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10 issues in the development of surgical devices

The media coverage of surgical devices is often dominated by robotics, to the extent that the public could be forgiven for assuming the majority of procedures were carried out robotically. In reality, though actual figures are hard to come by, robotic surgery accounts for less than 10% of US procedures, as a reasonable estimate. Talking with clients long established in surgical device development, there are several key issues that are potentially limiting innovation in this sphere. These underlying issues get very little publicity but have a great impact on the industry and its ability to develop and successfully market new devices to bring patient benefit. Following is a brief commentary on some of these issues:

In order to uncover unmet needs in surgical procedures, direct observation of live procedures is crucial. However, access to theatres is becoming more difficult, with reduced access thanks to tighter health and safety and patient confidentiality. There is no obvious reason for increased restrictions on theatre access for R&D staff; perhaps an indirect consequence of legislation such as the Sunshine Act, HIPPA or GDPR ? Device developers are having to work around bureaucratic processes to place technical staff in theatres. Several work arounds are often used to gain insight, including interviews, observing simulated surgery, video analysis and observation suites in teaching hospitals.

Traditionally, surgical devices that improved performance or functionality received a warm welcome in the market, particularly from surgeons eager to adopt the latest technology. Nowadays however, payers are challenging the need to purchase improved devices at higher cost. They require evidence of clinical benefit aligned to a cost benefit, or overall cost effectiveness compared to existing treatments. In the UK, NICE (National Institute for Heath and Clinical Excellence) has a formal system for evaluating cost effectiveness of new treatments, and is a good reference for healthcare economics. This scepticism from payers makes marketing a new product more difficult. Slower uptake results in a slower return on investment, and means that clinical evidence takes longer to generate. A device initially selling at low volumes with a slower increase in market penetration will limit or slow the benefit of scale, where increasing manufacturing volumes and associated efficiency reduce device cost over time.

Making procedures available to more patients – by reducing the costs or increasing their simplicity and availability – is an ongoing challenge. Traditionally device companies have collaborated with leading surgeons, or Key Opinion Leaders (KOL), to develop novel devices that allow procedures to be carried out more effectively. This can help benefit a greater patient population as, once a device is prototyped or fully launched, KOL can drive adoption by publishing results of studies, etc. We can alternatively access a greater population of patients by empowering less expert/specialist surgeons to carry out complex procedures, or by making procedures possible to carry out in a doctor’s office, rather than in theatre. This could involve developing devices that enable such changes; there is much talk that Surgical Robots will democratise surgery, but perhaps a greater opportunity would be to do so with more humble devices, or surgical education programs? Accessing these surgeons and uncovering the features that a new device would need can be very challenging. It is especially difficult for device development companies to access those outside of their user base, who do not use their devices or carry out certain procedures. Additionally, entering into a dialogue can be difficult, knowledge of the procedure will be limited and there is a risk of the device company feeling they are belittling the doctor.

Device companies are constantly scouting for new technology to incorporate into next generation devices. New technologies are developed to give an advantage over current devices – size, speed, ease of use, etc – but sometimes this technical advantage is divorced from real procedural need. Nowadays, the market will judge the potential of an improved device in the context of the overall procedure, or complete treatment. For example, a device that allows faster movements might not be judged to offer any meaningful overall benefit when the actual use time is a small percentage of a procedure, and not considered to be a limiting step. Innovating in areas identified as bottlenecks, or meeting previously unmet needs, is far more likely to yield devices that can demonstrate both clinical and overall cost benefit. This requires a more in-depth view of the context in which devices are used; observation of procedures and dialogue with surgeons and other stakeholders on an ongoing basis, to identify issues with current devices and unmet needs.

