Chad Schneider, P.E.

It wasn't long ago that a client, a leading provider of dental and orthodontic devices, needed help with documenting their processes and remediating a Design History File to address a recent FDA 483. The engineering team at Concise Engineering successfully finished the implementation of a new QMS system. ✔️ Completed the DHF remediation to the satisfaction of the FDA To help the client reach true success, our key team members supported this client on-site, during a follow-up inspection by the FDA. If you get stuck in this process, take a quick moment and schedule a chat with Justin to see what Concise Engineering can do for your product. #medicalequipment #medtech #innovation #medicaldevices #healthtech #fda

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The Importance of Precision Tooling in Medical Device Manufacturing In medical device manufacturing, precision is everything. The tools used to create your parts can make or break the success of your product. Whether you’re producing complex components or high-volume parts, well-designed and precise tooling is critical to ensuring quality, efficiency, and long-term cost savings. Here’s why precision tooling matters: Consistent Part Quality High-precision tooling ensures that each part produced is consistent, meeting strict medical device standards. This consistency reduces the risk of defects, ensuring your parts perform reliably in critical applications. When every micron counts, even the smallest flaw in tooling can lead to costly rework or failures down the line. Minimized Production Downtime Well-crafted tools are designed for durability and efficiency. This reduces the frequency of tool maintenance or repairs, which in turn minimizes production downtime. A properly maintained tool extends the life of your mold and ensures smoother production cycles. Cost Efficiency While investing in high-quality tooling may seem like a big upfront cost, it pays off in the long run. Precision tools reduce waste, improve cycle times, and eliminate the need for costly adjustments or repairs. The result is a streamlined manufacturing process that can scale efficiently as demand grows. Designing for Tooling During the design phase, consider how your part’s geometry will affect the tooling. Factors like parting lines, draft angles, and material flow can have a significant impact on tooling complexity and the final part quality. Working closely with a tooling expert can help avoid common pitfalls and improve manufacturability from the start. Key Considerations for Tooling: Material Selection: Choosing the right tool steel or aluminum impacts tool longevity and performance. Tolerance Management: Tight tolerances are often required for medical device components, and precision tooling ensures these tolerances are met. Mold Design: Proper gate placement, cooling channels, and venting are all critical in avoiding defects like warping or sink marks. In short, precision tooling is the foundation of successful medical device manufacturing. With the right tools in place, you can produce high-quality, reliable products while keeping costs and downtime under control. #PrecisionTooling #MedicalDeviceManufacturing #ToolingDesign #ManufacturingEfficiency #InjectionMolding #ProductDevelopment #QualityControl #ToolingTips #DFM #MedicalDevices #CostEfficiency #Engineering

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The Importance of Precision Tooling in Medical Device Manufacturing In medical device manufacturing, precision is everything. The tools used to create your parts can make or break the success of your product. Whether you’re producing complex components or high-volume parts, well-designed and precise tooling is critical to ensuring quality, efficiency, and long-term cost savings. Here’s why precision tooling matters: Consistent Part Quality High-precision tooling ensures that each part produced is consistent, meeting strict medical device standards. This consistency reduces the risk of defects, ensuring your parts perform reliably in critical applications. When every micron counts, even the smallest flaw in tooling can lead to costly rework or failures down the line. Minimized Production Downtime Well-crafted tools are designed for durability and efficiency. This reduces the frequency of tool maintenance or repairs, which in turn minimizes production downtime. A properly maintained tool extends the life of your mold and ensures smoother production cycles. Cost Efficiency While investing in high-quality tooling may seem like a big upfront cost, it pays off in the long run. Precision tools reduce waste, improve cycle times, and eliminate the need for costly adjustments or repairs. The result is a streamlined manufacturing process that can scale efficiently as demand grows. Designing for Tooling During the design phase, consider how your part’s geometry will affect the tooling. Factors like parting lines, draft angles, and material flow can have a significant impact on tooling complexity and the final part quality. Working closely with a tooling expert can help avoid common pitfalls and improve manufacturability from the start. Key Considerations for Tooling: Material Selection: Choosing the right tool steel or aluminum impacts tool longevity and performance. Tolerance Management: Tight tolerances are often required for medical device components, and precision tooling ensures these tolerances are met. Mold Design: Proper gate placement, cooling channels, and venting are all critical in avoiding defects like warping or sink marks. In short, precision tooling is the foundation of successful medical device manufacturing. With the right tools in place, you can produce high-quality, reliable products while keeping costs and downtime under control. #PrecisionTooling #MedicalDeviceManufacturing #ToolingDesign #ManufacturingEfficiency #InjectionMolding #ProductDevelopment #QualityControl #ToolingTips #DFM #MedicalDevices #CostEfficiency #Engineering

