The Top Medical Device Trends in 2020 - Qualio
https://www.qualio.com/blog/medical-device-trends
1. European Union Medical Device Regulation Preparation 1. European Union Medical Device Regulation Preparation
European Union Medical Device Regulation (EU MDR) readiness has dominated medical device manufacturer's focus recently. If you are a manufacturer, authorized representative, importer, or distributor of medical devices in the EU, compliance is required. Here are some of the most significant : Eliminate or reduce risks as much as possible, taking protection measures in relation to risks that cannot be eliminated
Provide information for safety and train users as appropriate
Inform users of any residual risks, eliminating or reducing risks related to use error
The characteristics and performance shall not be adversely affected during the lifetime of the device
The characteristics and performance are not adversely affected during transport and storage
All known and foreseeable risks shall be acceptable when weighed against the evaluated benefits to the patient and/or user. Recently, the European Council voted 27–0 to adopt an amendment to delay the application of the Medical Devices Regulation by one year. EU MDR, originally scheduled to go into effect on May 26, 2020, will now take effect on May 26, 2021.2. FDA Breakthrough Device Program Matures 2. FDA Breakthrough Device Program Matures
The Breakthrough Device Program is a voluntary program for medical devices that provide the treatment or diagnosis of life-threatening or debilitating conditions. The goal of this program is to provide patients and health care providers with timely access to these medical devices by speeding development, assessment, and review.
Devices subject to pre-market approval must meet the following : The device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions
The device also meets at least one of the following: Represent breakthrough technology
No approved or cleared alternatives exist
Offers significant advantages over existing approved or cleared alternatives
Device availability is in the best interest of patients To request a Breakthrough Device Designation, you can submit a "Designation Request for Breakthrough Device" Q-Submission. Procedures for submitting a Q-Submission are outlined in .3. Increased Focus on Quality Management 3. Increased Focus on Quality Management
Achieving a quality-driven culture enables your organization to reduce unnecessary quality costs and regulatory risks, which means you can introduce your product to market faster and more efficiently.
Qualio is the first cloud-based eQMS designed to help simplify comprehensive quality management at life sciences organizations involved in the development, production, and distribution of pharmaceuticals, medical devices, and biotechnology products. This solution includes all of the tools needed for fast-growing organizations to excel at audits, proactively eliminate defects, and achieve the business benefits of quality-driven growth.4. Increased Revenues in Medical Device Market 4. Increased Revenues in Medical Device Market
According to one , the United States remains the largest medical device market in the world at $156 billion (40% percent of the global market). By 2023, the medical device market is expected to grow to $208 billion.
"The industry includes almost 2 million jobs in the United States, including both direct and indirect employment. Medical technology directly accounts for well over 300,000 of these jobs. More than 80% of medical device companies in the United States consist of fewer than 50 employees, and many (notably startup companies) have little or no sales revenue."
When you consider the market potential, many new life sciences organizations are expected to emerge as key industry players.
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