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 Thinking, Lean Start-Up and Agile methods in
Medical Device Design and Development
– Innokas MedTech Design Studio Approach

Design Thinking, Lean Start-Up and Agile Approaches in Medical Device Design and Development

"With the selected partners, the development of our new product will benefit from a very strong base of clinical and technical expertise."Andreas Mollat
Andreas MollatCEO, Otivio AS
“We at CareFusion really trust on Innokas’ knowhow and we can count on that their engineering professionals can cope with all QA/RA requirements well.”Janne Ranta
Janne RantaR&D Director, CareFusion Finland
"Innokas has experienced designers, who have participated in wide variety of medical system design projects. The co-operation with Innokas brings us new knowhow that we might not have in-house."Jarmo Ruohonen
Jarmo RuohonenDirector of Philips MR Therapy in Vantaa
"Innokas Medical has functioned as Modz’s external R&D department. The collaboration with Innokas Medical has gone smoothly, and Innokas has proved to be an important partner in the development of the blood sugar meter."Salla Koski
Salla KoskiFounder, MODZ
“Innokas’ project team worked systematically but flexibly with us. We were able to finish product development and transfer to manufacturing in record time thanks to close collaboration with Innokas team."Tapani Taskinen
Tapani TaskinenOwner, HLD Healthy Life Devices
"During this project we’ve been able to manage large and complex problems and I see that Innokas’ capabilities as well as knowledge has grown even further during the project."Juha Rantala
Juha RantalaProduct Manager, Innokas Medical Ltd.
"Innokas was chosen to be Bonvisi’s partner because of its longtime experience in medical device design as well as its very strong experience in QA/RA requirements. The cooperation between Innokas and Bonvisi has worked well."Anders Möllstam
Anders MöllstamManaging Director, Bonvisi AB
"Innokas was selected as the design partner especially because of Innokas’ experience and industry knowhow. In addition, Innokas had the engineers with appropriate technical backgrounds available for the project."Pasi Laukka
Pasi LaukkaProject Manager, Ajat

Innokas MedTech

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:

Concept clarification

CONCEPT CLARIFICATION

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

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.

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.

INPUT CRAFTING

INPUT CRAFTING

Careful and comprehensive formulation of Design Inputs.

Reduce time to market with properly defined requirements specification.

DESIGN IMPLEMENTATION

DESIGN IMPLEMENTATION

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.

DESIGN TRANSFER

DESIGN TRANSFER

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.

Project Management

  • Following FDA-requirements
  • Following ISO 13485 requirements
  • Design for Excellence (DfX)

Software Development

  • According to IEC 62304
  • Embedded SW
  • User interface
  • SW testing, automated testing

Electrical Engineering

  • 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

Tester Design

  • Circuit Boards
  • Modules
  • Finished products

Mechanical Engineering

  • 3D Modeling
  • Complex plastic and metal design
  • Movements, mechatronics
  • Touch screen integration
  • Simulations
  • Rapid prototyping
  • DfA, DfC

Usability Design

  • 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!