Deanna Cavallaro

🚀 Ready to navigate the final steps of bringing your medical device to market? This week on MedTech Compliance Chronicles, we're diving into FDA market applications, covering everything from 510(k) submissions to PMAs and Class I device registration. Whether you're gearing up for a premarket notification or tackling a full PMA, our latest post will guide you through the process, helping you streamline your submission and ensure compliance. Don't miss out on these critical insights! #MedTech #FDA #MedicalDevices #510k #PMA #RegulatoryCompliance #QualityManagement https://lnkd.in/eSPWnuQk

2

I've witnessed a recurring oversight among many companies: the underestimation of Requirement Engineering (RE). While the drive to develop innovative medical devices is commendable, neglecting a solid requirement engineering foundation can lead to product launch delays, unexpected cost overruns, and even regulatory approval failures. Requirement Engineering is the cornerstone of medical device development. It serves as a roadmap for every stage of the process. It's crucial for accurately capturing user needs, meeting regulatory requirements, and proactively mitigating potential issues during development. Let's briefly explore the key stages of Requirement Engineering: ▶️ Elicitation: Collaborating with various stakeholders, including patients, clinicians, engineers, and regulatory bodies, to gather and analyze requirements for the medical device. ▶️ Analysis: Evaluating the gathered requirements for feasibility, consistency, and completeness, clarifying any conflicting or ambiguous aspects. ▶️ Specification: Documenting the analyzed requirements in a clear and organized manner, ensuring a common understanding among all involved parties, including the development team, testing team, and regulatory authorities. ▶️ Verification/Validation: Verifying that the specified requirements align with actual user needs and are technically achievable. ▶️Management: Tracking and managing requirement changes throughout the development lifecycle to maintain consistency between the requirements and the evolving product. The significance of Requirement Engineering in medical device development cannot be overstated: ✅ Ensuring Patient Safety: Clear and complete requirements are paramount for developing safe and effective medical devices, minimizing risks to patients. ✅ Achieving Regulatory Compliance: Requirement Engineering helps ensure adherence to medical device regulations and standards, such as ISO 13485 and FDA 21 CFR Part 820, facilitating a smoother product approval process. ✅ Reducing Development Costs: Addressing requirement-related issues early on can significantly reduce rework, development delays, and unnecessary expenses. ✅ Improving Product Quality: Requirement Engineering enables the development of high-quality medical devices that meet and exceed user expectations. ✅ Facilitating Effective Communication: Requirement Engineering provides a framework for clear communication among stakeholders, fostering a shared understanding of project goals and minimizing misunderstandings. #MedicalDevices #Regulations #RequirementEngineering #MedTech #SoftwareEngineering #SystemsEngineering #ProductDevelopment #ProjectManagement #Healthcare #Innovation #QualityAssurance #RegulatoryCompliance #ISO13485 #FDA #PatientSafety #UserNeeds #Elicitation #Analysis #Specification #Validation

33

2 Comments

Exciting progress for #cardiovascularhealth: HeartFlow’s new seven-year data from the ADVANCE-DK study, presented at TCT 2024, highlights the long-term benefits of their AI-driven FFRct and Plaque Analysis tools. This research shows that using FFRct Analysis alongside CCTA helps care teams anticipate potential adverse events in CAD patients and significantly reduces unnecessary invasive procedures in high-risk cases. Innovations like these demonstrate the power of AI in healthcare, improving patient outcomes and making precision care a reality. #HealthcareInnovation #AIinHealthcare #Cardiology

4

1 Comment

Good evening Linkedin, I apologize but there will be no new post for MedTech Compliance Chronicles this week. As many of you likely know, there are some important EU MDR deadlines coming up this month that are keeping me quite busy at my day job. For that reason and to continue to deliver well thought out, quality posts at a sustainable pace, I will post every other week. This will enable me a full week to research the topic and a full week to write the post. Next week we will begin the new schedule with a post on Monitoring and Measurement. See you then! #MedicalDevices #FDACompliance #QualityAssurance #ProcessValidation

5

Proactive approach to vestibular schwannoma treatment 🧠 Discover the latest advancements from a international, multi-center study led by UVA Health on treating vestibular schwannomas, also known as acoustic neuromas. Read this article to learn how these proactive methods are improving patient outcomes.

