Article By: Alex Stenzler
Respiratory Therapy Vol. 18 No. 4 Fall 2023
In this feature, Respiratory Therapy interviews clinicians and healthcare providers about the actual application of specific products and therapies. This interview is with Alex Stenzler, the Chief Science Officer of Monitored Therapeutics (MTI), a remote health monitoring company. He is also the President of 12th Man Technologies, an R&D organization.
Give me some background on Monitored Therapeutics; why and how it started
Monitored Therapeutics was started in 2011 following my departure as Vice President for Advanced Technologies from Viasys, Cardinal Health and CareFusion. In my role at these organizations, I had a real interest in improving the care of patients with respiratory diseases through the use of technology to remotely monitor and support patients, primarily with asthma and COPD. We had been working in collaboration with Battelle Memorial Institute in Ohio on this program until the program was closed in 2002. When we started Monitored, along with some of our former collaborators from Battelle and Michael Taylor, MTI ‘s CEO who I worked with at Viasys, we were building on concepts we had previously validated, so we felt we were on the right path.
What services does Monitored Therapeutics offer and what are its markets?
Monitored Therapeutics services three segments of the healthcare market. We have a clinical trials group that serves the pharmaceutical industry. Our solutions are utilized worldwide in studies monitoring lung function as an endpoint, as we manufacture one of the very few diagnostic spirometers that has been tested and certified for home use.
The second segment we serve is the disease specific monitoring needs of healthcare institutions. For example, we monitor pre and post lung transplant patients for a number of institutions such as the Cleveland Clinic and the Mayo Clinic, where we alert caregivers to sudden drops in lung function allowing them to intervene earlier. In other instances, we monitor patients with asthma, COPD, interstitial lung disease or cystic fibrosis.
The third segment brings our laboratory quality spirometry into the primary care space so that patients with lung disease can be diagnosed earlier and then managed with home monitoring, supported by educational materials.
Are there differentiating characteristics of your technologies?
While we have integrated more than 20 different physiologic monitoring devices, geolocation environmental data, and drug delivery devices, our primary differentiator is our technology associated with our monitoring of spirometry. There are a few special characteristics of our GoSpiro spirometer, which can collect hospital pulmonary laboratory diagnostic spirometry data from patients self-testing at home and from physician offices. It is the only turbine spirometer that can meet the low flow requirements defined by the ATS standards as it is a vertical turbine. Not all spirometers that are FDA cleared meet all the ATS standards. These standards also require that they not only pass waveform testing, but they are also able to measure flows down to 0.025 liters per second. While all FDA cleared spirometers can pass the waveform testing, no other turbine sold in the US can meet that low flow requirement. If physicians are using other turbine-based spirometers for monitoring patients at home, they may not be getting accurate measurements of FVC.
Another aspect of our unique solution is our avatar-assisted technology. The avatar, named Lisa, coaches patients through their spirometry measurements. Because the spirometer is Bluetooth connected in real time to the data collection platform, Lisa knows exactly where the patient is within the breathing maneuver and can coach the patient through the measurement. She knows whether the patient held their breath too long, didn’t blast the air out, and if the patient has reached a plateau on exhalation. She encourages the patient to keep blowing until a plateau or 15 seconds of exhalation has been reached. She then reviews the measurement against all the ATS/ERS requirements and tells the patient if they did something wrong and how to correct the maneuver. The result is hospital quality data, captured remotely. Lisa also speaks 29 different languages, so patients can be coached in their native language. Our technology has enabled MTI to collect more than a million spirometry measurements that meet ATS criteria from patients self-testing at home.
How do you differentiate your company from others in the remote monitoring space?
There are several differentiating characteristics of MTI’s remote monitoring solutions, namely our deep understanding and focus on lung function. The most significant differentiating capability as previously described, is our ability to get patients who are self-testing at home to consistently perform to ATS/ERS spirometry standards. We also have the capability to track medication use. Beyond that, we have embedded HIPAA compliant video conferencing on our data collection platform that enables a provider to chat with patients at home or watch them perform spirometry or other measurements remotely. Associated with our program are disease specific management CarePlans, as well as a collection of ePRO data from either custom or validated questionnaires. The automated billing components of the platform for providers includes reports allowing for reimbursement under the available remote monitoring codes.
Can you get ATS repeatability and quality from patients self-testing at home?
ATS repeatability begins with assuring that each measurement that is collected meets the ATS/ERS performance standards. Once you have good quality measurements, it’s far easier to meet the reproducibility requirements. Our avatar-assisted technology that coaches patients through each measurement and identifies and then corrects the patient for any errors, greatly enhances the likelihood of obtaining quality measurements, and therefore ATS repeatable results. From analyses of hundreds of thousands of measurements collected from patients at home, we have been able to get ATS/ERS grades of A or B from more than 90% of the testing sessions and when including acceptable Grade C’s, the rate increases to 95%.
