The medical device development process is usually split by experts into 4 phases which all require different levels of designing, documentation, and collaboration between teams to be navigated successfully.
This process of ideating, designing, and developing a medical device is hugely complex, with many moving parts, documentation requirements, and regulatory hurdles to beat.
Among the process, the first stages play a central role within the medical device development and may bring the new medical device to market more quickly and with greater success.
Let’s have a proper look to all 4 first stages of medical device development:
- Phase 1: Market opportunities
This first phase of medical device development includes initial ideation followed by crucial elements of opportunity and risk analysis which will determine whether you will proceed to the subsequent phase. These include:- Defining the purpose of the device and what its Unique Selling Proposition is going to be.
This is often about defining product-market fit. - Identification of target markets and relevant regulatory demands you’ll get to adhere to, according to the classification of the product. Which markets you would like to enter is prime as each market has its own regulations and challenges.
This is very important because it’ll determine the time and expense you’ll incur in bringing the device to market.
- Are there similar products to the one you’re brooding about developing already on the market, which can make getting regulatory approval quicker and reduce clinical test requirements? Otherwise, if you’re developing a product that nobody has produced before, confirm you protect it by filing for IP (Intellectual Property) and patent your idea.
Your marketing research is prime because it highlitghs if your venture is feasible or unfeasible.
Once you’re convinced that your device features a market position, is viable and financially feasible, then you’ll move to the subsequent stage.
- Defining the purpose of the device and what its Unique Selling Proposition is going to be.
- Phase 2: Regulatory obligations
The previous step is additionally important to classify the device to make sure the right regulations are followed during subsequent steps.
Medical device development is one of the foremost heavily regulated sectors within the world. We conclude, therefore, that within the future successful medical device developers will get to understand from the outset of their journey what their regulatory obligations are going to be, consistent with the type of equipment.
The classification will depend upon where you propose to plug the device. In the US, for instance, the subsequent FDA classifications apply:
Class I – for easy medical device industrial designs and products that carry little or no or no risk
Class II – for products with a more complicated design that pose some risk to users
Class III – for intricate designs and products that carry the best amount of risk
In Europe, the regulations that govern the event of medical devices will either be the Medical Devices
Regulation (MDR) EU 2017/745 or the In Vitro Diagnostic medical devices Regulation (IVDR) EU 2017/746.
In the EU market, these legislations will dictate and define the processes you’ll get to undergo to secure your CE marking, the sole method by which you’ll be legally allowed to plug your product therein territory.
- Phase 3: Medical device requirements
Start brooding about risks and customer requirements early. At this stage, you would like to listen to the voice of the customer and take feedback via surveys, competitor analysis, marketing research, etc and adopt this into the planning of your product. And don’t forget to document each step of the way!
The best start line to validate your idea is to research your chosen user group (these might include patients affected by a selected disease or condition or clinicians of a selected medical specialty).
Find out from them what their biggest problem or unmet need is. In fact, gathering a comprehensive set of ‘user needs’ for your medical device is a component of the wants of ISO 13485 and, therefore, necessary for successful CE marking or other regulatory product approval.
Ultimately, this may become a part of the need Specification against which you’ll design a tool to unravel their problem.
Design inputs include those mandatory elements and other requirements, derived from user research or regulation, that you simply will get to understand and incorporate into your final, definitive product designs.
You need them to deliver a product that will ultimately answer market needs.
Medical device design inputs include:- functional, performance, and safety requirements, consistent with the intended use
- applicable statutory and regulatory requirements
- information derived from previous similar designs
- other requirements essential for design and development, and
- output(s) of risk management
- functional, performance, and safety requirements, consistent with the intended use
According to some experts, the method of defining your inputs is completely essential to urge this right.
The design and development process is all about managing these inputs and turning them into outputs (designs, specifications, plans, prototypes, etc). The ultimate design and device outputs, in fact, should be capable of being verified and validated against these original inputs.
From your initial ideation process will emerge a group of specification documents that can govern your design work. These are your Product Requirements Documents (PRD).
Those documents should specify the way the device is meant to be used.
Without specifying solutions, they should state a series of discrete requirements for the device and the way the user should interact with it.
More precisely, the document should state:
- The known physical characteristics of the device to be developed
- The imagined operating logic of the interface
- How it should be interacted with
- How it’s expected to perform
- What is known about the user population and its characteristics?
- Will they be clinical professionals, trained or untrained?
- What age and gender are they?
- Are they likely to possess disabilities or infirmities which will affect the way they use the device?
- What training and knowledge will they have to use the device safely and effectively?
- What is known about the environment where the device is predicted to be used?
- Is it clinical or domestic?
- Will it be utilized in a home, hospital, or ambulance?
- What are the potential environmental impacts on the use of the device especially settings, i.e. is it expected that there’ll be noise, traffic?
It should be expected that a PRD will develop within the early phases of the project. Once initially issued, the PRD shall be subject to various control procedures.
The way the ultimate device functions will eventually be validated against these PRD.
- Phase 4: Development plan
So, you’ve had your brilliant idea. you recognize what device you would like to create. You’ve got a vision of the merchandise and a billboard proposition that has been validated by your research and now you’ve got to plan your next steps.
It requires that you simply put together an idea for the safe delivery of your outcome. It requires that you simply define and observe a group of systematic processes and procedures that will allow you to manage, review, and document every step of that plan and its delivery.
The plan should define the objectives and parameters of every stage of a project and assist you to deliver against them. Of course, particular elements within your plan will inevitably fail and disintegrate, change and reshape themselves as you go along.
The plan’s existence as a baseline for your projects’ deliverables and therefore the procedures you adopt to validate and deliver against it are what counts.
As a proper, approved document the plan should begin your assumptions and therefore the important decisions you’ve got made before commencing the build. It will form the idea of a shared understanding amongst project stakeholders, since it’ll contain within it the approved scope of the project, including a basic schedule and timeline for completion.
If you would like expert advice together with your next medical device, Creanova drives healthcare companies through the whole medical device development process, from the sooner stages of requirements definition and feasibility study to medical device 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 plan for your project and we’ll bring your idea to the market, together.
