Wearable medical device revenues are expected to explode from $2.8 billion in 2014 to $8.3 billion in 2019, according to analyst firm Mordor Intelligence. Healthcare startup funding surged to $4.1 billion last year, representing a 125 percent increase compared to 2013, and out of that sum, medical wearables were in the top-five categories to receive funding.

But while analyst forecasts and the fact that venture capitalists are betting billions of dollars and euros that medical wearables will pay off, hurdles remains before the devices can live up to their promise. Before the medical community begins to routinely adopt medical wearables as part of standard medical care practices, here are five hurdles that remain before wearables can begin to play a major role in the healthcare industry.

Convincing Consumers Their Data Is Safe 
Medical device wearables will transfer personal and private information to a data repository, which will often be on a cloud server. While intercepting that data flow from individual devices is not that lucrative of a target for hackers, a database containing millions of personal and healthcare-related records that wearables have uploaded can represent a potential goldmine for data thieves. Device makers and third parties that receive and store the data will need to convince consumers that their information will remain both reasonably private and safe before consumers will adopt the technology.

“Someone could always try to intercept data from individual wearables, but that is not the main concern,” Amichai Shulman, CTO for security firm Imperva, said. “Instead, attackers have a real incentive to access the data aggregation point associated with wearables from many users.”

Among security features device makers should offer, wearable data connections will likely need to be encrypted and users should have to enter a password to access data on the device. Understanding Health Information Privacy (HIPAA) regulations must also be strictly adhered to protect data stored on servers. But unfortunately, HIPAA compliance is not always enforced as much as it should be, Shulman said.

“A pre-emptive approach must be taken to make sure that HIPAA is adhered to before wearables become more popular,” Shulman said. “In two to three years, hackers will have more incentives to attack medical device wearable databases. If we start applying the regulation today, then most of the devices can already be locked down when they become more popular in the future.”

Consumers generally trust their physicians and healthcare providers, but they will likely be wary of third parties that manage the transfer and storage of their data. They will be especially concerned about non-healthcare providers that may broker their data for marketing, insurance, or other purposes.

According to Vaughn Kauffman, principal and U.S. health industries new entrants leader at PwC of PricewaterhouseCoopers International, more than half of 1,000 consumers surveyed in a study said they trust clinicians with their data more than they have faith in other parties to protect their privacy. “In order to retain that trust, companies will need to be transparent about what is being done with the data,” Kauffman said. “Companies need to make their data privacy policies crystal clear. The general trend of using wearable and do-it-yourself technologies will continue to rise and companies need to make sure information that is being passed back and forth with the consumer is being handled correctly and the information provided is the right information.”

Getting the Protocol Rite
The electronics industry has a mixed track record when it comes to compatibility. While this is not necessarily a problem for many consumer electronics device types, compatibility problems could put a brake on medical device wearables’ adoption. Different communications protocols, for example, would make it difficult for healthcare providers to connect to different devices that patients might wear if a single communications standard is not in place. 

“Right now, the data that wearables produce is fragmented and often incompatible across devices.  In the near term, we are seeing a few companies trying to drive interoperability, but the wearables market still has to go through a ‘shake up’ in order to figure out which companies will lead the way,” Kauffman said. “For all of this to work, not only will the sensors and devices need to ‘talk’ to each other, but standard protocols need to be developed for the integration of user-generated data into traditional healthcare.”

Smarter Devices
Medical wearables have so far been limited to communicating blood pressure, glucose level, EKG, and other medical readings to the users’ smart phones and other data-collection hubs. However, consumer and their healthcare providers will look for devices that can do more, such as offering deep analysis of medical readings. 

In order to do that, devices makers will have to make their embedded chipsets smarter for advanced applications that consumers will want. The components inside will also have to become more powerful than they are now in order to better process the information. 

“Wearables right now are still a companion device to a smart phone. They do not have the processing power or the visual display to make them fully a ‘hub’ for all health data analysis and visualization,” Kauffman said. “They currently are ‘sensors’ with some limited visualization. The real horsepower comes from the smart phone, and will likely remain there in the short term.”

Consumers Must Like them
Medical device makers must keep in mind that consumers will opt for medical device wearables that will not interfere with their daily lives and that remain discrete. According to a recent study by researchers from the Polytechnic University of Madrid (UPM; Universidad Politecnica de Madrid), for example, patients have a strong preference for wearables that remain hidden from view. Patients also almost invariably prefer using their smart phones to collect data over wearing a bulky data-collecting device attached to their belt.

The good news is that device makers are developing wearables that are discretely embedded in clothing or fashionable articles, such as watches. “Today we are only seeing the emergence of wearables in the simplest form factors,” Kauffman said. “In the future, the technology associated with wearables will be embedded either in traditional brands and other form factors that are not only fitness focused, but are for everyday use, such as compression socks for diabetics with sensors for fluid or flow.”
 
Wearables must thus not only be comfortable, but they also must be fashionable, Kauffman said. “Much like the smart phone, wearables are becoming a fashion accessory and a form of individual expression,” Kauffman said. “However, in some cases, the focus right now seems to be on those devices that go on the wrist or hip.  But we can very easily see health wearable earrings, necklaces, clothes, tattoos, etc. having a dual use of health and an individual’s expression and style.”

Wearable But How Robust?
Wearables that are meant to be constantly attached to the body will thus need to keep working wherever their user goes, which could be in wet and harsh environmental conditions. However, the jury is still out on how robust wearables will really have to be, since they have yet to adopt them on a massive scale. Consumers, for example, may be unwilling to pay extra for an ultra-sturdy device, even if it can be worn around the clock. 

“It is unclear how durability of a device plays a role in the decision process for consumers and is different to [how consumers will expect wearables] to offer richer and more interactive usage of the data and how that data may change their health premiums or provide greater visibly in how to improve aspects of their health,” Kauffman said. “Again, we are seeing where more fashionable (and some cases less durable) options coming out that consumers will be drawn to as well.”  

Bruce Gain is a freelance writer.