularly. 3️⃣ Reimbursement Strategies: Ensuring that there are clear paths for reimbursement will define your product’s financial viability. 4️⃣ Technical Risk: While important, this should be balanced with other risks associated with bringing a medical device to market. 5️⃣ Market Size Assessment: A realistic evaluation of your potential market size can significantly influence strategic decisions. 6️⃣ Net Present Value (NPV): Calculating NPV early can help you lock in your target price point and COGS. 7️⃣ Health Economics: Understanding the economic impact your device will have on the healthcare systems is crucial. 8️⃣ Intellectual Property (IP): Strong IP protection is a cornerstone for defending against competitors and establishing your market presence. 9️⃣ Budget and Timeline: Full understanding of the cost and time to get your product to market. Missing or underestimating any of these factors and its game over. Let’s ensure that your brilliant innovation not only sees the light of day but also thrives in a competitive marketplace. For anyone considering creating a new product or startup in the medical device field, let's connect. I’m here to share insights and guide you through the intricate journey of bringing transformative medical products to life.

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QUESTION: What is it that you are doing differently? A few prompts to make sure that your product has a competitive advantage. #medtech #innovation #marketing

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When a technology is as revolutionary as Perimeter's, it can take a while for people to believe the magnitude of the impact it has. But then customers become evangels, and data starts getting published, and adoption accelerates. This is how a technology becomes part of the standard of care.

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How Non-Competes have cost me 100k! The FTC decided to absolve non-compete clauses for all industry. I am 100% in support of this change. Why? Organizations should create circumstances which make people want to stay in them. And if they choose to do something else, that should be impetus to create a better working situation for all. Two years ago, we wanted to hire a truly excellent physician who worked at the hospital medical office across the street from our medical practice. We knew we were up against a challenge with the Non-Compete that she had in contract with this hospital. But we wanted to work with her, and she with us. So we contracted two attorneys with tons of experience in non-competes who helped us challenge the hospital. Due to my own sense of caution about the legal ramifications, we actually hired two different firms who separately came to the same answer for us. If the hospital wanted to fight this, they could make our lives difficult and cause huge delays, but they thought they could win if it went to court. The cost of this legal advice was 100k.  The medical practice paid for this advice, hoping that we would gain understanding of the limits of these structures. I wish the FTC had decided this two years earlier! With this physician, we flew under the radar for a little while, but after a few months the hospital served us a “Cease and Desist” letter threatening legal action if we continued to employ this physician.  This was very uncomfortable for everyone. We were fortunate not to endure the stress and the cost of this playing out in the courts because after we hired this doctor, we had an opportunity to buy a medical practice of a retiring physician a few miles away in Washington, DC.  Out of state, this non-compete contract was safe, and the physician was happy to take on a new role. All people should have the freedom to work where they choose and help to create the best environment that they can feel happy in. And for every physician who has felt totally stuck in their position – you are now free to live your best professional life, wherever you see fit.   Please follow me here to learn more about what is important to us at NVFP.

