Over the past few years, hospitals and healthcare providers have had their hands full and their wallets busy with ensuring that their businesses are adhering to new legislative provisions. Digitalization of patient and hospital data through electronic health records (EHR) implementations—the main focus of spending—is increasing exponentially across the United States. Cost cutting to counteract lower reimbursements, lower admissions rates and the upcoming move towards pay for value versus payments for transactions is in full swing. Infrastructure and support systems also are being actively implemented across the United States to support data collection and reporting for meaningful use, hospital re-admissions, and patient satisfaction.
The first part of this series (published in the June issue of Medical Product Outsourcing) discussed how mobile technology and the medical device market have collided to create exciting and unique opportunities for companies ready to seize them. In this final installment, we will address how collaboration with partners in the value chain can help provide highly desired, differentiated and valued products and services that drive more effective patient outcomes and contribute to lower healthcare costs.
Medical Device Connectivity Realities
The U.S. Food and Drug Administration’s (FDA) 2011 report, “Draft Guidance for Industry and Food and Drug Administration Staff—
Mobile Medical Applications,” provides a road map for the industry about conditions where a mobile device and mobile app would be considered part of the medical device and subject to FDA oversight.
In summary, mobile hardware and software applications fall under the FDA’s oversight if they are used to display, store or transmit personal health information; are intended as an accessory to analyze or interpret data from a medical device to create alarms, recommendation or information; control a connected FDA-regulated medical device; or transform a mobile platform into a regulated medical device.
Although the FDA is still in the process of finalizing guidance, a blossoming number of FDA-approved devices are hitting the market.
One example is the AliveCor Heart Monitor, available in the United States to licensed medical professionals and prescribed to patients to record, display, store and transfer single-channel electrocardiogram (ECG) rhythms. Using a proprietary wireless protocol and 3-volt coin cell battery, the device fits onto to an iPhone 4/4S and comprises two electrodes. Patients with heart conditions can see their ECG data on a high-resolution display using the AliveCor mobile application and can send their ECGs directly to their physician’s mobile device. Next-generation functionality could include cloud diagnostics and advice for the patient.
Another interesting example is the iRhythm ambulatory monitoring patch designed to improve diagnosis of cardiac arrhythmias through the support of a highly trained staff at iRhythm’s National Clinical Center in Lincolnshire, Ill. The device’s sleek, conformable form factor lasts up to 14 days, and is 100 percent recyclable by the company. It has one ECG channel and employs a simple one-button operation to mark symptoms. However, it does not yet have a wireless function. The device is mailed back to the company and the data is downloaded and analyzed by the company in its premises.
Another example is Preventice’s BodyGuardian, marketed to hospitals and clinics for use in detecting and monitoring non-lethal cardiac arrhythmias. It allows patients go about their daily lives while remaining connected to their physicians via a small wearable sensor with Bluetooth communication to a dedicated Samsung Galaxy S II smartphone. The phone transmits physiological data via mobile network to the Preventice Care Platform in the cloud. Physicians and/or monitoring centers then access the data via a Web or tablet-based portal. An interesting note is that, according to Preventice, Samsung Mobile will customize the Galaxy S II smartphone for use with the BodyGuardian RMS by “creating a dedicated mobile environment that will ensure a secure, reliable wireless connection for the transmission of biometric data.”
Like implanted cardiac devices, some companies will firmly choose to remain with proprietary device communicators for monitoring certain conditions due to the insecurity and instability of the consumer platform and the required additional functionality such as programming for treatments.
Collaborating With Your Value Chain
When defining new architectures, designing new products such as proprietary mobile communicators for a high-risk device classification or integrating medical sensing devices with consumer smartphones and tablets, many medical device manufacturers may find themselves in unfamiliar territory.
Typically, a device manufacturer’s expertise is in medical functionality, not consumer electronics. The need to design Bluetooth functionality into a biometric sensor could require the device maker to hire specialists, acquire new technological infrastructure and establish partnerships with consumer electronics makers.
A better approach may lie in collaboration with a design and manufacturing services provider. Design and manufacturing services companies have extensive experience manufacturing the latest consumer devices, as well as sophisticated facilities with cutting-edge technologies and highly trained staff. As an added benefit, certain design and manufacturing service providers also have deep experience with healthcare devices and regulatory requirements, enabling them to provide targeted services on both sides of the medical device-smartphone equation. Such collaborations can accelerate time to market by helping medical device companies ensure their monitoring technology is functional with popular phones and tablets, while managing inherent life-cycle risks in using short life-cycle consumer platforms with longer life-cycle medical devices.
