It’s no secret that the medical device industry is booming. Today, the global medical device market is valued at around $500 billion. Combined with a compound annual growth rate (CAGR) of 6.3% in the next five years, it’s an industry that shows no signs of slowing down. Driving this trend is a combination of sophisticated medical knowledge and cutting-edge tech.
But bringing new devices to market is tricky. Navigating the process requires a thorough understanding of the medical device development timeline under the United States Food and Drug Administration ( US FDA ).
In this article, we walk you through the medical devices research and development process, step-by-step. A solid grasp of these 8 fundamental steps will enable you to better communicate with your team, effectively meet FDA compliance regulations, and streamline your device’s time-to-market (TTM).
What Is a Medical Device?
A medical device is any product designed for healthcare applications. This usually takes the form of an instrument or an implant, an apparatus or a machine. Some medical devices (like tongue depressors) are simple. Others (like implanted cerebral stimulators) are complex.
Healthcare professionals depend on an array of medical devices to monitor, diagnose, and treat patients. Whether a device is simple or highly complex, each must comply with strict regulations to ensure the utmost safety and efficacy. Likewise, each follows a similar product development process . Let’s now look at those 8 stages to develop medical device technology.
Medical Device Development Timeline in 8 Steps
Understanding and adhering to the eight major steps of development will have an enormous impact on the success of your medical device. Below, we break down exactly what you need to know about each stage in the process.
Step 1 – Discovery
Every medical device product starts as a good idea. That’s why the discovery phase is the first stage of the medical device development process . The goal is simple: Develop a viable concept.
Of course, generating a good idea requires an extensive investigation into unmet clinical needs, user requirements, risk analysis , market potential, and existing competition. This will help to determine whether a concept is technically sound and commercially feasible.
The discovery phase often involves evaluating multiple concepts and selecting the most promising one to move forward with. Once a concept is accepted, it’s important to map out its basic features, specs, and any potential regulatory requirements.
Put simply, this stage begins with brainstorming and ends with a successful proof of concept and early design controls .
Step 2 – Design and Engineering
Once the concept has been defined, the design and development phase can begin. This involves creating detailed specifications for the device, followed by medical device prototyping for testing. Once a design is mature, a prototype goes into design freeze and is ready for medical device testing. These tests—known as verification and validation —ensure that the product functions as it should.
During this phase, it’s essential to consider things like quality, usability, safety, scalability, and regulatory requirements. With respect to the latter, be ready to prepare documentation that demonstrates how your product meets the regulatory requirements in order to receive approval from the FDA.
Step 3 – Preclinical Testing
Before a medical device can be studied in humans, it must undergo preclinical testing to ensure its safety and efficacy.
This phase of testing typically involves animal studies, although some devices may undergo simulated use testing, bench testing, or in-vitro testing. The objective is to identify any potential safety issues that may adversely affect human subjects.
Step 4 – Clinical Testing
If your medical device passes preclinical testing, it can move on to clinical testing. This phase involves testing the device on human subjects to determine how safe and effective it is.
Each clinical trial must conform to strict regulations, including obtaining informed consent from participants and reporting any adverse events to regulatory authorities.
These trials are usually conducted in three phases , aptly referred to as Phase I, Phase II, and Phase III. Together, these three phases offer mounting evidence to demonstrate your medical device’s safety, effectiveness, and usability in real-world patient populations.
Step 5 – Regulatory Approval
Once the clinical testing phase is complete, your team will need to prepare and submit a medical device application for regulatory approval. Documentation will consist of items such as clinical trial data, design information, manufacturing processes, and labeling.
Regulatory bodies vary by country. But, in the US, the FDA is responsible for regulating the medical device industry. Therefore, upon receiving FDA approval for your device, you will be legally allowed to begin commercialization.
Step 6 – Manufacturing and Quality Control
Now that your device has met FDA standards, it can enter the manufacturing and quality control phase. Broadly speaking, this involves setting up a medical device manufacturing process that adheres to FDA regulatory requirements and ensures the consistent quality of your product. For long-term viability, your process needs to be both safe and scalable.
A quality management system (QMS) will also be put into place to ensure good manufacturing practices . This involves testing and inspecting the device at various stages throughout the manufacturing process, prior to its release for sale.
Remember, quality control is an ongoing process and any QMS should be ISO 13485 -compliant. This ISO standard provides a framework that ensures your device meets international compliance standards.
Step 7 – Post-Market Surveillance
Once a device is available to patients and healthcare providers, it’s essential to monitor its performance and address any issues that arise.
Post-market surveillance is therefore largely a process of risk management . It involves collecting data on the device’s safety and effectiveness, developing and implementing corrective and preventive actions (CAPAs) to address identified issues, and reporting any adverse events to regulatory authorities.
Step 8 – Continued Development
A lot of medical device development carries on through the entire product life cycle. Over time, manufacturers may continue to refine and improve their products. This is especially true for class II devices .
Continued development may involve developing new features or capabilities, improving the device’s performance or safety, or making other modifications based on feedback from users and healthcare providers.
Depending on the significance of the change or improvement, a letter to file with the FDA is needed or in extreme cases, a full resubmission is required.
As we’ve seen, the medical device product development life cycle is a lengthy and detailed process. But, by following the eight steps outlined above, medical device manufacturers can successfully bring medical device products to market.
Remove the Guesswork From Your Medical Device Development Timeline, With RBC Medical
Medical device development is a complex and highly regulated process that requires a big investment of time, resources, and expertise. In fact, from concept to market, the development timeline can span several years.
To ensure a smooth timeline, it’s important for manufacturers to plan and manage the process effectively. The goal must always be to ensure the device’s safety and efficacy. But that’s often easier said than done.
Looking to streamline your development timeline and eliminate errors? Partner with RBC Medical . For nearly three decades, we’ve helped companies like yours navigate the choppy waters of medical device development. Our services include:
- Medical device design and prototyping
- Medical device design engineering
- Medical device manufacturing
- Medical device regulatory compliance
- And every step in between.
Contact us today to streamline your medical device development timeline .