Tell me more about your disease specific and disease severity management platforms.
Not all respiratory diseases or conditions are the same and there are different levels of severity in each, which require unique programs to best manage their conditions. MTI has developedunique programs for each disease that are also scaled for level of severity. We call these CarePlans. They are a blend of objective physiologic measurements from a wide range of integrated devices and patient self-perception of their health and well-being.
The CarePlans automate patient engagement with medication and measurement reminders. We also send out CareTips which are brief pieces of information to help a patient better care for themselves. These tips can include information on nutrition, breathing exercises, clearing mucus, infection prevention, sleep, etcetera. We use CareTexts for single question patient checks.The platform can also check on other related aspects of these diseases that are not of pulmonary origin such as depression and anxiety using validated questionnaires.
The CarePlan platform can also send alerts to the patient, a family member or a healthcare provider upon physician set thresholds for either physiologic measurements or patient self-perception of their health. This fully automated platform enables management of a large population of patients with these conditions with a minimal number of healthcare personnel.
What do patients think of this level of digital engagement and has it had an impact on their health or healthcare?
We collected follow-up surveys with some groups of patients we have monitored. A high majority of these patients liked that they felt someone was watching over them. They also thought the frequency of communication from our platform was on target and they appreciated the educational material we sent. The majority responded that the program had a positive effect on managing their disease.
It’s not always easy to find money in the budget to add new products and services. How does MTI assist in this solution?
There are two areas of need for a home monitoring program. First are how physicians acquire the technology to screen patients, and how do patients pay for the technology they use at home. Monitored Therapeutic has approached this problem with a two-pronged approach. For the PCP, who is concerned with investing thousands of dollars in equipment, we provide everything they need to perform tests for a low monthly fee that would be covered by the reimbursements from only 2-3 patients being screened per month. Fortunately for patients, the new Federal Remote Patient Monitoring (RPM) codes have enabled Monitored Therapeutics to provide the equipment and all of the associated services at no direct cost to the patient as it is reimbursed through CPT codes for RPM. This relieves both parties from the financial burden associated with diagnosis and monitoring.
Why do you think the primary care physician’s office is the key to better care of patients with asthma and COPD?
There are at least 40 million people in the US with some form of pulmonary disease that should be seen by a physician at least once a year. To manage them according to the AMA, there are only 3,110 active pulmonologists, which equates to 12,862 patients for each pulmonologist. This is an unmanageable patient population for each specialist, particularly if they see patients every 6 months. Therefore, we believe that the answer to this problem is to enable diagnostic quality spirometry performed in the PCP office along with interpretation support. This moves the triage of pulmonary patients from the limited number of pulmonologists to the 135,000 family practice and internal medicine practices. Then the moderately severe and severe patients can appropriately be referred to pulmonologists, while the mild and moderate patients can be managed by the PCP with treatment support including monitoring.
What are the roadblocks to getting PCPs’ participation in the early diagnosis of asthma or COPD?
PCP’s face multiple obstacles to implement hospital laboratory quality spirometry testing in their offices. Without the certainty of being able to operate this level of testing, many are unwilling to invest in the thousands of dollars in equipment that they may not be able to use. Beyond that, very few PCP’s would have a sufficient number of lung function tests to justify hiring a trained pulmonary lab technician to perform the testing. Also, the turnover of personnel in a PCP office is sufficiently high creating an undue burden of training replacement testing personnel. And lastly, most PCP’s don’t have adequate knowledge to interpret the test results.
The program for the PCP that MTI has created simplifies and addresses all of these challenges. MTI provides the solution for a monthly fee; testing only 2-3 patients a month provides sufficient reimbursement as pre and post bronchodilator testing more than covers that fee. Additionally, as our avatar Lisa I described earlier, coaches the patients through the measurements, staff members can collect accurate measurements with very little training. The demonstrated ability to collect hospital data with the avatar-assisted technology obviates both the need for highly trained personnel as well as the concern of personnel turnover.
The report generated for the PCP also includes an automated summary of the patient’s lung function as well as providing a clinical impression based on the 2021 ATS/ERS interpretation strategies. Thus, the PCP is provided with sufficient information to diagnose and manage most patients or refer the patient to a pulmonologist for follow-up if required. The platform then generates a billing invoice for PCP staff to use for reimbursement. This end-to-end solution enables the PCP to triage pulmonary patients, lowering the burden on the pulmonologists they refer to so they can focus on patients that really need to be seen. This can improve overall patient care and getting patients answers to their breathing concerns sooner than having to wait for a specialist appointment.
What are your thoughts on the future on remote monitoring of patients?
COVID made everyone from healthcare providers to patients recognize that remote care can improve the management of multiple conditions. While some services have returned to hospitals and clinics, we do not believe the transition to telehealthcare and remote monitoring will be reversed. The level of technological development that has occurred these past few years has been incredible. We are not at the end of telehealthcare, we are just at the beginning.