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Device Development - from User Research to Regulatory Support


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Device Development - from User Research to Regulatory Support


Multidisciplinary Capabilities

IcarusNova can assist you in discovering new product opportunities, creating Intellectual Property and developing ideas right through to production. Specifically, as part of our Product Development expertise, we offer Usability Research, Industrial Design, Mechanical Engineering, Embedded Electronics and Software Development as well as Testing and Regulatory support services.

 

 

PROJECTS


 

USABILITY RESEARCH

The goals of effective User Research at IcarusNova is to ensure that the demands of users, their tasks and their environments of use have been addressed adequately. Most Medical Devices are tools which need to work in an intuitive and efficient way from the point of view of the User. 

To understand Users and their environments we use a broad range of Design Research tools, Design Ethnography providing the observational backbone to our methods. In every case we are driven by a need for Insights which can help inform Device development decisions. Unmet and unarticulated requirements are source beds of innovation and our team focuses on uncovering them. 

Every project demands its own research tools and we work flexibly with them, however some of the broad areas of Research can be articulated as Design Research, Analysis and Synthesis and  Usability Evaluation.

Discovery as a goal lies at the heart of our research efforts.

 

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ID helps us draw a fine line between the professional and the empathetic.


ID helps us draw a fine line between the professional and the empathetic.


INDUSTRIAL DESIGN

“Experience” as a concept is not necessarily associated with “serious” Medical Device Development. However at IcarusNova the focus of the Industrial design team has been to deliver an Experience which enhances the “professional” feel of a device while at the same time making it non-threatening to the patient. 

20 plus years of experience ensures that we understand the trends in this space and the often unarticulated aspirations of our clients to deliver world class products. 

We are also comfortable working within the ID guidelines that some of our Clients may already have.

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A mature mechanical engineering team with broad capabilities...


A mature mechanical engineering team with broad capabilities...


MECHANICAL ENGINEERING

Our Mechanical Engineering team is involved in prototyping and Product Development. 

Mechanism development
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Component, part design and engineering
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Packaging and enclosure design
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Design for manufacturing and assembly
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Reliability engineering
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CAD surface and solid modeling using SolidWorks
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Rapid prototyping
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Production documentation

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Integrated product experiences through embedded electronics and software systems


Integrated product experiences through embedded electronics and software systems


EMBEDDED ELECTRONICS AND SOFTWARE

Analog
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Digital
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Communications
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Signal processing
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Sensors and signal processing
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Embedded systems
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Algorithms
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C/C++
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Machine language

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Functional testing and regulatory support to get your product into market


 

 

Functional testing and regulatory support to get your product into market


 

 

TESTING & REGULATORY SUPPORT

Creation and maintenance of Design History Files (DHF) and Device Master Records (DMR)
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Coordination and review of solutions with notified bodies and testing labs
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Verification testing to essential requirements and medical safety standards
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Compliance to design control requirements
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FMEA
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Performance
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Formal verification
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Compliance to standards
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Transit
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Reliability
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Life

Regulatory support is offered through one of our partners.