Medical Device Design Services
Expert design and development services for minimally invasive medical devices, from early concept through to prototype production, regulatory submission, and scale-up manufacturing.
Specialising in interventional catheters, guidewires, specialty needles, and minimally invasive access devices.
A Specialist Partner for Complex Medical Device Projects
We work with OEMs, MedTech startups, and established medical device companies to move complex device concepts from idea to validated, manufacturing-ready designs, while reducing development risk and avoiding costly redesigns.
Our focus is on precision, minimally invasive devices. This includes catheter systems, guidewires, specialty needles, and access devices that require exacting engineering and deep regulatory knowledge to bring to market. This narrow focus means our team has accumulated significant, repeatable expertise in the specific engineering challenges these devices present.
We offer a fully integrated service from concept to commercialisation, covering design, prototyping, regulatory documentation, and DFM (design for manufacturing), and pilot builds.
What Our Clients Say
Medical Device Design Capabilities
Our design and development team has deep experience across a focused range of minimally invasive device categories:
Catheter Design and Development
We design and develop a full range of advanced catheter technologies, including:
- Thin-wall catheters
- Reinforced catheters, including braided and coiled catheters
- Balloon catheters
- Steerable catheters
- Ablation catheters
- Multi-lumen catheters
- Diagnostic catheters
Specialty Medical Needle Design
We design specialty needles for interventional, biopsy, drug delivery, and access applications, including:
- Micro needle design for minimally invasive drug delivery and sampling
- Cannula and stylet design for access and drainage systems
- Custom tip geometry and grind profiles for specific clinical requirements
Guidewire Design
Our guidewire design capability covers core wire selection, tip shaping, coating specification, and torque performance optimisation across a range of diameters and stiffness profiles. We work across standard, hydrophilic, and nitinol-based constructions..
Minimally Invasive and Interventional Device Design
Beyond catheters and needles, our team designs a range of interventional devices for vascular access, neurovascular intervention, interventional oncology, and interventional radiology applications. We are experienced in the specific regulatory pathways, material requirements, and clinical use conditions these devices face.
Medical Specialties We Serve
Our device design work spans the following clinical areas:
Within each specialty, we understand the clinical workflow, device handling requirements, and regulatory classification landscape that shapes design decisions. This means we can contribute meaningfully from the earliest stages of concept development.
| Clinical Area | Specialty |
|---|---|
| Interventional Cardiology | Treatment and diagnosis of conditions in the heart and blood vessels |
| Interventional Radiology | For the diagnosis of conditions and/or to guide treatments |
| Interventional Oncology | For the diagnosis and treatment of cancer and related problems |
| Neurovascular | For the diagnosis and treatment of conditions in the blood vessels of the brain, spine, or spinal cord |
| Other | Vascular access, pharma, pain management, spine and biologics, sports medicine |
Our Six-Step Medical Device Design Process
We follow a structured, stage-gated development process aligned to ISO 13485 requirements and FDA design controls (21 CFR Part 820). This approach ensures each project progresses with appropriate documentation, risk management, and design verification at every stage.
Each stage ends with a formal gate review. Decisions to proceed, iterate, or redirect are made on evidence rather than assumptions, keeping projects on time and within budget.
| 1 | Requirements | We define the clinical and functional requirements for the device. This includes what it must do, in what environment, and for which patient population. |
| 2 | Concept Development | Multiple design concepts are generated and evaluated against the design inputs. We apply engineering analysis, material shortlisting, and manufacturability assessments to narrow down to the most viable approaches. This validat before committing to detailed design. This validates feasibility before committing budget. |
| 3 | Detailed Development | We further review manufacturing methods and materials, and 3D CAD models are produced. Concept options are narrowed further. |
| 4 | 1st Prototype | Physical models of each concept are produced for bench testing and further assessment. This also helps reduce design risks before regulatory submissions. |
| 5 | Refinement | One design is selected. It goes through further refinement, including design for manufacturability (DFM). |
| 6 | 2nd Prototype | A manufacturable prototype is produced. |
Regulatory Expertise Built Into the Design Process
Regulatory compliance is not a downstream activity at Arrotek. Instead, we integrate compliance consideration into every stage of the design process. Our team is experienced in the requirements of all major regulatory frameworks applicable to minimally invasive medical devices:
- ISO 13485:2016: Our quality management system governs all design and development activities
- FDA 21 CFR Part 820: Design Controls requirements are followed throughout the development process
- EU MDR (Regulation 2017/745): Ee design with European market requirements in mind, including technical file structure and clinical evidence requirements
- IEC 62366: Human Factors Engineering and usability principles are applied throughout design
- ISO 10993: Biocompatibility risk management for materials selection and testing strategy
- Risk management per ISO 14971: DFMEA and hazard analysis are part of our standard design process
This regulatory fluency means we can advise on classification, predict the documentation requirements your project will face, and structure design outputs from day one to support your submission, whether that is a 510(k), CE marking under MDR, or other requirement.