1

11-12 years ago my BME Capstone Team at ASU created an application called iHear, which administered a hearing test and created a custom hearing aid for the user based off that test. For this, we used basic wired headphones with a mic +the iPhone/iPod Touch technology available at the time. The idea was that it would provide an inexpensive way for people to have access to a hearing aid, using the technology they already had. Additionally, it was also meant to work with older versions of iPhone and the iPod Touch. To give some perspective, each hearing aid (not a pair) can range from $1000-3500. Ideally, one could probably create some sort of donation/gifting program of the older versions of iPhone/iPod Touch to increase access to helpful applications such as this. Today, Apple has released this as a feature of iPhone 16 + AirPods Pro. While we had zero involvement in this, the prototypes we had did work and there was initial interest from research universities investing in this, but that was not the path we chose to follow as we all had different career plans unfolding. Releasing technology for the right things seems to move slowly. I urge the technology space to invest more in the advancement of healthcare to push ideas like this to become widely available to everyone faster.

45

5 Comments

🚨 Heads up to all my fellow healthcare techs and biomed pros! 🚨 In just a few hours, there's a webinar to help clarify the FDA’s final guidance on remanufacturing medical devices. ~ While the guidance has been in place since May, this session aims to break down the key points and provide more clarity for those involved in repairs, refurbishments, or maintaining medical equipment. 🛠️ Why does this matter? The rules are tightening up on what qualifies as "remanufacturing," which means a shift in how we do our work—what parts we use, how we document repairs, and what oversight is needed to stay compliant. This could really shake things up for everyone in the field. But more importantly, it’s not just about checking boxes for compliance. It’s about ensuring the devices we maintain continue to perform safely and reliably for the patients who depend on them. The stakes are high, and staying informed is key to staying ahead! #FDA #MedicalDevices #HealthcareTech #Compliance #Repairs #Remanufacturing #PatientSafety (Thanks for the correction Binseng!)

5

3 Comments

From the first procedure to the last, dental composites can be a challenge. See how heat could make your restorations – and your day – flow better. #Filtek #Scotchbond #Solvers #Solventum

1

Curious about which steps you should be taking to make sure your curing light is working properly? Here’s everything you need to know. #curinglight #Elipar #SuccessSimplified #LifeAtSolventum

1

It's Free Task Thursday. Free Task Thursday is my made-up holiday where I’ll help you creatively with something personal or professional—for free. Free Task Thursday is conveniently between Taco Tuesday and Sashimi Saturday. (See thread below for some sample ideas) Why: Since 2006, ThunderFish Studios' success has always been directly related to a small network of people I know. Thank you. So, for the next six Thursdays—starting today—I’ve set aside pro bono time to help you create something. Offer ends on Thursday, December 19, 2024. If interested, call, text, email, or message me directly. All ideas are welcome. Obviously, this offer has some practical boundaries, but for now, think big, and let’s talk about that. What’s on your short list? Could be something practical, like repairing an old family photo. (See sample of a damaged photo my dad just scanned and sent me.) It could be traditional Photoshop/Illustrator tricks. A simple graphic portfolio to embellish your resume. Maybe I can help you bend reality with a goofy, gimmicky, or dramatic custom AI image generation. What about a custom coloring book image for yourself, or your kiddos? Or apropos graphic for a unique holiday card that will make your in-laws go "Hmmm"? Humor is always welcome. Profound, thought-provoking, and unconventional graphics live in my wheelhouse. Game on. Other tricks could be as simple as erasing that telephone pole from a favorite photograph, replacing an “ex,” for reasons, or fixing something about a precious old or new pet photo. __ Finally, should you feel compelled to pay it forward, I recommend the following groups I support with my creative professional time. My proudly supported pro-bono projects • CSU Flint Animal Cancer Center, csuanimalcancercenter.org • PAWSco, pawsco.org • NYAGI Project, nyagi.org • Zuma Horse Rescue, zumasrescueranch.com • Long Hopes Donkey Shelter, longhopes.org • Musical Artist, Taylor Tuke, taylortuke.com

