The medical device development process is typically broken down into five distinct phases. Each one requires intense planning, bullet proof documentation and controlled collaboration between teams to be successful.
Understanding how the five phases relate to each other and how their outputs can be stored, shared and controlled by using the right Quality Management tools, can help businesses determine the feasibility of projects much more quickly and bring their product to market with greater success.
We would argue 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, stage gating capabilities and risk management features necessary to develop a safe and efficacious product that will exactly meets user needs.
What are the 5 phases of medical device development?
Phase 1: Initial ideation and risk analysis
This first phase of medical device development includes initial ideation followed by the opportunity and risk analysis that will determine whether you can and should proceed to the next phase.
Activities during this stage include:
Defining what the product is going to do and what its USP will be. This is about defining product/market fit. Is there a sufficient demand and differentiation within your proposed product to make it worth pursuing?
Deciding which markets you are developing your product for. 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 trial requirements.
Formally documenting your business case building and research within an eQMS 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.
Phase 2: Conceptualisation and feasibility
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 will 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 market research to inform your planning and designs.
These customer needs will inform the initial design and development work 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, 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 will help you formalise these 'stop/go' moments in your 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.
Phase 3 - Design and development - Verification and validation
Now you have proof of concept, this phase is about controlling the design and development of a product to ensure you are
- Capturing user requirements effectively
- Turning user requirements into effective engineering specifications
- Designing and building your product according to those user needs & specifications
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
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'.
Phase 4 - Final validation, product tested and approved by competent authority
All data and documentation needs to be assembled ready for submission to competent authorities for product approval, including results from clinical trials..
This part of the process will include review and audit by notified bodies in the UK or the FDA in the US. They will need to audit your process and product, through inspection of your premises and detailed analysis of specific technical files including:
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' .
Phase 5 - Product launch and post launch assessment
Once you have approval for launch, you need to transfer your plans to your chosen 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 manufacturing partner can access all the relevant documentation they will need to produce your product.
Following 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)
This process of ideating, designing and developing a medical device is hugely complex, with many moving parts, documentation requirements and regulatory hurdles to overcome.
We have listed only a few of the processes and requirements integral to the five phases, but they all demonstrate how central good document management will be to your eventual success.
Implementing an eQMS that can ‘phase gate’ each stage of your 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, utlimately, make the whole process more efficient and profitable,