Commercialising Medical Sensors: 5 Challenges

May 8, 2019

Wearable and ingestible sensor technologies are rapidly emerging and could shake up the medical industry. They transmit information on vital signs, like heart rate and blood pressure, to a device such as a smartphone, and can be used to monitor those with long-term health conditions.

Wearable sensors are placed on parts of the body, sometimes as adhesive patches, belts or pendants. To manage diabetes, glucose sensors placed on the skin detect glucose in sweat and interstitial fluid, as demonstrated in a study by a team at the Department of Nanoengineering, University of California.

There are multiple obstacles to be overcome before these technologies are commercialised.

Simon Sherrington, MD

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Ingestible sensors are pills which are swallowed, and some can be partially powered by the body itself (see this article for details of energy harvesting for medical devices). An example of a company developing “smart pills” is Proteus Digital Health. Its technology can indicate if somebody has forgotten to take their medication. Another is Medtronic, which has brought various camera pills to market. These take images of the intestinal tract, sending the images to a belt-worn device and a computer where they can be reviewed by a doctor.

The five big challenges to MedTech commercialisation

Investors worry about the technology’s ability to disrupt

Gaining reliable funding can be difficult. Investors may waver if their trust in the technology changes. Also, those in the medical field may have invested interests in other technologies which compete with innovations. Dr Kalantar-zadeh (Professor at the School of Chemical Engineering at the University of New South Wales, Australia) co-invented an ingestible gas-sensing capsule, and has faced such challenges in its commercialization, stating “Regrettably, a few large companies and a number of medical doctors, with vested interest in current insufficient technologies.. would not like to see their loss of market to our product.” Kalantar-zadeh also commented that investors may not realize how disruptive this technology can be, and are unfamiliar with the fact this technology is very safe, low cost and non-invasive. Additionally, some investors have concerns about the steps required for bringing medical technologies such as ingestible sensors to the market.

After overcoming various obstacles, Dr Kalantar-zadeh and his team are moving forward, completing phase II trials, seeking help from the Australian government, and gaining market distribution approvals. Remaining resilient when facing these problems appears beneficial.

New technology must add real value over existing approaches

Value can be created in multiple ways. For instance, for long-term condition monitoring, it essential that wearables are conformable to the body and can last – this will result in reliable, simple monitoring compared with existing non-continuous monitoring methods. Adhesive patches may be suited for monitoring by the week, and sensor belts be suited for longer-term monitoring, as discussed in a study by McAdams et al (2010).

But the value of wearables and ingestibles can be much more significant. In a recent publication, Dr Heikenfeld (Director of Novel Devices Laboratory, University of Cincinnati, USA) and his team discuss the challenges faced in commercializing wearables. Dr Heikenfeld identifies creating value as the key challenge: “The value that simple optical | mechanical | electrical sensors can provide is limited … You need to get to chemical specificity if you really want to see the sensors themselves provide greater value.”

Heikenfeld emphasised that chemical sensors face the greatest commercialization challenge: “Chemical sensors offer the most upside potential, but also are the most challenging due to their sensitivity. They effectively are able to pick a needle out of a haystack by detecting a single type of chemical among a plethora of others in blood, sweat, tears, and saliva. By being so sensitive, they are also more fragile and susceptible to interference.”

The trust of the broad medical community is needed

There is a reported lack of an integration of wearable and ingestible sensor innovations with the medical industry. A key obstacle related to wearables was identified as long ago as 2010 in an article by McAdams et al (2010): – “Many of the systems which do not get past the prototype stage fail because they have not considered the clinical requirements nor those of the patient. It has been pointed out that most new products that fail do so because of a failure to understand real users’ needs, not for lack of sufficiently advanced technology.”

Demonstrating an understanding of medical processes may increase the trust in wearable and ingestibles among those in the medical industry. Dr José Bravo of MAmI Research Lab, Castilla-La Mancha University, Spain, has said “For the moment, I think physicians are not aware to accept new ways of vital signs monitoring by means of medical sensors. They see these approaches like intruders and don’t trust in their effectiveness.”

Innovators must focus on the needs of the user; the medical community expects demonstration of clinical relevance through the publication of research and clinical trials.

Software must be bulletproof

Software such as smartphone apps need to be reliable, without misinterpreting the data collected by sensors. For instance, we wouldn’t want an app to warn of a cardiac arrest when we have simply gone for a work-out at the gym. Dr Heikenfeld from the University of Cincinnati uses the example of AI to make the points that software must be robust:  “If you have such software systems, like AI, each unique data set coming in can improve the overall predictive value. However, software and AI always needs to be informed by ground truth. So you need some way to reliably train the AI.”

Ways of meeting data sharing and security regulations will change

The medical sector is well used to dealing with confidential data, but continuous monitoring from sensors in non-medical settings make the challenges harder. Monitoring data can be uploaded to the cloud and shared. Dr Bravo of Castilla-La Mancha University suggests this can benefit preventative medicine, though he points out that there are questions about who should be allowed to access the monitoring data, and how secure it is from hackers. Big data will require appropriate legislation to keep up-to-date with the technologies while preserving patient privacy. The wireless component of these technologies adds a new security concern.

As regulation plays a big role in the medical device industry, it is important for innovators to validate security for their medical devices. Rapid developments in the industry mean that  innovators, regulators and users must collaborate and find a balance to avoid risks, while utilising the power of these technologies, as has been recognised for several years (see, for instance, this publication by M. Schukat et al (2010).

Overcoming commercialisation challenges requires cross-industry support

Cutting-edge developments are underway for wearable and ingestible sensors which have great potential for clinical long-term condition monitoring. Though, challenges must be overcome in the near future, not only for innovators in raising capital and trust, but for regulators, and the medical industry who must keep up with the rapid innovations being made.

[Image licensed to Ingram Image]

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