Daniela Santos, MBA’s Post

We’ve reached an important milestone 🎯💯💪🏼 This isn’t just about growing our numbers – it’s about reaching a milestone that ensures we’re fully reliable, available, and capable of managing entire projects, from ideation to manufacturing. And after partnering with MGS, we even offer seamless integration with tooling and high-volume manufacturing.   100 professionals harnessing our mission to be a one-stop-shop within healthcare innovation & manufacturing. 100 minds helping clients to develop with reduced risk and increased speed in developing complex medical devices.    Our approach is unique with three key focus areas gathered in one team of (now more than 100) talented engineers crisscrossing areas of expertise - combining User & Stakeholder involvement, Regulatory compliance, and Engineering & Design considerations.   Team up with 100 nerdy minds for great innovations, great products, and great results🎯🏆   #Teamtechnolution #growingteam #Medtech #pharma  

🚀 The Medical Device Industry: Innovation Meets Life Saving Technology In our rapidly evolving field, every new device has the potential to save lives. But behind each innovation is a team of dedicated professionals. 🧩 Why Recruitment is Key to Success 🔍 Specialized Expertise: We need top talent with specific skills to push the boundaries of what's possible. Innovation and Collaboration: Diverse teams bring fresh perspectives, leading to groundbreaking solutions. Quality and Compliance: Skilled professionals ensure our devices meet the highest standards. Adaptability and Growth: As technology advances, so must our teams. Recruitment focused on continuous learning helps us stay ahead. 🌟 Investing in People, Investing in the Future By attracting and retaining the best talent, we ensure our capacity for innovation and deliver top-quality medical devices that patients worldwide rely on.

HEALING ENGINEERING Technology and innovation are the driving forces that can lead the medical industry into a new era An era of wellness and care. An era built by and for people, where access to health is available to all and is the key to a better life. CARE, COMMITMENT AND FLEXIBILITY The medical industry is part of our DNA, for more than 25 years our founders have lived closely its evolution. We are a family of doctors, friends and partners of professionals in the sector which allows us to deeply understand the customer´s needs Our team is committed to best help our customer´s needs. From flexibility, knowledge and experience in the manufacturing process to every technical detail of the product, to the quick and direct access to contact decision-makers Maximum passion in what we do

The situation in Med Tech these days is not easy Here are 7 reasons why this bumpy ride is worth it 1. Cutting-Edge Innovation Medical start-ups lead in innovation. They develop groundbreaking technologies. As an R&D member, you'll work on cutting-edge projects. 2. Faster Pace and Agility Start-ups move quickly and adapt fast. They pivot strategies as needed. This fast-paced environment fosters creativity. 3. Diverse Responsibilities In a start-up, you'll wear many hats. You'll contribute to various aspects of product development. This exposure accelerates your professional growth. 4. Potential for Significant Impact Medical start-ups tackle pressing healthcare challenges. Their solutions can profoundly impact patient outcomes. You could contribute to innovations that save lives. 5. Equity Opportunities Many start-ups offer equity or stock options. If the company succeeds, you could benefit financially. 6. Collaborative and Passionate Team Start-ups attract passionate individuals. You'll work in a close-knit team with like-minded people. This fosters teamwork and collaboration. 7. Rapid Career Growth In a start-up, you'll take on more responsibilities. You'll have opportunities for leadership roles. This accelerated growth is challenging but rewarding. Working at a medical start-up is challenging but rewarding. if you are a Mechanical Engineering Consider joining a medical start-up for a fulfilling career.

