Medical device design consultancy
Helping you solve tough engineering challenges, reduce risk early, and bring commercially viable devices to market.
From the earliest concept, the design decisions you make shape everything that follows. As a medical device design consultancy, we help MedTech teams define robust architectures, resolve technical uncertainty and develop commercially viable devices that can perform reliably, scale effectively and succeed beyond the prototype.
Getting the critical decisions right from the start
Early system-level decisions define long-term performance and must withstand the demands of patient use, clinical practice, regulatory scrutiny and manufacturing at scale.
Through close collaboration with your team, we focus on getting these decisions right from the outset. By integrating engineering, scientific, human factors, regulatory and manufacturing constraints early, we help ensure your design remains robust as development progresses.
With a team of 300+ experts, we support MedTech teams through complex device development, navigating the trade-offs between performance, usability, manufacturability and downstream risk.
Independent and factory-agnostic, we provide continuous technical leadership from first-in-kind concept through to pilot production - helping you avoid late-stage surprises and resolve the system-level challenges that ultimately determine success.
An ideal solution for the user minimises or automates user steps, often requiring a more technically-complex and highly-integrated architecture. Drawing on TTP’s extensive experience in electromechanical neurotechnology solutions, TTP developed several product concepts, each varying in complexity, to explore different levels of user involvement. By mapping out potential sources of frustration along the user journey, TTP was able to review each variant for its usability and make an informed recommendation for a final product concept.
TTP
TTP’s scientific team ‘went the extra mile’ time and again by asking questions, identifying and pursuing pathways, and presenting complete solutions to unforeseen findings.
Dr Paul Goode
Glucotrack, USA
Most importantly, smart implants need to be suitable for lifetime implantation. To eliminate batteries, and the associated risk of leaks, we developed a novel reader device that, when held to the patient, inductively powered the implant and simultaneously acted as the antenna for communications.
TTP
Medical device design services for complex MedTech programmes
We support medical device design from early feasibility and system architecture through to prototyping, verification planning, clinical builds and manufacturing transfer. Our role is to help teams make confident design decisions early, reduce technical risk and maintain design intent as the programme progresses.
As medical device product development consultants, we bring these elements together into a coherent framework, drawing on extensive experience delivering complex, regulated medical devices, so you can move forward with confidence.
Our capabilities include:
- Early-stage technology feasibility and systems architecture
- Risk-led product development
- Human factors and usability
- Embedded regulatory compliance (FDA, ISO 13485)
- Verification, validation and manufacturing transfer
- Software and embedded systems development
All delivered through ISO 13485-certified processes.
Turning development challenges into progress
MedTech companies turn to TTP when timelines are tight and development needs to move forward with clarity and confidence, bringing structure to complex decisions, resolving technical uncertainty and keeping progress on track.
- Deep technical expertise - Experienced, multidisciplinary teams solving complex engineering and scientific challenges.
- Accelerated time to market - Clear decision-making, rapid prototyping and integrated development reduce delays and keep programmes moving forward.
- Commercially grounded solutions - We balance usability, technical performance and manufacturing realities to strengthen product viability from day one.
- End-to-end technical leadership - ISO 13485-compliant development, maintaining design intent and reducing handover risk.
- Proven delivery in complex environments - We deliver where challenges are new, difficult or highly regulated, bringing clarity and forward momentum to your project.
- Integrated, collaborative approach - We work as an extension of your team, maintaining continuity and avoiding unnecessary friction or redesign.
Medical device design services - a track record built on delivery
Our experience is grounded in real-world delivery across complex and regulated environments. It reflects a measured, consistent approach to solving difficult engineering and development challenges.
- 38+ years of medical device design and development experience
- 300+ engineers, scientists and human factors specialists - all under one roof
- ISO 13485-certified development and manufacturing processes
- 1,100m² of dedicated manufacturing facilities, including cleanrooms, microfabrication and assembly
- Extensive experience supporting regulatory approval across multiple medical device programmes
- Seamless transition from prototype through to clinical builds and manufacturing transfer
Deep, proven expertise across MedTech domains
Our teams have deep expertise in specific MedTech domains, combining market insight, rapid onboarding and informed decision-making built on decades of experience.
Neuromodulation and neurotechnology
Developing neuromodulation and neural interface systems, from proof-of-concept to scale-up.
Biosensors
Engineering wearable and implantable sensors from concept through to commercial launch.
Cardiovascular and neurovascular
Developing diagnostic, interventional and therapeutic cardiovascular technologies.
Surgical systems and medical imaging
Transforming complex surgical, minimally invasive and navigation concepts into clinically ready tools and platforms.
Ophthalmology
Developing ophthalmic diagnostics, implant technologies and surgical innovations.
Drug delivery
Engineering advanced drug delivery devices across injection, respiratory and targeted therapies.
