The Design Process Of Medical Devices At Devicelab Part 7

Blog Archive

Mar
2021

How to Study and Market Your Device in Four Steps Based on the FDA’s Regulations


Medical device manufacturers can market their devices in the US once they meet all applicable FDA regulations. These regulations can be broken down into four main steps and can guide medical device design. These steps simplify how the FDA regulates medical devices as per the Federal Food, Drug, and Cosmetics Act. Step 1: Device Classification […]

Read More

Mar
2021

Medical Device Needs to Support Telemedicine


Previously, we wrote about COVID-19 making telemedicine a new normal and that it has a strong potential to remain in high usage beyond the pandemic. Telemedicine was once a niche model of health care delivery but has become more mainstream as an answer to providing healthcare during the COVID-19 crisis. Even with re-opening and the […]

Read More

Feb
2021

How to Study and Market Your Device in Four Steps


Medical device manufacturers can legally market their devices in the US once they meet all applicable FDA regulations. These regulations can be broken down into four main steps and can guide medical device design. These steps simplify how the FDA regulates medical devices as per the Federal Food, Drug, and Cosmetics Act. Step 1: Device […]

Read More

Feb
2021

”Breakthrough Devices” and the FDA SteP Program


  As part of the “21st Century Cures Act” in 2017, the FDA introduced a new program for innovative medical devices and combination products designed to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. This program is called the “Breakthrough Device Program,” and it is a voluntary program to facilitate market access by […]

Read More

Jan
2021

HIPAA Compliant Software for Medical Devices – What You Need to Know


Software as a Medical Device (SaMD) is defined by the FDA as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” Within the medical device industry, SaMD and cybersecurity have been a topic of conversation as the FDA implements a regulatory […]

Read More

Jan
2021

FDA Classification of Medical Devices


FDA has a public obligation to regulate and control the distribution of medical devices for public safety. To do this, medical device manufacturers provide information and data about their product to the FDA to assess the product for safety and effectiveness. However, not all products require the same level of review by the FDA. A […]

Read More

Nov
2020

The Medical Product Development & Design Process at DeviceLab – A Complete Guide


Part 1: Introduction Some of the information discussed will be the implementation of internationally recognized standards for quality systems, and the distillation of 20 years’ experience in project management, design, and engineering. You’ll learn how we organize our efforts and resources, and how we manage activities, timelines, and budgets. We also describe our commitment to […]

Read More

Jul
2020

The Design Process of Medical Devices at DeviceLab | Part 9


Part 9: When to Invoke Design Controls in a Medical Device Project Many medical device executives bemoan the burdens of Design Controls, claiming that they stifle creativity and drive up costs. That may be so, but we’re stuck with them. Given their unavoidability, we’re left to find ways to make these controls less burdensome and […]

Read More

Jun
2020

The Design Process of Medical Devices at DeviceLab | Part 8


Part 8: Tips for Outsourcing Medical Device Development DeviceLab has been doing medical device projects for 20 years, with over 100 major programs completed. Our team also includes members who have worked at other design firms, and have seen lots of different approaches to program management. As a result, we have developed a set of […]

Read More

Jun
2020

The Design Process of Medical Devices at DeviceLab | Part 7


Part 7: Leveraging Prototypes in Medical Device Development There’s a long list of reasons why we believe it’s wise to build prototypes when you’re developing a medical device, but the overriding reason is to facilitate learning. Even experienced designers, aided by powerful design and analysis tools, learn a lot by building prototypes. Predicting things like […]

Read More