Are you a medical device engineer but feel like you don't have much experience with research? Implementing the scientific method could greatly improve your work. ❓ Start with a Question  Begin by asking a clear, focused question related to the safety and effectiveness of your device. This could be as straightforward as, "How does material X affect the durability of our device under condition Y?" 💡 Research and Hypothesize  Gather existing knowledge about the problem. Based on your understanding, propose a hypothesis. This is your educated guess on how your device will solve the identified problem. Make it specific and testable. 🧪 Experiment Systematically  Design experiments to test your hypothesis. This could involve creating prototypes, running simulations, or conducting user studies. The goal is to gather data on your device's safety and effectiveness. Ensure these experiments are repeatable and that results are measurable. 📊 Analyze Data Examine the data meticulously. Does it support your hypothesis, or are there unexpected findings? Look for patterns, anomalies, and insights that can inform the next steps in your development process. 🔁 Draw Conclusions and Iterate  Conclude whether your hypothesis was correct.  This may involve going back to the drawing board, tweaking your hypothesis, or redesigning your experiments. Use these insights to refine your device, iterating the process until your goals for safety and effectiveness are met. 📢 Communicate Results Share your results with your team and stakeholders. Seek feedback from peers and potential users. External validation is vital for ensuring the safety and effectiveness of your device. 📝 Document and Share  It's essential to record your processes and findings, as this practice aids in supporting #regulatory submissions. Moreover, it enhances the collective understanding and collaboration among teams and other departments within your organization. 🌐 Collaborate Across Disciplines Embrace the expertise of researchers, clinicians, and other engineers. Cross-disciplinary collaboration enriches your approach with diverse scientific and practical insights. #MedicalDevices #Engineering #SimplifyingInnovation #Unplex

Manufacturing is hard. Add medical devices into the equation, it gets even tougher. → Identifying and addressing manufacturability issues early can significantly cut down on redesign and additional tooling costs. → Aligning design inputs with manufacturing capabilities ensures higher quality products by embedding quality into the design itself. → Streamlining the transition from design to production accelerates the overall development process, getting devices into the hands of healthcare providers faster. → Early consideration of manufacturing processes aids in meeting stringent regulatory requirements, smoothing the path for approval. → Planning for manufacturing from the start enables easier scaling of production to meet market demand without compromising quality or efficiency. → Efficient design and manufacturing planning minimizes material waste and optimizes resource use, which is both cost-effective and environmentally responsible. → Engaging manufacturing teams in the design process fosters a collaborative environment that leverages diverse expertise, leading to innovative and feasible product solutions. #MedicalDevices #Design #Manufacturing #SimplifyingInnovation #Unplex

In healthcare landscape, the creation of complex medical devices demands a meticulous approach. Our blog covers the critical role of systems engineering, guiding you through the process of designing and developing medical devices. Discover the role of systems engineers in every stage of the development lifecycle- from defining product requirements to managing risks and complying with regulatory standards. Read the blog - https://hubs.ly/Q02G3VRY0 #SystemsEngineering #MedicalDeviceDevelopment #ISOStandards #RegulatoryCompliance #HealthcareTechnology #EngineeringServices #MedicalDevices #HealthTech

Some years ago I was part of a team developing medical technologies that was all about innovation.  To start with, we didn’t really have any medical device or regulatory expertise, we had limited device quality experience. We were a group of inquisitive and highly motivated engineers with a loose understanding of the problem that we were trying to solve. We seemed to move quickly BUT we then had to reverse engineer and re-do a great deal of the work once we had fully understood the requirements and recruited and developed that missing quality and regulatory know-how. That first phase was exhilarating, the second phase quite tedious and the combined result was far from efficient. We weren’t making enough progress so recruited heavily and rapidly. The growing pains brought new lessons. The memories of re-work had an extended half-life. Although there was still an innovative spark, the team became increasingly cautious. Progress slowed. We were able to re-balance the team slightly and accelerated a little but as we moved towards market launch and brought in production and quality engineering experts we created further complexity and changed dynamics again leading to an almost grinding halt. The lessons learnt during this time as we regularly rebalanced and ultimately launched 6 class II and III products in 7 years inspired the development of the COALITIONteam profiling tool.  This has developed over the last 20 years into a system that is ideal for understanding and balancing teams in highly regulated industries so that progress can accelerate. To learn more, please contact me at [email protected].