Implementing Robust Measures

According to the World Health Organization, eight percent of all medical devices on the market are counterfeit, which is not only a danger to patients but also presents implications for OEM liability and brand integrity.

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.

Regulatory Guidance on SaMD

In December of 2017, the FDA released a guidance document addressing software used for medical purposes that is not part of a hardware device.

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.

Ensuring the Security of Embedded Devices

Embedded computing systems “smart” devices comprise the Internet of Things (IoT). Connected smart devices pose a significant security vulnerability compared to offline, “dumb” embedded devices.

Moving Data Processing to the Edge Prior to Transmitting the Cloud

Edge computing is the concept of decentralizing the processing of information: moving data processing power to the “edge” of a network, rather than processing that data in the cloud or a central data warehouse to be analyzed.

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.

Developing Complex User Interfaces In Devices With Embedded Systems

A restriction on elegant user interface design in medical and life science devices that incorporate embedded systems is that the smaller the platform, the less can be accomplished with the UI.

Consideration of Design and Regulatory Agency Requirements

As embedded and server based machine learning becomes more and more prevalent, verifying the performance of the systems for agency and regulatory compliance requires up front design considerations.

Architecting an Internet-of-Things (IoT)

The Internet of Things (IoT) is one of the major technological developments in recent years. IoT helps to connect people to people, people to physical objects and physical objects to other physical objects. Given the explosion of the number of “things” that need to connect to the internet (and perform complex functions); IoT architecture requires a three-tier approach, utilizing a “gateway”.

Including Utilizing TensorFlow, Google's Open Source Library

The healthcare industry is one of the many industries innovating with AI and deep learning technologies: healthcare is one of the leading applications of AI.

Incorporating Sustainable Design in Medical Device Development

As the majority of hospitals incorporate sustainability into their purchasing decisions and countries regulate sustainable design (e.g. Brazil), it’s prudent for medical device manufacturers to consider sustainable design in their medical device development.

The Low Powered Internet of Things

Launched in June 2012, Internet Protocol version 6 (IPv6) is a network protocol that is often referred to as the next generation internet. Using IPv6 allows every device to have its own IP address to connect directly to the Internet.

Considerations for Wearable Device Development

Healthcare is among the fastest-growing segments of the $13 billion wearables market, due to the overwhelming need to monitor diseases and aging populations.

The Key Steps to Identify A Regulatory Requirements Strategy

When developing medical devices it is important to understand the regulatory landscape that is applicable to your particular device and to jump start the approval process with the appropriate regulatory agency/agencies.

The Design Requirements and Agency Expectations for Connected Devices

The design of wireless medical devices needs to include aspects of system design which are not always obvious. The FDA document Guidance for Industry and Food and Drug Administration Staff Document issued on August 14, 2013, is an excellent starting point for identifying design aspects of a wireless system that must operate and ‘co-exist’ with other diverse devices as well as multiple instances of itself.