Skip to main content

A Deep Dive into the Medical Device Development Process

Taking a new medical device from the ideation phase to the finish line isn’t a sprint—it’s a marathon. Device discovery is just the first step of a long and winding road that medtech companies must travel to even have the opportunity to bring their innovative medical product to market.

For that reason, medical device research and development isn’t for the faint of heart. There are several stages of medical device development, from R&D to clinical trial design. Not to mention countless regulatory hurdles at every phase, that winnow out would-be entrants.

But the companies that undergo this gauntlet and emerge relatively unscathed do so with a product that’s been tried, tested, and certified.

So, what does the medical device product development process entail? What are the medical device design components? How long does it take? And what are the challenges medtech companies must prepare for?

Let’s dive in.


What Is Medical Device Development?

In the world of digitalism, technology that is widely considered to be the most advanced in its field can rapidly become outmoded in a matter of years, if not months. And the medtech space is no exception.

For that reason, billions of dollars are invested in medical technology development on an annual basis. And, as demand for medical technology innovation rises with each passing year, increasingly more companies enter the space.

Medical device development is the cyclical process of taking an idea for a medtech product and turning that dream into reality.

But, as mentioned, that’s easier said than done.

The companies that actually make it to the product market release stage are in the minority. According to Frontiers in Public Health:1

Quotes Icon

There are only a few technologies and resources that penetrate the market. Medical device development (MDD) is expensive and risky…Product development, from conception to release to market, is a very complex process.

It significantly relies on the application of exact processes that enable developers to optimally stage development, testing, validation, verification, and market release.

That said, there are different categories of medical product development that can impact the expected timeline and obstacles. The FDA classifies these products based on the risk they pose. The three classes are:

Class I: General Controls – These pose the lowest amount of risk to patients. Examples include surgical tools, sutures, or masks. These are subject to “general controls,” which consider the following elements:

Good manufacturing practices
Standards and reporting adverse events to FDA
General recordkeeping requirements

Class II: General Controls with Special Controls – This encompasses most medical devices, which pose a slightly higher risk to patients. Examples include powered wheelchairs, catheters, and syringes. As a result, they are given special controls in addition to the general controls. These include:

Labeling requirements (information that must be included on a product label)
Device-specific mandatory performance standards
Device-specific testing requirements

Class III: General Controls and Premarket Approval – These pose the highest risk to patients. They tend to be devices that are implanted, sustain or support life, or have the potential to cause unreasonable risk of illness or injury. Examples include pacemakers, breast implants, and ventilators. In addition to the controls listed above, class 3 devices must gain premarket approval, wherein medical device manufacturers demonstrate that the device is safe and effective.


How To Develop a Medical Device—What Are the Different Design Phases?

When it comes to the product pipeline, the FDA’s quality system regulation (QSR) outlines five stages of processing that every medical product must undergo to reach regulatory approval. The stages are:3


The inception of most medical devices typically comes from a moment where a researcher sees an unmet need in the medical market. From there, they create a concept for their idea or device that could meet that need, reduce costs, and optimize care delivery.

This is followed by a proof of concept brief that fleshes out the idea and the steps necessary to demonstrate that the product is viable and that there are financial opportunities that justify the exorbitant R&D costs.

As a part of the process, medical researchers need to categorize their product as a class I, II, or III device. How they classify the product will then impact what testing and certification it must undergo.


After the idea has met internal approval—i.e., demonstrated to have a market position, viability, and financial feasibility—the product enters phase two.

To begin, researchers produce a medical device prototype that can be safely tested—not on humans—but in a controlled lab setting.

During this stage, researchers begin brainstorming risks and customer or user needs. Here, customer feedback is essential, whether in the form of:

Parent and family councils
Focus groups
Competitor analysis

This input can then play a crucial role in optimizing the product’s design, which typically follows an iterative process where each newer model is tested and improved upon previous attempts.


As mentioned, these steps are established by the QMS framework. Therefore, the application process depends heavily on your product. A Class I product will have far fewer regulatory hoops it must jump through when compared to a Class III product.