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The selloff of Medrobotics Corporation assets comes just days after top company officials settled with a Chapter 7 trustee for $2 million over claims of breached fiduciary duties. (Note: The settlement was not an admission of wrongdoing.) Unfortunately, this is another example of just how tough it can be to compete in the #surgicalrobotics space. There also appear to be some lessons involving #intellectualproperty in this case. We have the details on MassDevice. #medtech #roboticsurgery

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Looking for last minute CE opportunities? We’ve got you 🙏 This self-instructional course for dentists discusses an innovative concept in custom CAD/CAM implants. Take the CE quiz after to earn 2 credits! 🔗 https://hubs.ly/Q030KWDH0 Expected outcomes: 🦷 Define subperiosteal implants. 🦷 Realize some history leading up to modern subperiosteal implants. 🦷 Identify various treatment solutions for the posterior mandibular region. 🦷 Realize various approaches that can compensate for certain anatomical. 🦷 Observe a procedure for subperiosteal implants. #implantdentistry #implantology

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🔬 As the owner of a leading dental lab supply company, staying updated on industry trends is key! Here's what's buzzing in the world of dental labs: 1️⃣ **Advanced Technology Integration**: From 3D printing to CAD/CAM systems, technology continues to revolutionize dental lab workflows, improving efficiency and precision. 2️⃣ **Sustainability Initiatives**: More labs are adopting eco-friendly practices, from using recycled materials to reducing waste, reflecting a growing focus on sustainability across industries. 3️⃣ **Customization & Personalization**: Patients seek unique, personalized dental solutions, driving demand for customized products and services in dental labs. 4️⃣ **Remote Work Adaptation**: The shift to remote work has prompted dental labs to explore innovative ways to collaborate and communicate virtually, leveraging digital platforms and tools. 5️⃣ **Quality Assurance & Compliance**: With stringent regulations in place, labs are prioritizing quality assurance and compliance to ensure the safety and satisfaction of patients. 💡 What other trends are you noticing in the dental lab industry? Share your insights and experiences in the comments below! Let's keep the conversation going and continue driving innovation in this dynamic field. #DentalLab #IndustryTrends #Innovation 💬

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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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💡Your daily reminder, that optical metrology is the only way to non-contact and non-destructive quality assurance. We never get tired of emphasizing that. You don't want scratches on the knee implant that goes into your body. #surgery #surgicaltools #medicaldevice #medicaldevices #qualityassurance #mdr #fda #contactfree #optical #implant #kneeimplant

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We are frequently engaged to consult with companies that seek adhesive solutions only after their part design is finalized. This approach can be costly, as many medical device materials are challenging to adhere to and often require specialized, more expensive solutions when we are not involved from the outset. We advocate for the principle of "Think Adhesives First" to help engineers avoid these pitfalls and optimize their designs for adhesive compatibility from the beginning. Read more about our perspective on this crucial design consideration. https://lnkd.in/g8y8XHpC

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However, if they don’t understand the art of design and where the failures lie in manufacturing a lot of resources will be wasted and failures will inevitably occur. Read more 👉 https://lttr.ai/ATHhh #orthopedicimplants #implants #failedback #AdditiveManufacturing #Medical3Dprinting #3Dprint #AlyssaHuffman

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My clone just answered this question... What are bio-integrative materials ? "Bio-integrative materials are the new frontier in orthopedic innovation, my friend. These aren't your granddad's metal implants. We're talking about materials that don't just sit there like a lump of metal in your body but actually integrate with your bone over time. Think of it as the implant becoming a part of your body, rather than just a foreign object that needs to be dealt with later. Companies like OSSIO are at the forefront, developing these materials that gradually become part of the bone, potentially eliminating the need for removal surgeries down the line [1][6]. It's a game-changer, reducing complications and improving patient outcomes. This is the kind of tech that's shaking up the industry, pushing us away from the old, static metal implants to something that's truly dynamic and revolutionary. Ask my clone anything and get an instant answer - https://lnkd.in/eP3m4H7H

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Don't sugarcoat it.  Communicate design challenges and "hard to manufacture" elements of your device with your vendors early on. They will thank you for it. Dive deep on this topic (and more) with Samantha Wagner in the full episode. Link in the comments. #medtech #innovation #supplier #medicaldevice #contractmanufacturing

