Sean Fenske, Editor06.09.16
Chronic disease management and drug delivery technologies, mHealth, and point-of-care diagnostics are all experiencing significant growth in healthcare. Not surprisingly, all three are interrelated and often used in conjunction to address medical conditions that are similarly on the rise. While there are certainly applications for each independent of the others, the synergies realized between these technologies are driving growth between them.
Each of the following presentations focuses on one of the three sectors and provides additional insights on technology development considerations and further examines the adoption by healthcare providers and patients. Unavoidably, each sector is touched upon within the other presentations, considering how linked these sectors are. – Sean Fenske, Editor
Chris Evans • Vice President—Innovation, West Pharmaceutical Services Inc.
Chronic diseases and conditions, such as diabetes, arthritis, multiple sclerosis, Crohn’s disease, and others, continue to be among the most common, and costly, of all health problems. According to the Centers for Disease Control and Prevention, about half of all adults in the United States have one or more chronic health conditions, which accounts for 86 percent of healthcare spending in recent years.1
For individuals with incurable-but-controllable chronic conditions, innovative injectable biologic therapies offer the potential to improve their quality of life by not only reducing symptoms, but also enabling new independence through at-home treatment. However, as biologic therapies for these chronic conditions are often delivered in higher volumes, this can create challenges for patients to self-administer repeated doses consistently and effectively without the expert oversight of their healthcare provider. This, coupled with increased regulatory scrutiny to ensure the quality and efficacy of therapeutic offerings throughout their lifecycle, has pushed our industry into a new wave of drug delivery.
Designing for Affinity
Patients who must regularly self-administer medication—not to mention the providers and health insurance payers that are invested in these treatments—have eagerly awaited the shift to more user-friendly drug delivery systems that better align with how they live their everyday lives. New dosing intervals, along with the growing trend of self-administration in the homecare setting, are giving patients an even greater role in deciding which delivery system works best for them. As these treatments continue to shift into the home, self-injection systems must be designed with a patient-centric focus to help improve adherence and outcomes. As an added benefit, this approach can also give the pharmaceutical manufacturer an edge in product differentiation.
With this in mind, proprietary drug delivery systems are being developed to aid patients with self-administration while also addressing the specialized needs of biologics. Wearable patch injector systems may include polymer cartridges that can be designed specifically to hold high-volume doses of sensitive biologics and offer subcutaneous, programmable electronic injection that can deliver the drug over an extended period of time. Additionally, user interfaces can be optimized by incorporating human factors practices and appropriate electronic indicators and feedback, aiding patient adherence and caregiver monitoring.
By striking the needed balance between a high-quality drug containment system and a user friendly delivery system, pharmaceutical companies can help to improve comfort and the experience for patients managing chronic conditions through self-administered therapies, while facilitating the effective delivery of new, innovative drug products.
Addressing Safety and Efficacy
From manufacturing to delivery, modern biologics used in the management of diabetes and other chronic conditions require innovative solutions for lifecycle containment. As these drugs continue to proliferate, greater scrutiny is paid to the interaction between the drug product and its container-closure system. In particular, stability during shelf life, particulate burden, and patient-friendly delivery are important factors to consider.
Regulatory agencies and pharmaceutical companies have increased quality expectations in an effort to enhance patient safety. In order to meet those expectations, all components that come in contact with a biologic should be designed with quality and ease-of-use in mind, but must also suit the unique characteristics of the drug product itself. For example, glass containment, while suitable for many drug products, may present compatibility issues with some protein-based therapeutics and other complex drug products. Glass is not a completely inert material. Its chemistry can and does interact with certain medications and, especially in the case of high pH medications and biologics, a process called delamination may occur, causing potentially dangerous glass particles in a drug product. Additionally, glass often requires the use of silicone oils and other lubricants to aid the movement of the plunger in a drug delivery system, which can potentially alter a drug’s safety, stability, purity, and effectiveness. Lastly, fixing a needle into a glass syringe can result in chemical reactions, as it may involve the use of adhesives or a molding process aided by a tungsten pin. As a result, greater consideration has been given to alternative containment systems and materials in recent years.
High quality, polymer containment systems, including those made from cyclic olefin polymer, can offer an alternative to glass with less risk of breakage and delamination. Additionally, integrating moldable cyclic olefin polymer into drug delivery systems can offer tighter dimension control and the flexibility to design self-injection systems holistically, along with customized primary containers that are specifically suited to both the appropriate form factor and performance parameters for this type of device and drug formulation. When combined with the highest quality, “ready to use” components, such options enable pharmaceutical companies to offer their product in truly integrated delivery systems, while reducing risk, helping to avoid costly drug recalls and, most importantly, protecting patient safety.
