Timothy Sutton

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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Why did the medical device go to therapy?... Because it had an identity crisis between being repaired and remanufactured! The FDA's new guidelines cleared things up, but now it needs a 510(k) clearance to feel complete again 😅 In all seriousness, the recent FDA updates are crucial for ensuring safety and compliance in our industry. We’re committed to meeting these new guidelines with thorough testing and documentation. Feel free to reach out if you have any questions or want to chat about how we can support you through these changes. Here’s to staying compliant and having a bit of fun along the way! #MedicalDevices #FDA #Compliance #HealthcareTechnology #Ultrasound #MedicalDeviceRepair #Healthcare #Regulations #Acertara #HTM #Guidelines #MedicalEquipment

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Another source of information in litigation In case you’re in litigation get the Pre Market Approval (PMA) and 510k clearances to see what the OEM told the FDA. Class 1 least likely to be inherently dangerous to patients. Class 2 devices generally only require one PMA before using 510k clearances as substantial equivalent for devices Class 3 use the PMA. In litigation FDA filing are essential in any litigation. The secrets are there

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If I had an FDA cleared medical device ready to be marketed to hospital groups in the US for the first time, here is what I would consider doing to bring on my very first customer... - Identify a major hospital group for collaboration on an initial pilot - Meet with the OBGYN department head of that group (e.g. Chair, Chief, Division Director etc) to introduce the device (assume you gain clinical buy-in) - Discuss parameters of an early pilot (what data needs to be collected by providers to support approval at the system level) - Offer a discount to support the pilot (or devices free of charge). Justified if this is the very first user (early adopter) in the country - Work with procurement/ value analysis to agree a free of charge evaluation (trial period, contract, vendor set-up, protocol, on-going pricing etc) - Obtain a zero charge PO to mark the start of the pilot - Provide initial and on-going on-site education to support the clinical teams using your device - Regularly engage with providers to monitor initial uses and obtain feedback (this might come via a clinical champion) - On completion of the pilot, have your clinical champion collate provider feedback for submission to the new product committee (or a committee of this type) - Assuming the above is a success and their experience is consistent with the benefits you initially articulated, you should have your first customer and orders to follow Ultimately, there will be nuance to the above list, but thinking about this process is a good start. Hospital and system internal approval processes will vary considerably. We know that healthcare systems are slow to adopt new technologies. In the obstetrics space especially. Target early adopters and key opinion leaders. Consider your distribution strategy - how will you move from your first customer to national adoption? If you need help with any of the above or would like to talk through, drop me a message. I spent many years building our US business from scratch and I now share that journey, knowledge, and network with others through OBG Access I'm enjoying working with exciting start ups in the medical device space, especially clinician-inventors, like my father who wanted to solve a clinical problem and will leave a lasting impact on his field. Maybe there's one more adventure left... #FDAClearance #MedicalDevices #Innovation #Obstetrics #Maternity #WomensHealth #Sales #Business #USLaunch

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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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#TBT Throwback Thursday. This is where this whole medical sales thing started for me. Working as a Nuclear Medicine Technologist made me aware of this career called medical sales. I was raking in a cool $22K/year at the time as a tech. My boss was trying to hire a medical sales pro to sell a new service and every experienced rep wanted a six figure guarantee. I laughed! Salesperson? Six figures? Let me try it. So I did. I sucked. I failed. Then I learned there was a strategy and process to selling. I learned it. Never looked back. Fun days! #MedicalSales #HealthcareSales #MedTech #PharmaSales #Hospital Sales

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Note: Devices with Breakthrough status are very likely to receive an NTAP from CMS. Because of the Breakthrough status, the device applications primary hurdle is the cost criteria, and most new devices meet this criteria. The FY 2025 proposed rule demonstrates this perfectly.

