The Design Control Process
Trying to make a design and development process with several teams on different fields can be quite burdensome if they don’t know where they should meet in the process and what they should deliver in order to get a product that meets everyone’s expectations, especially the user ones.
For that, we created a process that would allow us to define which deliverables would be needed through the whole process and who has the responsibilities of performing them. The division of the process in planned stages, with a revision performed at the end, allows us to understand where we and everyone else is standing in the process and work towards the same goal.
We took in consideration the guidelines of the applicable ISO on Quality Management Systems for medical devices (ISO13485:2016) and asked the teams and they feel it would be most valuable to get through the design and development process so it would make their work easier. We did some brainstorming sessions with all our team leaders and joined their feedback on a timeline.
Besides the mandatory items set by the standard, we considered what we would need to produce taking into consideration a user-centred approach, using design thinking methodologies.
The standard ISO13485:2016 mandates the following steps on Design and Development:
Design and Development Planning: before any project starts, planning is essential to understand the feasibility of the project, what will be needed and when should it be delivered. You should ask yourself the following questions:
Which stages of design and development will I need, and which outcomes do I want to get from them?
What reviews need to be made between each stage?
What are the verification, validation, and design transfer activities that will be needed?
Who should be responsible for each design stage or for reviewing the outcomes?
What resources will you need? It can be materials, training, human resources, man-hours, whatever is relevant.
2. Design and Development Inputs: these relate to the specifications needed to comply with each requirement set. Inputs should include:
Functional, performance, usability, and safety requirements, according to the intended use;
Applicable regulatory requirements and standards;
What should be taken into consideration given your risk management.
3. Design and Development Outputs: these will specify how the Design and Development Inputs were met, using the appropriate evidence.
4. Design and Development Review: between each stage, the progress should be reviewed to make sure the initial requirements are still being met and identify necessary actions if needed.
5. Design and Development Verification: verification activities ensure the outputs have met the inputs. This includes methods, acceptance criteria, and if appropriate statistical techniques.
6. Design and Development Validation: validation activities are performed to check if the resulting product is capable of meeting the specified application or intended use. It shall be conducted on representative products.
7. Design and Development Transfer: in this stage, the outputs should be documented into procedures for manufacturing, ensuring the production team also has the right tools and the knowledge from the development team is transferred.
8. Control of design and development changes: the definition of how changes should be controlled must be defined, to ensure changes are reviewed, verified, validated, and approved.
After taking those essential stages into consideration, we have considered some others to fulfill our needs:
User focus: start with researching who your main user is going to be, the environment they’ll be working on, what’s their current workflow, and where/when you can make a difference. If possible, co-designing a solution with your stakeholders is ideal to get the most resourceful product at the end. After you define the specifications and get the first prototype, and during your development it is essential to go back to your stakeholders and validate your solution. It is easier to implement their feedback when you’re still prototyping than when you have finished your product and are reaching a deadline to deliver. You can make use of strategies such as focus groups, thinking out loud (get them to tell what they’re doing while working with your product), feedback forms, recording their interactions with the system, etc.
Start planning for manufacturing from the beginning: make sure you design your product in a way that is scalable for manufacturing. List and contact potential manufacturing partners to understand the feasibility of making your product and identify your needed resources.
Design for sustainability: it was Adapttech’s decision to try and start making progress in making our products more sustainable. This is also a process that needs to start when you define the components and partners. By selecting low-impact materials, reducing the weight and volume of your product, optimizing the production technology and the distribution system, optimizing your product-life and ensuring you can create a sustainable end of life system, you can for sure have a lower impact on the planet while still providing a product that will improve your stakeholders’ lives.
Define a business plan at the beginning: it’s easier to motivate and guide the work of the development team when you have objective goals in mind: when do you want to start selling, what profit margin do you want to make, etc.
Keep on working with your stakeholders: even when you finish designing and send your product to the market, you need to understand how your product is behaving. Get easy ways for your customer to interact with you and take better advantage of the product: create a support line, get support scripts to easily tackle the client’s issues, do periodic user surveys and inform them of the newest releases and tips on how to use the device. To get a grip of their usage, define KPIs to monitor their usage and feedback of the system.
Our Design and Control system has many other guidelines, but I tried to resume some that I think are pretty essential and that are overlooked at the beginning of the design process. Don’t forget that planning ahead is your best tool to avoid your future self from facing issues you could have prevented in the beginning.