Ensuring Effective Patient Onboarding
Pairing new biologic drug formulations with novel self-injection systems can result in the need for optimized training for effective use and, therefore, innovative approaches to patient education. The typical illustrated instruction sheets can be greatly assisted by purposefully designed training systems that offer patients a “hands-on” experience to practice administering medications to manage diabetes and other chronic conditions, before actually doing it with a live product.
Earlier this year, West announced a collaboration with Noble, a patient onboarding innovator, to develop validated training solutions for self-injection systems. Together, West and Noble will offer multisensory education programs and technologies for patients using West’s SmartDose Electronic Wearable Injector and other self-injectors with the goal of improving patient onboarding and education. Collaborations like this can positively impact patient medication adherence and satisfaction. Additionally, they can improve data and feedback collection to lend valuable insights regarding potential product refinements or to gauge training effectiveness.
Why are these training systems suddenly more important? Patients with chronic conditions are self-administering care in their own homes more than ever. Yet a recent study by Noble analyzed by Auburn University indicated that more than 60 percent of patients self-reported that they didn’t completely read the instructions for their self-injection systems before using them the first time.
Through self-injection training systems customized to offer precise feedback, patients managing their chronic conditions can get needed reassurance that they’re following the instructions correctly. Feedback can include sounds and lights that indicate correct use of the trainer. They can also indicate incorrect use in the form of negative feedback, in real time, thus prompting patient or user correction. Auditory and visual cues are particularly important in this era of global drug supply, because they can reduce language barriers and regional contrasts in healthcare delivery.
Such training initiatives help ensure that patients are administering the right dose in the right place with the least amount of discomfort, which can lead to a better experience and maximize the benefits of both the drug and the delivery system. Additionally, providing options for this level of patient education is a way drug packaging and delivery system manufacturers can add significant value to their pharmaceutical customers’ offerings.
Encouraging Ongoing Adherence
Research indicates that a patient’s medication adherence is directly linked to favorable treatment outcomes for those managing chronic conditions. Yet patient compliance with chronic medication therapies is remarkably low—the World Health Organization estimates it at 50 percent internationally.2 Non-compliance can lead to poor clinical outcomes, increased costs for many healthcare financial stakeholders (including the patients themselves), and lost revenue for pharmaceutical companies worldwide.
To help address barriers to adherence, West collaborated with HealthPrize Technologies LLC to develop a connected health offering that is designed to improve and reward medication adherence with unique technologies in a gamified environment. As a concept, gamification has made inroads in online marketing by applying elements of game playing, such as scoring points, competing with others, setting a hierarchy of rules and, of course, reaping rewards for success. But it is showing promise in other sectors as well, including fitness and healthcare, helping patients find a new way to meet the daily challenges managing diabetes and other chronic conditions.
The West and HealthPrize offering integrates HealthPrize’s Software-as-a-Service (SaaS) medication adherence and patient engagement platform into injectable drug delivery systems with an app that tracks and rewards patients for taking their medication. This type of rewards-based patient motivation and engagement can be tied into delivery system training regimens as well.
In the first offering from West and HealthPrize, patients will manually scan barcodes or otherwise enter data about their medication compliance into a smartphone/tablet app, or on an Internet browser from a computer if they don’t have a wireless device. In the near future, app use will be even more automated, streamlined, and interactive. For example, drug delivery systems or packaging will be able to signal a smartphone to confirm, in real time, that a particular dose was used, the syringe safety system was deployed, all the medication was injected, and other details.
By leveraging connected health in chronic disease management, including incorporating apps and other systems that add positivity or “gamify” treatment regimens into integrated drug delivery, patients will have new motivation for caring for themselves, in both incentive and accountability, and clinicians will be able to better monitor patient data and medication adherence.
Conclusion
Medication adherence in the management of diabetes and other chronic conditions is a complicated puzzle, but one that has to be solved in order to help protect patients from potentially devastating consequences. Patient attitudes toward their diagnosis can evolve, along with how they view and use their drug delivery system; one size may not fit all patients, at all points, in different stages of different diseases. Additionally, with new biologic therapeutic offerings on the market, patients will have new options in how and where they manage their chronic conditions, including new opportunities for self-care in the home setting. With that, however, come challenges in ensuring safe, effective use of these needed therapies.
Forward-thinking pharmaceutical companies are addressing these challenges head-on by working collaboratively with drug packaging and delivery system partners early in the drug development process to ensure a patient-centric approach. Improving the patient experience through innovative injection system design, ensuring effective patient onboarding and education, and leveraging innovative, connected health offerings to incentivize ongoing adherence to treatment regimens is the next-generation approach to truly improving the health and wellness of the millions of patients globally managing diabetes and other chronic conditions.
