Design 1st is a full-service medical product developer that helps turn medical device ideas into commercialised products. We have in-house expertise throughout the medical product development process, including design, engineering, electronics, firmware, regulatory certification, and set-up for manufacturing.
Design 1st partners with medical professionals, including doctors, dentists, start-ups, biotechnology firms, and established companies to bring medical devices to market. Our senior experts can help clients navigate the complexities of product design within medical regulatory standards to bring products to market more quickly.
Our electronics, firmware, embedded software, and engineering teams can add connectivity to products while supporting clinical trials and verification testing.
Addressing medical product development challenges
Navigating the complexities of medical device product development requires experience in several areas, including hardware and software testing, regulatory certification, compliance, and quality system management. Design 1st’s in-house experts work alongside our clients to expedite product development, reduce costs, and ensure product quality.
Medical device companies can consult us for technical guidance in developing innovative, user-friendly products that meet stringent engineering, material, regulatory, and compliance requirements.
Redesigning and modifying existing medical devices
Design 1st integrates into clients’ engineering teams and can convert product ideas or existing products to new looks, forms, and functionalities. We aim to help customers deliver optimal performance in both traditional and emerging data-driven, high-bandwidth medical environments.
Our teams can also provide later-stage product development quality and manufacturer management capabilities to support both lower-volume and higher-volume production builds.
Manufacturing, regulatory and intellectual property support
Design 1st has an internal team for supply strategy and coordination, which helps clients select the most suitable parts, suppliers, and contract manufacturer early in the product development process.
Our network of more than 500 medical component suppliers and 12 contract manufacturers can expedite product design decisions by sourcing high-quality medical device components. This approach reduces time to market while ensuring products can meet the regulatory requirements of the medical device industry.
In addition, Design 1st’s product design and engineering team has experience in identifying strong, patentable elements to help clients build and enhance medical equipment portfolios. We understand that our clients must own all the intellectual property they create.
Research and development support for medical device production
Design 1st helps clients convert their new product ideas into production-ready solutions by following a proven process of designing, building, and testing. When risks are identified, we find cost-effective ways to qualify them and determine the best solutions.
Once a product has been defined, we will produce low-volume pre-production units for clinical trials and user testing. One recent example is our work with Joylux to design, prototype, user test, and receive Health Canada and US FDA approval for its pelvic floor therapy device, vFit.
Interconnecting medical devices to improve efficiency
Design 1st believes the future of medical devices involves connection to high-bandwidth networks, allowing private records and sensor data to be transferred securely between devices.
Our embedded electronics hardware, system architecture, and firmware teams are experts in modifying existing medical equipment to increase processing power, integrate sensors, modify interfaces, and add new features. This requires intrinsically safe wireless and wired connectivity with redundancy, as well as updated electronics for the latest in energy-efficient microprocessor, components, and embedded software.
About Design 1st
Design 1st is a trusted full-service product design firm based in North America, with a seasoned team contributing technical expertise in various areas. We have helped develop more than 1,000 products and secured 130 patents for clients since our foundation.
We enable companies to quickly scale their product development programmes by leveraging our core competencies in human behaviour, industrial design, mechanical engineering, electronics engineering, embedded firmware, and manufacturing setup.
Our team has helped clients transform their physical ideas into commercialised hard goods, serving millions of customers worldwide across a variety of industries.
