Medical devices are not easy to launch and are masked with layers of regulations. Medical device experts can help hold your hand to guide you throughout the medical device development and make sure you get your product to market.
The medical device development process is often broken down by experts into five distinct phases which all require different levels of planning, documentation and collaboration between teams, to be navigated successfully.
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.
Ideas, Opportunity And Risk Analysis
This first phase of medical device engineering includes initial ideation followed by crucial elements of opportunity and risk analysis that will determine whether you can and should proceed to the next phase. These include:
- Funding strategies
- Medical device market fit. Defining what the product is going to do and what its unique selling proposition will be. Is there a sufficient demand and differentiation within your proposed product to make it worth pursuing?
- Markets and regulatory environment. Which markets are you likely to be developing your product for? What are regulatory demands you will need to adhere to, what classification is the product likely to fall into? This is important since it will determine the likely time and expense you will incur in bringing the product to market.
- Market research to identify similar products. Are there similar products to the one you’re thinking about developing already on the market, which will make getting regulatory approval quicker and reduce clinical trial requirements?
Once you are convinced that your medical device has a market position, is viable and financially feasible, then you can move to the next stage.
Concept And Feasibility
The Concept and feasibility stage in a way is critical as it will be the phase in which you have a working device that proves your idea.
In this phase more formal risk assessment, regulatory and customer requirements gathering takes place with initial prototyping to act as proof of concept (POC) for another stop/go review before continuing with the project.
You need to start documenting 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 medical device 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.
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.
Design And Development
Now you have proof of concept (POC), this phase is about final medical device design and development that meets all the regulatory requirements.
Formal risk analysis requirements feed into this phase of design and, indeed the whole process should continue to be governed by design control processes which are outlined in ISO 13485 and elsewhere.
User requirements are further gathered and turned into a User Requirements Specifications document (URS), and then the physical product itself needs to be validated against the user requirements.
Ensure you know the regulatory requirements of the product and the regulatory requirements of the country/region you are about to sell in. The requirements in the US differ to those in Europe although there is very strong overlap, the submissions process is different. Your market research should have determined which region you wish to launch your product in first, so focus.
If you had determined earlier that you needed Clinical trials for your product, you should begin your Clinical plan and use the product for the trials from your design freeze through actual use in a clinical environment.
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.
Final Validation And Medical Device Launch Preparation
You should be completing your technical documentation now. Bringing together a file full of all the evidence required to put in front of a competent authority that will review/audit your file for completeness against their expectations.
All data and documentation needs to be assembled ready for submission to competent authorities, including results from clinical trials.
This part of the Medical device development process includes review and audit by notified bodies of technical file requirements listed by agencies such as the FDA which you will need to legally launch your product in various territories.
Medical Device Launch And Post Launch Assessment
Once you have approval for launch, you need to transfer your plans to your chosen manufacturer for medical device design.
Your regulatory clearance, technical file review is done and once you have your license or certificate you can place your device on the market.
If you are based outside the EU and you wish to sell your product in Europe, you will need an “Authorised Representative” who is appointed to represent your business in Europe.
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).
Conclusions
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 a Document Management Solution that can ‘phase gate’ each stage of your device development project, storing and collating documentation for approval by key stakeholders at key moments, can help you create a digital framework of constant commercial review.
Having a well managed and fully auditable DMS is part of ISO 13485 and allows you to meet the demands of regulators. It also brings a level of definition, order and efficiency to the five phases of Medical Device development that will only improve your chances of commercial success.
If you need expert advice with your next medical device, Creanova drives healthcare companies through the entire medical device development process, from the earlier stages of requirements definition and feasibility study to industrial design, medical device engineering and prototyping, up to contract manufacturing (certified with ISO 13485).
So, contact us and we’ll build with you the suitable plan for your project and we’ll bring your idea to the market together.
