Medical Product Development: How to Create a Successful Medical Device from Scratch

New product development is the way for businesses to encourage innovation and provide unique solutions to customer needs. However, in the medical industry due to strict regulatory standards for medical device manufacturing, it can be incredibly costly and time-consuming to make a product. 

Although regulatory standards differ from country to country, the product development life cycle follows a general trend when bringing new products into the market. 

After learning about the complications surrounding the creation of medical products, many medical practitioners may be hesitant. But with the right strategy, developing an innovative medical device leads to the betterment of thousands of lives and can be highly profitable.

In this article, we’ll discuss what medical product development is, its classifications, and the steps involved in the medical product development process.

What is Medical Product Development?

Medical product development is the process of developing medical devices to treat an existing disease or illness effectively. Often medical product development entails a lengthy regulatory process.

Generally, the process of creating medical products varies depending on the type and class of product you are creating, which is why it’s important to first understand the classifications of medical devices.

Classification Types of Medical Devices

Knowing which class your device falls into is important because it helps you understand what testing, claims, and certifications need to be done to get FDA approval and market your product.

Class 1 Device

Class 1 products are considered low-risk products carrying less potential for harm. These devices can be for external use like an oxygen mask and are subject to general controls after they have been manufactured. 

According to the FDA, general controls consist of:

  • Following good manufacturing methods and practices
  • Reporting negative events to FDA
  • Registering the process
  • Adhering to general recordkeeping requirements

It is relatively easy to manufacture and gain approval for Class 1 products compared to Class 2 & 3 devices, because they require less testing.

Class 2 Device

Class 2 devices pose lesser risk than Class 3 devices but are riskier than Class 1 devices. Class 2 devices are subject to two layers of control: general controls and special controls. General controls remain the same as Class 1, but special controls involve:

  • Including necessary product labels and requirements
  • Maintaining device-specific performance standards
  • Conducting mandatory device-specific tests

Class 3 Device

Class 3 devices pose the greatest risk when used on patients as they may be responsible for supporting/sustaining a person’s life, are injected into the body, or can cause life-altering injuries or illnesses. For this reason, Class 3 devices are subject to general controls and require pre-market approval from the FDA.

A pre-market approval may be achieved by the manufacturer by providing evidence that the device in question is effective and safe which may be done through the submission of a proof of concept.

Once you familiarize yourself with the above classifications you may be able to better understand how your production process will look so you can plan an effective strategy to ensure higher chances of approval for your medical device.

5 Stages of the Medical Device Development Process

  1. Research & Discovery

The first stage of medical product development starts with understanding your target  market and discovering the feasibility of your project. In this stage, you’ll be conducting market research, assessing the risk, claiming your idea, and setting up a quality management system to manage it all.

Market Research

Before starting development, it’s important to ensure that there’s a market for your product. Market research allows you to create successful products that satisfy a patient’s  medical needs. This research also informs how you will test your product, and what regulatory standards you are expected to meet. 

It’ll also allow you to identify whether or not your product is feasible. If it isn’t you may be able to locate another market and introduce your product there through an authorized representative.

It is vital to conduct market research to know the demands of your market because regulatory standards, testing requirements, customer demands, and competition may be different from one location to another. It’s also important to conduct competitor analysis to find out what’s working for your competitors and whether a product similar to your idea already exists.

Risk Management

After discovering the market you want to operate in and finding ideas for your medical device, you need to check the feasibility of your project and conduct a risk analysis. At this stage, it’s essential to assess the risk regarding the development and launch of your new product to develop a plan to effectively manage these risks.

By using risk management techniques and tools like FMEA or the Risk Management Matrix you can anticipate and monitor risks before they occur. Performing risk management will also save you money in the long run as it will give you an idea of whether or not your product is financially feasible.

File for Intellectual Property and Patents

If you are developing a product that’s not been made before, it’s important to secure your intellectual property (IP) by filing for a patent. 

Set up a Quality Management System

A quality management system (QMS) is a system that documents all your forms, procedures, policies, and controls during the medical device product development process. It should align with your business goals and vision as well as customer requirements.

ISO-13485 is the internationally approved standard and requirement for a QMS and is used by most medical companies.

