The New Medical Device Ecosystem: A transformation is underway in the realm of medical devices and medical sensor platforms — changing traditional definitions and creating new opportunities.
In this two-part series, we’ll define what constitutes a medical device ecosystem and how medical device manufacturers can capitalize on collaborative partnerships to achieve a successful medical device in today’s IoMT world.
- Part One – Medical Ecosystem Defined
- Part Two – Cloud Connectivity and Keys to a Successful Medical Device Ecosystem
In the new, connected world of the Internet of Medical Things (IoMT), a growing number of medical devices no longer function simply as stand-alone hardware appliances
Think of today’s medical device as an ecosystem formed by a secure, connected, and compliant infrastructure of hardware, sensors, software, user interfaces, and connectivity services – with different types of data and information flowing among these components to the ultimate benefit of the patient.
Fueling this transformation are rapid advances in sensor technology along with the growing use of medical implants, the emerging popularity of smart wearables and mobile devices, and the wider adoption of remote, real-time patient and hardware performance monitoring via cloud-connected platforms.
Challenges and Opportunities
Connected medical devices present opportunities for established players and new entrants especially those who can channel their potential and grasp the reality that competitive pricing and leading quality alone don’t guarantee success in the IoMT world.
By 2026, this new generation of medical devices will drive a global market that is expected to reach USD 176.8 Billion.
With new opportunities come fresh challenges. Unlike several other industries, medical device sensors used in wearable or implantable require design controls and performance metrics to ensure patient safety. Makers of today’s implantable and wearable devices must adhere to strict FDA regulatory guidelines and possess expertise in cloud connectivity, which is often outside their core competency.
In this report, Galen Data, provider of the industry-leading FDA-compliant Galen Cloud™ platform for connected medical devices, explores the medical device ecosystem in detail and provides guidance on what it takes for manufacturers to build cost effective, compliant, connected medical device solutions.
To unlock value in this next wave of market growth, medical device companies have two alternatives. They can proceed independently by allocating internal resources and acquiring the requisite expertise to launch and maintain a customized cloud-connected solution.
Or, as Galen Data advocates, manufacturers can adopt a collaborative approach and partner with firms who have medical device expertise. This approach can save R&D costs in developing and maintaining connectivity services outside their core competencies.
External experts, with existing robust, turnkey solutions, can provide sensor platforms and cloud connectivity based on industry standards and regulatory requirements, resulting in a medical device ecosystem- based solution. Protecting the intellectual property of the medical device company is also maintained.
As the research firm Deloitte concludes, for medtech companies and device makers to remain competitive, they will need to access talent through “collaborations and partnerships with a diverse range of existing and emerging players, especially academia, engineering companies, data first tech companies and innovative new start-ups.”
We’ll highlight the constituent parts that form the connected medical device ecosystem and how they work together. Then we’ll offer key considerations for success.
New Medical Device Ecosystem Constituent Parts
To understand the medical device as one ecosystem, it’s first helpful to break it down into constituent parts: the sensor platform (measures patient vital signs), the hardware appliance (applies therapies, communicate wirelessly, displays data), the mobile device that receives the data, and the cloud connectivity platform where the data is collected, stored, shared, and analyzed.
The Hardware Appliance (implantables, wearables, etc.)
Central to the new medical device ecosystem is the instrument and the data it collects.
Examples of medical device ecosystems that can leverage cloud connectivity include:
- High-frequency ventilators
- Cochlear implants
- Fetal blood sampling monitors
- Insulin pumps
- Medical imaging devices
- And a wide range of wearable vital sign monitors (temperature, heart rate, etc.)
The data generated and collected by devices can include:
- Physiological – temperature, heart rate, vital signs, etc.
- Therapeutic – neurostimulation, drug delivery, etc.
- Demographic – age, sex, location, etc.,
- Device data – battery level, on-board diagnostics, serial number, etc.
