The Design + Industry Standard – Designing compliant medical devices for the world

Design + Industry (D+I) are internationally recognised as leaders in the complete product development process. The team has won more than 230 global industry awards. Amongst these are three Good Design Award of the Year’s (2012, 2019 + 2022) and two Red Dot: Best of the Best Awards (2017 + 2022). D+I were recently identified as a Top 50 Medical/Healthcare designer in iF’s World Design Index.

An ISO 13485:2016 certified design consultancy, D+I has studios in Melbourne, Sydney and Newcastle. D+I’s electronics design teams have been expanding rapidly. Over the last twelve months medical device development services have doubled. This growth is due to D+I’s ability to design and engineer devices that are ready to be submitted for medical compliance certification and international regulatory standards.

“Designing medical devices that can be used in a clinical setting requires stringent design and version controls,” said Head of D+I, David Jones. “When you add in electronics, other considerations include IEC standards such as 60601 and 62304. These standards mean you have to follow very strict guidelines and testing protocols in order to meet medical compliance.”

For a medical device to be designed for clinical use there are multiple factors that need to be considered:

• Device classification — medical devices are classified on varying levels of risk. The classification determines the amount of regulatory scrutiny the device will receive.
• Quality management system (QMS) — a QMS is a set of policies and procedures that encompasses the design controls, risk management and compliant handling aspects of medical device development. It ensures that a medical device can be consistently manufactured to meet specific regulatory requirements.
• Regulatory requirements — each country has its own regulatory requirements. Approvals from these governing bodies is required in order to supply and advertise medical devices in their respective regions. Examples include Therapeutic Goods Administration (TGA) for Australia and Food and Drug Administration (FDA) for the US.
• Risk assessment — medical devices must be de-risked to prove efficacy, efficiency and mitigate any potential hazards.
• Device testing — verification and validation of the design, performance and safety are key elements for a device’s approval process.
• Maintain compliance — once in the market the device will need to maintain compliance with its respective regulatory requirements. Consistent monitoring and reporting of anomalies are crucial to ensure long-term lifespan.
   

Since the group’s inception 35 years ago, D+I has proven itself by consistently delivering commercial success for their clients through creative problem solving. D+I has vast experience in developing innovative medical devices designed for international compliance standards.

David continues, “A robust and constantly maintained quality management system supported by a sophisticated back-office system are other important factors in our business. The combination of these two systems allows us to deliver greater efficiencies for our clients. Equipping our team with world-class tools allows them to develop their skills and do some of their best work.”

Throughout their three offices, D+I’s specialist designers and engineers enjoy a wide diversity of projects. Encompassing all industries, from medical to renewables and beyond, the team are constantly working on unique design and engineering challenges.

D+I NSW’s Lead Electronics Engineer, Mitchell Bright commented, “At D+I our work is challenging and important, but we love it! Being able to collaborate in the design of medical devices that can and may ultimately make an impact on people’s lives is incredible. Our electronics division is growing rapidly and we’re currently on the lookout for engineers who want to help us make a difference.”

If you’re an electronics engineer with experience designing medical devices or have an interest in developing this skillset, D+I would like to hear from you. Visit: www.design-industry.com.au, or email: info@design-industry.com.au.