  1. Design & Development

After claiming your idea and finding a market for your medical device, the design and development stage will start to turn your idea into a reality. In this stage, designers and developers make a concept design of the medical device and manufacture it into a workable prototype that gives an idea of the final product.

Design Planning

Before designers start creating the concepts for the medical device, they need to gather all the requirements and research that were identified in the first phase. A formal design plan is then developed to document the product development process according to regulatory standards.

In this document, first, the design inputs will be identified as user needs. This will set the foundation for the medical device and help answer questions like: how will the medical device be manufactured, what kind of testing will be required, and what equipment is needed.

Developers also define design outputs. Here the medical device design inputs or user needs are translated into an initial concept under design control protocols. Product engineers may use sketches or CAD software to create a concept of the design that incorporates the aesthetics and functionality to be tested.

After the creation of a concept, this design is passed to manufacturing to produce a sample of the medical device for testing purposes.

Design Verification & Validation

Once the initial concept is designed and manufactured, testing is done to verify that the design was made according to the requirements mentioned in the document. After verification, the design has to be validated for effectiveness and accuracy and whether it meets the user’s needs or not.

This is an opportunity to point out any faults and design errors in the process. If the device does not work as intended or doesn’t look the way it should, there follows repeated iterations of the design process until the right design emerges. Through multiple iterations and constant feedback, the right design can be made, making for adequate proof of concept.

Proof of Concept

A proof of concept (PoC) outlines the steps and evidence derived from the medical device development process and indicates if a concept is feasible. When preparing a PoC you need to make sure that it answers questions revolving around the safety, regulations, efficiency, cost, and manufacturing of the product.

Prototyping

After multiple iterations of the initial concept and the creation of a PoC, developers create a prototype of the medical device for the purpose of preclinical and clinical trials. 

Although prototypes have to be made according to detailed documentation – including the design and product specifications – it’s important to know that they are primarily for testing purposes. That’s why a prototype may not have the exact functionality of the final product and may perform only the core functions of the product.

Consider Risks

The design has started to take shape and now you have a prototype in hand, however, it’s important to keep track of the possible risks your device may still pose to end users. 

Will the device cause any negative side effects? How will you control the potential harm of the device? Can you ensure that the product will be used beneficially? If not, how can they use it in a way to cause more harm than good? 

By considering risk management early in the process, before scaling up production, you can mitigate the risk and minimize the chances of failure of your medical device product launch.

Design Review

Design reviews carry overall importance in the medical device development process and are conducted throughout the development phases. A design review keeps track of the medical device design and helps the team determine if the proposed product meets user needs and is progressing as it should.

A great way to conduct design reviews can be through a design trace matrix, which highlights the relationship between your product and customer requirements and helps you find out if you are consistently meeting customer requirements or are steering off-track.

  1. Preclinical Research

The prototype developed in the prior phase is a basic version of the medical device and is not supposed to be tested on humans. Researchers first test it in a controlled setting through preclinical tests.

Preclinical testing is an essential part of developing a medical product because it ensures the device is suitable to test on humans. Below are three different types of preclinical tests.

  1. Bench Testing

Bench testing or performance testing is done to indicate any performance-related problems in the medical device prototype. It’s also designed to test the efficacy, endurance, and capability of the medical device to perform under different conditions.

  1. Reliability Testing

Reliability tests are conducted to assess how reliable the medical device is in different scenarios and check whether the medical device produces satisfactory results over a varied period.

  1. Animal Testing

Animal testing for medical devices is designed to see how the device interacts in a living system and to check the biological response it gives. 

Testing on animals provides significant evidence of the safety and efficiency of the device which can also help in getting approval. However, it should be mentioned that the FDA doesn’t specifically state that it requires animal tests for the approval of a product.

Other types of tests may be done such as compliance testing, GUI testing, interoperability testing, etc. 

Before conducting tests for your new medical product, you should first know and understand what types of tests need to be done and why, including which ones are obligatory according to regulatory bodies.

  1. Testing & Approval

Medical device testing largely depends on the classification of your medical device as each class is subject to different regulatory controls.

There are different types of medical device tests – some mandatory, others optional – that the team may need to conduct to receive FDA approval.

Premarket Approval (PMA)

Premarket approval (PMA) is necessary for a Class 3 medical device, whereas Class 1 devices don’t need premarket approval and are approved more easily. 

