Medical device design and development
Transforming bold ideas into market-ready solutions.
The medical device development process is a structured journey requiring meticulous planning, a deep understanding of the risks and trade-offs, a focus on quality assurance, and expertise in regulatory requirements. Each phase has unique activities, challenges, and deliverables, and a phased approach is crucial for meeting standards like ISO 13485 and FDA regulations, particularly in project management and design control.
The TTP medical device product development process
The following five stages outline how TTP directs you through this process, ensuring every step is optimised for commercial success.
Phase 1: Discovery
The Discovery phase begins with in-depth market landscaping to evaluate existing devices, user needs, and regulatory pathways. Early-stage exploration focuses on identifying and refining potential technological approaches, ensuring they align with patient safety and standards like ISO 13485. Feasibility assessments, including technical and operational analysis, uncover potential risks and validate key assumptions, considering scalability for both low- and high-volume manufacturing scenarios. A comprehensive evaluation of challenges informs pragmatic, risk-based decisions, laying the groundwork for strategic development. An outline business case considers regulatory approvals, clinical trials, and manufacturing requirements, providing a foundation for solutions that are focused on commercial, clinical and user-centric outcomes.
The TTP MedTech difference
With decades of experience in designing and developing commercially successful medical devices and drug delivery solutions, TTP's MedTech team brings a cross-disciplinary approach to uncover opportunities and address risks early. Leveraging expertise in engineering, science, and human factors, we conduct rigorous feasibility studies and apply strategic insights to de-risk projects from the start. This ensures alignment with commercial and clinical goals while positioning you for success in a competitive market. Through proactive collaboration, we guide you through complexity with confidence and clarity.
Phase 2: Concept Development
During Concept Development, detailed user needs and design inputs are captured to create robust system architectures. Core components are carefully evaluated for aspects such as biocompatibility, sterilisation and regulatory compliance, ensuring alignment with industry standards. Early-stage prototyping and testing explore multiple design concepts, validating feasibility and ensuring usability, safety, and effectiveness. A preliminary costed Bill of Materials incorporates specialised materials, manufacturing methods, and quality controls, balancing innovation with regulatory and market demands. Feasibility studies and early-stage testing focus on identifying potential challenges, enabling informed, risk-based decisions that guide the project towards successful development in subsequent stages.
The TTP MedTech difference
TTP’s ability to balance user needs, safety and regulatory considerations and commercial objectives ensures the selection of robust concepts that stand up to real-world demands. By integrating engineering excellence with a deep understanding of the healthcare landscape, we help you develop concepts that are optimised for scalability and commercial success. With a focus on early risk identification, we'll help you make smart decisions that will enable you to transform innovative ideas into tangible, impactful devices ready for the next stage of development.
Find out how TTP assisted Carbometrics in evaluating the technical viability of their Glucose Binding Molecules (GBMs) across different sensor implementations, providing insights into development challenges and manufacturing transfer.
Phase 3: Detailed Design
The Detailed Design phase focuses on refining and finalising the chosen concept through iterative, high-fidelity prototyping and Failure Modes and Effects Analysis (FMEA). These efforts address risks tied to the device’s functionality, manufacturing and use by its intended patient population. Design for Excellence (DFx) principles guide the process, ensuring compatibility with critical aspects such as sterilisation, biocompatibility, usability and scalability. Manufacturing processes and supply chains are defined and optimised to meet stringent regulatory standards for both low- and high-volume production. Verification test plans and user testing validate safety, functionality, and effectiveness, finalising the design for production and enabling a smooth transfer to manufacturing.
The TTP MedTech difference
Our collaborative process combines technical rigour with user-centric design, ensuring that every element of the device aligns with clinical, patient. regulatory and market demands. By integrating design-for-manufacturing practices early, we reduce time to market while maintaining compliance and usability. Incorporating insights from prototyping and testing to refine functionality and usability, we focus on scalability to support a smooth transition from development to full-scale production.
With decades of experience, TTP delivers tailored solutions that anticipate challenges and maximise the device’s commercial and clinical impact.