References
Chris Evans is vice president of innovation—pharmaceutical delivery systems at West Pharmaceutical Services. He has been in product development for more than 20 years, primarily in healthcare packaging and device development. With West for eight years, Evans is now responsible for new product and technology development, focusing on device usability and enhancing the patient experience.
Dr. Jennifer Schneider • Chief Medical Officer, Livongo Health
Point-of-care diagnostics have advanced medicine by speeding up the time between when a patient thinks something might be wrong (e.g., I am having chest pain) and being able to name exactly what is wrong (e.g., I am having a heart attack). Shortening this time interval, however, is only truly valuable if a care intervention can be quickly delivered to improve the health of an individual. The ability to detect early heart attacks through point-of-care troponin testing and large blood vessel ruptures through handheld imaging devices has demonstrated clear clinical outcomes when paired with interventions such as cardiac catheterization and surgery. Technological advancements, such as the ones listed here, have expanded the number of acute care situations for which point-of-care testing can be applied.
But perhaps even more exciting is the fact that these point-of-care diagnostics have merged into the world of chronic conditions, where the diagnosis is already known, but a disturbance in the overall balance of care for the condition can be detected. For example, when an individual who has been diagnosed with congestive heart failure (CHF) steps onto a connected scale at home, it can detect that his weight has increased, indicating the likelihood of a CHF exacerbation. In this example, the “point of care” has moved beyond the typical location of where caregivers see and treat an individual, such as the doctor’s office, into the world where individuals with chronic conditions live. Considering an individual manages his own condition away from and outside the walls of the doctor’s office 99.9 percent of the time, it makes perfect sense to designate the point (or place) of care where the individual resides.
There are a growing number of companies and organizations making this concept of “point-of-care disturbance monitoring” for individuals living with chronic conditions a reality by collecting patient-generated health data on an ongoing basis. The conditions for which such information is being generated include (but are not limited to): diabetes, depression, COPD, asthma, obesity, hypertension, obsessive-compulsive-disorder, and psoriasis. The collection of this data is distinctly made possible by the unique coupling of technology with standard and new diagnostics, such as home blood glucose monitoring, peak flow meters, interactive symptom trackers, and connected blood pressure cuffs.
As the diagnostics for individuals living with chronic conditions move away from the traditional healthcare arena to the outside world where life is lived and chronic conditions are experienced, so too must the interventions. When an extreme blood glucose reading (either high or low) is detected for an individual living with diabetes, the intervention must be available to the person at the point of detection. What might this look like in real life? If an individual has a low blood glucose reading of 44, receiving an immediate message advising they drink four ounces of juice or take three glucose tabs and check in again 15 minutes later is helpful. Even more helpful is direct outreach from a knowledgeable, certified diabetes educator ensuring the individual’s safety by both advising on actions to take and assessing the real-time danger of the situation.
When such interventions are delivered at the right point of care, the outcomes produced are meaningful. Imagine the sort of magical experience and behavioral compliance one would have if at 2 a.m., when an individual’s 6-month old daughter is up screaming, the pediatrician calls to advise that a 2.5 mL of acetaminophen will stop the teething pain that the infant is feeling. It is the same experience when an individual with diabetes who is in trouble receives a phone call from a certified diabetes educator at the right time, and at the right place of care.
Dr. Jennifer Schneider is the chief medical officer at Livongo Health, a consumer digital health company whose solutions improve the way people manage chronic conditions.
Jaquie Finn • Senior Consultant—Digital Services, Cambridge Consultants
The third industrial revolution is here in the shape of the Internet of Things (IoT). It is changing the way companies deliver their products and interact with their customers1. In the world of medical devices, this translates to completely new business models that are ultimately likely to support the transition to performance-based payment rather than volume-based models. In doing this, companies large and small are seeking vital access to deeply insightful behavioral and diagnostic information that has not been available to them before.
mHealth Is About My Health
The traditional application for mHealth—the use of mobile devices to deliver medical care—is one of education, outreach, and support. mHealth initiatives have been vital in connecting patient and physician in low-income countries, where vast distances coupled with poor transport and infrastructure present major challenges for direct diagnosis, treatment, and ongoing monitoring2.
In high-income countries, however, connected devices have led to consumer behavior such as the use of wearable technology for life logging (otherwise known as the QS movement). This technology allows people to track how many steps they take, how well they sleep, how many calories they consume, how their workouts are progressing, and much more. Consumers and patients alike are now generating vast amounts of healthcare-related data, with 30 percent of U.S. smartphone users now using at least one health app3 to track their health and fitness on a regular basis. The sheer volume of data streamed from wearables and smartphones is generating the largest accessible set of real-world health data ever seen by the industry.
