The explosion of healthcare devices developed specifically for home use is a component of a much larger evolution of an overall reduction in the complexity of healthcare. Equipment and supplies that are appropriate in lower-acuity settings, including the home, have become a natural extension of this evolution.

The combined US market for home healthcare products reached $4.2 billion in 2007, according to a report from Life Science Intelligence. This market is expected to expand by nearly 7% annually, reaching more than $5.9 billion in 2012. It is led by strong growth in the respiratory and wound management sectors. In addition, the report forecasts the second-to-largest durable medical equipment market, worth more than $1.2 billion, to grow at a rate of nearly 4%, reaching more than $1.5 billion in 2012.1

Many more patient-friendly devices from ventilator technology to drug delivery are being redesigned and recreated as they make their way into the home. The trick is keeping the functionality while simplifying the design.

“If you look at surgery, even though we’re not to a point yet where we’re doing surgery at home, procedures that used to require a five-day hospitalization and full recovery in the acute-care setting now sometimes require just a 23-hour hospitalization,” says Roger Mecca, MD, vice president of medical affairs for Covidien, Mansfield, MA. “There is a transposition of what used to be considered acute care to lesser levels of acuity, which oftentimes involve home,” he says.

Driving devices home

The pressures of today’s healthcare environment, including healthcare costs and reform, are driving device makers and other players in the healthcare industry to develop creative solutions in addressing these issues, says Ryan Shafer, director of consumer healthcare for Ximedica, Providence, RI.

The trends come from several different directions, converging to drive devices into the home at a greater pace than ever before. “Yes, the comforts of ‘aging in place’ and downward pressure on healthcare costs are key drivers, but also the impact of an increasingly college-

educated, more technology savvy generation of baby boomers and their children have driven a lower tolerance for poor product performance,” says Shafer.

Shafer points out that the Internet has established unlimited access to health information and innovative resources like patient communities, peer reviews, and online purchasing. “As a result,” he says, “the patient is a more discerning, interrogating consumer.”

The design of devices destined for home use is also different from those headed to a clinical setting. “The influence of more powerful, sleekly designed, user-friendly consumer products has transformed how the professional medical community views healthcare devices—ones they use in professional settings as well as those they recommend for in-home use,” explains Shafer. “Another driver is the decline in national homogeneity. The citizenship of countries is becoming more multicultural and is creating a need for products that are multilingual or language-neutral.”

As a result of the converging trends, equipment and supplies that are appropriate for safe use in lower-acuity settings, including the home, is a natural side effect, says Mecca. “So it’s not so much that everyone says, ‘We need devices that can be used in the home.’ The devices used in the acute-care setting need to become much more home-friendly and much more different-circumstance friendly.” For example, he says, people who are on mechanical ventilators used to be bed bound. Not anymore. “Now people on mechanical ventilators want to go watch grandson Johnny play his first T-ball game. Or, maybe little Johnny on the ventilator wants to play the T-ball game,” says Mecca.

Another significant trend involves patients administering medication themselves in different environments, whether it’s in the home environment or from a travel point of view. This trend has been on the rise for the last few years and will continue to grow, says Graham Reynolds, vice president of marketing and innovation, pharma delivery systems, West Pharmaceutical, Lionville, PA.

“We participate through a couple of areas today. There’s huge growth in diabetes, for example, and so there is a trend toward more-sophisticated devices to administer insulin, for example,” says Reynolds. “Traditionally, you may find the drug packaged in a vial with a syringe so you draw the liquid out of the vial and then inject it and throw the syringe away. That transitions to more disposable pens where you have multiple doses in one unit and then you throw the unit away.” Lately, he says, the trends include producing devices such as reusable pens with electronics, user-feedback, and compliance tools, as well as a shift toward the development of pump systems or patch systems that enable the user to actually have a pump attached to his or her body for continuous or intermittent dosing.

Jessica Willing-Pichs, Principal, Research and Product Strategy for Ximedica, notes three drivers that are pushing more devices into the home. “The length of hospital stays is decreasing as hospitals discharge patients faster. As a result, patients are expected to perform more self care, renting hospital grade equipment and purchasing their own supplies,” she says. She also notes that through wide prevalence of Internet access, both at home and on smart phones, patients have more health information resources available to them more often. “This has given them the ability to be much more informed about their medical conditions.” Finally, she says that patients themselves are becoming much more deft with new technologies in their consumer lives, and this sophistication is raising expectations of healthcare device functionality. Patients expect their devices to provide the same sort of features that they see on their smart phones: smaller footprint, portability, intuitive interfaces, quick power up, and seamless interconnectivity with other devices.

