In action: a diagram shows how drugs can be administed through breath

Using your own breath to administer drugs may sound like the stuff of science fiction. But patients using a device developed by OptiNose, a biopharmaceutical company, can do just that to treat inflammatory conditions such as chronic sinusitis, or to provide faster relief from migraine headaches and anxiety attacks.

“When you blow into the mouthpiece, the airflow picks up [a] drug, which enters the nose,” explains Peter Miller, the company’s chief executive.

The potential for technology and innovation in the device sector to improve care is seen by many as significant, but companies hoping to succeed have to navigate a complex landscape of clinical trials, regulatory approvals and resistance from insurers reluctant to pay for new products.

While OptiNose’s device relies on invention and design, much of the innovation taking place in the sector is being driven by digital, sensor and mobile technologies.

For example, Israel-based Oxitone has developed a bracelet that uses sensors to conduct continuous pulse oximetry, a non-invasive procedure that measures levels of oxygen in the blood. The company says the wearable device can capture the same amount of physiological information as conventional methods.

Pennsylvania-based Cerora has developed a low-cost headband that captures biosensor data to measure brain impairment. The device can detect damage caused by sporting accidents or assist in the diagnosis and management of dementia.

Data are wirelessly transmitted to a computer, analysed by software in Cerora’s cloud, sent to physicians for interpretation and given to trainers, nurses and others to help with immediate diagnoses, such as identifying sport-related concussion.

What counts as a medical device is also changing. “Even the smartphone is turning into a medical device,” says Unity Stoakes, president and co-founder of Startup Health, an accelerator and venture capital fund with a large global portfolio of early-stage digital health and wellbeing companies. “We are seeing a blurring of the lines of what is a medical device as sensors, mobile technologies and new tools are changing every aspect of healthcare.”

However, the sector’s complexities — with its consumers, payers, providers and tough regulatory frameworks — create a number of hurdles for companies, not least if they plan to use drugs that need to be approved.

For OptiNose, this was not a problem. “We are [using] drugs that are generally available,” says Mr Miller. “So we have a much less risky development pathway.”

And Mr Stoakes sees opportunities for companies that can work with regulators. “Many of these devices will and should be regulated,” he says. “But innovators should not be scared. That should be seen as a competitive advantage if you set it up right.”

Other difficulties include the need to explain to insurers the cost savings and benefits this technology provides.

Additionally, as medical devices rely heavily on digital and wireless technology, companies need to ensure their innovations can be integrated into the legacy systems of the healthcare sector. Interoperability — the ability of computer systems to talk to one another — is often lacking.

Regina Herzlinger, a professor at Harvard Business School specialising in healthcare research, says that in addition to developing devices that deliver measurable benefit to patients, companies must be able to conduct clinical trials. They need to work with insurers and doctors and to target products at the right category of practitioner.

Much of this can be unfamiliar territory for technology companies. Conducting clinical trials is something IT start-ups may have little experience of.

Mr Stoakes says the landscape is unlike Silicon Valley, where the emphasis is on total disruption. “What is different in healthcare is that you need to collaborate with government and work with the established industry very closely. We are talking about people’s lives, wellbeing and health.”

Avoiding turf wars is another challenge, says Prof Herzlinger, who teaches a healthcare innovation course at Harvard Business School. “Many times these technologies take from the expertise of one doctor and give it to a broad category of doctor,” she says.

She cites the case of congestive heart failure. “Right now, CHF is the province of people who have designated themselves as experts in this complex disease,” she says. “But once the sensor does its thing, a lot of cardiologists could enter the field as well.”

Despite the complexities, Mr Stoakes says there are plenty of opportunities. “It is a very exciting time for what is going on in the early stages of medical devices and diagnostics.”

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