Technolution’s Post

Ask yourself - as a leader do I encourage imagination and visionary behaviors in my healthcare technology development? It's essential to recognize that imagination and innovation are valued traits in any field, including healthcare. So, whether you are a healthcare provider, a medical device manufacturer or a drug developer, how do you know new technologies are available or being developed to transform and make imagination a reality? One important area is to foster collaboration between engineers and healthcare professionals via consultation. I encourage the exchange of ideas and knowledge, helping to bridge the gaps between technological advancements and healthcare needs. Environments like mine, often bring together professionals from different disciplines, fostering a collaborative and innovative atmosphere. Adopting a proactive approach to learning and staying connected with the broader healthcare and technology communities, engineers can better identify and integrate new technologies into their healthcare development projects. I am lucky to enjoy and be part of a collaborative team of imaginative thinkers and engineers, communicating a mutual understanding, technical competence, and a shared commitment to turning ideas into tangible developments. Being part of this dynamic interaction is a fundamental aspect of driving creative thinking so that success is when a person imagines something that impacts health, another is tasked with developing it. #digitalhealth #medicaldevices #pharmaceutical

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

“There's this culture that if you sit with R&D, they hear regulatory and the understanding is you're not creative, you're just a paper pusher and you don't understand innovation, that you're stifling innovation." Regulatory is about more than safety and quality. Regulatory frameworks are often viewed as hurdles, but I've found that they provide clear guidelines and incentives for companies to push technology's boundaries. Hopefully, Hasnaa Fatehi can help you see things my way. I’ve had regulatory and quality folks my whole career. They are part of the team and wo them the best product doesn’t sell wo approval. In medical device is especially takes a team to make this happen https://lnkd.in/gn8ewa3s #Regulatory #MedTech #Innovation

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 mat.stratton@coalition.ltd.

Medical Device Innovation: Key Stages: 1. Idea Generation ● Identify unmet medical needs or problems. ● Brainstorm potential solutions. ● Conduct market research. 2. Concept Development ● Refine the idea into a concrete concept. ● Assess feasibility and potential benefits. ● Develop a preliminary design. 3. Research and Development ● Conduct in-depth research. ● Develop prototypes and test them. ● Refine the design based on feedback. 4. Intellectual Property Protection ● Patent or trademark your invention. ● Protect your intellectual property. 5. Regulatory Compliance ● Understand and comply with regulatory requirements. ● Obtain necessary approvals and certifications. 6. Manufacturing and Production ● Establish a manufacturing process. ● Select suitable manufacturers. ● Ensure quality control. 7. Marketing and Sales ● Develop a marketing strategy. ● Identify target markets. ● Build relationships with healthcare providers. 8. Launch and Commercialization ● Introduce the product to the market. ● Monitor sales and performance. ● Gather feedback from users. 9. Post-Market Surveillance ● Track product performance and safety. ● Address any issues or concerns. ● Make necessary improvements. DAY 1 #researchanddevelopment #innovation #technology #science #engineering #tech #science #innovation #futuretech #technews #medicaldevices #medtech #healthcare #biotech #medicalinnovation #healthtech #medicaltechnology #biomedicalengineering #medicalresearch #medicaldevelopment #linkedin #linkedintopvoice #linkedininfluencer #linkedinthoughtleader #linkedincommunity #linkedinlearning #linkedintips

Establishing a reliable and compliant supply chain for medical device components is crucial for healthcare startups. ✅ Vet Suppliers Thoroughly Conduct comprehensive audits. Verify certifications and quality standards. Consistent assessments ensure reliability. ✅ Clear Communication Maintain open, clear, and regular communication with suppliers. Set expectations and document requirements. A clear channel prevents misunderstandings. ✅ Monitor Performance Implement a performance tracking system. Regular reviews help identify issues early. Address problems before they impact production.  ✅ Foster Strong Relationships Build strong, collaborative relationships with suppliers. Mutual trust and understanding lead to better outcomes. Engage in regular discussions about improvements and innovations. ✅ Compliance Checks Stay updated with regulatory standards. Ensure suppliers comply with industry regulations. Regular compliance checks mitigate risks. ✅ Diversify Your Supply Chain Avoid relying on a single supplier. Diversify to reduce risk. Multiple sources ensure continuous supply even if one fails. Building a reliable and compliant supply chain is a dynamic process. It requires diligence, regular monitoring, and proactive management. Follow for daily insights into tech product development. #MedicalDevices #SupplyChain #ProductDevelopment #QualityControl  #SimplifyingInnovation #Unplex

