Our modular approach to the delivery of medical device design and development services means we can help with whatever level of support you need, whatever expertise you need, and wherever you are in the development process.
While there are similarities across all medical device design and development projects, our experience at Arrotek is that every project is different. As a result, we have experience in everything from providing consultancy services to handling a single element of a larger project to providing full end-to-end services from ideation to commercialisation.
With our modular approach, we can slot in wherever you need us, becoming an extension of your team in a relationship based on partnership.
Whatever level of support you need, you retain full intellectual property ownership of your product and idea. You can also be sure of complete confidentiality from every member of our team.
Whatever Level of Support You Need
Our modular approach to service delivery means we can provide whatever level of support you need:
- Additional resources or expertise to help you progress through a specific stage of the development process
- A reliable partner to take responsibility for a sub-project or particular element of a wider project
- Full end-to-end services and project management
- Anything else in-between
We can also work with you on a time and materials basis. With this approach, we’ll become an extension of your team, allocating hours to whatever specific tasks are relevant at that time, and freeing up your other resources.
We find that a time and materials way of working is particularly beneficial for start-up companies where there are limited resources, as the hours worked are allocated and billed as required, keeping you in control. For example, you can delegate tasks to us at weekly project meetings. You’ll then be billed for the hours work at the end of each month.
Varied Resources
The varied resources on our team also mean we can provide expert support at any stage of the development process. Our expertise includes, but is not limited to:
- Medical device design, including ideation, concept generation, and developing innovative solutions to complex challenges
- Minimally invasive medical devices
- Advanced catheter technologies
- Materials and material combinations in medical devices
- Prototype production
- Regulatory submission in the EU, US, and other locations
- Ongoing FDA and EU MDR compliance, as well as compliance in other jurisdictions
- Usability engineering
- Tool design and fabrication
- Sterilisation
- Design for Manufacturing (DFM) and Design for Assembly (DFA)
- Assembly and packaging
Whatever Stage of the Process
Our team can step in to provide support, practical assistance, and expertise at any stage of your medical device design and development project. This gives you an unrivalled level of flexibility, whether you want Arrotek to look after a specific part of your project, or you want us to become an extension of your team, adapting to your requirements as needed.
Examples of the project stages we can help with include:
Ideation and Concept Generation
This can include defining functional requirement specifications and user requirements, before going through an ideation process. The latter involves external research and harnessing our internal expertise.
We’ll then go through an ideation process to generate potential concepts. These concepts are evaluated and tested, before one is selected for further refinement.
Concept Development
Developing a concept for a new medical device product requires a range of considerations, including user needs and the intended use of the device. We follow human factors engineering principles to bring the device to the stage one prototype phase for further assessment and testing.
Concept Refinement
For products that have already reached the stage one prototype phase, we can apply our expertise to further refine the device. We’ll apply usability engineering best practices, as well as implementing DFM and DFA principles.
We’ll also consider material selection and supply chain optimisation using a lean manufacturing approach in the design process.
The final output from this service is typically a stage two, clinical build prototype that is ready for further analysis and trials.
Regulatory Support
We can also help if you have a finished product that requires regulatory approval. This includes products that are already approved in other jurisdictions, but you now want to get regulatory approval in another.
We can help with practical assistance and expert advice throughout this process, including creating risk and manufacturing documentation and creating packaging, conditioning, and sterilisation procedures. We’ll also assist with the submission process and any other work required to obtain regulatory clearance for the product.
Commercial Manufacturing
With our advanced manufacturing equipment, cleanroom facilities, and production expertise, we can take on your project once when it is ready to commercialise. We offer ongoing, scale-up manufacturing support as your product gains traction in the market, with expertise that includes design transfer, tool design and fabrication, design verification, supply chain management, and product assembly.
Speak to a Member of Our Team
At Arrotek, we can help you progress to the next development stage or take you through the entire journey. We’ll remain focused on your goals, objectives, timelines, and budgets throughout, and we’ll exceed your expectations.To find out more and to discuss the level of support you require, please get in contact today using the form below.
