Upcoming EU MDR Replacing MDD: Implementation and Deadlines
The European Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) entered into force on May 25, 2017, replacing the Medical Device Directive (MDD), the Active Implantable Medical Device Directive (AIMD) and the In-Vitro Diagnostics Directive (IVDD).
The MDR is scheduled to come into effect on May 26, 2020.
Group Group will develop Single Connectivity Standard for Smart-Home Products
After years of failed efforts to dominate the smart home market with their own products and standards, tech giants Amazon, Apple, and Google, along with the Zigbee Alliance have agreed to collaborate on a set of common code to enable an array of smart home products to function together. Connected smart-home products range from cameras and thermostats to digital assistants.
Engineering Services Firms Can Be Valuable Partners
The global engineering services market size is $990 Billion, and the market’s growth is expected to accelerate in the coming years.
Traditionally, Engineering Service Providers (ESP) were categorized as third-party vendors. However, the dynamic changes for product development and manufacturing in the last decade has made them key players in the product development cycle.
Utilizing 900 MHz For Low Power Long Range Sensors
In the last 15 years, Wi-Fi has evolved to a robust and versatile technology; it is being improved almost constantly. The 802.11ah standard provides two things important for IoT sensor systems: range and low power consumption, expanding Wi-Fi’s integral role in collecting data from large amounts of sensors.
The Future of Voice User Interface in Healthcare
The potential for voice-user interface (VUI) technology has immense potential for applications within the healthcare field. With over 24% of U.S. households using either Alexa, Siri or Google, users are familiar with using voice commands and interacting with the voice-user interface (VUI). With voice technologies, healthcare providers can optimize their time and resources, and patient care can be maximized using artificial human responses.
Managing Cybersecurity Risks of Medical Devices in Hospital Environments
Healthcare is susceptible to cyber threats and therefore there is a need for cyber security to eliminate vulnerabilities. To address these risks, last December, the Department of Health and Human Services released cyber security guidelines for the healthcare sector, Health Industry Cybersecurity Practices (HICP): Managing Threats and Protecting Patients. The report’s procedures are not requirements; instead, it outlines voluntary cyber security practices to reduce security risks.
Replacing the MDD by May 2020
The EU Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in the EU and compliance with the regulation is mandatory for medical device manufacturers that want to sell their products in Europe. The MDR replaces the MDD (medical device directives) regulations that manufacturers currently must adhere to.
The "No-Deal" Scenario
With the defeat of the agreement on the withdrawal of the United Kingdom (UK) from the European Union (EU) and the March 29, 2019 deadline approaching, there is a real possibility that the UK will leave without a deal in place. In fact, it is recommended that medical device manufacturers be prepared for a “no-deal” Brexit. So, what does the “no-deal” scenario mean for medical device manufactures?
Potential Uses
Blockchain, a technology that allows computers to share information and exchange assets without a centralized gatekeeper, is ideal for recording transactional data. Once a block is added to the chain, it is nearly impossible to change it. These features have enormous potential for future medical device development.
Using Radio-Frequency Identification (RFID) to Identify and Track Tags
RFID technology is being increasingly utilized for complex use cases, such as device provisioning to other radio networks, detecting the presence of required accessories or disposables, the usage count of accessories or disposables, sterilization status, manufacturing date codes etc.
Narrowband IoT is Long Range, Low Power and Low Cost
NB-IOT is newest LPWAN network, with cellular carriers planning to launch in early 2019. NB-IoT was standardized in mid-2016 by 3GPP (Third Generation Partnership Project). It is intended for devices with low data rates, requiring much lower power for extended battery life, as well as ability to operate indoors. Although it is integrated into the LTE standard, it can be regarded as a new over the air interface.
Antenna Choice, Design, and Integration in Connected Devices
Antenna performance in connected devices affects the total system performance and drives many system and subtle design choices. Correct antennae choice, design, and integration are critical to achieving optimal data rates and link reliability in varying environments and time-varying use cases.
Overcoming Design Challenges Including Antennae Choice, User Interface and Required Certifications
Challenges in product design and performance appear as IoT medical devices become smaller. These include design functionality, constrained user interfaces, antennae choice, battery considerations, required certifications, and specialty testing.
Overcoming the Challenge of Achieving Compliance in Multiple Markets
The Medical Device Single Audit Program is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory compliance of up to five different medical device markets in lieu of the current market specific regulations.