The medical device marketplace can be a tough nut to crack. Aside from the conceptualization and manufacturing, there’s a ton of paperwork that needs to be done to see any success. It only gets more complicated when you want to enter various marketplaces—and you probably will if you want to make a profit—as each country has their own regulations and specifications to comply with.
If you fail to comply with regulations, your product is unlikely to see the light of day. So, designing a medical device is a complicated task for an organization, especially for a start-up. But to help you out, I’m going to go over the product development life cycle so you can get it right the first time.
I think it’s worth giving you the FDA’s definition of a medical device to ensure your product meets its most basic criteria. A medical device is:
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).”
The main takeaway here is that your device needs to assist in diagnosing, curing, treating, mitigating, or preventing a disease without the use of drugs.
New medical devices need to serve a purpose. Your new product either needs to be:
- Disruptive: A new design that fulfills an unmet need and is completely original. It could improve treatment outcomes, assist in managing or monitoring the health of patients, speed up the delivery of services, or improve on another facet of the medical industry.
- Incremental: An incremental design builds on something that has already been done. You could make a new syringe that is faster, safer, and more accurate than syringes of the past.
Analyzing the market is a necessary step in creating a product that will be successful. If you create something that nobody thought was needed, you’re unlikely to see much success.
The medical device industry is governed by regulations that monitor the design, development, and testing processes of the devices to ensure their safety. It’s important to work through the criteria and regulations while developing your product to ensure you’re meeting all the requirements.
Unfortunately, complications arise when you enter into the international market, as most countries have their own set of rules. While there is the International Medical Device Regulators Forum (IMDRF), whose goal is to create international regulations that all medical device manufacturers must follow, it’s still mostly a national issue. So, if you plan on entering the lucrative Chinese, European, and Canadian markets, do your research beforehand.
In the United States, medical devices are controlled by the FDA, who have their own set of rules that need to be followed when going through the process.
Design Control Process
The FDA ensures that all medical devices are safe to use before they hit the market. They must comply with the FDA’s Quality System Regulations (QSR). However, the medical device industry is extremely broad, so the QSR only outlines the final goal—how the manufacturers get there is entirely up to them.
Design controls are in place to ensure manufacturers meet specific criteria before going to market. Medical device companies usually create these systems while they move along in the life cycle, but they must be complete before you can sell your device. Put simply, they exist to make sure the product you end up creating is what you intended on developing and that it has a use in the industry.
This process has a few goals, some of which include:
- Ensuring that the final product works and is needed.
- Enabling manufacturers to easily meet regulations set out by the FDA.
- Making sure the prototype(s) match the concept, which helps manufacturers with the design process.
The design control process includes the phases listed below.
Design and Development Planning
Without a good plan, you’re bound to go awry. At this stage, you need to figure out all of the development phases as well as who is going to be responsible for what and how everyone is going to communicate. You also need to outline the verification and validation techniques for each phase, what kinds of records are necessary, and how they’re going to be kept.
This is not a one and done kind of plan. It needs to be kept up to date at every step along the way until the design is finished and tested.
The design input process is when you and your team use regulations, the devices desired performance, economics, and other factors to create your device. During this process, teams may create and distribute surveys among their potential customers, including doctors, hospitals, nurses, and whoever else may purchase the medical devices.
As you begin to receive the results, use the knowledge to improve your product and ensure its intended use is clear. Your team needs to identify how the design can address a need in the marketplace before starting to design the device, ensuring all the requirements are met along the way.
During this phase, the device specifications are compared to the FDA’s requirements to ensure that they are being met. The design output works in tandem with the design input and it’s a continuous cycle. When the design output finally matches the design input, the process is complete.
The team should be referring to the design input documents while creating the output. They need to keep in mind the outputs necessary for the device to work properly and ensure they are included. All tests done to ensure that outputs meet the inputs must be recorded. Possible examples of design outputs include the device itself, technical files, risk analysis, studies done on the device or anything relevant to it, and the user manual.
At this point, the organization needs to review all of the other phases, identify mistakes and deficiencies, and address them. Make sure many sets of eyes review the design besides the person directly involved in each design stage. They may catch something that no one else has.
Two types of design reviews are hazard analysis and failure mode and effect analysis. Hazard analysis refers to the process of identifying hazards that could result from the device and cause potential problems. Failure mode and effect analysis involves searching every part, component, and assembly of the device to look for potential failures, identifying how they are caused, and coming up with ways to fix them. These results should be recorded in the design history file (DHF).
Iterative testing of medical devices is crucial, as potential failures and safety hazards cause serious harm. The verification process is in place to make sure that the design output meets all the requirements set out by the design input.
The device needs to be verified by objective evidence. These tests and processes must be recorded in the DHF to prove that the design outputs were finished and successful. The design output process must be planned ahead of time and examined to make sure nothing is left out.
The design validation process determines if the product delivers what it was intended to and if it has any benefit for the medical industry. This step follows design verification. The device is tested using certified and regulated testing methods.
Any change in the device’s design must be recorded, verified, validated, and approved before moving forward.
Guarantee that there will be no problems when moving from development to manufacturing. Product specifications must be easily understood by manufacturers.
Design History File
A DHF is required to outline the entire history of the design. It’s a file that proves all of the design controls were followed and keeps track of the changes made throughout the process. It needs to be accessible to everyone who’s worked on the device.
As you can tell, medical device design and manufacturing is a very complex process, more so than any other device. There are tons of government regulations put in place to confirm medical devices are safe, necessary, and effective.
At Cad Crowd, we have medical product design specialists who can help you conceptualize your idea and work through this process. If you already have a completed concept and need help with manufacturing and design, we can also help with that. Just shoot us a message and we can provide a free quote!