Medical Device Design and Product Development

Medical devices come in many forms. In recent years, PDFact has developed medical devices and equipment to support a variety of functions including a syringe label position measurement fixture, medical device assembly systems, and vision systems for documentation and measurement.

According to the market research firm The Business Research Co., global sales of medical devices and other products reached $456.9 billion in 2019, with an increased compound annual growth rate of 4.4% since 2015.

Within the complex ecosystem of medical device product development, there is a need for custom automated solutions that support R&D efforts. Products and automations can be designed to optimize human usability and increase safety in specific clinical environments. 

Identification of opportunities to implement new products or custom automatons in specific environments helps to eliminate waste, decrease repetitious work, and streamline tasks required to meet regulatory requirements. 

While humans focus on complex functions, automations provide greater predictability and reliability for repetitive tasks. As a result, productivity increases.

Ultimately, the life science industry seeks automated solutions for the same reason as every other industry—to improve the lives of humans.

From Concept to Product Realization

Every attempt to create a novel product or process requires a skilled combination of art and science. The goal is to put things together in a useful way, that is technically sound, to solve a specific problem. 

Through the process, a range of factors come into consideration. In order to streamline the product development process, secure intellectual property rights, adhere to relevant regulatory documentation, and bring the product to life, a complex process unfolds. 

The objective is to find the simplest possible solution to achieve optimal usability. Through ongoing consultation and collaboration, the product or process will eventually meet the client’s exact goals and specifications. 

When determining the best way to perform necessary operations in a specific environment, layers of information and complex procedures are carried out through design, engineering, and fabrication. 

An experienced team will ensure that the product or system achieves respective project goals and adheres to intellectual property and regulatory requirements, when applicable.

Here are four key drivers behind product development in medical devices and equipment. 

  1. Intended Use: User Needs, Requirements, and Safety

Medical device development takes into consideration equipment design, ergonomics, repeatability, and safety to ensure that the product solves the initial problem with efficacy. 

When there’s a need for a new piece of equipment or a new device that will save time and improve productivity, it’s important to have clarity about the exact problem that needs to be solved by the end-user. 

Users should be able to focus on the task that needs to be accomplished, not on operating the device or equipment. The product or equipment should streamline work tasks and improve process flows with human-centered design.

Focus on user needs ensures that the product meets specifications and fits into pre-existing processes or systems. The product development team can help clarify intended use and the reasons why and how a new product should be introduced.

  1. Context of Use: Users and Environments

When devices are developed for clinical settings, there are environmental considerations and space restrictions that inform product design and development. Context of use for the product or system is another key consideration. 

The environment where the end-user will interact with the product and compliance requirements inform product design and development. In addition, functionality and maneuverability will be influenced by the context in which the product will be used. 

Through the work of industrial designers and mechanical engineers, medical products and equipment are made to exact specifications. Throughout the product development process, changes will occur and adjustments will be made as new information becomes available.

After careful consideration of the environment, opportunities to improve efficiencies in systems are identified, resulting in time-saving solutions, reduced costs, and increased safety. 

  1. Understand Where the Device Fits into Larger Systems and Processes

Product development efforts can overlap with various departments within an organization. It’s important to understand how the product development process and resulting products integrate with existing systems, processes, and procedures.

Product development firms factor in efficacy, safety standards, knowledge of regulations, best practices, and privacy through each step of the process. Knowledge of the IP and market landscapes are two huge factors that shape solutions.

Product developers can advise about additional features that appeal to target markets and help clients make choices about specific functional methods that minimize IP infringement.

High-quality products and equipment designed to be used in clinical environments are developed, tested, validated, and verified to perform in restrictive spaces under certain conditions. The design process is controlled with a systematic approach to ensure that requirements are met, and cost-benefit is clear for clients.

  1. Trends in Medical Devices and Products

Innovation moves quickly in the medical device space. Closed-loop medical devices are at the forefront. Leading-edge technology continues to increase the demand for wireless devices in medical products and equipment. Wearables are increasing in popularity as sensor technology improves.

As the medical industry trends toward at-home care, there’s increased demand for home health solutions. Millions of individuals and caretakers are in need of at-home care products and home-use drug delivery solutions.

Product development experts are instrumental in bringing medical and life science innovations to market. As technology allows for medical care adaptations to improve, product development firms will continue to create custom solutions that meet specific needs.


The demand for novel products, equipment, and automations in clinical environments continues. The medical industry is trending in favor of at-home care. Medical devices and equipment must be designed for user safety both within organizations and in-home environments.

PDFact offers a high level of design and engineering expertise, project management skills, and a commitment to collaboration. PDFact works closely with clients to develop products that meet unique specifications and exceed expectations. 

Every product and automation is built to meet client requirements and deliver a high degree of specificity. The goal is to continuously improve outcomes for clients and end-users. 

Please contact PDFact to learn more about medical product development processes and custom automation solutions to support your facility or business.