The implications are huge. If this data can be correlated to a disease state through appropriate validation, the vast pool of patient-generated data turns into a set of valuable digital biomarkers if analyzed and used intelligently. The understanding of these digital biomarkers could lead to valuable and seamless interactions between patients and physicians, better adjustment of therapies, and one day, even predictive/proactive intervention—all in all, leading to improved health outcomes. In the near term, digital biomarkers have great potential to enrich clinical trials4.
The Role of Health Tracking
There is little doubt that harnessing digital biomarkers as well as clinical data from a patient will provide a wealth of previously unavailable insight. So what are the key tactics that medtech companies should employ when creating service offerings that provide real value from any mHealth solution they might embark upon?
Get to Market Quickly
Providing evidence of improved outcomes based on digital biomarkers, and being able to claim as such, will require significant clinical trials and can take a long time. There is benefit in getting an mHealth solution to market quickly, however, independent of the regulatory or marketing claims, as it will provide the opportunity to gather data (similar to a phase 4) as well as learn from real-world use of the solution. Moreover, there is no better time than today to start building brand awareness and improving patient engagement. Take the approach of launching with a minimum viable product when it comes to an mHealth solution that does not require regulatory approval and work toward a more robust solution that can give the required claims for the longer term.
Provide Opportunities for Engagement
Solutions don’t have to revolve around data capture and validating digital biomarkers. Some mHealth solutions can be content rich, containing educational materials and videos, while others might focus on the social aspect—helping patients stay connected with a support group. The latter is a vital service for patients with chronic conditions who may want to use support groups for advice, reassurance and counseling when relapses occur. The facility for a physician to provide personalized feedback to the patient based on their data could also be built in—allowing remote management by the physician while also increasing patient engagement.
Keep Data Private
Extreme care must be taken to protect patient data privacy. It has to be absolutely clear to the patient that data is owned by them and not the company providing the application. Companies need to have users’ direct consent before they aggregate, store, process, or use the data in any way. The open-source Apple CareKit framework5 has noted potential privacy implications by storing patients’ data on their phone until the data is transferred to the physician, caregiver, etc.
Provide Real Value from Data
Completing 12,000 steps in a day means nothing unless information can be derived from it that is valuable, such as where a person’s health is headed. Real value comes from answering questions such as: How does heart rate and breathing impact how medicine is metabolized? How is medication efficacy affected by daily caffeine intake? Are there better outcomes from eating a more protein-rich diet?
Try to Improve Outcomes
As previously mentioned, current business models are undergoing disruption. Purchasing decisions are determined more on the basis of real-world outcomes rather than point solutions recommended by physicians. Creating systems to improve outcomes and create value provides payment opportunity.
Welldoc has done exactly this with the first mHealth product to secure reimbursement as a diabetes management therapy, adjudicated as a pharmacy benefit like other prescription products. Now insurers pay out $100 a month in reimbursement for use of the mobile-enabled diabetes management program BlueStar6. Once it is prescribed by a physician, companies can add BlueStar to their prescription benefit plans.
Keep It Simple for Physicians
If every patient comes to his or her physician with gigabytes of QS data, there is no time for proper diagnosis. Valuable information will be hidden in the noise like a needle in a haystack. Managing by exception is what’s needed. The physician should be able to quickly view trends and correlations, as well as receive alerts only when a patient’s data profile highlights inferences or data outliers that predict an oncoming exacerbation or other issue.
It’s All About the Services
The Internet of Things has been hailed as being as transformative for the world as the Industrial Revolution. This is not the whole story, however, as IoT is unlocking the age of services. The product becomes the means of delivering value to the customer, not the value itself. The perception of value, and the revenue that can be generated from it, is derived from the provision of innovative and useful experiences that deliver positive outcomes. Underpinning all this must be a digital service platform that can flex and scale as well as provide data interoperability and sharing. This allows a company to rapidly respond to market feedback and modify offerings as needed.
Ensuring great algorithms are part of the platform is important as data analytics becomes the method by which companies will engage with users and continue to provide great service offerings over time. Data analytics allows them to continuously measure, motivate, trigger, and cause action on the part of the user—providing a continuous circle of service where digital biomarkers may play a pivotal role.
References
Jaquie Finn is a senior consultant of digital services at Cambridge Consultants. With more than 15 years of product management and marketing experience in the high tech sector, she has taken many products through from concept to launch. Combining a deep knowledge of the healthcare world with the creation and launch of a digital services platform last year, Finn is well placed to advise clients on the strategy they may take when transforming their business to include digital services.
