Regulations in medical device production are costly but necessary. They are established by commissions like the FDA and EPA to create a regulatory framework, in the words of the European Commission, “that improves clinical safety and creates fair market access for manufacturer and healthcare professionals.”
With medical technology expanding its scope as a result of both technological advances as well as the COVID-19 pandemic, the industry is predicted to soon be worth more than $500 billion, with a particular emphasis on telemedicine and digital health advances. Within the framework of this growing industry, navigating these regulations has become a more significant aspect of any product development cycle. In this article, we discuss:
Why medical device regulations are necessary
The components of medical device regulations
A case study of medical device development
How to prepare for regulation using a skilled product developer
Why are Medical Device Regulations Necessary?
Medical device regulations apply to not only the devices manufactured in a country but any that are repackaged, imported, or otherwise sold there. In the United States, the main regulatory commission is the FDA, which enforces regulations for the safety of the patients and healthcare workers who use them.
Though they impose restrictions on the development process, these guidelines indicate a prospering industry experiencing growth in all technology sectors, which is good news for product development. As more breakthroughs are made, regulations become a more significant factor in how medical technologies are conceived and developed.
Medical device regulations adhere to four broad categories that product developers must take to heart to get their product finished and approved. These categories can be described as preclinical, clinical, post-market, and multi-phase regulations.
Preclinical – Preclinical regulations refer to manufacturing guidelines that must be met before devices are given premarket approval. This includes both a device listing and establishment registration.
Clinical – Clinical regulations must be followed before the device can be approved for its stated use. The FDA requires premarket notification backed by clinical studies before authorizing the product for clinical use.
Post-market – Post-market regulations involve making the regulatory commission aware of the device’s shortcomings, including any defects, side effects, or known issues.
Multi-phase – Multi-phase regulations include how the devices will be serviced after they are sold, including quality assurance, labeling, and the included instructions.
How to Prepare for Each Phase of Regulation
An experienced product developer can prepare your device to pass the relevant regulatory commission’s requirements. Here are some of the advantages of using a developer to create your product:
Cross-functional teams work through a product’s development cycle using insights and research to create a diverse market strategy.
Ideation involves developing an idea for a medical device into a functional plan using quantitative studies on the technology’s effectiveness, observing trends in the core audience, testing the concept for its pros and cons, and researching the intended consumer base, all of which require industry experience.
On-Site control allows the company to unify the design based on the stated goal, the clinical feedback, and the relevant regulations.
Engineering is a complex process of prototyping, testing, and changing. Product developers with on-site engineering facilities can create test versions and share them with your team and end-users to get the appropriate feedback.
Case Study: AURA by Sterifre
To demonstrate how we help client-partners navigate medical device regulations, we want to examine Sterifre’s disinfecting device, AURA, which was approved by the EPA in 2022. The AURA system is believed to be the first registered, automated, point-of-care solution providing fast disinfection for non-critical medical devices and common articles used in the healthcare environment. It replaces the need for cumbersome and often challenging manual disinfection with wipes, reducing exposure of health care workers and patients alike to pathogens that cause healthcare associated infections.
EPA approval came as a result of several key factors, including solving the procedural challenges of manual disinfection. This has been the focus of Sterifre’s team of expert founders and industry leaders for a number of years. The EPA registration allows them to now bring the AURA system to market and help improve the well-being of healthcare workers and patients alike.
The FDA examined how the device stacked up against its stated intentions and whether it received approval at each stage of its development.
Nottingham Spirk was hired to develop the overall design of the device, transforming a functional prototype into a microwave-sized device that is ready to head to market. As with other devices we have helped develop, such as TecTraum’s pro2cool and SoftVue by Delphinus, our goal was a unified development process that prepared the product both for its stated performance goals as well as for the FDA or EPA regulations.
The Takeaway for Product Developers
Medical device regulations operate on behalf of the patients and health care workers who will eventually use the devices. Developing devices that meet these regulations at each of the four stages of development requires a product developer that integrates feedback, testing, on-site development, engineering, and more. As the medical technology industry grows, these regulations will only become more significant considerations during the product development process.
There is no doubt that the regulatory hoops involved in medical device development are daunting. Luckily, we have a golden track record, and we are here to help. Contact us to discuss your project.