There has been significant consolidation in the surgical devices landscape, with mergers and acquisitions creating very large organisations, who offer numerous devices across a range of procedures. This shift has advantages in terms of scale: it allows large R&D budgets, and the ability to discount to payers based on volume of business – what buyer would not want to drive down procurement costs? However, this makes it hard for smaller new entrants with a novel device to displace a major in getting business, when large procurement contracts are in place. Similarly, established medical device companies have strong representative-to-surgeon relationships. New entrants will struggle to establish such relationships, and could therefore fail to gain vital feedback on devices in development, or struggle to achieve adoption after market introduction.

Medical device companies need to concentrate on volume of procedures, both to sell an increasing number of devices and to gain the clinical evidence to convince others to adopt their device. However, often their strongest surgeon relationships are with leading surgeons, pushing the boundaries of surgery with revolutionary and highly expert procedures. There are fewer relationships with the less specialised surgeons who actually carry out a greater range of common procedures. Academic surgeons rightly concentrate on the education of the next generation of surgeons. However, as the majority of procedures are carried out in less specialised centres, the focus of the medical device companies, and the feedback gained during innovation and development, is diverging from some of the groups who should be participating.

The vast majority of medical devices are approved in the US via the 510k or exemption route. This is entirely sensible given that many are based on, or very similar to, existing devices. The FDA exists to regulate devices and drugs, not to regulate the practice of medicine or surgical procedures. However, the incremental regulatory burden of a PMA is a major disincentive; the burden of regulation is offputting to developers, an important hinderance to innovation in surgery. This could limit the development of truly novel devices. This challenge advantages the ‘fast follower’ in consumer devices – devices which are very similar to a newly launched product, whose developpers thus benefit from the initial market entrant’s investment in market development. Their regulatory process is far simpler than that of the innovative device developpers’, who would have had to establish the regulatory pathway without a clear predicate, and then develop the market. Following medical devices will benefit from both these efforts.

Diagnosis Grouping (US) or NHS tariff (UK) are costing systems that seek to standardise the cost of providing a treatment, and pay the provider this standard amount rather than traditional ‘cost-based reimbursement’ or, to use more general industry parlance, ‘cost plus’. This often influences the amount (or perhaps perceived amount) that a medical device costs the user. It can be argued that fixed cost per procedure should drive innovation; devices that are cheaper, or which offer a reduction in overall treatment cost, should be ‘easy’ to sell to healthcare providers. Though they allow improved margin on providing the procedure, the practice is often more complicated.

Once approved, a device can be marketed and used. However, large-scale adoption increasingly depends on producing evidence of clinical efficacy and overall benefit, evidence which can only be generated by a large volume of procedures being carried out with the new device. The issue lies in that, if the new device is expensive, there’s little incentive for providers to initially procure it – a classic chicken and egg scenario. Major device companies will employ various strategies to overcome this situation and prompt initial adoption: providing samples to key surgeons, discounting, sponsoring research, etc. While larger corporations have the means to employ these tactics, start-ups with a novel device are rarely in a position to do the same…

Surgeons require many years of training and practice to become fully proficient at procedures. Many stick to tried and tested techniques and devices, and for good reason – they are practiced at these and so the outcomes are more predictable and low-risk. However, this reliance on familiar techniques fosters a reluctance amongst surgeons to adopt new ones. There is also the issue of new training. Device companies invest in surgical training centres, so that upcoming surgeons become familiar with new devices and are thus more disposed to using them on an ongoing basis. New devices and techniques will potentially come with a steep learning curve for surgeons, and thus are difficult to justify incorporating into everyday practice. In a recent report on the uptake of minimally invasive surgery (MIS) in the NHS (UK), one of the limiting factors reported was training and access to training for current practitioners of open surgery techniques. Interestingly, another barrier to adoption was the forthcoming robotic era – why train in the difficult field of MIS when robots will make adoption easier! So what? The above commentary seeks to highlight potential barriers for innovations, but does not necessarily offer solutions. The issues are complex, intertwined and ingrained and such solutions will take significant effort in identification, lobbying and revised practice to achieve. In future articles we will expand on several of these issues, offering a more detailed commentary, and suggesting how the future might look.

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