There are other things to consider and one of those is cost-effectiveness, says Mecca. He says another major driver is availability of resources and impact on people’s lives. If recovery can be achieved with a 23-hour hospital stay and then home, he says that is much more desirable than a five-day hospital stay in terms of cost and impact on the patient. Shafer echoes that point. “The economy is having an impact in this area as the costs can be lower at home,” he says.

In terms of drug delivery, other forces come into play. One driver is the continuing growth in drugs for treating chronic conditions that have to be administered on a regular basis. Drugs for conditions such as rheumatoid arthritis or multiple sclerosis “tend to be biologic drugs that must be administered usually by injection, typically on a very frequent basis, either daily or weekly or monthly, depending on the nature of the drug,” says Reynolds. “So there’s a real trend toward devices that can help make that process as easy and as effective as possible for patients who are typically not trained doctors or nurses with fairly minimal complexity and skill. And then, if you consider that as the underlying trend, you get into issues like whether they can administer this dose only once a week by having a slightly bigger dosage volume or different formulation of the drug instead of twice a week,” he says.

“That has benefits to the patient because they actually have fewer injections than in an ordinary situation. So, there’s a general trend in the market toward self-administered drugs, primarily driven by chronic conditions, such as diabetes, autoimmune diseases, and hemophilia, where people are typically treating themselves at home. And then within that growth, there are trends toward different types of devices that give the usability benefits, whether it is reusable, electronic, or dose-frequency.”

Home is where the heart is

It is impossible to ignore the fact that people simply feel more comfortable in their own homes than in a cold sterile environment. “Consumers are more comfortable at home versus the inconvenience of sitting in a doctor’s office,” says Shafer. Willing-Pichs adds that the expanding capabilities of mobile computing technologies, more powerful and more reliable wireless communications, longer battery times, and a more demanding consumer are driving consumers to demand the same performance from their medical devices.

Willing-Pichs says device capabilities already enable communication of data between patients and clinicians. And although not consistently implemented, data sharing to alert family members is also already available.

“The diabetes world is a good example of where there’s been a transition in the method of delivery—the drug itself really hasn’t changed much but the method of delivery has changed. Also, many companies see the device and its method of delivery as a differentiator. So, if you’re supplying insulin, you might want to leverage the fact that you have the best pen, or a better pen, or it’s better for patients, than some of your competitors,” says Reynolds.

The development of home devices

Devices are undergoing complete transformations in terms of look, feel, and functionality as they move into the home. “We are placing

professional-like diagnostic or treatment devices into the hands of a nontrained person,” says Shafer. “This requires more rigor and discipline in design for usability and risk mitigation to ensure patient safety.” In addition, he says, “FDA is expecting to see more evidence-based design; HE75 outlines process and documentation procedures to comply with FDA guidelines.”

Shafer notes that companies are finding that their products do not meet FDA requirements for usability testing, which leads to costly rework after the products have been tooled.

The importance of usability has become central in home healthcare device design. “It is no longer enough to assess prototypes in a generic patient’s hands in a focus group setting,” says Willing-Pichs. “Learning must be gathered across subgroups of users, including different demographics and skill sets. Understanding the diversity of use environments is also critical to successful product design, which has led to the growing use of in-depth ethnography research, as well as in-home and use-step simulation assessments much earlier in the development process.”

“Most of our research and development is aimed at solving problems for healthcare providers for their patients,” says Mecca. “There is very little point in making advances that aren’t specifically aimed at improving something. For example, the problems for people who require mechanical ventilation in the home space, fall into two general categories. The first is where a person is tied to a ventilator for some period of time and it impacts his or her ability to live like a usual person. The other category encompasses those patients whose ventilation and condition require some regular contact with the healthcare environment, but the patient can be at home rather than in the hospital.

“How can you minimize the hassle of the interface? In that first category, the major issues are impact on the home environment: how big is it, how noisy is it, how much ancillary stuff needs to be attached so it will work, how expensive is it to run, and how frequently does it need to be maintained. With respect to the environmental things, our goal is to make ventilators very small, very quiet, very durable so they don’t frequently break down, and relatively easy to operate. In that same vein, for people who are ventilator-dependent but nonetheless otherwise ambulatory and interested in life, portability and operability away from a power source are the two major factors to consider,” Mecca says.

He defines portability as lightweight, easy to carry around, in a form factor that doesn’t encumber the user, and how long can the user be out. “We want it lightweight and form friendly (very small, easy to pick up), and we want it to have as long a battery life with as light a battery as possible so that the vast majority of day-to-day activities that most people would like to do can actually be accomplished safely with one of our ventilators.”

Reynolds says such devices require much more extensive work with patients and with users to really understand those needs. “We’ve linked up with a company that is really an expert in that field that helps us to conduct those studies more effectively. So we’ve certainly recognized in terms of our offerings as a company that having that capability is as critical as being able to manufacture and design the product from an engineering point of view. It has to be designed around the patient,” he says. “So what we’re finding is that in order to create the ultimate delivery system, you really have to take into account not only how the device looks, but how the drug within that device is contained, and whether that container should be glass or plastic, for example.”

