Help the medicine go down - patient-centric designs

“We are not selling an iPhone, which is fancy and people like to show it off. Ultimately, no one really wants to inject themselves,” says Manfred Maeder of Novartis. A primary concern for pharmaceutical companies and medical device developers is that patients form positive relationships with their devices. If this does not happen, the consequences can be grim indeed. Maeder cites a figure he heard from speakers at a conference last year: in the US alone, $300 billion is wasted annually on problems that arise when medication is not properly taken.

This makes his job as head of device development and commercialisation in biologics technical development and manufacturing particularly challenging. “It is a very long job title, but it fits on a business card,” he laughs.

Maeder says examples abound of patients with transplanted internal organs who stop using the immune-suppressive drugs, there to ensure the body does not reject the transplanted organ: “They use it for half a year or nine months and they think this is really great and they feel really well, so they stop using the drugs, and then whatever has been transplanted is rejected.

“This is really life-threatening. Organs are not commodities and are not easily available, and, even when available, create huge costs, when patients could have just taken their tablets.”

To contextualise that $300-billion figure, a report published by Research and Markets projects the North American drug delivery technologies market to reach $758.7 billion by 2021 up from $520.0 billion in 2016. Self-administering medical devices is a growing market due to patients dealing with chronic diseases, an expanding biologic market and technological advances.

Other factors contributing to this growth are time and money. Many patients need a single shot of medicine and often will have to travel an hour or two to get to the treatment facility. The doctor administers the medicine in about a minute, before the patient travels the same distance home. Being able to self-administer medicine eliminates travel time and unnecessary cost.

Regardless of the reasons behind the boom, it is essential for the successful design and development of devices that companies conduct human-factors studies with potential patients or patient populations.

“Patients are at the centre of everything,” Maeder states. “This is most important. We have to design devices where we consider ease of use and intuition as the main points.”

The whole package

Expanding on the smartphone analogy, Maeder says designers should consider the “unboxing experience”. Packaging becomes a valuable tool as an inviting exterior encourages interaction with the product. They should then find simple descriptions and easy-to-follow instructions. Ideally, manufacturers should aim for no more than two-step instructions, Maeder says. Fewer instructional steps means there is less likelihood of patient error, which helps to reduce risk to the user.

“We want to turn it into a positive experience,” Maeder explains. “We’ve tried to develop intuitive devices that don’t require reading a booklet prior to using it.”

The device’s external packaging is obviously just the start but, once opened, patients need to feel safe and in control when using it. Consider autoinjecting devices. “A lot of people have needle phobia,” says Maeder, and even if they are not fearful, injecting themselves is generally not an enjoyable experience. “We make sure the needle is hidden prior to the injection and also that its size and dimensions are as small as possible to have the least impact. After the injection, the needle is not seen when retracted.”

There is a sense of empowerment that comes with self-administration. Patients often feel more in control of their illness or condition when they are able to measure and record their statistics and adjust medication appropriately. Those undergoing cataract treatments, for example, can complete an eyesight test on an iPhone and, if the results show they’re getting worse, can adjust their treatment regimen.

“There are multiple ways patients can diagnose or analyse themselves,” Maeder says. “People are very interested in their conditions and want to be kept up to date, not just once every six months when they visit their doctors who tell them, ‘OK, we should have increased or adjusted your treatment three months ago.’ If they are able to manage themselves and get early indications, then this is very helpful and they are interested in that.”

Doing tests on smartphones or using apps to measure personal medical data is some of the power afforded by technology. Maeder says the Novartis team is adding radio-frequency identification (RFID) labels to devices’ primary packaging that will use Bluetooth to link to an iOS and Android app on users’ phones to determine if the patient is about to administer the correct medicine at the right time and frequency.

