OUR SIMPLISTIC APPROACH

At TI MedTech, we believe in keeping things straightforward and effective. Our streamlined methodology ensures that we fully understand your challenges and provide the right solutions to meet your needs. Here’s how we work with you every step of the way:​

1. Problem Statement – We start by having detailed discussions with you to fully understand the problem and challenges. This helps us grasp your needs and expectations clearly.
2. Problem Scope – We define the scope of the problem and clearly outline TI MedTech’s responsibilities. This ensures transparency and sets the foundation for an effective solution.
3. Solution Package – We offer flexible packages tailored to your needs, including hourly rates, monthly engagements, or milestone-based solutions. This allows you to choose the best option that fits your budget and project requirements.
4. Problem Solving – Our team provides targeted solutions through medtech education, project management, and product design and development. We apply our expertise to tackle challenges efficiently and effectively.
5. Problems Solved – We deliver results in the form of detailed documentation, functional prototypes, or strategic discussions. This ensures clear and actionable outcomes to solve your challenges.

COMMONLY ENGAGED PDM SERVICES

At TI MedTech, our Product Development Management (PDM) services are designed to guide clients in bringing medical devices from concept to market with precision, efficiency, and regulatory alignment. While our capabilities span the full spectrum of medtech education, project management, and product design & development, the following services are among the most frequently engaged by our clients:

Comprehensive Testing Checklist
We develop detailed, product-specific testing checklists covering critical milestones such as Design Freeze, Process Validation, Design Verification, Preclinical Studies, and Final Production. These checklists empower teams to:

• Anticipate upcoming testing requirements.
• Facilitate efficient discussions with test laboratories.
• Understand and align with regulatory submission needs.
  
  

Product Design Intent (PDI)
Our PDI documentation provides a detailed summary of product requirements, specifications, design intent, and key test results, including outcomes from bench tests, animal studies, and cadaveric trials. PDI helps to:

• Establish a strong foundation of understanding for the product design.
• Enhance the likelihood of securing funding - showcasing deep understanding of the product.
• Streamline future regulatory submissions.
  
  

Quality Management System (QMS) Documentation
We craft customized Standard Operating Procedures (SOPs), forms, detailed reports, and conduct internal audits to ensure QMS alignment with ISO 13485 and/or US FDA 21 CFR Part 820 standards. TI MedTech also offers a unique, design-centric QMS framework that:

• Accelerates the documentation process for product design and development.
• Empowers teams to bring more products to market within shorter timelines.
• Ensures audit readiness and provides extended Stage 1 and 2 support.
  
  

Supplier Search and Component Procurement
We assist clients in identifying reliable suppliers and procuring high-quality components critical to the medical device development process. Our service includes:

• Assessing supplier capabilities and compliance with industry standards.
• Negotiating procurement terms to ensure cost-effectiveness and timely delivery.
• Ensuring prototype builds that meets the design input and requirements. 
  ​

Medical Device / Implant Design House
Our team specializes in the design and development of innovative medical implants, ensuring functionality, safety, and regulatory alignment. Amongst the medical devices that we have experienced with but are not limited to:

• Neurovascular implants and access.
• Structural heart prosthetic valves. 
• ​Ophthalmology glaucoma implants. 
• Gastrointestinal implants.
• Medical device packaging.
• Delivery systems and catheters.