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’s a risk that the information could be misinterpreted and endanger the patient.

Beyond patients’ physical wellbeing, there are inevitable concerns about data privacy. There are strong defences in place to protect personal data now, and medical data is among the most vigorously safeguarded because of its ultra-sensitive nature. So developers will need to ensure, and build confidence in the expectation, that a patient’s data is secure from external access and use.

And what about patient-developed devices, and the potential regulatory and safety consequences that could result from these? 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 associated 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 to keep on top of is accelerating 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.

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

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

As we move closer to an even more advanced age, Medicine 3.0 – which will see artificial intelligence capabilities being integrated into medical devices - companies will need 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. At the same time, the rise of big data—the combination of data collected about and by the patient—presents a wealth of potential, if managed properly.

Medical device companies must find ways to efficiently gather and manage all of this data so they can extract reliable, insightful and actionable knowledge and information for the benefit of patients, for population health, and with a view to overcoming potential technological and therapeutic challenges.

Forging ahead successfully will require strategic partnership with a range of different parties. These might include network service operators for the data connections, and biotech firms, as well as the regulators - whose job it is to ensure progress doesn’t happen at the expense of patient safety or the quality and integrity of care.

Loetitia Jabri is regulatory, pharmaceutical & medical devices platforms associate director at ProductLife Group, with responsibility for organising and managing regulatory and pharmaceutical platform services as well as leading the development of delivery activities for the medical device sector.