At TI MedTech, we apply three main pillars within the scope of PDM which consists of:
Medtech Education & Mentorship:
Mentoring teams through national initiatives and industrial platforms as medtech ecosystem key contributor
Equip teams through training programs that goes beyond theory with real-world case studies
Engaged as speakers and panelists in university and industrial conferences, with community service initiatives
Project Management Excellence:
Providing deep industrial expertise to proactively manage project risks
Optimized timelines and budget for projects
Customize a unique design control centric framework for company's Quality Management System (QMS)
Lead teams in obtaining ISO 13485 certification
Provide excellent strategies for early-stage market research and regulatory pathways
Setup manufacturing site with TI's proven ROSE methodology
Product Design & Development Excellence:
Spearheads a full-fledged design house specializing in the medical device innovation
Delivers expertise in the development documentation, adhering to regulatory and ISO standards
Deep industrial knowledge to provide technical due diligence and de-risking innovation
Without a structured approach to the PDM, companies risk falling behind in an increasingly competitive and highly regulated industry. TI MedTech ensures your concept to market is strategic, efficient, and successful, from the beginning of your journey.
PROJECT MANAGEMENT (PM)
TI MedTech employs a proven hybrid agile methodology, blending structured project management with agile flexibility to deliver exceptional project management. This approach enables rapid iteration, continuous feedback, and ensuring efficient execution of complex projects. By fostering collaboration and aligning stakeholders, we optimize outcomes, accelerate time-to-market, and drive innovation. Our commitment to continuous improvement ensures high-quality results, empowering teams to navigate the medtech landscape and achieve strategic goals with speed and precision.
PRODUCT DESIGN & DEVELOPMENT
At TI MedTech, we specialize in designing innovative medical technologies across a wide spectrum of device categories to meet the needs of our clients. Our expertise includes:
Pharma/Combination Medical Devices: Integrating pharmaceuticals with medical devices to create advanced therapeutic outcomes.
Biomaterials and Tissue-Based Devices: Designing devices using cutting-edge biomaterials and tissue-engineering techniques for regenerative medicine and advanced surgical applications.
Mechanical Devices: Crafting robust, precision-engineered mechanical devices that prioritize functionality and reliability in healthcare settings.
Electro-Mechanical Devices: Bridging mechanics and electronics to create smart, efficient medical devices that meet the demands of modern healthcare.
Fluid Dynamic Devices: Developing solutions that optimize fluid dynamics for applications like vascular systems, infusion technologies, and diagnostic devices.
Software-Driven Devices: Innovating with software-powered technologies, including connected medical devices and AI-driven diagnostics, for the digital health era.
Our team brings deep technical expertise and regulatory knowledge to every project, ensuring the development of safe, effective, and compliant products that accelerate time to market.