From the earliest stages of product development, designers must consider a wide range of factors, from regulatory compliance to the intricacies of production, to create a successful device that can be produced efficiently and cost-effectively;
A clear design brief is essential for developing a manufacturable medical device or new product. The design brief should include information about the device’s intended use, performance requirements, target market, and budget. By establishing clear goals and objectives at the outset, designers can create a more effective and efficient medical device that ticks all the boxes.
Design for manufacturability (DFM) is a critical consideration for designers and engineers. DFM involves designing a product that is easy to manufacture, assemble, test and disassemble. By considering manufacturing processes during the design phase, designers can reduce manufacturing costs, improve product quality, and reduce the time-to-market.
Medical devices and various new products are subject to rigorous regulatory requirements that vary by country or region. Designers must consider regulatory compliance throughout the design process to ensure that the product meets all relevant regulations. Early engagement with regulatory agencies can help identify potential compliance issues before they become major obstacles.
Material selection is one of the most important aspects of design, as the chosen materials can have an impact at every stage of development. Designers must select materials that are safe, reliable, and appropriate for the device or product’s intended use. Materials must also be cost-effective and readily available. Material selection must be balanced with performance requirements, manufacturing processes, regulatory compliance and considerations given to the type of environment for intended use.
Early testing can help identify potential design flaws, manufacturing issues, and regulatory compliance concerns. Designers should test prototypes frequently throughout the design process to ensure that the design meets performance requirements and is manufacturable.
Usability is one of the top considerations in medical device design, and is becoming more prominent in new product development. The device or product should be easy to use and operate, even for users with limited training or experience. Designers should consider user feedback during the design process to ensure usability requirements are met. If it is difficult to use, then it’ll never last, and will always be superseded by a simpler, easier to use option!
Design controls are a set of procedures and processes that ensure the consistency and quality of a product’s design. Design controls can help ensure that the device meets regulatory requirements, performs as intended, and is manufacturable. Design controls should be implemented early in the design process to ensure that all design activities are performed in a controlled and documented manner.
Risk management is a crucial aspect of medical device design. Designers must identify and manage potential risks throughout the design process to ensure that the device is safe and effective. Risk management should be an ongoing process, with risks assessed at each stage of the design process.
Manufacturing partners play a critical role in the design and production of medical devices and new products. Designers should engage with manufacturing partners early in the design process to ensure that the device is manufacturable and meets regulatory requirements. Early engagement can help identify potential manufacturing issues, reduce costs, and improve time-to-market.
In the current climate of medical technology and product development, sustainability is an increasingly important buzzword in medical device design. Designers must consider the environmental impact of the device throughout its lifecycle, from material selection to disposal. Sustainable design can reduce waste, conserve resources, and reduce costs. Designers hold the key to reducing the amount of difficult to recycle single use devices and products there are.
In conclusion, designing a manufacturable medical device or new product requires careful consideration of a wide range of factors, from regulatory compliance to manufacturing processes. By following the tips discussed in this blog, you can create effective, efficient, and successful medical devices that meet the needs of users. If you have any further questions or would like to discuss a project, please get in touch.
Discover how Haughton Design's diverse team leverages their extensive experience to drive innovation in device development. Learn about our expertise and unique insights that ensure successful project...
Explore how commercial constraints influence innovation in businesses. Discover whether budget limits, regulations, and market pressures drive creativity or stifle progress in today's competitive land...
HD strive to foster effective collaboration on all projects to push boundaries in innovation. We discuss how collaboration with the NHS can provide unique insight....
Why do we trust the accuracy of digital devices more than their non-digital counterparts? HD discuss the 'why' and how this improves device development....
We discuss the whether the medical device industry can embrace paper as a viable alternative to plastic as we advance towards Net Zero....
What is the impact of emerging technologies on medical device and product development? Design Engineer, Dan Kirkham, discusses their applications....
We discuss transforming medical device development through the utilisation of interdisciplinary, and cross industry teams....
A pharmaceutical company approached HD to enhance the performance and improve the usability of a Dry Powder Inhaler within a short timeframe and, a tight budget. ...
Pharmapack 2024 was a captivating blend of innovation, collaboration, and foresight. Read our round up of the eco-focused event here....
2023's DDL event brought together industry experts in the field of respiratory health. Here we discuss the latest breakthroughs and innovations....
Should Human Factors as a standalone discipline be made redundant? Design Engineer, Elena, considers this for medical device development?...
Can we achieve the perfect balance of usability, sustainability & connectivity in medical device design? Design Engineer, Rob, considers how....
2023's PDA & PODD conferences provided valuable insight into the drug delivery industry. Here we discuss trends and hot topics from the conferences....
Ahead of the 20th PDA Universe of Pre-Filled Syringes and Injection Devices Conference, we cover where medical device innovations are expected to go....
As the world becomes increasingly connected and user needs constantly evolving, the design of safety critical IFU’s must keep up with this. Design Engineer, Rob, discusses the future of IFU’s, and...
With the speed at which the medical device world is changing, collaborative partnerships will be essential for success. HD discuss the benefits....
