20+ years in product design & engineering
Medical device design from concept to production
We help medtech founders and teams turn ideas into safe, usable, and production-ready medical devices through design, engineering, prototyping, and ISO 9001 and ISO 13485 certified processes.
Medical and healthcare product experience
From patient monitoring and diagnostics to instruments for treatment and connected healthcare devices, ManGo can support your product development with industrial design, usability research and product improvements, engineering solutions, prototyping and testing, and assistance in setting up series production.
Goal3
Development of a pediatric patient monitor for low- and middle-income countries.
Adam Health
Turning a bulky prototype into a compact, discreet overnight health tracker.
Higo Sense
HigoSense telemedicine medical device to perform nine clinically validated examinations at home.
Vision Tech
Innovative nasal speculum with integrated LED to look inside the nose.
Severo
Design and engineering of severo portable pill grinder for healthcare professionals.
Romynox
Compact, easy-to-handle iris valve for biopharmaceutical cleanrooms.
A structured route from medical idea to market-ready product
We combine strategic product definition, human factors, engineering and supplier-ready documentation in a process that respects regulated development.
01
Design Strategy Analysis
ManGo combines user, market, competitor, and regulatory research to define the right direction for each product from the start.
02
Concept Development
Research insights are translated into refined product concepts through collaborative ideation, concept selection, and iterative 3D CAD development.
03
Engineering for Prototyping
Prototyping and testing bring the design to life, enabling iterative improvements in functionality, usability, and manufacturability before production.
04
Design For Manufacturing
The final design is engineered for production, integrating CMF, manufacturing methods, mechanics, electronics, validation, and detailed production documentation.
05
Industrialization
From supplier selection and tooling to assembly setup and quality control, we support the transition into manufacturing through your partners or our trusted network.
06
Production
Production is closely supported through pilot runs, quality control, supplier coordination, and series production to ensure consistent, reliable results.
Relevant insights
Explore our latest articles on medical device design, engineering, development, and production. Practical insights to help you navigate the journey from initial concept to a production-ready medical device.
Quadruple Aim in healthcare
How to turn the Quadruple Aim into medical-device requirements that improve patient experience, clinical workflows, population health and cost.
Reimbursement by design
Medical device reimbursement, billing codes and payer evidence can shape product decisions earlier than many teams expect. Here is what to check before launch.
Why medtech innovators choose ManGo
ISO 9001 & 13485 certified quality processes
Structured, consistent quality throughout every stage of your project.
Usability engineering & human factors
Human factors and usability integrated throughout the design process.
Designed for manufacturing from day one
Manufacturing requirements are considered early to reduce redesign and tooling risks, supported by our trusted manufacturing partners.
Strong partner network
We work with your existing partners or connect you with trusted specialists from our network.
Frequently asked questions
What happens after filling out the form?
We’ll contact you within 1–2 business days to schedule a short intake call.
How long does a medical device design project typically take?
It depends on several factors, including the complexity of the device, its current development stage, regulatory requirements, and the scope of the project. After the initial intake, we can provide a more realistic timeline based on your specific needs.
Who owns the IP after the project?
We offer an NDA before any project discussions begin, and all IP generated during the project belongs to you.
Can you support ISO 13485 compliance?
Yes. We can support your development process in line with ISO 13485 requirements and help ensure the necessary design and development documentation is properly structured.
Can ManGo help develop a medical device in line with MDR/CE and FDA requirements?
Yes. ManGo can support the development of medical devices with applicable European MDR/CE and U.S. FDA requirements in mind from the earliest design stages. We can assist with device classification, translating regulatory and safety requirements into design specifications, risk reduction, prototyping, usability and verification testing, and preparing the product for clinical evaluation or investigation where required. We can also coordinate with specialized test laboratories, Notified Bodies and other regulatory partners throughout the process.
By considering regulatory requirements early in development, we aim to reduce certification risks, avoid costly redesigns and create a clear path toward CE marking and the applicable FDA clearance or approval process.
Do you also help with finding a manufacturer?
Yes. We have a strong network of trusted manufacturing partners and can help connect you with the right supplier for your product. We also support the technical transfer to help ensure a smooth transition into production.
Can ManGo help with funding or grant applications?
We don’t provide funding directly, but we can help define the development scope, technical roadmap, budget assumptions and prototype evidence needed for investor or grant discussions. Where relevant, we can also connect you with specialists from our network.
Medical device design that moves from concept to market
We help medtech companies develop safe, usable and manufacturable medical products. Let’s discuss your project.