Each of the following presentations focuses on one of the three sectors and provides additional insights on technology development considerations and further examines the adoption by healthcare providers and patients. Unavoidably, each sector is touched upon within the other presentations, considering how linked these sectors are. – Sean Fenske, Editor
Chris Evans • Vice President—Innovation, West Pharmaceutical Services Inc.
Chronic diseases and conditions, such as diabetes, arthritis, multiple sclerosis, Crohn’s disease, and others, continue to be among the most common, and costly, of all health problems. According to the Centers for Disease Control and Prevention, about half of all adults in the United States have one or more chronic health conditions, which accounts for 86 percent of healthcare spending in recent years.1
For individuals with incurable-but-controllable chronic conditions, innovative injectable biologic therapies offer the potential to improve their quality of life by not only reducing symptoms, but also enabling new independence through at-home treatment. However, as biologic therapies for these chronic conditions are often delivered in higher volumes, this can create challenges for patients to self-administer repeated doses consistently and effectively without the expert oversight of their healthcare provider. This, coupled with increased regulatory scrutiny to ensure the quality and efficacy of therapeutic offerings throughout their lifecycle, has pushed our industry into a new wave of drug delivery.
Designing for Affinity
Patients who must regularly self-administer medication—not to mention the providers and health insurance payers that are invested in these treatments—have eagerly awaited the shift to more user-friendly drug delivery systems that better align with how they live their everyday lives. New dosing intervals, along with the growing trend of self-administration in the homecare setting, are giving patients an even greater role in deciding which delivery system works best for them. As these treatments continue to shift into the home, self-injection systems must be designed with a patient-centric focus to help improve adherence and outcomes. As an added benefit, this approach can also give the pharmaceutical manufacturer an edge in product differentiation.
With this in mind, proprietary drug delivery systems are being developed to aid patients with self-administration while also addressing the specialized needs of biologics. Wearable patch injector systems may include polymer cartridges that can be designed specifically to hold high-volume doses of sensitive biologics and offer subcutaneous, programmable electronic injection that can deliver the drug over an extended period of time. Additionally, user interfaces can be optimized by incorporating human factors practices and appropriate electronic indicators and feedback, aiding patient adherence and caregiver monitoring.
By striking the needed balance between a high-quality drug containment system and a user friendly delivery system, pharmaceutical companies can help to improve comfort and the experience for patients managing chronic conditions through self-administered therapies, while facilitating the effective delivery of new, innovative drug products.
Addressing Safety and Efficacy
From manufacturing to delivery, modern biologics used in the management of diabetes and other chronic conditions require innovative solutions for lifecycle containment. As these drugs continue to proliferate, greater scrutiny is paid to the interaction between the drug product and its container-closure system. In particular, stability during shelf life, particulate burden, and patient-friendly delivery are important factors to consider.
Regulatory agencies and pharmaceutical companies have increased quality expectations in an effort to enhance patient safety. In order to meet those expectations, all components that come in contact with a biologic should be designed with quality and ease-of-use in mind, but must also suit the unique characteristics of the drug product itself. For example, glass containment, while suitable for many drug products, may present compatibility issues with some protein-based therapeutics and other complex drug products. Glass is not a completely inert material. Its chemistry can and does interact with certain medications and, especially in the case of high pH medications and biologics, a process called delamination may occur, causing potentially dangerous glass particles in a drug product. Additionally, glass often requires the use of silicone oils and other lubricants to aid the movement of the plunger in a drug delivery system, which can potentially alter a drug’s safety, stability, purity, and effectiveness. Lastly, fixing a needle into a glass syringe can result in chemical reactions, as it may involve the use of adhesives or a molding process aided by a tungsten pin. As a result, greater consideration has been given to alternative containment systems and materials in recent years.
High quality, polymer containment systems, including those made from cyclic olefin polymer, can offer an alternative to glass with less risk of breakage and delamination. Additionally, integrating moldable cyclic olefin polymer into drug delivery systems can offer tighter dimension control and the flexibility to design self-injection systems holistically, along with customized primary containers that are specifically suited to both the appropriate form factor and performance parameters for this type of device and drug formulation. When combined with the highest quality, “ready to use” components, such options enable pharmaceutical companies to offer their product in truly integrated delivery systems, while reducing risk, helping to avoid costly drug recalls and, most importantly, protecting patient safety.
Ensuring Effective Patient Onboarding
Pairing new biologic drug formulations with novel self-injection systems can result in the need for optimized training for effective use and, therefore, innovative approaches to patient education. The typical illustrated instruction sheets can be greatly assisted by purposefully designed training systems that offer patients a “hands-on” experience to practice administering medications to manage diabetes and other chronic conditions, before actually doing it with a live product.
