Our Services
Each client has different needs and a different development roadmap. Our tailored approach reflects this
I want to…
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Product Definition
What you need:
Generating investor interest about your product
Help defining the key features of the product
A clear roadmap of your development journey
What you’ll get:
Early product renders or sketches
Definition of requirements based on market needs
Opportunity to intercept risks before they emerge
While a seemingly simple task, an improperly defined product can leave development swirling, stalling a product before it even has a chance to take shape. We can help you tune your product, filtering out the noise and feature creep and focus on showcasing your product’s market disruptive features while minimizing and managing its risks. This allows you to focus on what is important - ensuring that your product is positioned for maximum success.
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Conceptualizing and Prototyping
What you need:
Developing something functional you can showcase
Exploring different design options
Optimization of your product to suit user needs
What you’ll get
Prototypes that embody your vision
Iterative product development to maximize success
A deeper understanding of your product via testing
The first step from an idea on paper to something that works on a bench or computer screen can be both an exhilarating and frustrating journey. We can help remove some of that frustration by providing rapid iterative prototyping to optimize the design of your core technology. Our “fail-fast” approach means we can get you a prototype faster and with a deeper understanding of the design. Whether your product needs mechanical, electrical, or software engineers, our team becomes an extension of your own and together, we are committed to achieving your next milestone.
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Design and Development
What you need:
A complete full functioning product
Help navigating regulatory requirements
A design that can be mass produced
What you’ll get
A device capable of withstanding commercial use
A quality and regulatory pathway strategy
Detailed design for manufacturing files
If getting your product to work in a controlled environment is like running a sprint, getting it to work in the rigors of the wider world is akin to running a marathon. We can help not only design your product, we also test it them both in and out of a lab to ensure it functions exactly as you expect, helping you mitigate design risks. Our team of multi-disciplinary engineers are well equipped to refine and develop your concept to something that is efficient to manufacture, meets regulatory requirements, insulated from supply chain effects, and most importantly, ready for the real world.
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Industrial Design and Manufacturing
What you need:
A product that stirs interest at first glance
Taking the first step to mass production
Getting your product assembled
What you’ll get:
Connections with award winning ID firms
Minimized risks by using local manufacturers
Local assemblers that are responsive and reliable
Even the best device with the most innovative features will fail to gain traction if it doesn’t stir interest from your customers. Keeping an eye on how your product will be used by your customers and the feeling it imparts is just as important as how it functions in terms of commercial success. Leveraging partnerships with world class Industrial Design firms, we work with you to ensure that your product workflow is seamless and intuitive. In addition, we can assist with your manufacturing process with connections to clean room assemblers and injection molders.
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Regulatory Support and Risk Mitigation
What you need:
Help building your quality system
Meeting regulatory requirements relevant to your product
Identification of risks associated with your design
What you’ll get
Hands on guidance and a quality system that is appropriate for your business operations
A strategy to help address regulatory hurdles
Risk management activities in compliance with regulatory requirements
Nothing stalls a product like red tape. The ever changing North America quality and regulatory landscape can be a daunting challenge to navigate alone and dedicated consultants or off the shelf solutions may be overly complex and expensive. Like with all of our services, we offer solutions tailored to what your needs are. Whether it’s quality systems (ISO 9001, ISO 13485, 21 CFR 820, MDSAP), regulatory support (FDA, Health Canada) or risk management (ISO 14971), we offer guidance and support in developing your systems and processes so that you’re prepared and empowered.
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Guidance on Device Testing
What you need:
A cost effective way to test your device before design lock
Identification on what test standards are applicable to your product
Safety testing is a critical component of device design, particularly in regulated industries such as medical devices. We can provide guidance and support as you execute testing in areas such as Biocompatibility and Biological Evaluation (ISO 10993 series) or Medical Electrical Equipment (IEC 60601 Series). In addition, we are able to provide EMC/EMI pre-scanning to de-risk hardware design which saves you valuable time and money.
What you’ll get
Hardware pre-scanning to inform device design
Guidance on common MedTech standards as well as assistance in interpretation of test results