In the past, the expectation that a consumer manufacturer of smartphones would alter its architecture to accommodate the requirements for much lower volume medical applications was non-existent. But recently, there has been talk of alterations in smartphone architectures to provide better interface and security for medical sensors attached to phones for medical applications. Architectural changes to accommodate medical functionality are welcome. However, consumer electronics companies will not take on medical liabilities. So the risk in using consumer platforms as part of the medical device will remain in the hands of the medical device companies.
Contract manufacturing and service providers that have existing relationships with consumer electronics makers can help medical device companies analyze options for using an existing consumer platform or developing a semi-custom device. Design and manufacturing services companies also can help perform risk analysis as part of the risk management process, including identification and evaluation of known and foreseeable hazards in the hardware, analysis and estimation of the probability of occurrence of the hazards and severity of harm to the user, and recommended risk control procedures.
The key is to find a manufacturing partner whose capabilities lie in integrating customer or partner sensor IP into a complete miniaturized device by applying their own technology or partner technologies—such as integration of antennas into 3-D plastic parts by laser selective plating and use of ceramic printed circuit board assemblies (PCBA) to achieve both thinness and rigidity as well as highly accurate positional tolerances. Ensuring the right manufacturing processes for integrating new sensor technologies into a commercially viable product is critical. An example is using active optical alignment of components, using a microprocessor with an optical sensor to deliver real-time optical signals to the placement machine for highly accurate position alignment on the PCBA during manufacturing.
Value chain partners can help device manufacturers evaluate options for device connectivity, including the option to design the medical sensor as an accessory to an existing platform; interfacing to Android, iPhone or both; using standard or proprietary radiofrequency (RF) protocols; or developing a semi-custom design to ensure security and stability, and minimize unknown risks of using a consumer smartphone. Due to the controlled, closed nature of the iPhone ecosystem, some developers feel that it allows for a more stable and predictable operation. Apple has implemented the “Made for iPhone” program to provide an easy interface and technical support for development of accessories.
Android is an open platform, with many different devices based on the operating system. The Android platform gives you significantly more control and flexibility of design, component selection and performance—including cameras and wireless interfaces. If designing proprietary semi-custom designs, the open Android platform is a popular choice.
There are some foreseeable hazards with using a standard Android smartphone in a Class II medical device ecosystem, however. First, battery lifetime and loss of power is a critical issue as power must be retained and provided for critical medical functionality. Recommended architecture changes include protecting part of a remaining battery charge of medical application or adding a precision battery gauge for higher accuracy.
Wireless interference may compromise the medical function. RF communication needs to be reliable and secure. Solutions include altering the choices of the RF frequency for medical function or including algorithms to manage and prioritize the medical function. Better notification to the patient on the strength of their mobile signal can be implemented in software to prompt them to use a backup monitoring methodology when signal integrity is minimal.
Also, a reliable clock function often is required in medical device applications for time-stamping data and checking expiration dates of disposables. Implementation of a separate real-time clock is suggested and, depending on form factor and power environment, it could be implemented in the sensor.
Due to high computing and graphics capabilities, the temperature rise in a smart phone might have a negative impact on a medical function and can be characterized and monitored with a very accurate temperature sensor placed close to medical function and associated algorithms.
Analysis of the architecture’s adherence to ISO IEC60601-1 (a series of technical standards for the safety and effectiveness of medical electrical equipment) might be required. Alarms, alerts and reminders designed according to the ISO standards are important functions in a number of medical devices. They may be visual, tactile or audible, or a combination based on performance and patient requirements. Acoustic alarms have the big advantage of being non-directional. Additionally, biocompatibility and design for ease of cleaning are becoming stricter for medical devices. For avoiding gaps between parts where substances and bacteria can collect, recommendations include reduction of housing parts, choosing the right materials (e.g., antibacterial), and better integration technology for user interface elements. Environmental issues such as electromagnetic interference can cause the device to function improperly, and can be mitigated through design elements compliant with IEC60601-1.
For software, effects on the medical function from uploaded, unverified software can be an issue. Adding specific software elements for performing verification of functionality on startup and during operation can be designed. Implementation of protocols for managing medical device function in the presence of specific software errors via alarms, actions or reporting can be used. For wireless devices, pairing devices is critical and requires a secure verified pairing procedure with compatibility checks. Ensuring the software development process follows ISO’s IEC62304 standard (which specifies life-cycle requirements for the development of medical software and software within medical devices) is required and, if using a mobile development tool, framework or platform that provides back-end mobile functionality such as authentication and texting, it is recommended that the mobile platform vendor use a quality management system for clearly defined development, verification and validation processes as well as any required standards for compliance with FDA and patient information privacy regulations.
