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  • The Ins and Outs of Making Medical Devices

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Most people have a general understanding of what a medical device is. The first examples one might think of are a pacemaker for the heart, an intrauterine device, or an insulin pump.

In recent years, however, the number of all-new and innovative medical devices that have come onto the market is astonishing.

In fact, the market value of the medical device manufacturer industry was an estimated $176.7 billion in 2020. It surpassed $186 billion in 2021. The five-year forecast is for this sector to reach $262 billion by 2028.

Timeline to Create a New Med-Tech Device

While many people may take these life-saving devices for granted, developing a new medical device takes years of research and testing. The average development time from concept to FDA approval is three to seven years.

This is a complex industry with layers of deeply involved facets, all of which must come together to produce a viable medical device that helps people live better lives –- and which produces a profit for the developer.

One of those complex facets is the regulatory process itself. Tasks such as handling global medical device registration regulations, compliance with government oversight agencies, and tracking statistical success/failure rates are a heavy lift for any entity in the medical device sector.

More on that in a bit, but first let’s take a brief look at the types of medical devices.

Three Classes of Medical Devices

Class 1

Yes, some medical devices can gain regulatory approval in just a couple of weeks.

Simple Class 1 medical devices are tools like electronic toothbrushes, PPE masks, or tongue depressors. The risk of side effects is extremely low with Class 1 devices. They are usually non-invasive.

Class 2

These are devices that bear more risk to the user and are more invasive of the body than Class 1. A good example is contact lenses. Others are a catheter, a home pregnancy test, or an ultra-fine needle pen syringe. About 43% of all medical devices are Class 2. The average time to achieve FDA approval is 177 days or about six months. Fewer than 20% get approval in less than three months.

Class 3

About 10% of medical devices are in the Class 3 category. They are mostly invasive and pose the highest risk to the user. Classic examples are a heart pacemaker, cochlear implants, implanted prostheses, or a defibrillator.

The level of testing and checking of such devices required during development is of a far higher magnitude than any Class 2 device. Numerous rigorous scientific studies are involved. With this in mind, it is surprising that the average approval time for Class 3 devices is about 243 days after submission to the FDA.

That’s down from an average of 345 days from about 10 years ago, however.

Remember that FDA approval is only a segment of the timeline. Before a device even gets to that stage, three to five years of development has most likely occurred.

Bureaucracy and Regulation

After years of R&D, testing, clinical trials, and navigating the stringent FDA approval process, a medical device that is ready for the market still must accommodate all kinds of regulatory issues and hurdles.

Consider that a medical device manufacturer must market its device on a global scale to make a profit. FDA approval is just for one country – the United States. It is not uncommon for a medical device to be introduced into 150 nations, all of which have a unique process and set of requirements to ensure compliance with local standards.

The Software Solution

That’s why medical technology firms have turned heavily to software solutions to handle what is truly an immense and ongoing facet of managing this asset class. A regulatory information management system (RIMS) is an effective way to accomplish multiple tasks, such as streamlining the application process itself, managing device application requirements, and making sure that regulatory requirements are met.

Furthermore, an effective RIMS software can make it easy to access a vast network of industry experts for fast consulting to solve key problems with compliance issues and the maze of regulations.


Finally, to get an idea about how much money a medical technology firm needs to develop a device, the mean development cost for a complex medical device is $54 million –- and that does not include further outlay for needs like post-approval studies.

It’s not uncommon for $200 million or more to be spent on the development of a single medical device.

By Rayanne Morriss
who has shared this article.

Member since January, 2023
View all the articles of Rayanne Morriss.

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