Active implantable medical device development (AIMD)

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

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.

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.

Every project is shaped around the specific challenge and aligned with your own ways of working, governance and decision-making processes. 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.

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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.

Yes, depending on volumes. TTP has facilities that support prototype, low-volume and selected mid-volume builds, helping bridge the gap between development and transfer to a large-scale manufacturing partner. We do not provide bulk manufacturing, but we can produce quantities suited to activities such as verification, clinical trials or pilot launch — for example, hundreds of instruments/ devices or thousands of consumables, depending on the product and programme needs.

This capability helps clients move beyond prototypes and build consistent, reliable devices while the manufacturing process is still being refined. By developing product and process understanding together, we can make later transfer to a CMO of your choice smoother, better informed and lower risk. TTP is not, however, the legal manufacturer of products.

Read more about our medical device manufacturing capabilities

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 shape the right team around the challenge, bring in specialist expertise at the right moment and adapt the project as technical, commercial or regulatory needs 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.

Our experience includes not only client development programmes, but also commercialising technology through our own ventures, giving us a practical understanding of the decisions needed to take complex products from concept towards market.

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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.

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We work with ambitious, well-funded companies across the healthcare landscape, from venture-backed start-ups, scale-ups and biotechs to established global MedTech and pharma 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.

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We agree a communication rhythm at the start of the project, usually including regular update calls, written summaries and clear next actions. We also give visibility of progress, spend and any decisions that could affect budget, raising risks early rather than waiting until the budget is exhausted.

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 travel to meet your team, and clients are always welcome to visit us.

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.

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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.

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TTP is ISO 13485 certified, with certification covering medical device and IVD design, development and contract manufacture, including implantable devices and active implants.

Our approach to quality is tailored to the stage, risk and regulatory needs of each project, and is flexible enough to integrate with a client’s own systems.  

Because our development and manufacturing teams work closely together, quality, documentation, traceability and process understanding can be built in as the product evolves. This supports smooth transfer of documentation, evidence and decisions throughout the project, and helps clients move from technology demonstrator to clinical trial manufacture, early production and, where needed, transfer to high-volume manufacturing.

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Our consultancy work is usually delivered on a fee-for-service basis, with the scope, budget and commercial terms agreed before work begins.

For the complex development projects we typically undertake, success depends on close collaboration between our team and yours. These programmes usually involve technical uncertainty, complex trade-offs and important decisions about risk, cost, performance and route to market. A clear fee-for-service model means we can commit the right team, maintain momentum and make objective recommendations based on what is best for the product and programme - not on future equity value, fundraising outcomes or ownership incentives.

As an employee-owned business, TTP is built around long-term client relationships, shared accountability and a commitment to the quality of our work.  In rare circumstances, we can look at alternative funding models.

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Our clients work with us because they gain access to decades of accumulated expertise, proven technologies and multidisciplinary know-how.

We recognise that IP is often central to our clients’ commercial strategy, so we agree IP terms at the outset of every project that gives you the rights you need to commercialise your products while making the best use of the capabilities that both organisations bring to the engagement.

In many client-funded programmes, clients own the project outputs within their field of application, with arrangements tailored to reflect background IP, enabling technologies and new developments.

From day one, ownership, licensing and confidentiality are clearly defined and robustly managed, giving both parties the confidence to focus on creating successful products.

Our aim is to make the IP position clear, so you understand how ownership, access rights and use of project outputs will be handled before work begins.

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We usually work with clients around the world and are used to running international projects across multiple time zones, cultures and working styles. Because project teams are often spread across different locations, we agree communication rhythms, meeting times and decision points upfront, so collaboration is clear and progress is maintained.

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.

We hand-pick the team around the needs of the project, factoring in how those needs are likely to evolve. With more than 300 engineers, scientists and designers under one roof to draw from, we can bring together the right mix of market knowledge, technical expertise and delivery experience.

Depending on the challenge, this can include specialists in areas such as fluidics, sensing, optics, electronics, software, modelling, materials, mechanics, robotics, human factors, industrial design and design for manufacture.

Most teams are multidisciplinary, with specialists brought in where needed, and your initial contact will usually stay involved as the project progresses.

Each project is led by an experienced technical project leader who is actively involved in the work, not by a separate account manager. This gives clients direct access to the people making the technical decisions, while maintaining continuity throughout the programme.

Our teams also have access to extensive on-site facilities, including dedicated manufacturing space, cleanrooms, microfabrication, assembly areas and specialist labs. This means we can move quickly from concept to testing and build, while drawing on trusted suppliers and partners where additional capability or scale is needed.

That depends on how you want to work. We can operate as an extension of your team, working closely with your engineers and stakeholders, or take on a more independent role with agreed review points and decision gates.

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We hand-pick the team around the needs of the project, and factor how those needs will evolve during the project, drawing on the right mix of market knowledge, technical expertise and delivery experience. Most teams are multidisciplinary, with specialists brought in where needed, and your initial contact will usually stay involved as the project develops.

Our teams also have access to extensive on-site facilities, including dedicated manufacturing space, cleanrooms, microfabrication, assembly areas and specialist labs. This means we can move quickly from concept to testing and build, while drawing on trusted suppliers and partners where additional capability or scale is needed.

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TTP is often the right fit when the technology is complex, multidisciplinary or novel, especially where it needs to work reliably in a heavily regulated environment.

We help clients bring together science, engineering, user needs, commercial goals and regulatory expectations, whether the challenge is defining the right route forward, integrating complex systems, accelerating development or resolving difficult technical trade-offs.

Complexity is not the only reason to involve us. Clients also come to us when they need senior technical judgement, fast mobilisation or the right specialist expertise brought 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.

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.

We do not have a rigid engagement process, but projects typically start with a non-confidential discussion to understand the opportunity, challenge and potential fit. From there, we can put a confidentiality agreement in place, explore the brief in more detail, involve the right technical people and start shaping the scope together.

This usually develops through outline discussions, team introductions and iterations towards a formal proposal. Once the terms of business and statement of work are agreed, we move into project kick-off. Because we have a broad internal team and a flexible way of working, we can often move quickly, assemble the right expertise and adapt the process around your development goals.

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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.

We work with clients around the world, with many based in the US, UK and Europe. Our project model is designed to support collaboration across geographies and time zones, using structured communication, regular project touchpoints and in-person meetings or workshops at client or TTP sites where useful.

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