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What happens when an ortho startup catches their first FDA clearance ? For ortho startups, FDA clearance feels like the holy grail. It’s the “yes” they’ve been chasing, the green light after all those nights in the lab. But here’s the reality: your FDA clearance is just a "fishing license." It’s permission to play, not a business yet. Think of it like a dog finally catching the car it’s chased for months. It’s thrilling — but then what? FDA approval is just the beginning. Now comes the hard part: building a real business. 1/ Product-Market Fit: Clearance is just step one; you still need proof that the market truly wants what you’re selling. Are you solving a real pain point, and is there real demand? Without product-market fit, no amount of clearance or funding will turn your idea into a sustainable business. 2/ Business Model: Clearance doesn’t pay the bills. You need a model that scales — will you sell the product once, or is there a recurring revenue opportunity? 3/ Funding: Investors now want to see growth, not just the product. Without a clear path, you’re back to chasing cash. 4/ Sales & Distribution: Great products don’t sell themselves. You need relationships, logistics, and a plan to get into the OR. 5/ Value Analysis Approvals: Hospitals have Value Analysis Committees to ensure new products add measurable value without unnecessary costs. Getting through this gate is no small feat — you’ll need data to prove cost-effectiveness, clinical benefit, and strategic value. Without this, your product stays on the sidelines. 6/ Marketing & Education: Surgeons need convincing. That means educational outreach and clinical studies. 7/ Customer Support: Once in use, you’re on the hook for support, troubleshooting, and proving long-term value.

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What happens when an ortho startup catches their first FDA clearance ? For ortho startups, FDA clearance feels like the holy grail. It’s the “yes” they’ve been chasing, the green light after all those nights in the lab. But here’s the reality: your FDA clearance is just a "fishing license." It’s permission to play, not a business yet. Think of it like a dog finally catching the car it’s chased for months. It’s thrilling — but then what? FDA approval is just the beginning. Now comes the hard part: building a real business. 1/ Product-Market Fit: Clearance is just step one; you still need proof that the market truly wants what you’re selling. Are you solving a real pain point, and is there real demand? Without product-market fit, no amount of clearance or funding will turn your idea into a sustainable business. 2/ Business Model: Clearance doesn’t pay the bills. You need a model that scales — will you sell the product once, or is there a recurring revenue opportunity? 3/ Funding: Investors now want to see growth, not just the product. Without a clear path, you’re back to chasing cash. 4/ Sales & Distribution: Great products don’t sell themselves. You need relationships, logistics, and a plan to get into the OR. 5/ Value Analysis Approvals: Hospitals have Value Analysis Committees to ensure new products add measurable value without unnecessary costs. Getting through this gate is no small feat — you’ll need data to prove cost-effectiveness, clinical benefit, and strategic value. Without this, your product stays on the sidelines. 6/ Marketing & Education: Surgeons need convincing. That means educational outreach and clinical studies. 7/ Customer Support: Once in use, you’re on the hook for support, troubleshooting, and proving long-term value.

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The #SMARTtrial 1-year outcomes presented at #ACC2024 show fundamental design differences in #TAVR devices can impact valve performance. Explore the evidence. https://bit.ly/4bjE62N Risk info: https://bit.ly/4bkMTkW

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LS - Long stroke for Slides Can you imagine having up to 100mm of slide travel with only a 110mm mold opening?

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Surgical Robotics fans: So here's the link to my exclusive blog - where for 19.99 you get access to all current and future exclusive articles on robotics and surgical robotics. You're not going to want to miss what's co ming next ! Just buy a subscription and get detailed insights into the work of #surgicalrobotics >>> articles already available>> Force Feedback / Haptics in surgical robotics Strategies to sell against Intuitive's amazing da Vinci 5 100 academic medical centers' top 10 operational priorities Strategies to sell against "Modular" Main frame robots Is time running out for the strategics in surgical robotics? Strategies to sell against "Boom" multiport main frame surgical robots The bridge between manual laparoscopy and robotic assisted surgery: Advanced Assisted Laparoscopy (AAL) If you're going to fight da Vinci 5 - fight them in a phone box da Vinci 5 Force Feedback instruments: Spot the difference 1 Hour deep dive into da Vinci 5 Updated: 21 Soft Tissue Surgical Robotics - Multiport systems - list and overview (Systems that compete with daVinci Xi) UPDATED: What could be the impact of daVinci 5 on the market and competitors Updated: 26/3/24 Intuitive Da Vinci 5 vs Xi an early review - but it’s more what they’re not telling you that you need to know UPDATED: Intuitive daVinci Gen 5 - so what's still expected Surgical Stapling in Surgical Robotics - the next frontier Why surgical robotics (soft tissue) is a hard mountain to climb Intuitive leading the shift to Surgical Robotics becoming a service Industry How AI is affecting and will affect Surgical Robotics (Exclusive Content) Nothing is new in surgical robotics - The Early history of soft tissue robotics and how modern systems are just better working copies Why bother having a Surgical Robot? Robotic Instrumentation - a deep dive (Exclusive Content) What's next in soft tissue surgical robotics - Part 1- Main Frames (Exclusive Content) Interesting for #surgeons #intuitive Intuitive #medtronic Medtronic #stryker Stryker #medicaroid Medicaroid #cmrsurgical #distalmotion Distalmotion #moonsurgical Moon Surgical #ronovosurgical Ronovo Surgical and all the other #generalsurgery tower companies like #karlstorz KARL STORZ #olympus Olympus Corporation and many more #surgery #laparoscopy https://lnkd.in/eKgWe-qX

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