Design for Manufacturing
Engineering medical device products that can be commercially produced
A medical device that works in the lab but cannot be manufactured reliably at scale is not a finished product. At Arrotek, DFM (Design for Manufacture) principles are applied throughout the design process.
Because our design team works directly alongside our manufacturing capability, we make material and geometry decisions with production in mind from the outset. This means:
- Tighter alignment between prototype and production-intent design
- Fewer design changes required at transfer to manufacturing
- Better visibility of target manufacturing costs during the design phase
- Reduced risk of scale-up delays caused by unmanufacturable features
For clients with their own manufacturing operations, we can document DFM outputs in a format that transfers cleanly to your own production team or CMO.
Why Work With Arrotek
Focused Expertise
We work exclusively on minimally invasive, catheter-based, and needle-based devices. This focus means our engineering team has deep, repeatable experience with the specific challenges these products present.
Design & Manufacturing
Our design capability sits alongside our manufacturing operation. This supports design for manufacturing engineering and allows prototypes to be built, tested, and iterated quickly, without the need for third-party suppliers.
Full Lifecycle Support
We support the full product lifecycle, from initial concept design to prototype development to regulatory support to scale-up manufacturing to ongoing product version iteration and development.
Flexible Engagement Model
We will adapt our engagement model to your situation, e.g., augmenting your existing engineering team on a specific workstream, taking full ownership of a development project, or providing targeted, specialised support.
Intellectual Property Protection
All client work is treated in strict confidence, and you will retain 100% of the intellectual property rights over your device concept and design outputs. We do not use client IP for any purpose beyond the agreed scope of work.
Proven Track Record
We have a proven track record of successful projects designing and developing novel medical device products and components for medical entrepreneurs, start-up companies, and established OEMs.
Who We Work With
Medical Device OEMs
Established OEMs work with Arrotek to extend their internal engineering capacity, accelerate specific development programmes, or access specialist capabilities such as catheter design or micro needle engineering. We have experience working within existing quality systems and adapting our outputs to fit your DHF structure and document control requirements.
Start-Ups & Early Stage Companies
Early-stage companies and entrepreneurs use Arrotek to access the engineering and regulatory expertise needed to take a device concept from idea to investable prototype. We are experienced in helping founders understand the regulatory pathway for their device, structure their development programme efficiently, and produce manufacturable prototypes for testing.
Client Testimonial
Discuss Your Medical Device Project
Share your device concept or development challenge and our engineering team will review your requirements and advise on feasibility, regulatory considerations, and next steps.
You can submit your enquiry via the form or email us at [email protected]. All enquiries are treated in strict confidence.
We support medical device companies across Europe, USA and internationally, from early-stage concepts through to scalable manufacturing. There is no minimum project size required to begin a technical review.
Frequently Asked Questions
What types of medical devices does Arrotek design?
Arrotek specialises in minimally invasive medical devices, with particular expertise in interventional catheters, guidewires, specialty needles, cannulas, and access devices. We work across interventional cardiology, interventional radiology, interventional oncology, neurovascular, and vascular access applications.
What is the typical timeline for a medical device design project?
Timelines depend heavily on device complexity, regulatory classification, and how many development iterations are required. A typical concept-to-functional-prototype programme for a catheter-based device runs between four and twelve months. We provide a project plan and timeline estimate during initial scoping.
Do you work with startups as well as established companies?
Yes. We work with early-stage companies and entrepreneurs who need to develop a first prototype and understand their regulatory pathway, as well as established OEMs who need to extend their engineering capacity or access specialist capabilities.
What regulatory standards do you work to?
Our quality management system is ISO 13485 certified. Our design process follows FDA 21 CFR Part 820 Design Controls requirements and EU MDR technical documentation requirements. We apply ISO 14971 risk management and IEC 62366 human factors principles as standard throughout the design process.
Do you handle the full project or can you support just part of it?
Both. We can take full ownership of a design and development programme from concept to manufacturing transfer, or we can provide targeted support on a specific phase (such as detailed design, prototype build, or DFM review). We’ll adapt our involvement to your needs and existing team structure.
Where is Arrotek based?
Our medical device design teams are based in Sligo, Ireland and Massachusetts, USA. We also have manufacturing facilities in Sligo and Massachusetts as well as Costa Rica.