Another issue is design and adherence to user interface and human-factor engineering found in IEC62366 (which specifies a process for a manufacturer to analyze, specify, design, verify and validate usability, as it relates to safety of a medical device).
Numerous reports of confusing or unclear on-screen user instructions, which may lead to improper treatment, should be examined for patients using tablets and smartphones for critical treatment decisions.
Finally, there is still a big chasm between the consumer and medical world in regard to product lifetime. Time from concept to end of production for a consumer device may be less than 24 months. For medical devices, with the exception of disposable devices, normal time span has ranged from five to 10 years—with a fraction of the volume compared to mobile phones. As medical devices head into the consumer realm, volumes will increase and lifecycles will decrease but the disconnect will remain. Supply chain partners can help mitigate this issue by developing risk management guidelines and procedures adherent to ISO 14971 (which outlines a process to ensure that all aspects of risk management are considered throughout the product life cycle for medical devices), including management of critical outsourced and single-sourced components, selection of long-term support parts from automotive or industrial sectors, order management and negotiation of dedicated parts under special contracts and management of required lifetime buys.
The right design and manufacturing partner can offer device companies a deeper understanding of wireless, compute, storage and consumer architectures and technologies for planning next-generation devices. Miniaturization of sensors for a desired form factor, integration of wireless connectivity and antennas through a module or on-board circuitry, use of innovative process technologies for reduced manufacturing complexity, identification of bio-compatible materials, handheld design for communicators and programmers and after-market services all are managed under a quality management system and ISO 13485-certified environments (13485 deals with medial device quality management systems.
Competitive differentiation is becoming harder to define and sustain in the medical device market. As tablets and smartphones become the user interface to medical devices, and as computing and analytics move from the device to the cloud, medical
device manufacturers should be concentrating more on the value and profit in solving the problems on the edges, simplifying the
Continuing to drive development of intellectual property through higher accuracy, increased performance and less costly front-end sensing technology is highly differentiating. Many companies in the healthcare industry are focusing on development of algorithms for data interpretation and treatment guidance combined with high-level data analytics in the cloud. User interface must be redefined from a static display and keypad to the incorporation of forms that promote patient engagement throughout various interactions with devices, social media and physical and web communities. Support services must morph from a call to the doctor’s office or a random internet search to easy retrieval of education and support sprinkled through patient touch points, such as phone, texts and face-to-face visits.
Cost savings to the overall system must remain a priority by continually removing redundancies in the system and in the devices. Reductions in product cost might be offset with new services along the value chain. The right partner can help medical device firms manage product portfolios through these difficult transitions.
Whether it is the current smartphone or a new future form factor, consumer devices with mobile apps should remain the preferred method of self-management of health and wellness. Medical devices will continue to be impacted as new trends and technology advancements shape generations of our medical device sensing and remote monitoring ecosystems.
No matter what you call it, change is coming. The entire industry must focus on containing unsustainable increases in healthcare costs and extending access to care. Collaboration with your partners in the value chain can help ensure that you continue to provide highly desired, highly differentiated and highly valued products and services that drive more effective patient outcomes and contribute to lower healthcare costs.
Ralph Hugeneck is the director for medical technology for Jabil HealthCare & Life Sciences. He joined Jabil in 2005 as a business unit manager and was named to the current position in 2009 and is responsible for developing and implementing strategies and technologies to accelerate the growth of Jabil’s medical portable on-/in-body devices. Prior to joining Jabil, Hugeneck spent 14 years with Royal Philips Electronics. His most recent position was director of process development & manufacturing engineering at Philips Creative Display Solutions. Prior to that role, Hugeneck had several management positions in the product development and process development area of Philips Consumer Electronics division. Hugeneck holds a bachelor’s and master’s degree in mechanical engineering from Vienna University of Technology in Austria, including a degree in biomedical engineering.
Donna Fedor is the lead strategist for The Arden Group, which she founded in 2009. During that time, she also was director of strategy for the healthcare industry sector at Jabil Circuit Inc., an $18 billion global electronics design and manufacturing services company. Throughout her career of more than 20 years, Fedor has held numerous strategy, technology, business development and management, channel management, and marketing positions with Flextronics and National Semiconductor. She also founded a Web-based startup company focused on employee services during the early Internet boom. Fedor holds a bachelor’s degree in electrical engineering from Boston University.