Media coverage of surgical innovation is often dominated by robotics, however it’s hard to determine how much of this has really been incorporated in surgical practices. There will need to be a big shift towards earlier diagnoses and preventative interventions as opposed to the current method of reactive treatments. This will likely be enabled by the improvement of imaging capabilities both extra- and intra-operatively and the introduction of augmented and virtual reality to assist the surgeons in real time. However, as it stands today, these technologies are not quite ready and major investment is required on both the R&D side and in the operating theatres themselves to ensure these devices can be used to their full potential.
There are several underlying issues that have a significant impact on the industry and it’s ability to innovate in the surgical sphere. The following is a brief overview of ten of these issues and how they impact the ability to successfully develop and market new surgical devices to bring patient benefit.
01 – Limited access to theatres for observation
Being able to observe live procedures is a crucial way to uncover unmet needs in surgical procedures, however access to theatres is becoming increasingly difficult. Tighter health and safety measures and patient confidentiality has lead to reduced access for R&D staff. Though this was likely an indirect result of legislation such as the Sunshine Act, HIPPA and GDPR, it has meant that device developers are having to work around bureaucratic processes to place technical staff in theatres. There are several workarounds that device developers use to gain insights, such as interviews, simulated surgery, video analysis and observation suits in teaching hospitals, however these are only substitutes for observing live procedures.
02 – Increased cost focus
In the past, surgical devices that improve performance or functionality received a warm welcome in the market, especially from surgeons eager to adopt the latest technology. Recently however, payers are challenging the need to purchase such devices at high costs, requiring evidence of clinical benefit and overall cost effectiveness compared to existing methods and treatments. This can be seen in formal systems such as the NICE (National Institute for Heath and Clinical Excellence) cost-effectiveness threshold in the UK, which acts as a good reference points for healthcare economics.
The increased scrutiny and scepticism from payers following such systems means that marketing a new product can be difficult. Slower uptake and a slower return on investment mean that clinical evidence takes longer to generate. Should a device initially sell at a lower volume with less market penetration, it could limit or slow the benefit of scale, with developers losing the efficiency and reduced costs of increasing manufacturing volumes over time.
03 – Democratisation of procedures and disruptive innovation
Making procedures available to more patients 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, these KOL can drive adoption by publishing the results of studies and promoting them.
An alternative approach is to empower surgeons with less expertise or specialism to carry out complex procedures, ideally without the need for an operating theatre. New innovations in surgical devices could help to enable these changes. While a lot of focus is currently on surgical robotics as a way to democratise surgery, there is also an opportunity to focus on more humble devices that take minor surgeries away from the theatre and into local clinics. Disruptive innovations have become a new trend in surgical healthcare, whereby the aim is to deskill procedures through technology to empower GPs or even nurses to carry them out.
Surgical education programs could also be a way to empower more surgeons to offer specialist care in their local areas. This makes access for patients much easier, as they can be sent home the same day and continue to have outpatient observations.
Accessing the appropriate surgeons and identifying the features that a new device would need can be very challenging however. It is especially difficult for device development companies to access surgeons outside of their existing user base, who do not use their devices or carry out certain procedures. Additionally, entering into a dialogue can be difficult, especially where the device company has limited knowledge of the procedure in question and risk feeling they are belittling the doctor.
04 – Tech-push rather than needs-led innovation
Device companies are constantly scouting for new technologies to incorporate into next generation devices. While these technologies are developed to give an advantage over current devices, from size, speed and ease of use, sometimes these improvements are divorced from real procedural needs. Often 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 may not be considered worth an additional investment if the actual use time makes up only a small percentage of the procedure and isn’t considered a limiting step. Identifying bottlenecks and unmet needs offer much better opportunities to innovate and develop devices that demonstrate both a clinical and overall cost benefit. In order to achieve this, device developers need to carry out a more in-depth view of the context in which devices are used, observing procedures and opening up dialogue with surgeons and other stakeholders on an ongoing basis. This is an important way to identify issues with current devices and unmet needs to be addressed.
05 – Newcomers struggle to break into the market
A number of mergers and acquisitions have led to significant consolidation in the surgical devices landscape, resulting in very large organisations who offer numerous devices across a range of procedures. Such a shift to larger companies has advantages in terms of scale, allowing large R&D budgets and discounts for payers resulting from higher volume of business. However, it has also made it hard for new, smaller entrants and start-ups with novel ideas to get a foot in the market. Such companies are often faced with the challenge of displacing a major player in getting business, who already have large procurement contracts in place.
