Quality-Driven Design and Development

Design and product development expertise dedicated to medical devices, software and healthcare digitalization.

Innokas Medical’s Design Studio is one of the leading engineering players in the Nordics. We have a mission to improve people´s lives by crafting healthtech ideas to reality.

Our team helps you to focus on your own core business by flexibly solving different kinds of outsourcing needs of your company – anything from concept elaboration, new product development and smaller design renewal projects to individual specialists helping you to reach the next critical milestone in your device development roadmap.

We have all the necessary competencies to design and develop medical devices to international markets: electrical & mechanical engineering, software development & data science, UX design, prototyping, verification & validation as well as QA/RA, risk & project management.

We have +25 years of experience in solving our customers’ toughest engineering challenges and bringing ideas to life. Our wide competence pool, flexible and scalable service center model and tailored services will offer the biggest impact for your business.

WHAT ARE YOU LOOKING FOR?

We’re here to solve your challenges!

FROM IDEA TO CONCEPT

Are you looking for a partner to evaluate the success potential of your idea? Let’s develop your business case, sharpen your concept and validate the feasibility of your idea!

During Concept Elaboration, we investigate the potential of your idea in your target markets, validate your business and potential risks, and verify the technology choices and regulative feasibility. During Concept Validation, we implement iterative prototyping to verify that the concept has practical potential, including the validation of the feasibility together with the end users. Commercialization Roadmap creation helps you to create the initial budgetary estimate, regulatory framework and program plan, ready to be presented to various stakeholders.

DESIGN, DEVELOPMENT & ENGINEERING

Are you looking for a partner with whom to co-create your medical device or who can update your existing product? Let’s innovate and execute faster by co-creating together!

Our cooperation can be anything from Turn-Key Product Development projects – including concept clarification, prototyping, design & development according to ISO 13485 QMS and FDA QSR, technical file creation (DMR, DHF) and verification & validation – to Design Renewal projects, aiming for improved quality & competitiveness, reduced costs and secured materials supply (REACH, RoHS etc.). The project plan and the needed team of specialists will be built according to your needs. You’ll have a validated end-product that meets the regulatory requirements & quality standards of your target markets, and can be manufactured cost-efficiently.

ON-/OFF-SITE SPECIALISTS

Do you have changing needs in your medical device design & engineering or quality & regulatory management, and have difficulties in finding the right talent in right time? Let’s reach the next critical milestone in your device roadmap together!

We provide you a flexible way to deal with rapidly changing resource needs, even for short periods – to speed up your development cycle. We’re able to strengthen your in-house product development projects with competent design and QA&RA experts from Innokas – flexibly working either at your or our premises. The needed team of specialist(s) will be selected from Innokas competence pool according to your needs.

DESIGN CONSULTATION PROJECTS

Are you looking for experienced consultants to match your missing project preferences? We provide clear and concrete consultation enabling you to reach your targets.

As an example, during Design Controls project, we help you to establish effective design controls fulfilling the regulations. In Risk Management consultation, we support you in achieving and demonstrating safety & effectiveness of your product according to ISO 14971. We understand the essence of usability in medical device development and provide Usability consultation to help you improve the safety and effectiveness of your product according to IEC 62366. During DfX Feasibility Studies, we create the recipe for your high-quality and economically successful product while optimizing its manufacturability & design reliability. These are only a few examples – you name your targets, we reach them together!

Our highly skilled Design Studio team is ready to guide you through design & engineering challenges!

Project Management

  • On-target project implementation
  • Agile execution and tooling
  • Following ISO 13485 & FDA-requirements
  • Design for Excellence (DfX)
  • Requirement traceability throughout projects

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

Software Development

  • According to IEC 62304 & MDR
  • Embedded SW
  • User interface
  • SW testing, automated testing
  • UX & UI development
  • Web apps & mobile
  • IoT & connectivity

Mechanical Engineering

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

Data Driven Solutions

  • AI & Machine Learning
  • Analytics Solution & Workshops
  • Edge Device Machine Learning / AIoT
  • Algorithm life-cycle and regulation management
  • Productization
  • Sister company Cubist IT AB in Sweden, specialized in Data-Driven and Intelligent Solutions

Usability Design

  • According to IEC 62366
  • Focus on usability and ergonomics
  • User interface and industrial design

QA&RA Expertise

  • Technical file (DHF, DMR) according to MDR / IVDR
  • Mastering EU harmonized and FDA recognized standards
  • Regulatory intelligence and submission experience
  • Ensuring compliance throughout the product life-cycle

We’re here for you – this is how we operate!

1. Fill out the form to reach us

After getting your message we will forward it to appropriate person who will get back to you shortly. Usually we will reply within 24 hours (Mon-Fri).

2. Meet our team virtually or F2F

Our experts will arrange a meeting with you so we can map out your potential needs together. The meeting does not obligate you to anything.

3. Our tailored proposal

After the meeting our experts will tailor the cooperation proposal based on your needs.

WELCOME TO WORK WITH US!


We’re already trusted by innovative global and Nordic Healthtech Brands, like: