A clinical perspective: 6 challenges that remain in the operating room

11 Apr 2024 34min read

For many consumer products or devices, any creative person can identify problems and potential solutions. For surgical devices, the real challenges are not as clear to those of us outside of the operating room, where access is restricted for very good reasons. To fully understand these problems, it is therefore essential that we involve surgeons and surgical staff in identifying them. Only then can we avoid “tech-push” and developing technology which is not actually needed.

The following Team report highlights the common challenges surgeons face in the operating room, based on real insights from a range of surgical staff from the National Health Service (NHS) in the UK. Covering six key areas in the operating room and beyond, it explores the current opportunities for medical device developers to tackle these clinical challenges, as well as the potential barriers to adoption.

The outcome was incredibly insightful for me as a medical device developer, highlighting a wealth of opportunities for new innovations to solve the common challenges of the operating room, as well as several things which should be avoided.

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1. Wires and cables

Kirsty Sewell has worked for many years as a scrub nurse and is now a robotic surgery coordinator. In this role, she has access to most of the latest surgical technology. For Kirsty, wires and cables are the first things which come to mind when asked about challenges within the operating room. A large part of her role is the logistics of the operating room (OR) and ensuring the environmental safety of her colleagues while patients are undergoing procedures. The presence of so many cables within the operating room requires significantly more planning and organization to ensure this happens.

“This is our biggest headache because there’s lots of kit that has to be joined together using cables. This is fine, but we just need to make sure that everybody is safe and not going to trip over them.”
Kirsty Sewell

This is a problem compounded by the presence of Robotically Assisted Surgery systems (RAS). In Kirsty’s opinion, RAS requires more cables which are both fragile and expensive. If a cable is caught and unplugged from the robot, this can delay the operation and cause frustration.

“If somebody tripped on the cable and it gets pulled out of the back of one of the devices, the whole system turns off and you’ve got to restart it. If the cables get broken by continuously being stood on, we’ll not be able to use them and we’ll have to wait for new ones to be delivered.”
Kirsty Sewell

surgeons performing robotic surgery with many wired and tubes on the operating table

For laparoscopic surgeons Duncan Light and Carlo Frola, cables are also an issue. Performing surgery is a difficult task already and any hindrance of the surgeon’s movement can make intricate tasks even more challenging. As Carlo highlights, his aim is to do the best for his patients with as few interruptions as possible. While wires do not impact the quality of his work, they are something he would prefer not to deal with.

“When performing laparoscopic surgery, the scope has optical wires which can get caught and hinder my movements. This has no impact on patient outcome but causes frustration to the surgeon.”
Carlo Frola

Duncan Light shares Carlo’s view and highlights that a cluttered sterile field can have consequences for the cost and sustainability of an operation:

“We can often end up with an operative field really cluttered with cables that are not always secured, so they can often fall off, hit the floor and then we are required to open another one.”
Duncan Light

When an instrument touches the floor, it is no longer sterile and therefore cannot be used in the remainder of the surgery. With the NHS aiming to achieve net zero by 2045, the environmental impact of requiring a new device needs to be taken into account. There is a clear need for better organization and less “clutter” within the operating room, to help avoid the unnecessary costs of instruments being wasted.

Overcoming the problem: reduce cables with new medical devices

The clearest message for medical technology developers would be to reduce cables and tubing where possible for new devices entering the market. Some companies like Lazurite are already developing wireless scopes for use in Minimally Invasive Surgery (MIS), which will be a welcome addition to the operating room for surgeons.

Others looking to innovate in this space should also consider exploring wireless solutions, ideally at the beginning of the device development. It is common in concept generation sessions for device developers to come up with ideas for how to solve problems using pneumatics or fluids, which require a tube to be connected to the device. This is clearly not something which will be liked by surgeons and alternative ideas should be explored.

For technology where cables are essential to their operation, cable management should be considered and included in the design to limit damage and ensure environmental health and safety for operating room staff.

