Our product strategy, design, and engineering teams help you create compliant, market-ready medical devices
Expertise for startups and established organizations
Our team excels at guiding you and your breakthrough idea through the medical device product development process. Through a collaborative approach, we provide deep industry knowledge and experience:
and risk management specifically for medical device development
Digital and physical
systems, sub-systems, embedded software, and connected devices
Regulatory requirement compliance with a proven track record of FDA, Health Canada and CE approvals
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Connected medical devices are in demand
Whether you’re starting with an idea or have an existing product that could be enhanced with an IoT solution, Novo technical teams can help you identify opportunities and strategically develop market-ready IoT medical device innovations.
“Working with Novo allowed us to quickly show investors a certified, effective, well-designed and attractive ready-to-market medical device that addresses critical human factors in a hospital environment. We’re moving forward with additional certification and collaborating with our Novo team on the next phase of development.”
François Lellouche MD, PhD,
OxyNov Co-Founderdownload case study here
Novo has helped develop a range of medical products including digital health systems, patient monitoring systems, cardiovascular and respiratory devices.
Our human-centered design approach, solid engineering, and knowledge of FDA, CE and Health Canada compliance requirements help companies produce high-quality products approved for use.
Compared to the devices currently on the market, this product had to be more compact, lightweight, ergonomic and intuitive. In coordination with the electronic engineers, our designers developed the smallest possible envelope to make the product compact and lightweight. Successfully housing the mechanics and electronics in this case was a major challenge. Some adjustments had to be made following the risk analyses. The reliability and precision of the product were the main priorities.
Expertise: industrial design, mechanical engineering, electronics, embedded software, verification and validation, regulatory documentation.
After developing the processing automation algorithm, OxyNov needed support to optimize its prototype. To bring a redesigned CE-certified device to market, our team provided support in consulting services, design, engineering and embedded software development. Our innovative strategic design approach also optimized the features included to meet the human needs of all types of users.
Expertise: product strategy, ux design, industrial design, mechanical engineering, electronics, embedded software, verification and validation, regulatory documentation.
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BJ Nimo approached Novo to develop an ophthalmology diagnostic tool using offline image analysis software driven by AI. The design required a manual and guided process for target alignment, and image capture and validation to ease patient treatment.
Our engineering and design teams worked closely together to develop the patent-pending technology into a highly intuitive, non-invasive medical device. The prototype met safety requirements, manufacturing and price considerations, and user needs.
BMT Canada, a subsidiary of Bavaria Medizin Technology - GmbH, specializes in the development of devices for arterial heart valve replacement. Novo supports BMT in the development of their products and especially in the handling of catheters. From concept development to clinical trials and production start-up, we support them throughout the design process.
McKesson worked with Novo to develop a revolutionary software-driven approach to improve the manual preparation and verification of blister cards (drugs). The simple, economical BlistAssist™ solution guarantees accurate preparation.
Expertise: product strategy, industrial design, mechanical engineering and electronics.
In addition to developing the prototype, our team also provided the supporting documentation required for certification. The redesigned Dermadry product passed the first trial to receive Health Canada approval. The Dermadry team is pursuing additional certifications so that the device can be sold in worldwide markets.
Expertise: product strategy, industrial design, mechanical engineering and electronics verification and validation, regulatory documentation.
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Contact us to learn more about medical device development.