Earlier this year, West announced a collaboration with Noble, a patient onboarding innovator, to develop validated training solutions for self-injection systems. Together, West and Noble will offer multisensory education programs and technologies for patients using West’s SmartDose Electronic Wearable Injector and other self-injectors with the goal of improving patient onboarding and education. Collaborations like this can positively impact patient medication adherence and satisfaction. Additionally, they can improve data and feedback collection to lend valuable insights regarding potential product refinements or to gauge training effectiveness.
Why are these training systems suddenly more important? Patients with chronic conditions are self-administering care in their own homes more than ever. Yet a recent study by Noble analyzed by Auburn University indicated that more than 60 percent of patients self-reported that they didn’t completely read the instructions for their self-injection systems before using them the first time.
Through self-injection training systems customized to offer precise feedback, patients managing their chronic conditions can get needed reassurance that they’re following the instructions correctly. Feedback can include sounds and lights that indicate correct use of the trainer. They can also indicate incorrect use in the form of negative feedback, in real time, thus prompting patient or user correction. Auditory and visual cues are particularly important in this era of global drug supply, because they can reduce language barriers and regional contrasts in healthcare delivery.
Such training initiatives help ensure that patients are administering the right dose in the right place with the least amount of discomfort, which can lead to a better experience and maximize the benefits of both the drug and the delivery system. Additionally, providing options for this level of patient education is a way drug packaging and delivery system manufacturers can add significant value to their pharmaceutical customers’ offerings.
Encouraging Ongoing Adherence
Research indicates that a patient’s medication adherence is directly linked to favorable treatment outcomes for those managing chronic conditions. Yet patient compliance with chronic medication therapies is remarkably low—the World Health Organization estimates it at 50 percent internationally.2 Non-compliance can lead to poor clinical outcomes, increased costs for many healthcare financial stakeholders (including the patients themselves), and lost revenue for pharmaceutical companies worldwide.
To help address barriers to adherence, West collaborated with HealthPrize Technologies LLC to develop a connected health offering that is designed to improve and reward medication adherence with unique technologies in a gamified environment. As a concept, gamification has made inroads in online marketing by applying elements of game playing, such as scoring points, competing with others, setting a hierarchy of rules and, of course, reaping rewards for success. But it is showing promise in other sectors as well, including fitness and healthcare, helping patients find a new way to meet the daily challenges managing diabetes and other chronic conditions.
The West and HealthPrize offering integrates HealthPrize’s Software-as-a-Service (SaaS) medication adherence and patient engagement platform into injectable drug delivery systems with an app that tracks and rewards patients for taking their medication. This type of rewards-based patient motivation and engagement can be tied into delivery system training regimens as well.
In the first offering from West and HealthPrize, patients will manually scan barcodes or otherwise enter data about their medication compliance into a smartphone/tablet app, or on an Internet browser from a computer if they don’t have a wireless device. In the near future, app use will be even more automated, streamlined, and interactive. For example, drug delivery systems or packaging will be able to signal a smartphone to confirm, in real time, that a particular dose was used, the syringe safety system was deployed, all the medication was injected, and other details.
By leveraging connected health in chronic disease management, including incorporating apps and other systems that add positivity or “gamify” treatment regimens into integrated drug delivery, patients will have new motivation for caring for themselves, in both incentive and accountability, and clinicians will be able to better monitor patient data and medication adherence.
Conclusion
Medication adherence in the management of diabetes and other chronic conditions is a complicated puzzle, but one that has to be solved in order to help protect patients from potentially devastating consequences. Patient attitudes toward their diagnosis can evolve, along with how they view and use their drug delivery system; one size may not fit all patients, at all points, in different stages of different diseases. Additionally, with new biologic therapeutic offerings on the market, patients will have new options in how and where they manage their chronic conditions, including new opportunities for self-care in the home setting. With that, however, come challenges in ensuring safe, effective use of these needed therapies.
Forward-thinking pharmaceutical companies are addressing these challenges head-on by working collaboratively with drug packaging and delivery system partners early in the drug development process to ensure a patient-centric approach. Improving the patient experience through innovative injection system design, ensuring effective patient onboarding and education, and leveraging innovative, connected health offerings to incentivize ongoing adherence to treatment regimens is the next-generation approach to truly improving the health and wellness of the millions of patients globally managing diabetes and other chronic conditions.
References
- http://www.cdc.gov/chronicdisease/overview/
- http://www.who.int/chp/knowledge/publications/adherence_Section1.pdf
Chris Evans is vice president of innovation—pharmaceutical delivery systems at West Pharmaceutical Services. He has been in product development for more than 20 years, primarily in healthcare packaging and device development. With West for eight years, Evans is now responsible for new product and technology development, focusing on device usability and enhancing the patient experience.