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Be careful when choosing a third-party testing lab, and if you do, be sure to review all the data they send to you before submitting to the FDA. Well, duh, Michelle, you might be saying. That's just plain old common sense. Apparently not. Earlier this year, FDA released a letter to industry regarding "𝘢𝘯 𝘪𝘯𝘤𝘳𝘦𝘢𝘴𝘦 𝘪𝘯 𝘴𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯𝘴 𝘤𝘰𝘯𝘵𝘢𝘪𝘯𝘪𝘯𝘨 𝘶𝘯𝘳𝘦𝘭𝘪𝘢𝘣𝘭𝘦 𝘥𝘢𝘵𝘢 𝘨𝘦𝘯𝘦𝘳𝘢𝘵𝘦𝘥 𝘣𝘺 𝘵𝘩𝘪𝘳𝘥-𝘱𝘢𝘳𝘵𝘺 𝘵𝘦𝘴𝘵 𝘭𝘢𝘣𝘴. 𝘛𝘩𝘪𝘴 𝘢𝘭𝘢𝘳𝘮𝘪𝘯𝘨 𝘵𝘳𝘦𝘯𝘥 𝘩𝘢𝘴 𝘳𝘦𝘴𝘶𝘭𝘵𝘦𝘥 𝘪𝘯 𝘵𝘩𝘦 𝘍𝘋𝘈 𝘣𝘦𝘪𝘯𝘨 𝘶𝘯𝘢𝘣𝘭𝘦 𝘵𝘰 𝘳𝘦𝘢𝘤𝘩 𝘢 𝘴𝘶𝘣𝘴𝘵𝘢𝘯𝘵𝘪𝘢𝘭 𝘦𝘲𝘶𝘪𝘷𝘢𝘭𝘦𝘯𝘤𝘦 𝘥𝘦𝘵𝘦𝘳𝘮𝘪𝘯𝘢𝘵𝘪𝘰𝘯 𝘰𝘳 𝘰𝘵𝘩𝘦𝘳𝘸𝘪𝘴𝘦 𝘢𝘶𝘵𝘩𝘰𝘳𝘪𝘻𝘦 𝘮𝘢𝘳𝘬𝘦𝘵𝘪𝘯𝘨 𝘧𝘰𝘳 𝘮𝘦𝘥𝘪𝘤𝘢𝘭 𝘥𝘦𝘷𝘪𝘤𝘦𝘴 𝘸𝘩𝘰𝘴𝘦 𝘴𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯𝘴 𝘪𝘯𝘤𝘭𝘶𝘥𝘦 𝘴𝘶𝘤𝘩 𝘥𝘢𝘵𝘢." In many cases, I bet this was a decision made solely on price, as so many pre-launch business decisions are. And I get it. Bringing a product to market is not cheap and I completely understand why a $15K testing budget is much more appealing than a $150K testing budget. So what should you keep in mind when selecting a testing lab? 𝗗𝗼 𝘁𝗵𝗲𝘆 𝗵𝗮𝘃𝗲 𝗮 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝘀𝘆𝘀𝘁𝗲𝗺? Remember, YOU are still responsible for vendor/supplier/partner quality issues, so do your due diligence here, too. 𝗪𝗵𝗮𝘁 𝗶𝘀 𝘁𝗵𝗲𝗶𝗿 𝘁𝗲𝘀𝘁𝗶𝗻𝗴 𝗰𝗮𝗽𝗮𝗰𝗶𝘁𝘆? Do they really have the capacity and the capability to perform mechanical, electrical, chemical, human factors and biocompatibility testing? And what about their turnaround times? 𝗪𝗵𝗮𝘁 𝗱𝗼𝗲𝘀 𝘁𝗵𝗲𝗶𝗿 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗵𝗶𝘀𝘁𝗼𝗿𝘆 𝗹𝗼𝗼𝗸 𝗹𝗶𝗸𝗲? I'll make this one simple: if they haven't had an FDA inspection (or competent authority/notified body assessment, or MDSAP audit, etc) and can't produce documents to prove it, walk away. 𝗪𝗵𝗮𝘁 𝗶𝘀 𝘁𝗵𝗲𝗶𝗿 𝗰𝘂𝗿𝗿𝗲𝗻𝘁 𝗮𝗰𝗰𝗿𝗲𝗱𝗶𝘁𝗮𝘁𝗶𝗼𝗻? Just because they say they're accredited doesn't mean it's true, so do your due diligence and ask for proof before signing on the bottom line. There are other things to consider, of course, but these are the big ones. Choose carefully, and your submission will remain on course. #medicaldevices #qualitymanagement #compliance #regulatoryaffairs #medtech #biotech #FDA

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Part 1 of 2... Great article by Duke Rohlen Regina Herzlinger and Will Kynes Ajax Health on their named Growth Driver Model. I would highly recommend reading. I have been calling the same concept the "build to buy" model for years, #buildtobuy. Others like myself at Front Foot Ventures, Rick Anderson Todd M. Pope (Revival Healthcare Capital), Pat Donnelly (Veranex) and David Hochman (Orchestra BioMed) have been working this model as well. And we have seen it in action with Medtronic with their Blackstone structured deal and Medtronic with their structured deal with Ramin Mousavi (CathWorks) Peter Fitzgerald (Triventures) with Andrew ElBardissi, MD (Deerfield Management). And I was CEO at Verb Surgical which was a structured deal with Johnson & Johnson MedTech and Google where Johnson & Johnson bought Verb Surgical after 4 years of development. I wholeheartedly agree with the assessment and issue in #medtech innovation. Strategics like Medtronic, Stryker, Abbott and Boston Scientific do product extensions very well, they also acquisitions and integrations very well. It is not them specifically on innovation, large companies in general don't have the cultures, people, comp plans, income statement budget availability, and timelines to do game changing innovation. But the strategics do have balance sheet capacity, they have cash and they have need for innovation to fuel growth. They also have global distribution, manufacturing and other key operational areas to leverage early stage medtech to faster clinical benefits for patients and commercial success. The other issue is a shrinking pot of capital for #medtech versus other verticals like #biotech and other areas of technology. Medtech investing has gotten harder in the last 10 years given higher barriers to technical development, clinical requirements, regulatory approvals and heightened commercialization/reimbursement hurdles in the U.S., Europe and China. The technology is there (Ai, robotics, sensors, material sciences, computing power, connectivity), the patient needs are there, but we need better financing solutions that work for investors, strategics, and management teams/employees. Patient benefits are suffering. We need to solve this. I believe "build to buy" is that solution in many circumstances. Continued in part 2/2 #medtech #hbr Harvard Business School Joe Mullings The Mullings Group #srs2024

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