Similarly, established medical device companies already have strong representative-to-surgeon relationships, making it hard for new entrants to establish similar relationships of their own. This can result in a failure to gain vital feedback on devices in development, or a struggle to achieve adoption after market introduction.
06 – Isolation from the bulk of surgical procedures
Concentrating on volume of procedures is important for medical device companies, both to sell an increasing number of devices and to gain the clinical evidence to convince others to adopt them. Despite this, there is often a lack of communication between device developers and the less-specialised surgeons who carry out a wide range of common procedures. This is generally because developers tend to focus on fostering relationships with leading surgeons who are at the pioneering end of surgical innovation and involved in highly expert procedures. As a result, the focus of medical device companies and the feedback they gain during innovation and development may be diverging from some of the groups who should be participating.
07 – The challenge of getting a device through regulation
In the EU market, the introduction of the Medical Device Regulation (MDR) has broadened the definition of a “medical device” to include implantable devices, invasive devices, software for medical purposes and accessory devices. This covers surgical robotics, minimally invasive surgical devices, joint replacements, invasive drug delivery and many more. The impact of this is that far more devices are under the scope of the MDR than were under the Medical Devices Directive (MDD). This effects the regulatory burden for both on the market devices and new technology. The need for clinical evidence has greatly increased for higher class devices, which many surgical devices fall under.
In the US, the vast majority of medical devices are approved via the 510k or exemption route. This makes sense 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. Despite this, the incremental regulatory burden of a PMA is a major disincentive to developers and a significant hinderance to surgical innovation. This could limit the development of truly novel devices.
The regulatory challenge advantages the ‘fast follower’ in consumer devices – devices which are very similar to a newly launched product, whose developers therefore benefit from the initial market entrant’s investment in market development. The regulatory process for the following company is far simpler than that of the innovative device developers, who would have had to establish the regulatory pathway without a clear predicate and then develop the market. In turn, future similar devices will then benefit from this again.
08 – Reimbursement basis
Diagnosis Grouping (US) or NHS tariff (UK) are costing systems that seek to standardise the cost of providing a treatment. They are used to pay the provider a standard amount rather than traditional ‘cost-based reimbursement’ or ‘cost plus’ as it’s often referred to in the industry. This can influence the amount (or perhaps the perceived amount) that a medical device costs the user.
It can be argued that a 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. However, though they allow improved margins on providing the procedure, the practice is often more complicated.
09 – The challenge of producing clinical evidence
While a device can be marketed and used from the point of approval, large-scale adoption increasingly depends on producing evidence of clinical efficacy and overall benefit. Such evidence can only be generated by a large volume of procedures being carried out with the new device. The issue here is 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 tend to employ various strategies to overcome this situation and prompt initial adoption. This might include providing samples to key surgeons, discounting, sponsoring research and more. However, once again there is a significant disadvantage to start-ups and smaller companies here, who are rarely in a position to employ these tactics.
10 – The need for new training
Surgeons require many years of training and practice to become fully proficient at procedures. Because of this, many stick to tried and tested techniques and devices, owing to the fact they are practiced at these and so the outcomes are more predictable and low-risk. New devices and techniques will potentially come with a steep learning curve for surgeons, therefore they are difficult to justify incorporating into everyday practice. As a result, there can be a reluctance among surgeons to adopt new techniques and devices.
In order to tackle this, device companies need to invest more in surgical training centres, targeting upcoming surgeons to make them familiar with new devices and therefore more disposed to using them on an ongoing basis. In a 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 mentioned here was the forthcoming robotic era. Why train in the difficult field of MIS when robots will make adoption easier?
While there are clearly many potential barriers for surgical innovations, are there any solutions? It’s true that these issues are complex, intertwined and ingrained, meaning any solutions will take significant effort to identify, lobby and revise practices to achieve. However, institutions like the UK government have already begun to identify the need to accelerate development in the surgical sector through investment. This can be seen for example in a recent government position paper published on syringe free vaccination delivery, as part of efforts to change how future vaccines are administered by supporting novel delivery methods and technologies. If we are to find new ways to improve our surgical practices, making them safer, more efficient and more accessible to patients, then these new solutions are worth exploration and investment.
Iain Ansell, Consulting Director, Team Consulting
Kathryn Thompson, Mechanical Engineer, Team Consulting
 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0158510  https://www.ohe.org/publications/barriers-uptake-minimal-access-surgery-united-kingdom  https://www.gov.uk/government/publications/life-sciences-vision/life-sciences-vision-html