The PMA is a scientific and regulatory review of the medical device which looks at the safety & efficacy of a Class 3 device.

PMA may consist of exhaustive tests because its purpose is to minimize the risk of the medical device. These tests may include experimenting with:

  • Polymers
  • Metallics
  • Ceramics
  • Composite materials
  • Pharmaceuticals

For businesses to get PMA they need to ensure that their product has:

  • Scientific evidence proving that potential benefits outweigh potential risks to patients
  • The potential to benefit its target population

Stability Testing

Stability testing for a medical device further assures that the product can withstand different environmental conditions. Its purpose is to determine how the medical device reacts to environmental effects such as temperature, moisture, light, pH, and agitation.

Shipping Testing

Before starting mass production of the medical device, it’s also important to make sure that the product is ready to ship. Shipping tests are conducted to see how the medical device interacts with packaging while identifying any weaknesses in the packaging system.

FDA acknowledges packaging design as an essential step in the medical device production process so testing to ensure it performs well can set you up for success. The most common shipping tests include:

  • Manual checking
  • Vehicle stacking
  • Low-pressure, high-altitude testing
  • Peal, burst, and bubble test
  • Microbiological tightness testing

Produce Technical Documentation

After performing all the tests, you’re finally ready to produce your technical documentation. This document includes all of your studies, findings, experiments, and processes as evidence of your medical device development process. 

This is needed to provide evidence to the FDA, or any other authoritative body in your region, that your device meets regulatory standards and is made through a formal process.

FDA Approval

The FDA has established a risk-based classification system that varies the approval process according to the device type. For Class 3 devices you should gain pre-market approval first whereas Class 1 and Class 2 devices may be approved without PMA.

Regardless of the device type, the FDA still needs to hold a public meeting and meet with the FDA Advisory Committee which consists of expert consultants who advise on the decision of approval. The FDA then decides whether the device should be approved or not. The FDA then publishes its decision along with supporting evidence in the Federal Register.

  1. Commercialization

Commercialization of your product is the final stage. This is where all your hard work is turned into a usable product with the potential to drive massive profits. 

Getting approval for your medical device allows you to officially launch your product. Prior development phases should have given you adequate information to refine your packaging system, reducing the chances of market failure post-launch. 

There are many processes that you may need to implement to convert potential customers and minimize risk of failure.

Post-Market Launch

After launching your product in the market you need to closely monitor it to track customer complaints and feedback. You should have quality systems installed that will allow you to capture post-market complaints and enable you to use this information to update your risk management system.

Getting feedback and incorporating it into the product early on will help maintain the product and its effectiveness, keeping you on top of competitors, enabling you to update the product based on safety and performance requirements.

Perform Audits

A post-market assessment is vital to ensure your technical documentation is up to date with the product design and functionality. After receiving feedback from customers you may need to consider whether you must update your technical documentation, design documentation, and/or perform additional testing of the product.

If you come across significant problems in the medical device post-launch, developers should inform the FDA through their reporting platforms.

Reporting Problems

Although preclinical test results and technical documentation provide enough information on the safety & efficacy of a device, problems can still occur in a product that has been approved.

If you’ve managed to identify a problem(s) then you can report them to FDA through two of their official programs:

  • MedWatch – a program run by the FDA to give medical professionals and manufacturers a platform to report adverse events. You can also subscribe to MedWatch to get regular updates on safety information and alerts.
  • Medical Product Safety Network (Medsun) – a program where 350 healthcare professionals are located throughout the U.S. to report problems they find in medical devices that could potentially cause serious harm including major injuries or death. You can subscribe to their newsletter to be notified of their consumer reports on important medical device safety information to ensure the safety of your product.

Conclusion

Product development in the medical device industry is a high-risk high-reward activity. Extensive regulatory requirements, high costs, and time-consuming processes may make people – health professionals and manufacturers alike – hesitate to engage in medical product development.

Despite the possible risks associated with the manufacturing of medical devices, new product development (NPD) in the medical industry carries significant importance. Developing medical devices can lead to efficient solutions to treat illnesses and help thousands of people. Also due to regulatory standards and high barriers to entry, a successful medical device may stand the test of time because of low competition while driving higher profits to the business.