Speak to one of our experts
Catherine Wyman
Catherine leads TTP’s Advanced Surgical team. With a strong background in mechanical engineering and project leadership, she excels at guiding multidisciplinary teams through complex development challenges. Having worked across drug delivery, eyecare and surgical systems, Catherine is always keen to explore opportunities for TTP to develop new products that can change markets and improve patients’ lives.
Chris Dawson
Chris Dawson leads the Wearables and Implantables team at TTP, bringing deep experience in taking technologies from proof of concept through to scaled production. Holding a PhD in engineering from Brunel University, he collaborates with ambitious clients to develop and commercialise innovative sensing technologies across a wide range of real-time clinical sensing applications, including continuous glucose monitoring (CGM).
Will Cramer
Will Cramer leads TTP Manufacturing, delivering low to medium volume production of consumables, devices, and instruments to ISO13485 standards. A mechanical engineer with over 25 years’ experience across medical, life science, consumer, and industrial markets, he previously served as VP Engineering and Production at a TTP spin-out. Will holds a master’s in engineering from Cambridge University.
Justin Buckland
Justin is the technical lead for multiphysics analysis and sensor development at TTP. He holds a PhD in Surface Physics from the University of Cambridge and has played a pivotal role in the development of a wide range of sensing technologies including microfluidic, electrochemical, acoustic and piezoelectric.
Meet some of the team
Catherine Wyman
Chris Dawson
Will Cramer
Justin Buckland
Medical device manufacturing at TTP
The hardest part of manufacturing isn’t volume, but the transition from design into regulated production. TTP bridges that gap by helping you develop the device and the manufacturing process in parallel, supporting agile clinical and early production builds. With no minimum volumes, no CMO lock-in, and no process IP constraints, you retain control of your product and supply chain.
Software capability at TTP
Engages 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 development.
Frequently asked Questions
You should engage a medical device design consultancy as early as possible, particularly when defining system architecture, technical feasibility and key design decisions. Early involvement helps identify and retire risks before they escalate, reducing costly redesign and improving confidence as development progresses.
TTP combines deep market-specific experience with the science and engineering strength needed to solve complex medical technology challenges. Even when the concept is unclear, the requirements are evolving or the route forward needs to be worked out from first principles, we can add value - from early opportunity discovery and next-generation systems through to late-stage troubleshooting and end-to-end technology development.
Our systems thinking approach means we look beyond individual components to understand how the full product, user, software, manufacturing route and commercial context need to work together. Dedicated human factors and software teams work alongside our engineers, so usability, digital architecture and technical performance are considered as part of one integrated system.
We are 100% employee-owned, with a flat, collaborative structure that gives clients direct access to the technical people solving their challenges. With science, engineering, software, human factors, manufacturing and lab capabilities all on one campus, we can assemble the right team quickly, bring in specialist expertise when needed and adapt the shape of the project as your development goals evolve.
Because we are technology-, factory- and CMO-agnostic, our recommendations are guided by what is right for the product, the programme and the commercial objective. Our ISO 13485 quality management system and small-batch manufacturing capability also help us move beyond prototypes, building product and process understanding in tandem so transfer to manufacture is smoother and lower risk.
We support both. TTP can act as an end-to-end product development partner or provide targeted support at specific stages such as feasibility, system design, human factors, verification or manufacturing readiness.
We support a wide range of devices and systems, including (but not limited to) wearable and implantable systems, minimally invasive surgical and robotics, navigation and imaging tools, drug delivery and injection devices, ophthalmic systems and diagnostic platforms. Our experience spans multiple MedTech domains, allowing us to tackle multidisciplinary challenges.
We work with ambitious venture-backed start-ups, scale-ups and established global MedTech leaders developing breakthrough technologies. Whether expanding established product lines or creating something entirely new, our clients usually share a need to solve complex challenges and turn bold ideas into commercial outcomes.
Every project is shaped around the specific challenge, but we usually start by agreeing the objectives, scope, risks and key decision points. From there, we work in clear phases, with regular reviews so the project can adapt as understanding develops. We often work as an extension of our clients' teams, providing hands-on technical leadership and maintaining continuity throughout development. This avoids handover friction and supports faster, more aligned decision-making.
We reduce risk by identifying the biggest unknowns early,when there is still flexibility to test assumptions, fail fast and pivot ifneeded. This helps teams make better decisions before significant time andinvestment are committed.
For medical device projects, our approach is grounded in ISO13485 design controls, good engineering practice and effective risk management.Where relevant, we work with the expectations of key standards such as ISO14971 for risk management, IEC 60601 for electrical medical equipment, IEC62304 for medical device software and IEC 62366 for usability engineering.Combined with a systems view of the full product, including technicalperformance, software, human factors, quality, regulatory expectations and manufacturingroute. This helps risks be identified and resolved before they become costlylate-stage problems.
Read more about our approach to navigating risk.