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Have you added the DAT closure device to your bag of tools? -indicated for defect closure up to 5cm. -no suture setup time required. Let’s connect and discuss how DAT can support your next case. Micro-Tech Endoscopy #EMR #ESD #3rdspace #GI #GITwitter #Gastroenterology #Endoscopy #interventionalendoscopy #DAT

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Happy Friday everyone! To all candidates pursuing med device sales, please take a few minutes and read this great article (link in comments) by Brad Terry talking about the 6 miss steps of candidates in the interview process that are pursuing medical device sales. the big takeaway from my end is to make sure you implement the pro tips that Brad is talking about because this will definitely help you be more prepared in your interviews and help you break into med device sales sooner. Keep up the great work out there. Shooters SHOOT! 🙋🏽‍♂️🎧👌🏽🏀 #recruiterlife #medicaldevicesales #interviewtips #finishstrongfridays #corporatebuckets

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Intuitive is doing it again. If you are in medical device, you are currently witnessing the first medtech company who is positioning themselves as a lifestyle brand. Intuitive Returning from SAGES this past week, it is clear that the team at Intuitive is executing on playbooks that were written by Apple and Steve Jobs and taken even further by Tesla and Elon Musk. If you attended SAGES, you saw it first hand and may not have realized it. Now that it is called out, you know. The new form factor of D5, the clear attention to the industrial design factors, the finishes.......seems Apple-like. Go to the Intuitive LinkedIn page and view their postings from the last week: - Dave Rosa's "What is Belief?" pic - The video from SAGES of "Transforming Surgery Together Again" - The Intuitive gamer headset on a customer The Intuitive website alongside the Tesla and Apple websites, have very similar vibes. Creating a visceral connection and taking a product to the level of a surgeons lifestyle creates legions of deep connections for the products to follow. You become part of a family, tribe, a community, a subculture. And now that I showed you, you will see it everywhere :) Well done Intuitive.

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Ways to get into a tough lab or OR if you’re a new med device rep (please comment other creative ways you set meetings with tough accounts): 1. Offer an in-service to new techs or nurses. This is very basic but there’s often additions and turnaround, so it’s in everyone’s best interest to get them trained asap. 2. Offer continuing education credits for techs. See if your company has presentations you can give to staff in order to give them credits. I used ASRT presentations for IR labs a lot post Covid when restrictions were tighter. 3. Connect with a Physician, Tech, Director, Nurse, etc via phone, email or LinkedIn and ask their advice for the best way to set up an in-service or office visit to share new products. Don’t give up after 1-2 tries. These people are all busier than you could imagine. 4. Network with other reps. Earlier in my career I was too focused on myself and viewed other reps as threats. Now I network as much as possible and have developed incredible relationships that have led to some BIG intros that I wouldn’t have had just by cold calling all the time. Shoutout to Matt Abrams, MBA for being selfless with intros when I first moved to Cali. 5. Ask your boss for help, ha. This is overlooked. I’ve been trying to set a meeting with someone for a while now and told my boss I’ve been having difficulty. Turns out she’s called on him for a decade and sent him a text. Meeting has been set. 6. Ask happy customers if they know anyone at the hospital you’re trying to get into. I’ve gotten cell phone numbers of lead techs, lab directors and Drs from happy customers with permission to say they sent me. If their friends are happy with you and trust you, this will increase the chance of someone meeting with you. Lake Odom any other advice you’d give or good stories of reps setting meetings in your lab?

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What if you flash forwarded only 3 years into the future to the year 2027…? What does that look like for you and do you see a likely retirement from dental practice ownership in that upcoming timeline….? If the answer is yes- feel free to personally reach out to chat about the steps involved to get to your financial goals, including the most important step of getting your practice properly appraised in order to prepare for eventual retirement. #appraisers #dentist #brokerlife #appraisals #oralhealth #teeth #dentalpractice #dentistry #dentalprofessionals #dds #valuation #dentalpracticesales #oda #dentists Timothy A. Brown CEO and Broker of Record ROI Corporation

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Philips It took 731 deaths on approximately 10,000 injuries for Congress to enact major changes to the FDCA. Do what’s it going to take to bring Philips to justice? Thousands of event reports, hundreds of death, multiple consent decrees, thousands and thousands of failed FDA inspections deficiencies, selling thousands of CT scanners with no 510k clearance, failed reporting of complaints and much more So how many deaths and injuries will it take? How much litigation is enough? Philips what are you going to do? 1976 Medical Device Amendments (PL 94-295) These Amendments were introduced in response to a US Senate report that faulty medical devices had caused approximately 10,000 injuries, including 731 deaths. It requires that all medical devices be classified into one of three classes: Class I (General Controls): devices deemed low-risk for human use. Class II (Performance Standards): devices considered moderate-risk for human use. Class III (Premarket Approval): devices deemed high-risk for human use. Philips FDA U.S. Department of Justice Marshall Shannon Reed Smith LLP Tommy Geske GE HealthCare Siemens Healthineers Radiological Society of North America (RSNA) American College of Radiology