For drug delivery, Reynolds also sees a trend toward plastic drug-containment systems for several reasons. One is that glass often breaks when put inside a mechanical device with forces, posing a risk. Second, there have been a lot of recalls recently driven by glass particulates in drug products. Small particles of glass can be formed or created in the drug product, putting the patient at risk. Finally, glass systems—particularly glass systems that move like syringes—have to be lubricated for the system to operate effectively.

He says that focusing on the drug container, particularly on plastic systems without silicone that are highly dimensionally tolerant, overcomes many of the issues of glass but also gives more design flexibility.

The impact of smart technology

Shafer notes that there is a move to utilize smart phones as diagnostic devices. Implementation includes a body attachment or interface sensor that communicates via Bluetooth to the smart phone to put health information into the hands of consumers. “This is being facilitated via Bluetooth or corded sensors/devices,” he says. “Applications for smart phones have become more useful in consumers’ daily routines, providing tools and information at their fingertips.”

Reynolds says that smart devices could be a fairly significant trend for drug-delivery devices. He says that through the utilization of smart devices drugs typically administered in a hospital environment could actually transition the point of administration into a home environment or rather than requiring hospitalization.

The future of home healthcare

So, how far will it go? Shafer says we will see more clinical and professional-like consumer products sold at stores like Target, Wal-Mart, and CVS for at-home use. He also predicts a future in which the consumer purchases the device that is a Swiss Army–like smart phone packed with the basic diagnostic tools found at a doctor’s office, perhaps including a thermometer, blood pressure cuff, heart rate sensor, and camera that allows the doctor to prescreen a patient for basic ailments. “I also think a home ultrasound as entertainment for expecting parents could be in our future,” says Shafer. “One that may even plug into a home video console, like an Xbox, for instance.”

Willing-Pichs says that, although controversial, she envisions a future where there is an intermediary diagnostic role embedded into the system that can assess a patient’s medical records against new data captured to prioritize patient cases. “There is a projected shortfall of clinicians to serve the anticipated patient population in the next 15–20 years, and methodologies that can be deployed to better prioritize workload and cognitive burden will be quickly adopted,” she says.

Interfacing with the healthcare environment is just over the horizon for Covidien, says Mecca. Right now mechanical ventilators are very effective, very safe, light, quiet, and they have a long battery life. Using all the years of experience with their high-end ventilators, Mecca says the company’s next home-based device will internally gather important information on how well the patient is doing, monitoring the patient continuously and perhaps timed against different cycles of the day. “It would be great to store that data and allow for download and potentially adjust the therapeutic regimen in a much more refined way than is currently available to healthcare providers. Even more interesting in the future will be to simply transmit that data 24/7 to allow someone to monitor you peripherally and to even get an alert if something is odd.”

These are all things for which technology exists and for which relatively cost-effective solutions are now available that Mecca says can be built in, including better documentation and record keeping of what is actually transpiring in the home environment.

But, he says, there are several obstacles. One is the actual technical ability to do it, but the other is the feasibility of implementing it in a way that actually works in the home care setting. The ventilator pitching the data to the healthcare providers is only one small portion of the equation, he says. The healthcare providers must have a way of receiving the data, appropriately banking and processing it, and even trickier, responding to it. “Right now the healthcare system is not set up for that amount of input from continuous home care feedback and responding to it like we do in an intensive care unit. It’s challenging especially in an era of scant healthcare resources to begin to justify the level of expenditure it would take to set up that system and to make sure that it works safely and effectively. So it’s much more challenging than just designing a device that will do it. The device needs to be placed into a holistic paradigm of care that will support it.”

Mecca foresees technologies where you will be able to see just by monitoring a home environment whether grandmother took her medication, or is well hydrated, or is up moving around. Using technology to extend care provider presence when a care provider isn’t in constant attendance is also an opportunity to expand into this market.

Reynolds says that electronics offer a lot of flexibility for devices that when activated, will guide the user through the administration steps via digital recorded messages. “There are a couple of devices on the market today that have that type of technology. There’s also the ability of electronics to give you compliance tools. You could link how frequently the dose was given or what time of day was it delivered, etc., so a lot of newer devices incorporate electronics to give that sort of feedback,” he says. A product that West Pharmaceutical is actively working on is an electronic patch injector. It’s a pump that sits on the body with a small needle piercing the body that can be customized to delivery dosage over a certain rate or frequency or a certain speed. The device in that scenario gives a lot more flexibility in terms of being able to customize the drug delivery to suit either a particular patient or a particular condition.