Our Services

Each client has different needs and a different development roadmap. Our tailored approach reflects this

I want to…


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.

We can help give refine your idea and position it for long term success

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.

Using services like 3D printing develop prototypes that communicate your design intent

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.

We offer custom design, testing, verification and validation services

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.

Using industrial design, we ensure your product is human-centric

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.

We can help support you in establishing your Quality Management System

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

We adhere to ISO 14971 and ISO 60601-1 for risk mitigation and safety testing