Dr. Jennifer Schneider • Chief Medical Officer, Livongo Health
Point-of-care diagnostics have advanced medicine by speeding up the time between when a patient thinks something might be wrong (e.g., I am having chest pain) and being able to name exactly what is wrong (e.g., I am having a heart attack). Shortening this time interval, however, is only truly valuable if a care intervention can be quickly delivered to improve the health of an individual. The ability to detect early heart attacks through point-of-care troponin testing and large blood vessel ruptures through handheld imaging devices has demonstrated clear clinical outcomes when paired with interventions such as cardiac catheterization and surgery. Technological advancements, such as the ones listed here, have expanded the number of acute care situations for which point-of-care testing can be applied.
But perhaps even more exciting is the fact that these point-of-care diagnostics have merged into the world of chronic conditions, where the diagnosis is already known, but a disturbance in the overall balance of care for the condition can be detected. For example, when an individual who has been diagnosed with congestive heart failure (CHF) steps onto a connected scale at home, it can detect that his weight has increased, indicating the likelihood of a CHF exacerbation. In this example, the “point of care” has moved beyond the typical location of where caregivers see and treat an individual, such as the doctor’s office, into the world where individuals with chronic conditions live. Considering an individual manages his own condition away from and outside the walls of the doctor’s office 99.9 percent of the time, it makes perfect sense to designate the point (or place) of care where the individual resides.
There are a growing number of companies and organizations making this concept of “point-of-care disturbance monitoring” for individuals living with chronic conditions a reality by collecting patient-generated health data on an ongoing basis. The conditions for which such information is being generated include (but are not limited to): diabetes, depression, COPD, asthma, obesity, hypertension, obsessive-compulsive-disorder, and psoriasis. The collection of this data is distinctly made possible by the unique coupling of technology with standard and new diagnostics, such as home blood glucose monitoring, peak flow meters, interactive symptom trackers, and connected blood pressure cuffs.
As the diagnostics for individuals living with chronic conditions move away from the traditional healthcare arena to the outside world where life is lived and chronic conditions are experienced, so too must the interventions. When an extreme blood glucose reading (either high or low) is detected for an individual living with diabetes, the intervention must be available to the person at the point of detection. What might this look like in real life? If an individual has a low blood glucose reading of 44, receiving an immediate message advising they drink four ounces of juice or take three glucose tabs and check in again 15 minutes later is helpful. Even more helpful is direct outreach from a knowledgeable, certified diabetes educator ensuring the individual’s safety by both advising on actions to take and assessing the real-time danger of the situation.
When such interventions are delivered at the right point of care, the outcomes produced are meaningful. Imagine the sort of magical experience and behavioral compliance one would have if at 2 a.m., when an individual’s 6-month old daughter is up screaming, the pediatrician calls to advise that a 2.5 mL of acetaminophen will stop the teething pain that the infant is feeling. It is the same experience when an individual with diabetes who is in trouble receives a phone call from a certified diabetes educator at the right time, and at the right place of care.
Dr. Jennifer Schneider is the chief medical officer at Livongo Health, a consumer digital health company whose solutions improve the way people manage chronic conditions.
Jaquie Finn • Senior Consultant—Digital Services, Cambridge Consultants
The third industrial revolution is here in the shape of the Internet of Things (IoT). It is changing the way companies deliver their products and interact with their customers1. In the world of medical devices, this translates to completely new business models that are ultimately likely to support the transition to performance-based payment rather than volume-based models. In doing this, companies large and small are seeking vital access to deeply insightful behavioral and diagnostic information that has not been available to them before.
mHealth Is About My Health
The traditional application for mHealth—the use of mobile devices to deliver medical care—is one of education, outreach, and support. mHealth initiatives have been vital in connecting patient and physician in low-income countries, where vast distances coupled with poor transport and infrastructure present major challenges for direct diagnosis, treatment, and ongoing monitoring2.
In high-income countries, however, connected devices have led to consumer behavior such as the use of wearable technology for life logging (otherwise known as the QS movement). This technology allows people to track how many steps they take, how well they sleep, how many calories they consume, how their workouts are progressing, and much more. Consumers and patients alike are now generating vast amounts of healthcare-related data, with 30 percent of U.S. smartphone users now using at least one health app3 to track their health and fitness on a regular basis. The sheer volume of data streamed from wearables and smartphones is generating the largest accessible set of real-world health data ever seen by the industry.