Medical devices and the data they collect are carefully regulated by the Food and Drug Administration (FDA) and must go through a rigorous process to test for device safety and effectiveness Under Section 510(k) of the Food, Drug and Cosmetic Act, device manufacturers must register to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification (PMN).
The FDA assigns devices into one of three classes. Device classification depends on the intended use of the device as well as its indications for use. Classification is also determined by the risks and the level of control needed to ensure a device’s safety and effectiveness. Class I devices generally pose the lowest risk to the patient and/or user and Class III devices the highest risk.
The FDA defines Class III devices as products that “usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury.” It generally applies to permanent implants, smart medical devices and life support systems.
Devices must demonstrate that measures are in place to guard against vulnerabilities, counter cybersecurity threats, address service reliability, and ensure data is protected if disaster recovery is needed.
The sensor, along with sensor platform, is how a medical device initiates patient data.The sensor measures characteristics in its environment, often with electronics whose physical properties change in response to temperature, impedance, capacitance, position/acerbation (motion), and other basic, physical measures. The input could be light, sound, heat, motion, moisture, pressure, or magnetism. The sensor provides as output a weak electrical analog signal, which is amplified, cleaned, and typically converted to a digital signal. That signal is finally converted to a readable display or sent for additional processing where it can then be collected, stored, shared and ultimately analyzed.
The sensor embedded within the hardware appliance generates a signal that is then used in helping a device diagnose, measure, monitor or treat conditions and diseases — ranging from temperature sensors and glucose meters that measure approximate concentration of glucose in the blood, to ECG, and also EMG sensors that track electrical and muscle activity in the heart.
Given their specialized functionality, medical device sensors in wearable or implantable devices need to:
- Comply IEC 60601-1 safety and essential performance standards published by the
International Electrotechnical Commission . Most, if not all, medical device companies
have to comply this widely recognized industry standard that assesses device and
software safety and performance degradation.
- Comply with regulatory specifications and standards for quality management, risk management, usability and functional safety in order to ensure that given device functions correctly with response to given inputs
- Deliver precise measurement with high accuracy
- Measure quickly with high stability and fast response time
- Provide digital outputs such as I2C protocols for microcontrollers and microprocessors connectivity
* Source: RF Wireless World
The sensor, along with typically a microprocessor, firmware, the radio that transmits the wireless signal and an interface between the microprocessor and the radio form a sensor platform.
Sensor platforms typically focus on a narrow range of CPT codes for a particular medical surgical, and diagnostic procedure or service.
The sensor platform may be connected using the Bluetooth Low-Energy (BLE) protocol, which is specific for applications where small amounts of data are transmitted at infrequent intervals. BLE is slower and less secure than Wi-Fi but it consumes less energy and therefore is better suited for battery-powered devices.
The signal containing the device’s serial number, patient identification and the data itself may be transmitted and received by a mobile device or base station or docking station.
One such sensor platform is produced by BraveHeart Wireless. Braveheart’s 510(k)-cleared wearable biosensor patches are a part of the BraveHeart platform that enables continuous real time remote monitoring of physiological patient data in a variety of clinical settings to address multiple patient use cases that are reimbursed by a variety of CPT codes.
According to Ted McAleer, vice president of business development at BraveHeart Wireless, a sensor platform should optimally be an open, customizable architecture that provides:
- Configuration for three types of data delivery to manage efficiency: pure streaming, store
and forward, and snapshot modes. Pure streaming is data that is continuously generated.
Store and forward is a process where data is transmitted and temporarily stored before
being forwarded to the destination node. Snapshot mode as the name implies captures data
a specific point in time; it’s useful for data backup while consuming less storage space.
- Modular hardware architecture (to enable multiple sensor packages for different client and use cases)
- Open RESTful API for easy integration and interoperability.
- Superior Bluetooth Low-Energy performance
- Battery management/performance
- The ready ability to Integrate into the electronic health record (EHR) and other monitoring applications and dashboards
Later this month, look for part 2 where we’ll discuss cloud connectivity and keys to a successful medical device ecosystem.