These labels will also enable devices to communicate with healthcare providers (HCPs) and relay information as a further safeguard for patients. This type of technology can also be used to remind patients of their drug schedule and whether the medicine is coming from a legitimate source such as a pharmacy. “There are multiple opportunities available when medical devices communicate with electronic gadgets,” Maeder says.

Another benefit comes from using technology to collect information from large patient populations and share it with HCPs, which could deliver a huge benefit, according to Maeder.

However, this is a sensitive topic, he says, as questions of data protection still need to be answered, particularly in Europe, with its strict personal data laws.

He suggests patients would be more willing to share their data if they understood how it could be used to improve treatment for the overall community and provide better knowledge of the disease, or how data could be delivered to HCPs in exchange for better contracts with patients.

Wearable devices form another part of technological treatments and are fast becoming important additions to patients self-administering their medication.

“In my previous life, I worked with insulin.” Maeder says. “We have wearable devices such as patch pumps that you stick on your belly for three days. You can shower with them. They apply insulin throughout the day. It is very useful because you control your blood glucose levels far better than if you are injecting yourself three times a day.”

Looking through the lens

These patch pumps have been on the market for about eight years, which Maeder attributes to developments in insulin treatment being ahead of other areas.

He says Novartis is working on a contact lens with Google that will indirectly determine glucose levels in the blood by measuring glucose in the tear fluid, send this information to an insulin pump and deliver insulin accordingly.

Taking a few steps back along the technological timeline, Maeder says Novartis’s oncology product is using similar technology to insulin patch pumps. When it comes to injections for cancer treatment, there is a “very narrow therapeutic window” that means incorrectly administering the dose in an injection or quickly metabolising the medication can have worrisome side effects or even render the medication useless.

“Wearable pumps that stay on a patient for a few days would guarantee a steady state level without any problems and side-effects,” Maeder says. “Depending on the type of treatment and indication, wearable devices can be valuable and useful.”

Part of the appeal of these devices is that given time they become a part of the patient’s daily or weekly routine. They are designed to be non-invasive, but Maeder says for people who have lived with a condition for long enough, or who know they will have it for ever, discovering optimal treatment methods trumps other concerns.

As with apps, wearable devices are valuable tools for collecting patients’ data across a vast population. MS patients, for example, can wear a device that measure how fast and frequently they move, which can indicate the progression of their illness.

“People want to figure out how to live with their illness and are eager to find new and better ways to do this,” Maeder says.

Broad demands

While technology is helping devise better ways to treat patients, there remain persistent considerations when designing self-administering devices for conditions affecting broad populations.

An obvious concern is age: Maeder says a way to manage this is to have the very young treated by a parent or carer. He cites a patch pump as being a useful device for the young that could dose them over a few days without any further need for intervention.

“Where it gets difficult is if a device is more complex to use and requires more than two-step instructions,” he says. “You have to consider the patient may have difficulty reading or understanding. So this can be really challenging sometimes.”

Until recently, devices went to market with multiple handling steps and needle changes, “but all of that becomes unacceptable,” Maeder says. “We have to focus on making it as simple as possible to patients.

“There are huge differences between countries such as levels of education and background. What works well in Europe may not work as well in the US and vice versa.

“What is good for the US because of bodyweight may need a third of that for Japan and this is also true for the average size of a person’s hand, which is far smaller in Japan. If you look at a simple syringe, for example, you have to consider the hand size and the force you can apply.”

Requirements and standards of acceptance among different regulatory bodies are also important considerations. Multiple human-factors studies in many countries in Europe may still not be accepted by US authorities, Maeder says.

While a discussion and resolution of regulatory discrepancies are necessary, he says the patient must come first: “If an arthritic patient cannot grip the device or open a bottle, then questions of regulation are meaningless. The device first needs to be improved.”

While a medical device will be hard-pressed to grab attention from a smartphone, the two can be combined to enhance patients’ self-administering experience.

Technology flexes powerfully in this segment, but what remains fundamentally important is the patient. Human-factored design needs to remain at the core of all device developments.