Concise Engineering, Inc.

Getting a medical device to market is no easy feat. The journey is full of tough challenges, from making sense of complex regulatory requirements to managing multiple specialists. That means that for biomedical engineers, project management isn't a "nice to have"—it's a must-have that can make or break your innovation. . https://lnkd.in/e-xd8_FS . Think about this: According to PMI, organizations that undervalue project management have 50% more project failures. . When one mistake can cost years of delay, can you afford to take that risk? . #medtech #innovation #medicaldevices #entrepreneurship #startups #medtechman #engineering

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Top takeways from this episode: 💡 1. Alignment of R&D and Production: Ensure that testing environments and protocols in R&D align with the standards of production to avoid costly discrepancies and rework. 🛠️ 2. Regulatory Understanding Across Teams: Companies need to educate teams on the specific regulatory standards that apply to their product types to avoid misinterpretation and gaps in compliance. 🖥️ 3. Cross-Departmental Collaboration: Maintaining a startup-like collaborative culture, even as the company scales, is crucial for innovation and quality. 🎧 LISTEN NOW: https://lnkd.in/esW2zCZ8 #MedTechMan #FDA #Regulations #R&D

Wishing you a wonderful Thanksgiving from the team at Concise Engineering! 🦃🍂 This season, we're grateful for the opportunity to drive innovation in healthcare and improve the lives of patients everywhere. Your trust and partnership inspire us to keep pushing boundaries and delivering cutting-edge solutions. May your holiday be filled with joy, warmth, and good health. Thank you for being a part of our journey! 🙌🍁 #ThankfulForInnovation #MedTechAdvancements #HappyThanksgiving #MedTechMan

Getting stuck trying to get to your next round of funding? The key to successful funding is strategic planning. Start by mapping out the major milestones in your product development journey. These value inflection points are the moments when your company's value increases significantly, making it more attractive to investors. Common milestones in MedTech are: 1) Proof of concept 2) Prototype development 3) Successful clinical trials 4) Regulatory approvals At each step, calculate the funding needed to reach each milestone - be realistic! Make sure you buffer for unexpected setbacks. So what are you waiting for? Read the blog now: https://lnkd.in/eGFacpXE 🖊️Subscribe to our newsletter here https://lnkd.in/eNUXv6bB #MedTech #ProductDevelopment #RiskManagement #Regulation #MustRead #blog #MedTechman

Neuralink announced that it received FDA breakthrough device designation for its vision-restoring Blindsight implant. 👀 The remotely rechargeable implant goes along with electrode-laced threads that go further into the brain. 🧠The company also has an R1 robot designed to implant the BCI system while avoiding vasculature. 🦾 Check it out: https://lnkd.in/g3RdTWH8 #ImproveSight #MedtechMan #Innovation #FDA #VisionImplant

For Deadpool and Wolverine fans, these 17 fascinating facts will change how you watch this movie! For example, Ryan's entire family was involved in making the film, they each were credited including his wife Blake Lively. It's nothing but a family thing. https://lnkd.in/ePjsh6Az #MovieFund #RandomFacts #MedtechMan

Medical device innovation isn’t always about fancy tech or earth-shattering science. The most impactful innovations come from small changes. Small changes that make a big difference in patient care or clinical efficiency. For entrepreneurs in the medical device industry, determining if your idea is truly innovative can be a tough question. Creating a truly innovative medical device is a long process, but it's possible with the right approach and guidance. At Concise Engineering, we help entrepreneurs tackle those tough questions. Read the blog now: https://lnkd.in/efzDqc88 🖊️Subscribe to our newsletter here https://lnkd.in/eNUXv6bB #MedTech #ProductDevelopment #RiskManagement #Regulation #MustRead #blog #MedTechman

How do you know if your #medtech idea is innovative enough for market? Here are some practical steps that you can apply to your idea to gut check marketability: Review procedures with diverse clinical staff. Listen for unexpected feedback and opportunities. Document everything for future reference and investor pitches. Iterate based on feedback. Think of the whole system. Prioritize user experience. Stay up to date with regulatory requirements. Creating a truly innovative medical device is a long process, but it's possible with the right approach and guidance. At Concise Engineering, we help entrepreneurs tackle those tough innovation questions. Read the blog now: https://lnkd.in/efzDqc88 🖊️Subscribe to our newsletter here https://lnkd.in/eNUXv6bB #MedTech #ProductDevelopment #RiskManagement #Regulation #MustRead #blog #MedTechman

The FDA named Ross Segan as director of the medical device center's Office of Product Evaluation and Quality (OPEQ), following a nationwide search. 🌍 He is passionate about patients having access to innovative medical technology. 🖥️ The future looks bright for our industry! ✨🚀 https://lnkd.in/eUj8Ww6R #NewFDADirector #MedTechMan #FutureOfInnovation

🍂Do you know what was served at the first Thanksgiving? 🎉How about how many calories are consumed on average on Thanksgiving Day? 🦃 🍁 https://lnkd.in/gQtqgM-n #FunFacts #ThanksgivingFun #MedTechMan