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Navigating the Complexities of Medical Device Design and Development

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Advancements in the fields of medicine and technology continue to spur innovation. MedTech companies and device makers are pushing the boundaries of what’s possible, bringing on the next evolution of modern healthcare with game-changing devices that include everything from wearable sensors to IoT technology. In 2021 alone, the global medical device industry had a value of almost $489 billion.

Forecasts show that number significantly growing in the coming years. While medical technology was already making impressive strides, the global pandemic kicked product development into high gear.

If you’re looking to design and develop a medical device, you have a massive undertaking ahead of you. Whether you’re a new MedTech startup or an established company with plenty of capital to invest, creating a new medical device requires successfully executing many critical processes to reach your desired outcome.

Navigating the Complex Development Cycle

Compliance is one of the biggest hurdles when turning ideas into tangible products. All medical devices sold in the USA must go through the United States Food and Drug Administration (FDA) approval process. The FDA regulates the sale of medical devices, ensuring that everything that hits the market is safe and efficacious.

As you can imagine, complying with FDA standards impacts the entire development process. Unless you want to risk injunctions, fines, and possible criminal prosecution, you must consider FDA regulations during every step of the design phase. Similar regulations exist for devices sold in other countries, particularly European CE requirements.

Medical Device Design and Development

There are many ways to approach the design process of a new medical device. However, the FDA’s design control process provides a formalized approach to developing Class I, II, and III medical devices. It’s a requirement for Class II and III, and some Class I products.

Regulated under 21 CFR 820.30, this process ensures safety and efficacy are designed in during the development cycle. Following this process carefully reduces issues and helps you bring your product to market as smoothly as possible.

1. Conceptualization

The first general stages of design and development begin with a core concept. Every great product starts with simple ideation. You should gather a team of key decision-makers from all facets of your company to flesh out simple ideas. This stage is holistic and organic. It might involve multiple brainstorming sessions and constant back-and-forth with various teams of your organization.

Whether you have an existing idea, this stage typically involves identifying user needs and looking at the larger market. It’s about figuring out what type of product you want to create, who the end users will be, and what it can do to address their unique needs.

2. Due Diligence

Once your ideas start to take shape, you can begin your due diligence. Developing a new product is a significant investment. Before you take any steps to bring your plans to life, you must determine if it’s feasible from a practicality and business standpoint.

Here’s where you perform in-depth market research and feasibility studies. Market research ensures a need and demand for a device like yours. Meanwhile, feasibility studies help you gain more insight into functionality and other core device concepts.

It’s also an excellent time to analyze risks and take steps to mitigate issues moving forward. Risk management is an ongoing process. But the earlier you start, the easier it becomes to plan for all possible scenarios later in the development cycle.

Mitigating Risk in Wearables Medical Device Design

3. Product Requirements and Specifications

This step in the design process is where your product begins to come to life. Writing product requirements for medical devices is critical. Your device’s requirements define what the product is, how it works, and what types of functionalities the finished design should have. Establishing core mechanical, electrical, and software specifications can clarify details across your teams, eliminating confusion and avoiding unnecessary setbacks.

Requirements make it easier to understand device structure and functions. The information you create will also play a crucial role in helping you stay compliant with FDA regulations and other medical device standards. Making requirements takes time and will likely evolve after further product development. But, establishing these specifications will help guide the design moving forward.

Requirements must be written such that each item can be determined to pass or fail when tested. The verification testing, step 7, consists of testing each item in the requirements. If the result is ambiguous, it will be hard to show that the requirements have been met.

Guide to Developing Product Requirements for Medical Device

4. Design Inputs

Design inputs refer to the physical and performance requirements of your device. It includes the requirements and other documentation that define how the device is to operate and the standards it must meet. Design inputs are the starting point for development and act as the foundation of your entire project. Think of it as the basis of the design.

In this step, you want to gather the information you have created that lays out precisely what you want your device to do, how it looks, and other core considerations. The design input is what you’ll build on, so you must ensure that the physical and performance requirements are appropriate for the device’s intended use.

For example, will this device be portable? If so, your design input will include details like weight, final size, etc.

You should specify standards the device must meet, such as ISO 13485, ISO 60601, and ISO 62304 for software. Being detailed and complete avoids confusion and problems later. You should specify the version of these standards that will apply and for ISO 60601, specify the sections that apply.

5. The Design Reviews

Your product should go through a strict review stage at several points during the design process. These are significant milestones that can help you track development progress and mitigate issues in the future. The goal at each review stage is to examine the work and ensure that everything is on track.

There are many moving parts during the design process. Different teams have their hands in the work, and you must check in periodically to spot potential issues and resolve them before moving into production.

Reviews are best if done formally and involve well-documented investigations. You may test against specific criteria or perform physical tests and simulations. Either way, the objective is to spot flaws and improve communication within the team.

The results will highlight redundancies, failures, and other issues that need reworking. You can then go back to the drawing board, make corrections, and review again before getting satisfactory results and continuing with development.

6. Design Outputs

The design outputs refer to the results of every design effort. The best way to look at the design output is to view it as the end product of every design phase. You’ll use the design outputs to ensure that the work conforms to the design inputs and support the set requirements through the process called verification testing (See #7 below).

Like the design inputs, outputs must be well-documented. These are the documents from which the device will be manufactured. They must be precisely accurate, or you will have manufacturing problems. Furthermore, they often become the basis of the design phases to follow.

Some examples of design outputs include chosen specs, diagrams, drawings, and other supporting documents or steps.

Are You Making A Medical Device?

7. Verification

Verification is yet another test. However, this one gauges how your design compares to the requirements. Formal testing is done to test that each requirement is met.

This step needs careful documentation. Verification testing is done for every facet of your device. More importantly, these tests must be well-documented with a formal process required by the FDA. You must provide objective evidence that all specified conditions are met to meet FDA compliance.

8. Validation

Verification and validation are two sides to the same coin. While verification ensures that a product design meets all requirements, validation revolves around the end user’s needs. Does your medical device fulfill user needs and provide the functionality you claim? That’s what validation figures out.

Typically, third-party testers will validate a design. It’s an external process involving clinical trials, specialists’ simulations, and more. The FDA often requires this step to get approval. If your device is shown to be similar to another approved device, you may not need to do any clinical trials, saving a lot of time and money.

9. Design Transfer

This step marks the end of the design process. As the name would imply, it’s when the development team transfers the design to the production team. It actually occurs after verification and validation (V & V). The verification and validation need to be done with devices designed according to your design outputs. There may be revisions as a result of V & V, so you may do the design transfer again after V & V.

While no designing occurs in this phase, it does involve careful documentation. Typically, developers create a detailed checklist to maintain all control standards as the project transitions to the next stage.

Put Your Project in Good Hands

As you can see, designing and developing a new medical device is complex. This description is just a glimpse of what it takes to turn ideas into fully functioning products. The logistics of gaining FDA approval or clearance can make things even more challenging.

Luckily, you don’t have to go through this process alone. Let Voler Systems help you develop your next medical device. We understand what it takes to build a product from the ground up. Our team has decades of experience navigating federal regulations, and our attention to detail will help us bring your product to life as smoothly as possible.

Contact Voler Systems Today

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