2. Space in the theater

“One area that I’ve been reflecting on a lot recently is the space during laparoscopic surgery. There’s often a lot of crowding around the patient when you’re operating in most procedures, but especially in colorectal surgery; you often have two assistants, a scrub nurse and the anesthetist at the head end.”
Duncan Light

As mentioned in the previous section, surgeons need to have freedom of movement around the patient during a procedure. As the operating theater space is already busy with surgical staff, large equipment can be another contributor to this issue. From Kirsty Sewell’s perspective, advances in technology often seem to result in larger equipment. This can cause issues for surgeons, but also for the rest of the staff in the theater.

“We don’t have enough space because things seem to be getting bigger and bigger. The diathermy machines that are new are larger than ever and a lot of it looks like wasted space. So again, it’s space, it’s trip hazards.”
Kirsty Sewell

Similarly, Duncan is looking to less complex technology to solve this issue of space. He highlights how he has been using surgical products from Mediflex, which enable him to undertake some procedures without an assistant to hold the laparoscope, freeing up significant space around the patient.

“The benefits and yields of improving space are that you can improve the ergonomics of the surgeon and the assistant, which obviously is a big selling point for robotics. But we can improve this in laparoscopic surgery too with these kind of assistant devices.”
Duncan Light

crowded operating theatre with five surgeons performing robotic surgery

Solving the problem: think about space in new device design

In a world where technology is becoming increasingly more advanced, developers can inadvertently cause problems by solving others. Space in the operating room is critical and any new technology should aim to improve this issue rather than contribute to it, where possible.

When creating new surgical tools, companies should aim to solve problems with the simplest possible solutions. It can be tempting to approach challenges with questions such as “how can we solve this problem with a robot?” or “can we do this with electronics?”. During the concept generation phase of device development, it is important to focus on technologies which are suitable for the problem you are trying to solve.

If the problem can be addressed with a simple mechanical system, this will often be a better and more cost-effective solution than something more complex.

surgeon holding big surgical tool performing robotic assisted surgery

3. Efficiency

While NHS waiting lists saw a small decrease at the end of 2023, moving into 2024 there were still approximately 6.3 million people waiting for treatment in England. Combined with the time it takes to train new surgeons, efficiency is a key part of enabling surgeons to treat as many patients as possible.

There are several factors that the surgeons interviewed in this report noted as impacting their efficiency, including the ergonomics of surgical tools and equipment, availability and access and also visibility.

Ergonomics

Emily Mills operates frequently (up to 20 procedures a week) in her role as a core surgical trainee. Her challenges come from a lack of ergonomics in the design of existing equipment and laparoscopic instruments, which has an impact on her operating efficiency. Poor ergonomics in the design of her tools can cause discomfort and prolong operating time:

“One of my main challenges is in laparoscopic surgery; the design of the devices can be quite difficult sometimes to hold. When you open some of them, they’re quite wide and they’re at the maximum capacity of my hand.”
Emily Mills

For Emily, it’s not only instruments which can impact her physical comfort during a procedure, but also other equipment such as the surgical table. Due to the length of the laparoscopic instruments, her arms can still be in an uncomfortable position when the surgical table is at its lowest position. The current solution to this is to provide a simple step; however, this limits her ability to move around the patient and changes her center of gravity. Poor ergonomics has also proven to be a widespread health concern for surgeons, with a reported 80% of surgeons impacted by work-related injuries related to this.

“In terms of workforce and long-term disability, for a lot of surgeons, it matters. It’s probably something that’s been overlooked for a long time because people just get on with it. As surgeries get longer, we’re going to be operating for longer. So, if we’re not adaptively placed with laparoscopic surgery, we’re going to get injuries going forwards over decades.”
Emily Mills

 

Availability and access

“When I need to repeatedly swap instruments during surgery, I often have to rely on the scrub nurse, who may be busy preparing something for the next step of the operation. Limiting the number of instrument swaps between the surgeon and scrub nurse would be ideal. If something were available where instruments are laid out in a specific order and the surgeon can help themselves, this would make procedures more efficient and less time consuming.”
Carlo Frola

In addition to physical obstacles, concentration is key for efficiency. This is not just the case for Carlo, but also for his colleagues within the operating room. Reducing distractions and improving workflow are both critical factors for improving efficiency. An example of where this could be improved is in the availability and ease of access of surgical tools.

For David Rawaf, an orthopedic surgeon, it is not just the usability and ease of access to the tools during procedures that is a challenge, but the condition and stock of them after this reprocessing cycle. Traditional instruments used in orthopedic surgery are metal alloys and reused after being safely re-processed. For David, the condition of his tools do not always meet requirements when he begins a procedure:

“It’s not that rare that we open up a kit and either something’s missing or something doesn’t work. So, thinking about the logistics behind ensuring that your kit is clean and properly taken care of is critical.”
David Rawaf

Visibility

For laparoscopic surgeons, visibility of the area they are operating on is essential. The surgical site is viewed on a screen above the patient where the image is captured by a camera within the patient’s body, called a laparoscope. These “scopes” can regularly become soiled by blood or fog up due to the humidity within the pneumoperitoneum. As a result, surgeons must remove the laparoscopes regularly to clean them to see what they are doing.

“It causes a frequent problem that the camera has to be removed, cleaned and replaced and that can add significant extra time onto procedures and sometimes add frustration and even a safety risk. If there has been a surgical problem – for instance, if a blood vessel is cut and blood is firing across the abdomen – it can obscure the camera and then you can’t see anything. That can often be a scenario where surgeons are forced to cut the patient open for safety. Perhaps some of those times could be saved if we could clean the camera better.”
Duncan Light

There are several solutions to this problem currently available on the market. Some are simple but seen as ineffective; others require significant investment. Duncan’s desire is to have a low-cost solution which is compatible with existing laparoscopes. He is currently working on the development of a novel trocar which will enable cleaning of the scope without removal from the patient, at a similar cost to existing trocars.

Laparoscopic surgeons viewing the image captured by a laparoscope on a screen above the patient in the operating theatre

Using human factors engineering to overcome the challenge

At a minimum, when designing new devices, medical device developers should ensure they are using good anthropometric data for all potential users. This is something which a good ergonomics engineer or industrial designer will bring to a development and should not add much additional time or effort to your project. When designing a new handle for an instrument, for example, the length and diameter should be defined by what is comfortable or usable for all intended users of the device.

For availability and ease of access to tools during procedures, there are several companies trying to tackle this problem via the tracking of instruments and consumables in the operating room. However, reusable instruments and their packaging need to adhere to existing hospital procedures for reprocessing to ensure patient safety. For an innovation in this space to be truly impactful, it will need to work within the confines of these requirements.

To improve visibility during laparoscopic surgery, current on-market solutions range from the very simple through to the more complex. What is important for all companies looking to innovate in this space and gain adoption in the NHS, is to ensure compatibility with existing laparoscopes and require minimal investment from the hospital.

4. Safety

When developing medical devices, risk management is a fundamental part of the process. However, this is usually focused on the safety of the patient. For some surgeons, their job has many occupational hazards as well.

Professor Michael Parker was a specialist colorectal surgeon who, along with his colleagues, pioneered the use of laparoscopy in the UK and in Denmark. In his retirement, Mike spends his time in various clinically linked roles, including as Executive Director of Sirius Genesis, a company which is focused on developing innovative medical devices to solve the clinical challenges Mike has seen throughout his career. Two of the devices currently being developed are focused on improving safety in the operating room. This includes a device to prevent sharps injuries from used scalpel blades.

“Every year in the UK, there are in excess of 100,000 sharps injuries, most of which occur in the operating room. The long-established practice of handing over sharps in an open kidney dish is frankly medieval. The dish provides little or no protection for the operating room staff or the surgeons. Consequently, we have designed and patented a new type of handover tray which helps to prevent these dangers which should reduce the number of injuries and also the number of consequential infections, such as hepatitis B and C, HIV and even Covid, among others. This will reduce the dangers of such infections to the staff, as well as the amount of time off work for those individuals. It will also reduce the huge potential litigation costs to the Health Service.”
Professor Michael Parker

surgeon holding a scalpel

For Kirsty Sewell, environmental health and safety is another key concern. As technology advances and becomes more electro-mechanical, noise has become an unwelcome addition in the operating room:

“The robots can be really noisy… We know that computers need fans and fans make noise – which then increases the level of noise in the operating room.”
Kirsty Sewell

Aside from exceeding noise limits for environmental health and safety, this increase in noise also limits the training which can be undertaken in the operating room. Usually, trainee surgeons are brought into the operating room and talked through what is happening, but with an already high level of background noise, voices need to be raised to be heard, which can be distracting for the operating surgeon.

“The background noise of all the machines is a big nuisance and sometimes it means we have to ask people to be quiet because that’s the one thing that we can control.”
Kirsty Sewell

Sometimes, the procedures themselves are the danger. For many branches of surgery, imaging is used to enable clinicians to see inside the body or track the position of a device while performing a procedure. Some of these imaging technologies use radiation (X-ray, C-arms, etc.), which means a low exposure for the patient undergoing the procedure, but repeated exposure for the clinician. This is understandably a cause of concern for clinicians and there is a desire for safety to be improved where there is exposure to radiation. Emily Mills currently works in urology where X-rays are used for the placement of stents:

“When we do stents, we use X-rays to look where the stent placement is. We use lead gowns, but I always find these are massive and open at the side. So, my pelvic organs are still very much getting radiation. I think lead gowns have always been a traditional thing. But I wonder if there’s something else that could be looked at that people haven’t thought about before to protect surgeons against radiation.”
Emily Mills

The importance of prioritizing risk management in new device design

Ideally, companies should focus on designing medical devices which create no new risks to the clinician using them, something which should always be highly prioritized during device developments. As a minimum, medical device developers should ensure that they are considering the safety of the clinician, as well as the patient in their risk management processes. These risks should be mitigated as much as possible through the design of new technology.

There is also the opportunity to use clinician safety as an area for innovation. There are several medical device companies that have launched technologies where clinician safety is a driving factor. One example is Radial Cradle, a device which reduces radiation scatter during interventional cardiology procedures. Another is the teleoperated robot for endovascular surgery being developed by Sentante, which enables the clinician to perform surgery away from the radiation of the C-Arm machine (a medical imaging device based on X-ray technology).

Innovations such as these highlight how medical technology can be applied effectively to improve clinician safety.

5. Training

As identified in the Future of Surgery report from the Royal College of Surgeons of England, the training of surgeons needs to be a focus for healthcare providers such as the NHS, to ensure retention of staff and to meet the future needs of an aging population. There is also a focus on encouraging surgeons’ exposure to new technologies, to enable the delivery of “the most innovative care and best patient outcomes.”

For Josh Burke, Director of Education for the Innovation Hub at the Royal College, it is the variation in technique between surgeons that makes it difficult to evaluate the effectiveness of new technology. His passion is to ensure evidence-based decisions are made for the future of healthcare:

“I think that the biggest challenge is around variation in technique and therefore variation in the instruments and devices required to complete an operation. It’s a balance between utilizing the latest evidence and tweaking surgical routine, to ensure that outcomes remain improved.”
Josh Burke

In addition to extensive academia, surgical training has historically involved knowledge passed down from experienced surgeons to juniors. This may be during live procedures or through cadaveric studies. As a result, teachers will often share their own personal approaches with juniors, which can result in fantastic patient outcomes but variations in how this is achieved.

“Variations in technique and understanding which elements of a procedure have the biggest impact on outcomes is difficult to unpick. Generating evidence which considers this and other factors, such as learning curves, is often poorly carried out when assessing surgical interventions and medical devices. Historically this has slowed the adoption of new techniques and devices by the surgical community.”
Josh Burke

There is perhaps a need to improve the standardization of surgical training to promote a more consistent approach to surgical procedures, which could make it easier to make evidence-based decisions when it comes to adopting new technology.

