The term “technology fusion” describes the innovative combination of differing technologies to produce new inventions. Good examples include the combination of satellite communications with automotive technology to produce vehicle guidance products such as OnStar and GPS devices, the combination of power generation and distribution with communications to produce the modern smart grid, and the incorporation of business application software with communications to create networked business applications such as enterprise resource planning systems.

The medical device industry has recently seen technology fusion of two sorts:

• Medical devices and communications
• Medical devices and energy harvesting

These areas of technology fusion have created the potential for new IP development. With or without the added layer of energy harvesting, the fusion of medical devices and communications has opened the door to inventions in the areas of integration, interfaces and infrastructure for many new devices and systems.

The Enabling Technologies

Over the past decade there has been an accelerating movement towards the adoption of remote patient monitoring (RPM) systems, particularly in the treatment of chronic conditions. As more sophisticated technologies have become available, more complex forms of RPM have emerged, including remote monitoring of medical devices and remote consultation and assessment. Chronic diseases such as asthma, diabetes and congestive heart failure (CHF) carry high costs of care and, as a result, are often the focus of RPM initiatives. Chronic diseases such as these account for three quarters of America’s health care expenditures, 80 percent of hospital days and 96 percent of home health care visits (source: "Technologies for Remote Patient Monitoring for Older Adults" Oakland, CA Center for Technology and Aging, 2010.). These conditions have also been shown to respond positively to proactive management programs such as RPM.

Medical Devices
The four key trends in medical device evolution that support the RPM concept are:

1. Miniaturization leading to less invasive, more comfortable and more powerful  devices
2. “Communications enablement” of devices allowing them to deliver results/data to a variety of audiences  on a continuous basis
3. Convergence of monitoring functions in single devices
4. The use of power harvesting to mitigate battery size, weight and replacement issues

From the perspective of the technology supplier, remote monitoring offers an opportunity to add value to mature devices and markets.

Communications
Many new wireless transmission protocols and technologies adapt easily to new applications. Some technologies and protocols most applicable to RPM include:

• Bluetooth
• Zigbee 
• Mobile phone protocols (GSM, CDMA, EVDO and EDGE)
• WiFi (IEEE 802.11)
• WiMax (IEEE 802.16)
• Radio frequency identification (RFID)

Diagnostic and Analytical Software
A critical issue associated with RPM is what to do with the data that is collected on a more or less continuous basis. Generally, this data is delivered to a local repository and/or remote repositories, which are accessible to a variety of care providers and other users. However, the true value of the data can be further optimized if advanced diagnostic and analytical software is used to draw meaningful conclusions about the patient’s condition from the raw data. Software can flag readings outside normal limits, thereby bringing potentially dangerous conditions to the patient’s and the provider’s attention.

Networks
The ideal network infrastructure combines medical devices, data repositories, and diagnostic and analytical applications together in a seamless network that becomes transparent to health care providers and patients. The implementation of such an infrastructure requires standard interfaces, scalable technologies and network management tools. In current practice, each implementation deals with its devices and data in a unique fashion. To date there is no generally accepted method, best practice, or standard.

Fusion Business Opportunities
Although the technologies required to implement RPM are maturing rapidly, mainstream adoption has been comparatively slow. However, the changes for market acceptance are obvious: the most important factors are to reduce costs and to demonstrate improved clinical outcomes.

Reduce Costs
A key objective for the deployment of RPM systems is to reduce health care costs by reducing emergency room and physician office visits, hospitalizations, and diagnostic testing procedures. Although it is intuitively clear that this should be the case, this has been difficult to quantify in actual practice.

The best clinical evidence on the cost-effectiveness of remote monitoring has come from cardiac patients with implanted devices. Clinical studies have shown that in most cases, scheduled in-person physician office visits do not result in a change of therapy. Thus, most in-person monitoring visits might be considered time and resource-consuming without a tangible clinical benefit. Current guidelines suggest that it is safe to reduce in-person clinic visits to once a year, provided remote equipment and data are checked every three to six months.

From the perspective of the patient, remote monitoring of cardiac devices offers the benefit of greatly reducing lost work time and transportation costs associated with in-person clinical visits. 

Demonstrate Improved Patient Outcomes
Remote monitoring of cardiac devices has been shown to be safe and to confer clinical benefits. It has the potential to provide earlier detection of lead failure or clinical problems such as atrial fibrillation (AF), ventricular tachyarrthymias or impending cardiac decompensation.

RPM has also been shown to improve clinical outcomes in heart failure (HF) patients. For example, studies have provided evidence that remote monitoring of weight and other signs (blood pressure, heart rate, heart rhythm) can be used to improve clinical outcomes in this patient population. A recent study demonstrated that remote monitoring of HF patients has the potential to reduce the frequency and duration of hospitalizations. However, finding a user-friendly interface for technically-challenged patients remains an obstacle to wider adoption.

IP Opportunities - Focus on Integration, Interfaces and Infrastructure
Fusion dynamics exist when integration takes place across technology boundaries. As technology fusion happens, natural opportunities for new IP development will generally exist in three areas, regardless of the particular technologies:

• Integration – combining of technologies from multiple areas in individual devices
• Interfaces – specific methods for differing technologies to interact with one another and with their users
• Infrastructure – approaches that make the whole greater than the sum of the parts by insuring seamless operation of fused technology at a system level

Applying these general areas to RPM suggests the following possible ideas for IP development (certainly others may exist):

Integration:

• development of medical devices that monitor multiple functions
• development of medical devices that make use of energy harvesting instead of batteries

Interfaces:

• development of standard interfaces from medical devices to local and centralized repositories
• Easy-to-use device and system interfaces for elderly or disabled patients

Infrastructure:

• development of turn-key RPM systems consisting of devices, repositories, communications, diagnostic software, billing and  network management
• development of analytical and diagnostic software specific to various health conditions that provide further processing of raw sensor data to aid health care professionals

Summary

The greatest challenge to the mainstream adoption of RPM technology is the willingness of third-party payers to provide reimbursement for its deployment. While improved patient outcomes have been demonstrated for cardiac conditions and devices (among others), the ability to reduce cost has been mired in a “Catch-22” situation: reimbursements will not flow until cost effectiveness is proven, but the investments in technology that will reduce the cost won’t be made until reimbursements are assured.

This logjam will ultimately be broken when the results of ongoing clinical trials become available. Once the logjam clears, deployments will proceed quickly. Technology providers with existing IP portfolios will be best positioned to capitalize on the deployments. IP dealing with networked infrastructure and interfaces will be particularly valuable, since these facilitate rapid deployment and interoperability.

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