𝗧𝗿𝗮𝗻𝘀𝗳𝗼𝗿𝗺 𝗬𝗼𝘂𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗻𝗰𝗲𝗽𝘁𝘀 𝗶𝗻𝘁𝗼 𝗠𝗮𝗿𝗸𝗲𝘁-𝗥𝗲𝗮𝗱𝘆 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻𝘀 𝘄𝗶𝘁𝗵 𝗚𝗧𝗜 𝗠𝗲𝗱𝗶𝗰𝗮𝗹! At GTI Medical Ltd., we excel in turning groundbreaking ideas into tangible successes, especially when time is of the essence. Our venture with a Tier 1 medical device leader in manufacturing an advanced ENT surgical tool showcases our prowess. Originally set for a three-year timeline, our synergy and commitment to excellence dramatically reduced this to just 10 months! 𝗪𝗵𝘆 𝗚𝗧𝗜 𝗠𝗲𝗱𝗶𝗰𝗮𝗹? 𝗘𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲 𝗶𝗻 𝗖𝗼𝗺𝗽𝗹𝗲𝘅 𝗣𝗿𝗼𝗷𝗲𝗰𝘁𝘀: Our team navigates the intricate journey from design to manufacturing with unmatched skill. 𝗦𝗽𝗲𝗲𝗱 𝘁𝗼 𝗠𝗮𝗿𝗸𝗲𝘁: We significantly cut development time, understanding the urgency of innovation in today's healthcare landscape. 𝗣𝗿𝗼𝘃𝗲𝗻 𝗣𝗮𝗿𝘁𝗻𝗲𝗿𝘀𝗵𝗶𝗽: For R&D developers, designers, and engineers aiming to transition from early-stage development to prototype and serial production, GTI Medical is your ideal partner. Explore how our swift, cost-effective manufacturing superiority can turn your idea into reality. Reach out at info@gti-medical.com or visit www.gti-medical.com. #medicaldeviceinnovation #rapidprototype #engineeringexcellence #partnershipsuccess

Glenn Enterprises thrives on its methodical approach to cultivating relationships with cutting-edge medical device companies. Meticulous research and market analysis form the foundation of their strategy, enabling them to pinpoint potential partners with innovative solutions. The decision to align with a specific company hinges on a rigorous evaluation process, assessing factors like technological advancements, regulatory compliance, financial stability, and sustainability efforts. Glenn prioritizes collaborations with companies that not only enhance its capabilities but also share a common vision for the future of healthcare. This strategic alignment in values and goals ensures a robust foundation for sustainable partnerships. By fostering open communication and collaboration, Glenn Enterprises creates an environment where both entities can leverage their distinct capabilities effectively, ultimately driving advancements in medical technology and improving healthcare outcomes. #researchanddevelopment #techadvancements #stability #sustainability #partnermanufacturing #manufacturing #engineering #medicaldevicedevelopment #medicaldevicemanufacturing #medicaldevices

Are you an Early-Stage Medical Device Startup in California or Boston? We are looking to create lasting impact with you. 🤝   From day 1, we have had the privilege of working with physician entrepreneurs, innovators and startups to transform their technologies into market-ready products. FDA submissions, risk assessment, requirements management, V&V strategy, product-market fit and road mapping are among some of the works we have done.   🌟 Picture us as your strategic ally and your intellectual partner — walking with you through small steps, adapting to your budget, and helping you hit milestones.   🔍 We are a small team with in-depth experience in regulatory and development strategies tailored for complex areas including:   - Software-as-a-Medical device (SaMD) - AI/ML-Enabled Devices - Digital Health and Digital Therapeutics - Clinical Decision Support (CDS) Software - Data capture, integration, sharing, collaboration, and analysis tools - Electro-mechanical Systems   If your medical device technology leverages data, analytics, and AI, or if it's a low to medium-risk electromechanical system, we're eager to connect.   📩 Send me a message on LinkedIn or connect with us through our web portal at: www.eliomedica.com     #MedicalDevice #RegulatoryStrategy #SAMD #MedicalSoftware #MarketEntry #FDARegulations #dhf #AdvaMed #IMEWest #BioMedBoston #OctaneSummit #riskassessment #requirments #humanfactors #devicealliance #DigitalHealth #RegulatorySubmissions #Strategy #MedTech #AI #MachineLearning

Are you an Early-Stage Medical Device Startup in California or Boston? We are looking to create lasting impact with you. 🤝   From day 1, we have had the privilege of working with physician entrepreneurs, innovators and startups to transform their technologies into market-ready products. FDA submissions, risk assessment, requirements management, V&V strategy, product-market fit and road mapping are among some of the works we have done.   🌟 Picture us as your strategic ally and your intellectual partner — walking with you through small steps, adapting to your budget, and helping you hit milestones.   🔍 We are a small team with in-depth experience in regulatory and development strategies tailored for complex areas including:   - Software-as-a-Medical device (SaMD) - AI/ML-Enabled Devices - Digital Health and Digital Therapeutics - Clinical Decision Support (CDS) Software - Data capture, integration, sharing, collaboration, and analysis tools - Electro-mechanical Systems   If your medical device technology leverages data, analytics, and AI, or if it's a low to medium-risk electromechanical system, we're eager to connect.   📩 Send me a message on LinkedIn or connect with us through our web portal at: www.eliomedica.com     #MedicalDevice #RegulatoryStrategy #SAMD #MedicalSoftware #MarketEntry #FDARegulations #dhf #AdvaMed #IMEWest #BioMedBoston #OctaneSummit #riskassessment #requirments #humanfactors #devicealliance #DigitalHealth #RegulatorySubmissions #Strategy #MedTech #AI #MachineLearning