What is Production Equivalent?

In the FDA’s 21 CFR Part 820: 820.30(g) Design validation requires that devices used for validation are "production units, lots, or batches, or their equivalents.”

Although 21 CFR 820.30 does not require design verification on production equivalent devices, in general, it is beneficial to perform final system-level verification, standards compliance testing, and verification of risk controls using production equivalent devices because this provides the confidence that any changes made throughout the development process did not impact the ability of the device to meet requirements.

Power Consumption Design Challenges

The COVID-19 pandemic has created an unprecedented need for remote patient monitoring. Most of the patients who test positive for COVID-19 are in self-isolation at home, increasing the need for alternative medical solutions, including remote patient monitoring. On March 20, 2020, The FDA issued guidance for expanded use of certain remote monitoring devices to facilitate patient management while limiting physician-patient contact during the COVID-19 pandemic.

From a Static Regulation Model Towards Regulation as Iterative Checkpoints

Artificial Intelligence (AI) has the power to improve health outcomes for patients because AI can distinguish patterns in data that are not discernible to the clinician. These patterns rely on a supply of health data to train machines that learn responses to diagnose, predict, or perform more complex medical tasks.

Traditional, or non-adaptive, Machine Learning (ML) utilizes two separate paths--training and prediction, whereas adaptive AI uses a single path process that monitors and learns the new changes made to the input and output values and their associated characteristics.

Analyzing Data Locally Within Devices

With the increasing performance and power efficiency of embedded processors, there comes the ability to embed sophisticated machine algorithms in deeply embedded systems, bringing computing and machine learning closer to where sensors gather data.

Smart Sensors are Modernizing Connectivity and Analytics

The internet of things (IoT) is getting smarter due to increased processing capabilities of embedded processors, distributed processing and data reduction capabilities of embedded systems and gateways. Smart buildings, smart cities, and now even wearable devices can use smarter sensor processing to compile and process data locally, allowing more efficient utilization of valuable communication bandwidth, as well as allowing intelligent decision making locally versus having to go to the cloud and back.

The Benefits of an Algorithmic Approach to Medicine

The purpose of a medical algorithm is to improve the delivery of medical care by removing some of the uncertainty from medical decision-making.  These algorithms are able to predict and diagnose diseases with extreme accuracy.  They are also able to predict related factors such as the likelihood of death, the length of hospital stays, and the chance of hospital readmission

FDA Issues Guidance to Limit Physician-Patient Contact

On March 20, 2020, The FDA issued guidance for expanded use of certain remote monitoring devices to facilitate patient management while limiting physician-patient contact during the COVID-19 pandemic. It allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure.

A New Decade Brings New Risks and Solutions

Cyber-attacks are no longer a question of if, but of how and when.

The use of connected IoT devices will accelerate dramatically with the rollout of 5G networks, massively increasing networks’ vulnerability to large scale, multi-vector 5th generation cyber-attacks. IoT devices and their network and cloud connections are still a weak link in security. A growing need for IoT security therefore exists, combining legacy and innovative controls to protect these ever-growing networks across all industry and business sectors.

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.

Innovative Multi-Band Solutions

In order to meet the demands of current and future IoT and communications requirements of embedded devices, higher integration and lower power are driving innovative multi-band radio solutions and processors on a single die.

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.

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.