In addition to his work as a practicing orthopedic surgeon, David Rawaf is also the associate medical director at Inovus Medical, which is developing affordable surgical simulators to enable access to standardized surgical training beyond the operating room and cadaver labs.

“What we’re trying to do is get you to that peak of your training quicker and safer and bring that learning curve away from the patient’s bedside and into a safe and simulated space.”

David Rawaf

The benefit of this is that trainee surgeons can observe procedures in traditional ways, but are then able to practice what they have seen and learned again outside of an operating room on a trainer. This means surgeons can both maintain their familiarity with procedures and ensure their skills are honed both outside and inside of the operating room.

person using surgical simulator training technology

Why medical device designers need to stay on top of surgical developments

If surgical procedures are going to become more standardized, device developers need to ensure their devices are compatible with those procedures. They will also need to work harder to ensure that any new innovations which deviate from these standardized procedures are not blocked from entering markets because of this. Despite these potential hurdles, a benefit will be that generating clinical data to prove a device’s effectiveness should be simpler, with a standard baseline to compare against.

For surgical training, there are some amazing companies which have already established technology in this space. Alongside Inovus mentioned above, companies like Proximie and Touch Surgical are improving access to surgical training through the sharing of data and observation of procedures.

6. Administrative burden

For some surgeons, the operation itself is not the biggest challenge they face. What takes up a lot of their time and causes frustration is the administration which needs to be completed before and after the procedure. In a world where we are considering powering surgical robots with artificial intelligence, it is surprising that a lot of the patient notes remain paper-based in the UK. David Rawaf would like to see this change. As an orthopedic surgeon, most of his procedures are elective, with significant pre-planning undertaken before the operation to ensure a smooth and efficient process.

“Within the elective world, everything is very controlled. We’ve seen the patient before in clinic, they’ve usually come in for an X-ray and we should have both the clinic letter and the X-ray in advance.”
David Rawaf

However, pre-operative and post-operative tasks are not as refined; for operational notes and consent, the process is very manual and can be a frustration.

“I work in a paper-based hospital where we’re having to dig out old notes and folders which can delay the conversation we have [with patients]. We’re relying on things like patient stickers and not every page is stickered. What if one page went missing?”
David Rawaf

Grant Nolan is a plastic surgeon and founder of MyOpNotes, a company which creates software to streamline and standardize operation notes. Grant would like to see a reduction in the amount of time surgeons have to spend writing notes to enable more time with patients, with paperwork sometimes taking as long as the procedure itself:

“You can often do quick operations that last 20 minutes and it might take you as long to do the paperwork as it does to actually do the operation.”
Grant Nolan

With paper-based notes, Grant often finds himself re-writing the same things repeatedly, which are usually not specific to the patient. His motivation for starting MyOpNotes was to free surgeons from the shackles of paperwork. The company he has built aims to reduce the time taken to write notes for surgeons, standardize these notes and improve quality and legibility. An additional benefit to this is that it gives the clinician time between operations to reset and prepare for their next procedure.

“When you finish the surgery, there is a quick turn-around in order to get the next patient’s operation started. This is the time when you have to write the operation note. Inefficient paper-based systems can result in a surgeon working flat out, moving from operating to completing paperwork without any natural breaks. This is an unsustainable work pattern and can contribute to burnout.”
Grant Nolan

Solving the problem with software

Largely, medical devices themselves will not help to reduce administrative burden in hospitals. Innovation in this space will come from clinician-led companies like MyOpNotes and Concentric Health, which have developed elegant software platforms to standardize consent forms and patient notes.

When developing new medical technology, the key to addressing this challenge is to avoid bringing in new processes or systems which contribute to the already significant administrative burden put on surgeons and their colleagues.

What are the barriers to adoption for new surgical technology?