Find out how TTP transformed Serac Imaging Systems' prototype into a portable gamma-optical imaging device through innovative design, advanced prototyping and integration of engineering, user-centric design and software to ensure clinical usability and manufacturability.
Phase 4: Design Verification
Design Verification ensures the device meets all specified requirements through exhaustive testing, including simulations under real-world conditions. Testing protocols align with ISO 13485 and FDA guidelines, addressing unique medical device challenges such as sterility assurance, biocompatibility and electromagnetic compatibility. Customer validation confirms the device’s suitability for real-world use, while the technical file is finalised for regulatory submissions.
The TTP MedTech difference
Leveraging state-of-the-art facilities and expertise, TTP ensures your device exceeds clinical and market expectations.
A detailed documentation and verification process helps to smooth the path to regulatory approval, minimising delays and unforeseen hurdles. By combining technical precision with a deep understanding of regulatory landscapes, we de-risk the verification process, ensuring your device is ready for the next stage.
Our commitment to quality and compliance helps position your product for success in competitive and highly regulated markets.
Find out how, during the COVID-19 pandemic, TTP conducted rigorous testing and finalised the CoVent ventilator's technical file in record time, ensuring readiness for mass production, even amid rapidly evolving clinical needs.
Phase 5: Product Validation and Transfer to Manufacture
The Product Validation phase ensures the device is ready for full-scale production and real-world use. Pilot production runs validate the readiness of manufacturing processes to meet GMP and medical device quality standards. This phase finalises the transition from development to production, including knowledge transfer to manufacturing teams and the establishment of robust workflows to ensure scalability. Formal testing confirms consistent device performance, while packaging and labelling compliance are addressed to meet regulatory and market requirements.
Post-market surveillance plans are established to monitor device safety and effectiveness, enabling continued regulatory compliance and patient safety.
The TTP MedTech Difference
Our capabilities extend beyond development, facilitating a seamless transition from prototype to production. By addressing potential challenges early and establishing scalable manufacturing processes, we minimise risks and ensure a smooth transfer to manufacture. Our expertise in pilot production and knowledge transfer to manufacturing partners supports reliable scaling without compromising quality. With a deep understanding of regulatory and operational demands, we provide the insight and support needed to keep your product performing consistently and reliably throughout its lifecycle.
Our areas of focus:
Medical Devices & Drug Delivery
“The modelling phase is an area where TTP has excelled in producing unique applications to our problems. TTP engineers developed laboratory test beds that verified the modelling process and provided the ability to test theorized solutions without the need to do full-scale pilots. By narrowing down proposed solutions first by modelling and then on a test bed we could focus on a few key possibilities in our manufacturing environment, saving time and resources in this critical area.”
Chuck Lynch
Senior Engineering Manager
,
Roche Diagnostics
“TTP has been exceptional to work with. They are sharp and experienced and were able to quickly adapt to changing business needs. They are clearly expert at what they do, which made our job easier. We felt we could trust them to do the job right and communicate results clearly. They were also fun to work with, having laid-back styles and engaging personalities. I’d highly recommend TTP and will definitely use them in the future if the need arises!”
Meredith Seaborn
Director of New Therapies, Marketing and Neuroscience
,
Medtronic
“TTP have been an invaluable long-term partner for AstraZeneca. They have both the deep expertise and creativity to generate innovative concepts, and the horsepower to rapidly accelerate these through design verification.”
Dan Deaton
Executive Director, Patient Experience and Innovation
,
AstraZeneca
Our approach and capabilities
We deliver across the entire life of a project, from opportunity discovery to production engineering. Discover how our interdisciplinary teams of experts collaborate to tackle the toughest product development challenges.
Our campus and facilities
Our award-winning campus has been designed with a clear vision. To create space which can suport our people and our clients as we develop and deliver the very best technology solution.
Software capability at TTP
Engaged in all stages of software and product development, our software capability at TTP covers the full spectrum—from in-depth analysis and system architecture to prototype design, implementation, and test development.
Manufacturing capability at TTP
Working seamlessly with our development teams, we take clients' products through prototype builds, clinical trials, pilot manufacture and more. Using TTP Manufacturing reduces uncertainty, risk and time to market for our clients.
Meet some of the team