28

12 Comments

I find it quite exciting to hear of companies using all the resources we have available, while sticking to the tried-and-true methods and knowledge, to create new products that will influence better patient outcomes. Curiteva, Inc. has been using additive manufacturing and the science of bone healing to do just that! And if you're looking for a Titanium alloy cage - ZSFab can supply its newly approved cervical Interbody System. Innovasis, Inc. did it first though, with a range of interbody fusion products using Ti, HA, and PEEK. * Use what we know to work, combine it with new technology, and make sure we're putting computing power to work for us! * The Old Guard: - Materials (PEEK, Ti alloys, nanoHA coatings) - Bone-like structure design Not-so-New technology: - 3D Printing Now, let's take it to the next level... - Add a compatible engineered bone filler such as OssDsign Catalyst to promote rapid and reliable bone formation Get Data Science on the payroll: - Add Altair's OptiStruct: 3D modelling tech based on bone growth patterns to influence structure design and model corresponding stress responses - Integrate Canary Medical Inc. integrated motion sensing technology (optional for patients who wish for more stringent privacy) to track mobility performance as patients heal - Follow Innovasis, Inc. lead - They recently surpassed 3000 patients enrolled in BioBase, their patient outcome registry that utilizes AI image analysis and provides an important repository for surgeons to compare outcome data. Web sources: https://lnkd.in/etrm4VcF https://lnkd.in/e35n6tJ3 https://lnkd.in/ebf7reET https://lnkd.in/eWwEzfcc https://lnkd.in/emqtVyvF https://lnkd.in/e2MDntk7 #buildtoheal #bonehealing #3Dprinting #additivemanufacturing #spinalfusion #spinesurgery #meddevice #medtech #orthospine #AIintegration #dataanalysis

1

Delays and arguments are not good strategies when dealing with the FDA. It should be the exact opposite. Respond ASAP, acknowledge FDA's concerns, explain actions already in progress as a result, and commit to a date for the next update. And lastly, whenever claiming to have completed an action, provide evidence of not only what was done but how you've determined that it worked. #QRxPartners #QRxInforms #FDA #WarningLetter #InadequateResponse #MLV

10

1 Comment

Hiring for Associate Director, Excellence - Sparks, MD Position Details Location: Sparks, MD Type: 100% Onsite, Full-Time, Direct Hire Key Responsibilities: Capability Development: Lead Operational Excellence at 4-6 sites, focusing on product family capabilities within factory environments. Cost to Win (CTW) Program: Manage CTW initiatives to enhance plant performance with a 3-year improvement funnel. Collaborate with plant managers, finance, and category managers to meet Continuous Improvement (CI) goals. Improvement Strategy: Partner with Plant and Site OPEx Managers to develop and execute improvement strategies for site-specific operational excellence. Lean Implementation: Guide and deploy Lean tools, coordinate Kaizen events, and leverage the Lean Academy to build and sustain excellence. Performance Monitoring: Conduct KPI reviews, coach plant associates, and lead Zero Loss Workshops to ensure performance targets are met. Lean Coaching: Act as a Lean Production System expert, teaching and mentoring associates on KPIs, strategic vision alignment, and performance indicators. Focused Improvement: Drive critical initiatives at key sites, such as OEE (Overall Equipment Effectiveness) improvement projects. Global COE Support: Develop best practices, standards, and methodologies for manufacturing technologies and support maturity assessments across business units. Project Management: Oversee plant cost-saving projects to meet goals on Zero Loss, working across departments to build a multi-year portfolio. Set priorities and manage projects to completion. Value Stream Optimization: Lead continuous improvement strategies for primary manufacturing processes, focusing on throughput and waste reduction. Barrier Resolution: Champion solutions to overcome process challenges, drive cost-effective strategies, and maintain an optimized loss landscape for the business unit. Strategic Contribution: Support the business unit's strategy execution, and influence operating plans and cost-to-win performance. Required Qualifications: Education: Bachelor’s degree in Engineering or related field. Experience: Minimum 10 years in manufacturing/leadership within a plant setting. Operational Excellence Expertise: Proven experience in Lean and Six Sigma; Six Sigma Black Belt preferred. Continuous Improvement: Demonstrated history in CI, Lean, and Six Sigma, with a passion for safety, customer service, and operational excellence. Communication: Effective communication skills for all organizational levels. Project Management: Strong background in managing programs or projects across sites and diverse cultures. Travel: Willingness to travel up to 50% for on-site Kaizen facilitation and capability development. Preferred: Minimum 3 years as a Production System practitioner or specialist with expertise in operational systems. ITBrainiac Inc Direct Line: 609-357-9477 Email ID: [email protected] www.itbrainiac.com

