Homecare, mHealth, and wearable medical devices have the potential to convert inpatient surgical procedures to the outpatient setting. Here's what's needed to encourage this shift.
Andreas Pfahnl, Sc.D
There is an increase in healthcare and medical devices being pushed into the home with one intended benefit of reduced healthcare costs. This is spawning a new group of devices commonly referred to as homecare, mHealth, and wearable medical devices. This cost reduction can manifest itself in healthcare policy changes, such as the fairly recent evidenced-based waiting period for an ICD (implantable cardiac defibrillator). All this emphasis on remote care as an enabler to cost reduction is resulting in the re-evaluation of telemedicine devices and implementation methods. One specific cost reduction opportunity is converting inpatient surgical procedures to outpatient ones, since there have not been any changes for many years.
What Decides Inpatient Versus Outpatient?
Outpatient procedures are generally well established. They are less complicated, have faster recovery times, and better pain management mostly because they inherently involve lower-risk patients. By definition outpatient procedures are ones where a doctor has not written an order to admit the patient to a hospital as an inpatient, which generally happens if two or more midnights of medical care are required. Ambulatory Surgical Centers (ASCs) have been established that focus on providing only outpatient-based surgical procedures.
A surgical procedure itself is done in one day, but additional days for more complex procedures and higher risk patients is necessary for follow up care of comorbidities and complications. Outpatient procedures cost less as they reduce the number of in-hospital days. Recent publications reported $3,000 to $8,000 in savings per procedure for different surgical spine procedures done outpatient versus inpatient. The difference was even higher (up to about $15,000 in 2006) for reported thyroidectomy procedures.
Where Are the Opportunities?
In order to understand the type of medical devices and the requirements needed to better support and enable outpatient surgeries, one must examine complications and comorbidities with each procedure. In the past, the complications and comorbidities with outpatients were minimal because they were the basis for selecting inpatient versus outpatient.
Therefore, examining the complications and comorbidities associated today with inpatient surgical procedures that are exclusion criteria for outpatient ones should be the focus to identify the real home-care medical device opportunities.
Complication types and frequency vary for each type of surgical procedure. As an example in spine surgeries, some of the highest inpatient complications are dysphagia, cardiac related, hematoma, and respiratory related. Airway compromise is noted as one of the most significant complications as it is life threatening and can result in the need for reintubation. This complication historically does not appear until about 36 hours post operatively, which for an outpatient would be when they are at home.
Comorbidities generally involve major diseases such as diabetes mellitus, congestive heart failure, coronary artery disease, arthritis, and chronic obstructive pulmonary disease. Each of these manifests itself with different clinical indications and treatments, and may also trigger other issues.
Surgical procedures continue to evolve with new devices and surgical systems allowing for more minimally invasive techniques, and implants that increase the ability to move procedures to outpatient. These technologies include robotics which enable more precise and dexterous control reducing tissue trauma. However, additional medical device technologies are required outside the controlled clinical setting to continue the patient care into the home by enabling clinicians to monitor, manage, and even treat the patient remotely, for key complications and comorbidities.
Mobile and Homecare Devices to Support Increasing Outpatient Procedures
The use of remotely-transmitted data enables device and patient monitoring and management. One of the biggest advancements in home monitoring are implantable loop recorders, pacemakers and ICDs (CIEDs). Virtually all the CIEDs are remotely monitored from home using a monitor with a built-in GSM transmitter. Key parameters that can be assessed include battery longevity, device settings, percent pacing, heart rate histogram, activity level, lead parameters, arrhythmias, thoracic impedance (e.g. Optivol) to assess fluid/heart failure status.
A specific example of a relatively new technology is the St. Jude Medical CardioMEMs™ HF System, an implantable device that provides heart failure monitoring. Another example is in the field of diabetes care: the Telcare Blood Glucose Monitoring System has an integrated cellular module for remote data transfer.
Much of the publicly marketed mHealth and wearable markets have been driven initially by the consumer industry for fitness and wellness devices. The adoption of these types of devices for actual medical use has been slow for a number of reasons, one being they are not medical devices. From the consumer industry perspective this is likely frustrating, since it is not difficult to get physiological measurements from the body or create software apps for smartphones. It does take a whole different level of development rigor, verification, and validation to get meaningful measurements and use them for a marketed intended use and indication for use. Medical devices, including home care, require extensive understanding and management of risks involved with the use of a technology, and compliance with industry standards.
Homecare, mHealth, and wearable medical devices involve use of electronics, and therefore would need to adhere to IEC 60601 and IEC 62304 standards. IEC 60601-1 considers the safety of electronics applied to a person, and particular collaterals of the main standard address other related aspects such as collateral IEC 60601-1-11 for Home Healthcare Equipment. Usability is important because users are now also patients themselves and their caregivers. HE75 is a standard providing ample information on human factors that can be leveraged to develop devices, and IEC 62366 provides the method for incorporating human factors into medical device development.
Architecting a Solution
The best approach to developing the hardware requirements for a connected medical device involves defining intended use and use-case scenarios along with an architecture diagram(s). Key parameters to explore and define include:
- Data Transfer: short / intermittent bursts vs. long duration / real time.
- User Types: Clinicians, Emergency personnel, Professional caregivers, non-professional caregivers (family members), Patients
- User Interaction & Interfaces (UI, GUI): Directly with device, Remotely with device.
- Mobility & Use Environment: Handheld, Desktop, Wearable, Outside, Inside, Emergency Use
Consider the Personal Emergency Response Systems (PERS). The person wearing the device can still be mobile enough that they can leave the home. Therefore maintaining long-range connectivity is an important feature. Products to support this requirement now have integrated cellular connectivity. For example, the Philips GoSafe has a pendant with integrated cellular connectivity, and a short range communication capability to a home base station (communicator) which provides voice functionality. The GreatCall® Splash system on the other hand does not have a base station and instead incorporates voice into the pendant; it is an all-in-one pendant with only cellular connectivity.
Increasing outpatient procedures will require focusing on higher-risk procedures where today overnight observations (inpatient) are required. The complications of such in-patient procedures are the basis for the key design inputs for home care medical devices that would enable changing the procedure to out-patient. Size, portability, user types, power, and connectivity are key aspects of a device solution that is defined by the system architecture developed from evaluating use-case scenarios. The remote connectivity backend data management and storage must also be carefully architected whether “cloud” based or based out of a provider / hospital.
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Andreas Pfahnl, ScD (GM & CTO) is general manager and chief technology officer of Devicix, an international contract medical device product development and commercialization company in Minnesota. Devicix focuses only on medical devices and specializes in electromechanical devices particularly complex surgical systems, home care, and mHealth devices. Devicix is a division of Nortech Systems Inc. Dr. Pfahnl holds doctoral and masters degrees from MIT and a bachelor's degree from Rensselaer with studies at the ETH-Z.
[Image courtesy of DAVID CASTILLO DOMINICI/FREEDIGITALPHOTOS.NET]