 

Quality of clinical data

When developing a medical device, it is easy to assume that once a device gets clearance or approval, the hard work is done. But market adoption has its own challenges, particularly in the UK, where manufacturers need to sell not to the NHS as a whole, but to individual trusts. Likewise, even when devices are procured, surgeons still have a say on whether they use them on their patients or not.

“My main concern with new technology would always be patient safety because ultimately, while we can design whatever we want and it could change the world, if that causes harm or has the potential to cause harm, it’s absolutely not worth it, especially if there’s already an alternative. You can’t justify anything that could put a patient at risk because that’s the whole ethos of what underpins us as clinicians, as physicians, when you go back to the Hippocratic Oath of ‘do no harm’.”
Emily Mills

In a profession where patient safety is paramount, surgeons will scrutinize clinical data extensively and will only use devices where there is a clear benefit to the patient. Clinical data is not just a tick box exercise to enable clearance/approval either – it should be gathered and presented with consideration to the fact that surgeons will read it before using a device. Poor quality data will reflect poorly on the device, which may impact the chance of it being used. Surgeons do not necessarily take CE marking or FDA clearance as gospel for device safety and efficacy.

Emily Mills highlights how she looks closely at any clinical data which accompanies new medical devices: “There is going to be a risk when you’re bringing something new, even if it’s been clinically tested and trialed, because new technologies should be looked at very closely under the microscope. This is because if things go wrong, people get harmed.”

For Josh Burke, evidence-based assessment is also key when he is considering using new medical devices: “There is a lack of trust of the evidence-based assessment of new devices by industry and the slow regulatory process that exists within the UK and Europe.”

Duncan Light adds: “We’re so deep into the information age and there’s so much material around. What we do know as physicians or surgeons is how to read a paper and read research; that’s the one thing that we’ve got that we can trust.”

The need for quality clinical data should come as no surprise to many device manufacturers, especially for higher risk medical devices where clinical evidence is essential to getting to market. However, the quality of that data and how it is presented may also be critical for adoption. Surgeons will always put their patients first and a lack of quality in clinical data can result in a lack of trust in your device. Just as involving surgeons in earlier phases of development is critical to identifying unmet needs, having input into your clinical data reporting and analysis will improve its quality.

Sustainability

As the world becomes more focused on sustainability, this is also a big consideration for surgeons. With the NHS contributing 4-5% of the UK’s carbon emissions and the operating room contributing to a significant part of that, surgeons are growing increasingly aware of their impact on the environment. So much so that it can influence their decision of which medical device to use.

Josh Burke reflects on this in his role as Trustee of The CORES Patient Safety Charity:

“Patient safety is paramount when considering utilizing a new medical device. Historically, if two similar devices offered similar clinical outcomes and usability profiles, the decision to use would usually come down to availability and cost. More recently attitudes within the NHS have rightly turned to the sustainability of the devices we use, which one has the lowest carbon footprint and whether we in fact need to use particular devices at all.”
Josh Burke

This is a sentiment shared by several of the surgeons interviewed for this article. If devices have significant packaging, disposable elements or are single use, surgeons may opt for a device which has a lower environmental impact at the expense of their own comfort or time (though only if there is no difference in patient safety or benefit).

As SSIs (Surgical Site Infections) remain a significant cause of morbidity and mortality in surgery, there is a rise in new single-use technology which aims to tackle this. However, as awareness of surgery’s carbon footprint increases, single use devices may struggle with gaining adoption. To tackle this, new surgical instruments can be designed to improve compatibility with reprocessing methods, which can reduce the chances of SSIs occurring.

pile of surgical tools wrapped individually in plastic

The best way to overcome operating room challenges: ensure surgeon involvement in device design

Across all the clinicians interviewed for this report, there was a clear message: device developers need to involve clinicians in their development to ensure the solution is both needed and that it can be used.

Professor Michael Parker has been involved in multiple device innovations throughout his 45-year career as a surgeon, some of which involved seeking clinical feedback far too late.

