The medical device development process is certainly not as simple as bringing an idea from thought process to production. There are many different obstacles to overcome, the potential hazards to consider and those that must be approved before equipment can be manufactured. Creating new products is no easy feat, and this blog post aims to dig deeper into the product development process of medical devices.
Understanding the medical device development process
The planning stages of developing a medical device will include investing in market research, assembling a development team, and identifying your target audience. In this section, we will look at a proper example of the development process.
Part 1: Research, Opportunity and Risk Assessment
In the early stages of product development, important aspects to consider include funding, development teams, market research, and documentation. Keep records of any plans, designs and anything else related to the development of the medical device.
A quality management system (QMS) will be needed to match your documents, forms, procedures and templates to how a company’s activity is handled. The most common standard used is ISO 13485 because it is internationally recognized and is often chosen by medical device companies.
Part 2: Concept and Feasibility
This is when a more serious risk assessment must be performed to determine how well the product will meet the requirements of regulatory bodies, such as the FDA or MHRA, as well as the needs of customers. Part 2 is where the initial prototyping begins. It is important that client needs are closely observed and customer feedback is collected using surveys and discussions with physicians and patients.
The feedback received and prototype demonstrations can be used to support the concept and demonstrate how viable the product would be in its target market. If it is not, this is the stage where changes must be made until you have a reliable product with which you can proceed.
Part 3: Design and Development
At the end of Phase 2, the product concept should have been finalized. Now, in Phase 3, the focus is on verifying and validating the medical device to make sure it is suitable for the public.
Customer requirements are a key component in this phase and they will become the User Requirement Specification Document (URS) which is used to develop the Engineering Design Specifications (EDS). A plan should be set out to determine how the product will be tested against these requirements and a manufacturing and quality plan will be set.
Risk management is also important because designers need to consider any and all potential risks to medical equipment and how they can be prevented. If the risks are sufficiently extreme to be fatal, consider how likely it is that the device will be approved.
Part 4: Getting Final Verification, Product Launch and Approval
During this phase, marketing and branding can be developed and all the data obtained in phase 3 should be aggregated and prepared to be presented to the relevant bodies. These entities will then audit your product, your premises and the documents provided.
Part 5: Product Launch
If the product arrives in part 5 – congratulations are in order! Before finally releasing the product to market, do a final check of any technical documentation, make any final updates required and prepare for product launch.
Once a product is available, a strategy will be needed to handle orders, feedback and complaints as well as a plan for further testing and updates.
Although developing a medical device requires a lot of time and effort, it can be extremely rewarding. There are a few points to remember: Be ready to constantly update and improve, listen to customer feedback, and don’t cut corners.
Regulations for the development of medical devices
Exact product development strategies differ in all regions, as there are different standards that must be met. However, these requirements are governed by relevant authorities such as the Food and Drug Administration (FDA) in the United States and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
In the United States, the FDA has a 5-step process for developing new products to ensure that they are safe and run effectively when manufactured.
The FDA has a responsibility to research information and data about equipment before it is made available for use, to continue monitoring the equipment for any problems, and to maintain the required standards.
The device development process is done in the following five basic steps.
- Phase 1 Discovery/Concept: This is when research is initiated for a new instrument in a laboratory.
- Phase 2 Preclinical Research: Testing is done on equipment to check basic safety levels.
- Phase 3 clinical research: At this stage, devices will be tested on people to make sure they are safe and effective.
- Phase 4 FDA review: Review teams will examine all information about the device and decide whether to approve it.
- Phase 5 Post-market Safety Monitoring: The FDA will continue to monitor any device that is made available to the public.
Jordi Labs and Developing Medical Devices
Jordi Labs plays a number of roles in the development of medical devices. Our goal is to help companies bring high quality, compliant and safe products to the market. We are able to do this in a number of ways, including:
- custom deformation
- small scale manufacturing
- Assist in design, fabrication and characterization processes
- Witness Services for Litigation Scenarios
- contamination and failure checks
- A wide range of regulatory testing
If you would like to request a quote or speak to an expert for any of our services, please do not hesitate to contact us.