We do not provide standalone regulatory consultancy, however, we design and develop medical devices with the relevant regulatory expectations in mind, helping clients build the evidence, traceability and development documentation needed to support future submissions. TTP is also ISO 13485 certified, with certification covering medical device and IVD design, development and contract manufacture, including implantable devices and active implants.
By embedding the right level of regulatory structure early, we help teams gain long-term development efficiency and reduce risk. From concept feasibility through to verification and transfer to manufacture, we design with compliance in mind. Our multidisciplinary teams combine deep technical expertise with strong regulatory fluency, embedding safety and performance considerations at every stage. The result is a more robust product, fewer late-stage surprises, and a clearer, faster route to regulatory submission, turning compliance from a requirement into a genuine development advantage. This regulatory fluency is embedded at every level: within individuals, project teams, and our organisational systems.
Read more about our approach to regulatory compliance
Yes, depending on volumes. TTP has facilities that supportprototype, low-volume and selected mid-volume builds, helping bridge the gapbetween development and transfer to a large-scale manufacturing partner. We donot provide bulk manufacturing, but we can produce quantities suited toactivities such as verification, clinical trials or pilot launch — for example,hundreds of instruments or thousands of consumables, depending on the productand programme needs.
This capability helps clients move beyond prototypes andbuild consistent, reliable devices while the manufacturing process is stillbeing refined. By developing product and process understanding together, we canmake later transfer to a CMO of your choice smoother, better informed and lowerrisk. TTP is not, however, the legal manufacturer of products.
Read more about our medical device manufacturing capabilities
We consider usability from the outset, not as a final check once the device has already been designed. Our dedicated human factors team works alongside engineers and software specialists to understand users, environments, workflows and use-related risks early in development.
This can include user research, behavioural insight, task analysis, prototyping and formative usability testing, with activities tailored to the stage and needs of the project. By designing around real clinical and home-use contexts, we help create devices that are safer, more intuitive and more likely to be adopted in practice.
Read more about our approach to human-centred design and human factors engineering.
Yes. TTP develops software for regulated medical devices, including Class A, B and C devices under IEC 62304. Our dedicated software team works closely with systems, engineering, human factors and quality specialists, so software is developed as part of the full product architecture, not treated as a separate workstream.
We support embedded software, firmware, connected device software and device-to-cloud ecosystems, building in security, reliability, documentation and traceability from the start. For connected products, we also consider cybersecurity, update pathways, configuration control, SBOMs and long-term lifecycle management, helping software evolve safely within a regulated medical device environment.
Read more about our in-house software team.
We have established product development approaches, procedures and quality processes, but we do not force every project through a rigid, one-size-fits-all stage-gate model. Instead, we adapt the development structure to the client, the technology, the level of risk and the decisions that need to be made.
Where clients already have their own stage-gate process or QMS, we can align with it and provide the documentation, reviews and decision points needed to support it. Where clients need more guidance, we can help define an appropriate development roadmap, breaking the work into clear stages that reduce risk, support investment decisions and build confidence before moving to the next phase.
This means projects remain structured and well controlled, while still being flexible enough to respond as the technology, requirements or commercial priorities evolve.
We recognise that IP is often central to our clients’ commercial strategy, so we discuss it early and agree an approach that fits the project, the technology and your business needs.
In many client-funded development projects, the intention is for the client to own the project outputs, but the right arrangement will depend on factors such as existing background IP, newly created developments, platform technologies and the intended route to market.
Our aim is to make the IP position clear from the outset, so you understand how ownership, access rights and use of project outputs will be handled before work begins.
We usually work with clients around the world and for the past 40 years we have run international projects across different time zones, cultures and working styles. We agree communication rhythms, meeting times and decision points upfront, so collaboration is clear and progress is maintained even when teams are not in the same location.
We also believe face-to-face contact is important, particularly at key moments such as early scoping, workshops, major reviews or build phases. Where useful, we will travel to meet your team, and clients are always welcome to visit us.
In many cases, time differences can be an advantage, allowing work to progress across extended hours. With four decades of global client experience, a multinational team and a high level of repeat business, we have a proven model for making international collaboration work well.
TTP is best suited to projects where science, engineering, user needs and commercial goals must come together - whether the challenge is defining the right route forward, integrating complex systems, accelerating development or resolving difficult technical trade-offs.
We often support clients with complex, multidisciplinary development challenges, but complexity is not the only reason to involve us. Sometimes the need is speed, senior technical judgement or the ability to bring the right expertise together quickly to keep a critical programme moving.
We are less likely to be the right fit for routine engineering capacity or simple execution-only tasks where the solution, requirements and route to delivery are already fully defined. But if the project carries technical risk, strategic importance or urgency, we are always happy to discuss whether and how we can help.
A medical device design consultancy provides specialist engineering, scientific and human factors expertise to support the design and development of medical devices. This can include everything from early-stage feasibility and system architecture through to verification, regulatory support and manufacturing readiness. The role of a consultancy is to help teams navigate complex technical and commercial decisions, accelerating development while reducing risk.