The implications are huge. If this data can be correlated to a disease state through appropriate validation, the vast pool of patient-generated data turns into a set of valuable digital biomarkers if analyzed and used intelligently. The understanding of these digital biomarkers could lead to valuable and seamless interactions between patients and physicians, better adjustment of therapies, and one day, even predictive/proactive intervention—all in all, leading to improved health outcomes. In the near term, digital biomarkers have great potential to enrich clinical trials4.
The Role of Health Tracking
There is little doubt that harnessing digital biomarkers as well as clinical data from a patient will provide a wealth of previously unavailable insight. So what are the key tactics that medtech companies should employ when creating service offerings that provide real value from any mHealth solution they might embark upon?
Get to Market Quickly
Providing evidence of improved outcomes based on digital biomarkers, and being able to claim as such, will require significant clinical trials and can take a long time. There is benefit in getting an mHealth solution to market quickly, however, independent of the regulatory or marketing claims, as it will provide the opportunity to gather data (similar to a phase 4) as well as learn from real-world use of the solution. Moreover, there is no better time than today to start building brand awareness and improving patient engagement. Take the approach of launching with a minimum viable product when it comes to an mHealth solution that does not require regulatory approval and work toward a more robust solution that can give the required claims for the longer term.
Provide Opportunities for Engagement
Solutions don’t have to revolve around data capture and validating digital biomarkers. Some mHealth solutions can be content rich, containing educational materials and videos, while others might focus on the social aspect—helping patients stay connected with a support group. The latter is a vital service for patients with chronic conditions who may want to use support groups for advice, reassurance and counseling when relapses occur. The facility for a physician to provide personalized feedback to the patient based on their data could also be built in—allowing remote management by the physician while also increasing patient engagement.
Keep Data Private
Extreme care must be taken to protect patient data privacy. It has to be absolutely clear to the patient that data is owned by them and not the company providing the application. Companies need to have users’ direct consent before they aggregate, store, process, or use the data in any way. The open-source Apple CareKit framework5 has noted potential privacy implications by storing patients’ data on their phone until the data is transferred to the physician, caregiver, etc.
Provide Real Value from Data
Completing 12,000 steps in a day means nothing unless information can be derived from it that is valuable, such as where a person’s health is headed. Real value comes from answering questions such as: How does heart rate and breathing impact how medicine is metabolized? How is medication efficacy affected by daily caffeine intake? Are there better outcomes from eating a more protein-rich diet?
Try to Improve Outcomes
As previously mentioned, current business models are undergoing disruption. Purchasing decisions are determined more on the basis of real-world outcomes rather than point solutions recommended by physicians. Creating systems to improve outcomes and create value provides payment opportunity.
Welldoc has done exactly this with the first mHealth product to secure reimbursement as a diabetes management therapy, adjudicated as a pharmacy benefit like other prescription products. Now insurers pay out $100 a month in reimbursement for use of the mobile-enabled diabetes management program BlueStar6. Once it is prescribed by a physician, companies can add BlueStar to their prescription benefit plans.
Keep It Simple for Physicians
If every patient comes to his or her physician with gigabytes of QS data, there is no time for proper diagnosis. Valuable information will be hidden in the noise like a needle in a haystack. Managing by exception is what’s needed. The physician should be able to quickly view trends and correlations, as well as receive alerts only when a patient’s data profile highlights inferences or data outliers that predict an oncoming exacerbation or other issue.
It’s All About the Services
The Internet of Things has been hailed as being as transformative for the world as the Industrial Revolution. This is not the whole story, however, as IoT is unlocking the age of services. The product becomes the means of delivering value to the customer, not the value itself. The perception of value, and the revenue that can be generated from it, is derived from the provision of innovative and useful experiences that deliver positive outcomes. Underpinning all this must be a digital service platform that can flex and scale as well as provide data interoperability and sharing. This allows a company to rapidly respond to market feedback and modify offerings as needed.
Ensuring great algorithms are part of the platform is important as data analytics becomes the method by which companies will engage with users and continue to provide great service offerings over time. Data analytics allows them to continuously measure, motivate, trigger, and cause action on the part of the user—providing a continuous circle of service where digital biomarkers may play a pivotal role.
References
- http://bit.ly/mpo0616a
- http://bit.ly/mpo0616b
- Neilson, research2guidance, Digital Health Consumer Adoption
- http://bit.ly/mpo0616c
- http://bit.ly/mpo0616d
- http://www.welldoc.com/product/bluestar
Jaquie Finn is a senior consultant of digital services at Cambridge Consultants. With more than 15 years of product management and marketing experience in the high tech sector, she has taken many products through from concept to launch. Combining a deep knowledge of the healthcare world with the creation and launch of a digital services platform last year, Finn is well placed to advise clients on the strategy they may take when transforming their business to include digital services.