Although there are a number of existing design process’, through our history of challenging, fast turnaround, product, medical device and engineering projects in a broad range of industries, we recognised that the process of developing a new product wasn’t always clear to all stakeholders.
Clients typically need to know what work needs to be done, clearly understand the investment required and when to expect delivery – our Development WorkFlow is perfect for that!
Our workflow was created to enable every project stakeholder, to easily see what needs doing and when. It’s used from our very first client meeting until our involvement in the project is complete. It’s a highly visual, one page document, so a project’s requirements are crystal clear and all in one place. Our clients quickly understand they can enter, or leave at any phase or stage of the process. They can access just one or two services to complete their projects faster or, work with us on their full product or medical device project from concept to manufacture.
The added bonus for our own project managers and design team is that it’s just as clear to them. It enables everyone to work together toward the same, clear, goal. Combining this approach with our ISO systems means we can develop products and medical devices more efficiently, robustly and to the correct standards.
Our general process is broken down into 10 clear phases. However, no two projects are the same, therefore we create a bespoke WorkFlow with tailored tasks and deliverables for each project we undertake. Everyone who’s used it loves it’s simplicity, and the logic it brings together.
Our process is based upon BS.7000-2 with adaptations to suit learning from many projects over 20 years of design and engineering work. If you are considering new product development for the first time, it’s well worth spending some time getting to know the standard and our process before you start. If you have a team of designers who are regularly developing new products, then creating a bespoke workflow should be considered as this enables the whole team work to an effective process. This ensures more flexibility for people to move across projects as it’s much easier to pick up a project in a standardised workflow process than lots of projects all run in a different way. We recognise there are times for less structured and sprint type work, sometimes this can fast progress and bring rapid gains. However, this is early stage design work, and particularly for highly regulated industries, these activities still need to be incorporated into a structured and controlled process.
Here’s a quick summary of each stage of the workflow we have created together with what we do and the benefits each stage brings to the overall project:
Thorough discovery and design immersion will kick start your project with a solid foundation and clear inputs for rapid start-up. It is essential to understand user requirements, conduct technical research, identify risks and review regulatory requirements. We may also research your competitor’s products, investigate patents and undertake focus groups to generate a detailed Project Input Document.
Blending our engineering and manufacturing know how with design creativity, generates innovative concepts and develops valuable intellectual property for you to exploit. We start by producing ideas, which are formed into hand sketches and broad-brush designs for you to review. Levering both sides expertise, we develop the strongest ideas to a more refined level, 3D CAD models are built and photo realistic renders or animations generated to bring a product to life. Proof of principle and styling prototypes are often built to gather feedback from stakeholders, reduce risk and identify areas for further development.
Gathering costings and identifying potential suppliers allows the project’s feasibility to be confirmed before committing to further development and investment. As many designs will be highly innovative, some projects may need further technical research to ensure concept ideas are feasible before full scale development.
Concept designs are developed to a more detailed level so prototypes so or, one-off bespoke pieces of equipment can be manufactured. We engineer our designs with consideration for manufacture from the outset, utilising 3D CAD and simulation techniques to ensure it is fit for purpose. At this stage, it is important to develop designs swiftly, with a right first-time mentality. Often blending traditional manufacturing and 3D methodologies for the best balance of cost/performance, it is common to make prototypes for novel and complex projects. Activities may need to suit regulatory requirements and the detailed scope of work.
Manufacturing drawings are produced and supplied with 3D or 2D data, for efficient manufacture of parts and assemblies. With critical dimensions, materials, heat treatments and finishes detailed, the drawings allow designs to be easily manufactured through various sources. Alternatively, prototypes for additive or CNC manufacturing may not require sophisticated drawings so a design intent document will be supplied as an alternative.
The manufacture, build and test of prototypes allows concepts to be proven and early-stage products to be developed quickly. Some complex and novel projects may require several iterations of prototypes (Phase 2B) to achieve the breakthrough required. We physically build prototype mechanical parts and bought out items together with basic PCB and breadboard components. This gathers knowledge for volume manufacturing. Prototype test rigs and external test houses may be utilised to gather key performance data and results.
Design optimisation through detailed development and thorough engineering is used to ensure the product is robust and cost effective to manufacture in higher volumes. The prototype design is rebuilt to suit volume production techniques and to suit the manufacturing methods selected for each component. This stage is likely to include advanced CAD techniques, such as FEA, tolerance analysis and automated assembly considerations. Development activities may be monitored and managed using techniques such as dFMEA’s and FTA to ensure compliance with regulatory requirements.
Manufacturing drawings are produced and supplied with 3D or 2D data, for efficient manufacture of parts and assemblies. With critical dimensions and toleranced features, materials, heat treatments and finishes, the drawings allow designs to be cost effectively manufactured and assembled in high volumes. We liaise with suppliers throughout the design optimisation process to ensure robust design and manufacturing requirements are achieved.
Production intent prototypes are manufactured, often from soft tooling, built and tested to confirm functionality and performance. We liaise with suppliers during tooling manufacture and provide support whilst trials are conducted, to ensure all design requirements are met. First-off components and assemblies are checked to ensure designs can be verified and the final product validated.
The design is transferred during industrialisation through delivery of a final data pack and provision of support for all stakeholders. We will liaise and can provide our services, tooling or components to ensure the transfer is smooth so the product can be fully industrialised and marketed as efficiently as possible.
We hope this answers some of your questions around what is the new product development process with examples and benefits. Developing new products and medical devices can be time consuming and expensive so adopting a suitable workflow and development process will provide clear direction of what needs to be done, will reduce iterations and minimise design loops.
Please get in touch to discuss the process in more depth and how we can help you with your product or medical device development!
Human Factors Design Engineer & Marketing Manager
Amber graduated from Cardiff Metropolitan University with a degree in Product Design. She has a particular interest in the medical field stemming from her personal experience of using a medical device. She pairs her design background with her personal experiences to apply empathy and develop improved user experiences. Amber also combines this understanding to liaise with customers and create digital content at HD.
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