“It is pointless developing a new instrument without consulting with the surgical profession first, since the outcome may well be a beautifully designed and constructed instrument at considerable expense with absolutely no application for use in real life! You need to examine the areas in which problems occur and design technology specifically to counter those problems. For that reason, innovators and the surgical instrument industry need to speak to people like me who’ve had a whole lot of problems for many years. We just need innovators and medical technologists to recognize that and liaise with and talk to surgeons, preferably at the birth of a new concept.”
Professor Michael Parker

Carlo Frola shares this view, highlighting the need for increased access to clinical insight for smaller companies developing new technology: “The big companies operate a panel of clinical experts as an integral part of their asset, to come to the market with valuable solutions.

However, even the smaller companies/start-ups should embrace a larger number of clinicians through hiring or consulting opportunities, in order to generate more scalable and marketable innovative products, with a view to minimize failure risks in such a fast-growing competitive market.”
Carlo Frola

Seeking feedback from clinicians right at the beginning of a development can help reduce the duration of projects and requires fewer iterations of prototyping. To this end, there are also companies trying to make clinical feedback more accessible. Flux HealthTech matches expert clinicians with technology developers through an easy-to-use portal. Technology developers can search for clinical specialists relevant to their development and engage them on a consulting basis.

Managing new surgical device development costs

All product development requires investment. The more complex your technology, the longer it can take to develop and the more investment is needed to manufacture and sell it. With medical devices, the additional tasks required by regulations will increase development costs and the controls around manufacturing and validation require more investment. All of this will need funding. For large strategic companies, development can be self-funded through revenue generated by selling existing devices. But for start-ups and smaller companies, funding has to be sought elsewhere.

This can be a huge barrier for clinicians who understand the problems which need to be solved and wish to do something about it. Mike Parker highlights this challenge:

“The challenges are getting new innovations to market and to production. Patenting is very expensive, especially if you look for worldwide cover and then getting things like the CE UKCA or CE mark – it all adds up and so it’s a lot of money to actually get something to the point where it needs to go is ready for clinical use. Then, the critical thing is finding a company that will help you to get it market ready and then produce it and market it.”

29% of tech start-ups fail because they run out of cash to fund their development. This may be down to a lack of business planning or an underestimate of development and commercialization costs or that companies are not able to access the next round of investment funding to take their business further.

Even for mid-sized organizations wishing to develop new technology, development costs can be a barrier. Any investment requires a return, which can mean that sometimes technology is developed to be profitable, rather than to be the one most needed. The ideal solution of course is to create a commercially viable product that is both successful on the market and that meets real user needs.

What's next for surgical device development?

The world of MedTech is exploding with new technology being developed across the globe. Despite this, the rate of attrition for medical device start-ups remains high, with 90% failing to make it to market. A significant number of these start-up failures are due to a lack of clinical need. Simply put – technology is being pushed into markets where it isn’t required.

To avoid “tech push” and ensure medical device manufacturers are focused on solving real clinical challenges, we need to know where there are areas for improvement in healthcare. Feedback from key opinion leaders on industrial design is common practice within larger MedTech firms, but can sometimes come too late in the process – i.e. when the developer has already spent considerable money on the device. At these later stages, questions may be centered around how to improve the device, rather than whether the device is even needed in the first place.

From the research summarized in this article, it is clear there is an appetite from surgical staff to be involved in the development of new surgical technology. By involving clinicians and their colleagues in device development as early as possible, devices can be made that meet real user needs, while avoiding adding additional burdens or problems for surgical staff.

To increase the chances of adoption by clinicians, companies need to consider how their new technology will impact space and safety within the operating room and ensure it does not impair the surgeon in any way. Ergonomics and intuitive design should be seen as minimum requirements in addition to safety and regulatory compliance, while additional factors such as sustainability are becoming more integral to new devices, rather than simply a “nice-to-have”.

The clear solution to these problems is to bring clinicians into the development process. Only then can we develop solutions that meet real surgeons’ needs.

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