A design history file (DHF) chronicles the tests and controls the product has passed and also outlines the design and manufacturing steps taken to develop the product to its current state. This document is then subject to FDA audits to confirm that the medical device is safe for the general public.


After DFH and FDA testing is completed, medical device manufacturers must apply for FDA clearance. Typically, they will need to file one of three applications:

Humanitarian device exemption
Premarket notification or 510(k)—Class I, II, and III devices
Premarket approval application—Class III devices

If necessary, the FDA may consult an Advisory Committee about whether or not the product should be granted FDA approval. After this, the FDA decides whether the device is:

Not approved
Needs further information

The findings are then required by law to be submitted with all supporting evidence into the Federal Register.


Despite all of the testing a medical device undergoes during the previous four stages, it’s still possible that new problems emerge after it hits the market.

Therefore, the FDA monitors the device’s performance and safety even after it has been approved and gone to market. There are three means by which the FDA engages in safety monitoring. They include:

Manufacturer inspections
Reporting programs
Active surveillance

How Long Does it Take to Develop a Medical Device?

According to Gail A. Van Norman, MD,4 “Bringing a device to market takes an average of 3 to 7 years, compared with an average of 12 years for drugs.” But, in truth, the answer to expected timelines depends heavily on the device itself, with the utmost factor being its classification.

Put simply, the more regulations a product faces, the longer it will inevitably take to reach the market. So, although it’s not always the case, the rough estimate timeframe by classification looks as follows:

A simple class I device could take as little as 18-24 months
A class II device typically takes 3-6 years
A class III device typically takes 5-9 years

What Are the Challenges with Medical Device Development?

There are four primary factors that make medical device development a serious undertaking. Each of these elements can contribute to the length and the cost of the entire process. They include:

Research & Development – R&D is a lengthy and exorbitantly costly process. It requires rigorous clinical trials, studies, and intense collaboration, sometimes on a global scale. Naturally, these preexisting R&D challenges were exacerbated by the pandemic. But this is where virtual work platforms—such as Within3—make it easy to control costs, interact and collaborate from anywhere in the world, and conduct clinical studies.

High costs – EAccording to FDA Impact on US Medical Technology Innovations Survey:5 “The average total cost for participants to bring a 510(k) product from concept to clearance was approximately $31 million, with $24 million spent on FDA dependent and/or related activities. For a Class III Medical device going through a Premarket Approval (PMA), the average total cost from concept to approval was $94 million, with $75 million spent on stages linked to the FDA2.”

Regulations – There are dozens if not hundreds of regulatory requirements even the most simple of medical devices must satisfy. Design control includes:

Design and development planning
Design input
Design output
Design review
Design verification
Design validation
Design transfer
Design changes

Security – Both the physical device, the IP, and the information systems hosting this research are under constant threat of malicious activity—whether by internal or external forces. This data needs to be protected from unauthorized access and use. Therefore, secure software and IT processes must be put in place to ensure the confidentiality, integrity, and availability of information regarding the device’s design and development.


How the Medical Device Development Process can Be Improved

Taking medical devices from concept to market may take several years and cost tens of millions of dollars. And even then, due to the complex nature of the process, there’s still a significant chance that the product fails to produce impactful ROI by the time it finally crosses the finish line and reaches the market.

So, how can you change that? How do you increase your odds of producing a viable product, and do so faster and cheaper?

So, how can you change that? How do you increase your odds of producing a viable product, and do so faster and cheaper? Using Within3’s insights management platform, your team can streamline the various phases of medical device development. Our solution is trusted by the world’s top medical device organizations to help them collaborate virtually, manage the insight lifecycle, and perform clinical trials.

Request a demo today.


  1. 1 Frontiers in Public Health. Medical Device Development Process, and Associated Risks and Legislative Aspects-Systematic Review.
  2. 2 FDA. Device Development Process.
  3. 3 FDA. Quality System (QS) Regulation/Medical Device Good Manufacturing Practices.
  4. 4 Science Direct. Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices.
  5. 5 StarFish. White Paper COst to Develop Medical Devices.