23 May 2013

Rise of the (Surgical) Robots

Surgical robots (and their surgical imaging and organ preservation siblings) have been deeply transforming not only the lives and hopes of patients, but also the market for medical technology, investment patterns and risks. Most importantly, the market is brilliant, increasingly fast-paced, but relatively fragmented.
Robot-assisted surgery is increasingly being used around the world, as minimally-invasive surgical (MIS) techniques garner popularity. In robot-assisted MIS surgery, the surgeon inserts special instruments in the patient’s body through tiny incisions and operates them remotely, under video guidance, through robotic arms. Thus, while the surgeon no longer looks directly inside the patient’s body, surgical robots become his eyes and hands. After MIS is performed, the trauma and recovery times for the patient are much reduced compared to traditional, open-incision interventions.

At about the same time, European Union legislation on medical devices is being reviewed and updated. Surgical robots will feel the impact too.

The burden of genius


U.S.-based Intuitive Surgical is the company that invented the da Vinci surgical robot. Approved and launched in 2009, it is currently used for complex interventions across cardiac, thoracic, urology, gynecologic, and pediatric surgical disciplines. Corindus Vascular Robotics, also from the U.S., pioneered robotic cardiovascular interventions, and recently began cooperating with Philips who received exclusive rights to market their CorPath 200 System. In the field of mobile surgical imaging, GE Healthcare’s C-arm is rivaled by contestants such as Siemens and Philips. In the UK, the OrganOx metra (by OrganOx Ltd.), revolutionizes transplant surgery. This automated device maintains a liver prepared for transplantation viable for up to 24 hours, in body-like conditions, running on oxygenated blood (as opposed to keeping it in ice, for no more than 14 hours).

Research in robotic surgery is buzzing with activity, but how many breathtaking achievements reach the production phase and widespread distribution? Healthcare technology can spearhead public health improvements, with one condition: the legislative framework must be appropriate to unleash its full potential and turn great ideas into healing patients. To what extent is this condition met in the European Union? How can the EU regulatory package be(come) a standard for third countries? What transformations does it have to undergo before it turns into a model, and what do they mean for the patients, their doctors and the creators of surgical robots?

Mutatis mutandis ... or not quite so?


It is safe to say that relevant legislation regarding surgical robots is still incomplete in many regions of the world, including most European Union (EU) Member States. At a supranational level, they fall under the EU medical devices legislation, which is currently under review. The field is also covered by the EU Directive on the application of patients’ rights in cross-border healthcare, and the EU Directive on Electronic Commerce (the eCommerce Directive).

The Regulation on medical devices aims to revise the existing framework. It refers to a wide range of products ranked according to the risk they pose, from Class I (low-risk, e.g. pregnancy tests) to Class III (high-risk, such as surgical robots). The EU legislative process was kick-started in September 2012, when the European Commission (EC) published its proposal, and is currently awaiting the European Parliament’s 1st reading phase, tentatively scheduled for the November 2013 Plenary meeting. Once adopted, the proposal will replace the existing Directives on medical devices with draft Regulations that will enter into force incrementally between 2015 and 2019.

The Parliament’s Environment, Public Health and Food Safety (ENVI) committee (and rapporteur Mrs. Dagmar Roth-Behrendt, a German Member of the European Parliament from the Socialist & Democrat political group) has the lead. In the meantime, the Council of the EU has been organizing rather frequent working groups of the member states’ health attaches also negotiating their countries positions on the medical devices law revision. Already a large part of the debate revolves around how to organize the approval process of Class III high-risk devices: the Commission intends to keep in place the decentralized system of national Notified Bodies (NBs) that approve the products, but allow them to also scrutinize decisions taken in another EU Member State. At the same time, the NBs would respond to a newly-created Medical Devices Coordination Group (MDCG) - a committee of experts from the Member States, chaired by the Commission. Yet the Parliament is keen on taking the opportunity to replicate the U.S. centralized system of pre-market approval for Class III devices. According to Rapporteur Roth-Behrend MEP, this would only simplify the procedure by eliminating the mutual recognition requirement, save time and increase safety. As revealed in a debate in the ENVI committee, her stance is backed by MEPs of other political colors, who also call for increased transparency and public accessibility of industry data (including clinical investigations on Class III devices), arguing that safety is central and that patients’ trust in medical products of high-level risk has been lost and needs to be restored.

The operating room of the future is upon us - now what?

Other proposed changes to the EU legislation on medical devices include creating a central European Database managed by the European Commission in order to enable the reporting of negative events; reclassifying certain products and including them in Class III; and introducing the Unique Device Identification (UDI) system for a better traceability of the medical devices. Making sense of the regulatory landscape and the way it evolves is a complex yet indispensable task. This is especially true because the risks of misunderstanding, non-knowing or overlooking can easily turn into high costs. Yet apart from the EU legislation undergoing transformation, the industry of surgical robots faces other challenges too … or are they opportunities?

Identifying and accessing funding can be one example: the European Commission has been funding research in surgical robotics via its FP7 program (of the total €53 billion shelled out in 2007-2013, €600 million was for robotics). Another seven year program, the so-called Horizon 2020, will attempt to take the achievements of FP7 to the level of reaching the marketplace through mass production. Horizon 2020 is expected to roll out a total of €80 billion, of which robotics might benefit again.

Another important aspect is awareness-raising among hospitals and surgeons, other medical practitioners and patients regarding surgical robots. It is essential to hear and answer their questions, understand their fears, help them overcome uncertainties. Through open and frequent communication with these groups of people, the message of surgical robots about their potential to heal can reach them. Myths can be dismantled and negative stories can be clarified. Indeed, knowing how to identify various groups of users, learning how to talk and listen to them, can guide research better, can help implement existing devices, and one day may even make the difference between life and death.

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