ABOUT US
TI MedTech is a BioMedTech ecosystem partner that helps innovators and organizations move medical technology from concept to regulatory approval and commercial success. We bring together strategic guidance, technical expertise and a global network of partners to help teams navigate the full product journey from defining the need and shaping the design to preparing for regulatory submissions, manufacturing and market entry. Our work is guided by our proprietary IntenTIon™ Framework, which helps identify priorities, address gaps and align development activities with each product’s needs. Because every product and organization is different, we tailor our support to the team, technology, target markets and stage of development, working alongside partners to turn promising ideas into products that are ready to progress.
WHAT WE DO
TI MedTech supports medical device companies from early product planning through development, regulatory preparation, quality management and business growth. Through our four service pillars: Strategic, Execution, Education and Fractional; we help teams define the right direction, build and document their products, establish the systems needed for quality and regulatory readiness, and strengthen their capabilities as they grow. Our support can be tailored to a specific project or provided as ongoing strategic and operational expertise, all guided by the TI MedTech's IntenTIon™ Framework.
StraTIgic
We help teams set a clear direction for their medical device or technology project and make informed decisions about what to do next. This includes project management planning to align activities, responsibilities, timelines and resources; product design documentation to capture the design intent and development requirements; and product specifications and testing plans to define what the product must do and how its performance will be assessed. We also develop regulatory strategies suited to the product and its target markets, and conduct due diligence to identify project strengths, gaps, risks and priorities.
ExecuTIon
We work alongside teams to turn plans into practical development and implementation activities. This may include product design and prototyping, helping translate requirements into a product concept and assess it through iterative models or prototypes. We support the setup and implementation of a Quality Management System (QMS), including preparation for ISO 13485 certification, and help compile regulatory document packages needed for submissions. We can also assist with grant applications by shaping the technical and project information required to support funding proposals.
EducaTIon
We build the knowledge and capabilities teams need to develop medical products in a structured and controlled way. Our education and training can cover product development, design controls, QMS requirements and ISO 13485, helping teams understand how these areas connect to their day-to-day work. We can also support business planning, helping teams clarify their development pathway, resources, milestones and commercial direction.
FracTIonal
We provide experienced, flexible support to teams that need ongoing expertise but may not require a full-time senior resource. This can include fractional product development and business development support, as well as investor engagement preparation and support. We can also serve in a fractional QMS Management Representative (MR) capacity, helping oversee quality system activities, guide the team in maintaining the QMS and provide leadership on quality matters as the organisation develops.