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❓Big question is…. ❓ What is going to happen to all the non-solicitation agreements that have been signed? 🧐 With the FTC ruling on non-competes, I’m now wondering about the non-solicitation. How does the ftc ruling apply to those agreements? Is that where we are going to get held up in court? What are everyone’s thoughts? #medicaldevice #medicaldevices #meddevice #medtech #zimmer #strykwr #smithandnephew #depuysynthes Richard Southgate Stu Brandon Kevin Brown 🎸 Kris Jones Jerry Ennett Mark Copeland Chad Bonner

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𝐅𝐃𝐀 𝐈𝐬𝐬𝐮𝐞𝐬 𝐑𝐞𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞 On May 10, 2024, the FDA issued a guidance document on “Remanufacturing of Medical Devices.” Remanufacturing is the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use. The document is intended help clarify whether activities performed on devices are likely to be considered “remanufacturing” in an effort to provide consistency and a better understanding of applicable statutory and regulatory requirements. Also included are recommendations for information that should be included on labeling to help ensure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. The document addresses activities performed on devices that are intended to be reused and maintained, discussing whether activities performed by original equipment manufacturers (OEMs) and third parties on such devices are likely considered as remanufacturing. Contrarily, the guidance is not intended to adopt significant policy changes, but to clarify FDA’s current thinking on applicable definitions, while not changing the regulatory requirements applicable to remanufacturers. Read the full guidance here: https://lnkd.in/dRFjbUU Visit AlvaMed's website for more industry news and insights. https://lnkd.in/eGrnpRdv

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Ultrasound technology enhanced with artificial intelligence (AI) improves the precision and interpretability of ultrasound imaging. This combination brings a new dimension to ultrasound's capabilities, making it a more powerful tool for early diagnosis. Acertara's ongoing research and development efforts aim to evolve ultrasound into a predictive tool for preemptive medical intervention. This breakthrough marks a pivotal shift in healthcare, positioning ultrasound as a fundamental driver in preventive medicine. #EarlyDetection #Ultrasound #ArtificialIntelligence Learn how Acertara’s ultrasound technology is pioneering early detection in healthcare. Visit https://bit.ly/3RfNOtp for more information.

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Hey everyone! Please join me on Thursday, June 27th as I present a webinar all about Adverse (Mode 3) Wear Testing of arthroplasty devices. It'll be a great opportunity to learn about the latest particulate methods and how OIC has used them on a variety of devices. Sign up here: https://lnkd.in/gYvPwTTZ   I will be covering topics like: • What is adverse wear testing versus traditional wear test methods? • Why is adverse wear testing so important? • What are the different approaches for adverse wear testing? • How we at OIC modify existing methods for adverse wear testing? • Answers to frequently asked questions about adverse wear testing.   #FreeWebinar #OrthoWebinar #Orthopaedics #Orthopedics #MedicalDevice #MedicalWebinar #MedicalTesting

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Here is the real takeaway from this: If you have a new project or an existing one where you may want an additional manufacturer for redundancy or simply want a vendor that is easy to work with, Bentec Medical has literally every medical silicone technology you may need. If your current vendor is delivering less than desired quality, delivery times, or customer service, perhaps it's time to look elsewhere. We understand the needs of the Med Device world, as we have six products we sell direct to hospitals, and have been through the same regulatory situations your products go through and the experience to navigate this challenge smoothly. Let's discuss your projects and allow me to show where we are the true one-stop shop, with all the capabilities you could need and a desire to be the partner you want. #lsr #contractmanufacturing #silicone #extrusion #siliconesheeting #woundcare #medicaldevice #biopharma #molding #overmolding #pharma #iso13485 #drugdelivery #implantable #dipmolding

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