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Going digital

Medical devices, Medicine 2.0 and beyond


The digitalisation of everyday life has led to the emergence of e-patients – empowered and eager to engage in their own health matters.

A new era, Medicine 2.0, is dawning too, where healthcare starts to harness the latest technology and the scope for personalised treatment grows. ProductLife Group’s Loetitia Jabri charts the developments and discusses some of the practical implications for the medical device industry.

The barriers between physicians and patients have been breaking down for more than a decade, bringing about a revolution in medicine – the rise of e-patients. And that in turn has led to the era of Medicine 2.0, as healthcare catches up with the advances that technology has enabled in other industries.

Innovations include the digitalisation of diagnosis and prevention through the use of wireless, mHealth solutions such as smartphone apps, wearables, gamification and remote monitoring.

More than any other area of healthcare and life sciences, medical devices represent a natural fit for Medicine 2.0, and innovative companies have been quick to take advantage of the possibilities.

The journey to digitisation

Over the last 10 to 15 years, the technological revolution has seen the emergence of digital medical devices that empower patients and close the communication gap with healthcare providers. Today smartphone apps and devices such as Fitbit, the Apple Watch and other connected objects – such as connected blood pressure monitors – keep track of patient activity and generate valuable data.

All of the medical information generated is playing an increasingly important role in the new doctor-patient relationship, which in turn is becoming more collaborative. ‘Connected’ medical devices give patients greater control over their health data, and in turn enable doctors to use the data to prompt beneficial patient behaviour.

With advances in telemedicine, meanwhile, and with rapid increases in the numbers of next-generation medical devices capable of harnessing artificial intelligence, both doctors and patients now have even more medical information available to them.

Regulatory authorities, too, are eager to promote Medicine 2.0 through the development of wireless devices. In October 2010, the US Federal Communications Commission and the US Food and Drug Administration (FDA) came together to encourage investment in wireless healthcare devices, and the European authorities have become increasingly willing to give such solutions the CE marking required for drug products to be sold in Europe.

The complex nature of advancement

Despite regulators’ moves to encourage digital innovation, the complex nature of the new types of devices, added to their speed of development, the ways data is used and by whom, means both the life sciences industry and the authorities will have to prepare for change. Policymakers and regulators must keep pace with the innovations emerging across the industry.

One of the biggest challenges involves efficiently achieving validations of digital health devices and smartphone apps – that is, ensuring the intended use of a medical device and the management of its data. Companies must have objective evidence of validation to meet product specifications. Consider, for example, wireless technologies, whose validations will be needed to ensure the quality of the device, and to protect patients from interference and unsecured lines. Complexity arises because device validation will also depend on the network being used to transmit and receive data.

As medical devices increasingly look to harness advances in artificial intelligence – enabling devices to guide patient therapy, for instance – regulatory processes will have to adapt here too.

Another issue may be a future requirement to perform double-blind studies involving large patient cohorts for combination products. Indeed, the FDA has encouraged randomised, double- blind, sham-control trials for class III devices such as pacemakers.

Regulators must also take into account the changing patient-physician relationship. Today’s patients expect to be more involved in their own care, and digital medical device solutions are making that increasingly possible. But how that involvement might affect the regulatory framework is not fully understood, despite ongoing workshops between the European Commission and medical devices manufacturers.

Certainly, medical device manufacturers will need to tread a fine line between innovation and patient safety. Data from patient sensors must be properly integrated with medical information; otherwise there is a risk that the information could be misinterpreted and endanger the patient.

It’s not only patients’ well-being that is potentially at risk but also data privacy. How will developers ensure that patients’ data is secure from external access and use?

And then there’s the issue of dealing with patient-developed devices and the potential regulatory and safety consequences that could result. For example, the #WeAreNotWaiting diabetes movement resulted in the development of apps, cloud-based platforms and reverse- engineering of currently marketed products aimed at helping people with diabetes. Most notable was the development of an artificial pancreas. But because the system was developed without regulatory oversight, its reliability is unknown, which raises concerns that patients could be put at risk.

Perhaps the most complex issue for regulatory authorities is rapid change in other markets. For example, China has made significant changes to its medical device regulations, aimed at reducing the complexity of the approval process and making it easier for smaller medical technology companies to bring products to market. That change removes a lot of complexity for medical devices companies in China and enables them to become more competitive.

Finding the potential

Despite regulatory challenges and other issues digital devices can introduce, there is enormous potential for companies to leverage new capabilities in the age of Medicine 2.0 such as wireless body sensors, 3D printed patient-specific implantable devices, pumps that enable people with diabetes to deliver insulin to themselves, and even implants with sensors via which patients can send a message to their doctor.

Companies can take advantage of the widespread use of smartphones to develop medical device apps for patients, too. Another powerful avenue would be to develop monitoring devices for children – particularly young children who are unable to easily communicate their health issues.

Then, as we move closer to an even more advanced age – Medicine 3.0 – which will see artificial intelligence capabilities integrated
into medical devices, companies will have to be nimble in responding to the market’s demands and expectations, and regulators will have to be ready to adapt to ever-changing innovation.

The future is here, and patients are ready to embrace it. Personalised medicine means giving doctors and patients the abilities to adjust and calibrate treatment through the use of data derived from a range of self-indicators. Equally, the rise

of big data – the combination of data collected about and by the patient – has the potential to be a treasure trove of real-world data if managed properly. Medical device companies must find ways to efficiently gather such data so they can extract knowledge and information for the benefit of patients, for population health and for overcoming potential technological and therapeutic challenges. Without the right approaches, that treasure-trove of knowledge will be nothing more than a chaotic jumble of data.

To thrive in a patient-centric era, medical device manufacturers will have to stay a step ahead. They’ll need to partner with a variety of companies – from telecommunications providers to biotech firms – as well as regulators to ensure progress is not impeded and that patients remain safe.

medical device

Article by
Loetitia Jabri

Loetitia Jabri is Regulatory, Pharmaceutical Associate Director at ProductLife Group

18th February 2019



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