Breaking down the device development process into phases helps medical device companies meet ISO 13485 and FDA requirements for project management and design control. It allows user needs to be gathered and formally converted into specifications. It ensures deliverables are continually validated against designs at key stages of your process.
While phase gating your process is a key part of compliance, working in cycles of continual review can also be a useful commercial tool for businesses keen to avoid wasted time and resource in already long and complex product cycles.
So, what is the right project framework for correctly transforming required design inputs into validated design outputs? And what digital tools do you need in place to accelerate and automate your process?
This first phase of medical device development includes initial ideation followed by the opportunity and risk analysis that will determine whether you should proceed to the next phase.
Activities during this stage include:
Are you intending to sell in EU and the US? What classification is the product likely to fall into in these markets? This is important since it will determine the likely time and expense you will incur in bringing the product to market.
You should also research to see if there are similar products to the one you’re thinking about developing already on the market, This could make getting regulatory approval quicker and reduce clinical investigation requirements.
Formally documenting your business case building and research within an eQMS (electronic Quality Management System) will help bring your ideas together and share them with your team more successfully. It will ensure all feedback is stored in one place and your decision making can be properly audited in the future.
Once you are convinced that your device has a market position, is viable and financially feasible, then you can move to the next stage.
In this phase more formal risk assessment, regulatory and customer requirements gathering takes place with initial prototyping to act as proof of concept for another stop/go review before continuing with the project..
You should now be documenting detailed customer needs, taking feedback via surveys and research with patients and clinicians. This will all be supplemented by competitor analysis as well as life science market research to inform your planning and designs.
These customer needs will inform the initial design inputs that aids conceptualisation and proof of concept via prototyping of all (or part) of a conceived product.
This process needs to be done iteratively through a cycle of design, development and review controlled by a Quality Management System.
At the end of this phase you will know if the concept is feasible. You'll have the proof that it can be translated into a product that can be manufactured for practical use in the market, while meeting customer needs in a way that improves on existing solutions.
The right eQMS (electronic quality management system) will help you formalise these 'stop/go' moments in your product development process. It will help you specify and gather required documentation for approval by key stakeholders before the next phase of development can be triggered.
Now you have proof of concept, this phase is about controlling the generation of design inputs and design outputs to ensure you are:
User requirements are further gathered and turned into a User Requirements Specifications document (URS).
Engineering Design Specifications (EDS) are then developed through an iterative process, which leads to the creation of a complete set of designs.
Design verification and device validation
Those designs need to be verified against the EDS before the product is built, and then the physical product itself needs to be validated against the user requirements (URS).
Throughout this stage, a constant process of planning, design, review and approval needs to take place that will create an auditable trail of the steps you have taken to reduce risk of failure and harm to the end user.
If you had determined earlier that you needed Clinical trials for your product, you should enact your Clinical plan at this point.
The digital tools that come with an eQMS are a key way of triggering and automating all these required processes at the right moment so that these controls become simply 'the way you do things'.
All data and documentation need to be assembled and ready for submission to competent authorities for product approval, including evidence of design verification and results from clinical trials.
This part of the process will include review and audit by notified bodies in the UK, EU or the FDA in the US in the US. These authorities will need to audit your process and product, through inspection of your premises and detailed analysis of specific technical files.
Technical file requirements for FDA approval
The Device Master Record (DMR) - the definitive ‘instruction manual’ for the safe and compliant manufacture of your medical device.
The Design History File (DHF) - the complete record of the way that instruction manual was designed and compiled in the first place.
The Device History Record (DHR) - the demonstrable proof that you have used that instruction manual in the manufacture of your device.
The right eQMS will have been helping you collate and index all the relevant documentation for these technical files as your project has progressed, so that they are available for audit ‘on demand’.
Once you have approval for launch, you need to transfer your plans to your chosen medical device contract manufacturer for production.
It’s worth noting the quality of the eQMS tools you have deployed throughout the development process will determine how easy it is for you to share your IP securely with an outside organisation in a seamless and error-free way.
A good set of QMS tools will allow you to publish files to an Extranet where your medical device manufacturing partner can access all the relevant documentation they will need to produce your product.
Following the launch, your QMS will also need to be capable of capturing customer complaints and feedback, with a proper mechanism for triggering appropriate action (for example, product recall, incorporating new features for future releases etc).
Using an electronic Quality Management System (eQMS) underpinned with the right document management tools, will help you establish a digital framework early on that can define and structure this phased approach.
It will help you deliver the required design and document controls, with the phase-gating capabilities and risk management features necessary to develop a safe and efficacious product that exactly meets user needs.
This process of ideating, designing and developing a medical device is hugely complex, with many moving parts, documentation requirements and regulatory hurdles to overcome. With the increase of IoT and medical device software integration into devices, the complexity of development, documentation and validation is only going to increase.
Implementing an eQMS that can ‘phase gate’ each stage of your medical device development project is vital. It needs to be able to store and collate documentation for approval by key stakeholders at key moments in the process. Without this you'll never be able to prove to regulators that you have the necessary controls in place to develop products that meet required quality standards.
An eQMS will bring the required structure and momentum to a large and sprawling project. It should bring a continual cycle of ‘plan, act, do, check’ into your working processes, to record each stage of your journey for future audit, and help you manage all the commercial and regulatory risks such a project entails.
Having a well-managed and fully auditable eQMS is vital for gaining ISO 13485 and meeting the demands of regulators to create a safe and efficacious product that exactly meets customer needs.
In doing so it can also bring a level of definition, order, and efficiency to the five phases of development that will, ultimately, make the whole process more efficient and profitable,