Agile Medical Device Development
with Innokas MedTech Design Studio
Design and product development expertise dedicated to medical devices and co-creation, from early concept clarification phase to high-quality design, prototyping, commercial product and cost-efficient manufacturing.
Since 1994 we have specialized in medical technology services. Throughout these years our service offering has covered all the aspects of medical device product development, from the early product idea enrichment phase through device development and project implementation to transfer to production, and has always been tailored to meet our customers’ specific requirements.
Through digitalization and fast technological development the operating environment as well as medical products and services itself are getting more complex at the same time when user experience and safety issues are being emphasized – it is clear that next generation medical products and services cannot be developed without co-creation and well-thought, modern design methods, tools and processes.
Innokas MedTech Design Studio’s view of Medical Device design and development utilizes Design Thinking, Lean Start-Up and Agile methodologies in our controlled design processes, which we have built to be compliant with current medical device quality standards, regulatory requirements and directives (e.g. ISO 13485, FDA CFR 21 part 820.30 and MDD/IVD/AIMD).
Design Studio Offering
Innokas Medical has created well-defined and structured service packages, which are designed and targeted for each product development phase.
The specific ingredients of each package below:
Develop a deeper understanding of end-user needs, their priorities and technical challenges.
Create a roadmap for turning the feasibility phase results into a finished product.
By well-facilitated workshops and use of standardized design tools and approaches prove the success potential of your idea.
REGULATORY & RISK IMPACT ASSESSMENT
Ensure the safety and effectiveness of your product according to ISO 14971 – application of risk management to medical devices – standard.
Succeed in your medical device & IVD regulatory approvals with Innokas’ long-term and hands-on experience.
PROOF OF CONCEPT
Prove the workflow and concept with iterative prototyping and testing.
Mitigate the technical unknowns and utilize our in-house sourcing and manufacturing experience.
Careful and comprehensive formulation of Design Inputs.
Reduce time to market with properly defined requirements specification.
Develop a high-quality product that can be sold on the markets and manufactured cost-efficiently.
Cost-efficient prototyping in real manufacturing environment, including feedback on manufacturability and component selection.
Reliable and predictable transfer to production with our in-house engineering, sourcing and manufacturing experts.
All in-house services offer insight and guarantee smooth design transfer for pilot-series and production ramp-up.
Innokas MedTech Design Studio
Locations and Competencies
Innokas MedTech Design Studio
– Locations and Competencies
- Over 60 professional design resources
- Development projects according to ISO 13485 QSM and FDA QSR
- Technical file (DMR, DHF) according to MDD/IVD/AIMD
- Understanding EU harmonized and FDA recognized standards
- Quality & Risk Management expertise
- Regulatory intelligence and submission experience
Our highly skilled engineering team includes all the necessary competences of product development, such as electrical and mechanical engineering, software development, industrial and usability design, tester development, prototyping, verification and validation as well as quality, risk and project management.
- Following FDA-requirements
- Following ISO 13485 requirements
- Design for Excellence (DfX)
- According to IEC 62304
- Embedded SW
- User interface
- SW testing, automated testing
- Real-time control boards, Digital IC design
- Power electronics, high voltages
- Design for EMC
- Interfaces eg. wireless, USB, LAN
- Battery technology, charging algorithms, wireless charging
- Circuit Boards
- Finished products
- 3D Modeling
- Complex plastic and metal design
- Movements, mechatronics
- Touch screen integration
- Rapid prototyping
- DfA, DfC
- According to IEC 62366
- Focus on usability and ergonomics
- User interface and industrial design
Integrated design of system, electronics, mechanics and software in-house at Innokas – seamlessly working complete device efficiently!