1

Whether it’s identifying DNA or protein, when the flu hits, you want to know! In my latest #publichealth video, I dive into the weeds on how these tests work. From the precision of PCR to the speed of antigen tests, I’ve got you covered! 😉

5

Last week at DeviceTalks Boston, I had the opportunity to join a panel to discuss sustainable strategies for evolving MedTech device manufacturing.    Key takeaways:  -Integrate sustainable practices into your company’s daily operations with measurable KPIs.  -Prioritize social and environmental education for business and customers.  -Communicate that sustainability is everyone's responsibility. It comes back to business value and behavior change that drives results.   #Sustainability #MedTech #DeviceTalksBoston

92

4 Comments

Solid conversation between Omar M. Khateeb and Mark Copeland about Value Analysis Committee secrets on the State of MedTech podcast. I don’t know what I don’t know, and this episode exposed how I have a lot of room for improvement in the realm of value analysis. Are you asking enough questions and the right questions?

7

2 Comments

Stryker Acquires NICO Corporation to Strengthen Brain Tumor and Stroke Care Portfolio. Stryker has made its fourth acquisition in four months, acquiring Nico Corporation to enhance its minimally invasive brain tumor and stroke care solutions. Nico’s portfolio includes devices for brain navigation, visualization, and tumor and clot removal. The acquisition integrates Nico’s BrainPath and Myriad products into Stryker’s neurosurgical unit, which has seen strong growth. Nico’s minimally invasive technologies have shown promise in improving outcomes for intracerebral hemorrhage patients, achieving lower mortality rates and better disability scores compared to standard care. The acquisition reflects Stryker’s strategy of targeting fast-growing, innovative assets. Stryker’s rapid-fire acquisitions signal a sharp focus on high-growth, innovative technologies, positioning the company to lead the evolving medical device market in 2024. By integrating minimally invasive solutions like Nico’s into its portfolio, is Stryker not just expanding its neuro portfolio— but also setting the bar for strategic M&A in medtech? #MedTech #Neurosurgery #BrainHealth #StrokeCare #Innovation #Stryker #HealthcareTransformation #MandA #aquisition

11

Safety Risk Management for a product ensures not only safety of the patients and users but also the environmental safety considered as the Risk Management is the process to be carried out from the product design to decommissioning. Thus, Risk Management of a product ensures a "Sustainability".

4

1 Comment

Do you think a Breakthrough Device Designation from FDA is a fast track to market for your innovative products? Think again. This article from HPM shows that only 95 of 933 BDDs since 2015 have actually been cleared by FDA, and it lays this poor rate of clearances at the feet of FDA's clinical study requirements. The authors do, however, lay out a good strategy for better predictability in how these requirements might affect your submission and attempts to get a BDD. Definitely worth the read. https://lnkd.in/g-AsJ4MH

47

2 Comments