“I was told not to worry about safety features—the priority was getting the device out immediately.” An anonymous account of speaking up in medtech

Summary

Medtech companies are continually developing new medical devices and products for use in healthcare, and ensuring that each one is safe to use should be the top priority of every company. In this anonymous blog, a nurse shares their experience of being employed by a start-up producing a new piece of equipment for use in cardiac surgery. They soon discovered their values did not match up, as the company prioritised getting their new product to market above patient safety. The writer talks about the personal cost of repeatedly speaking up for safety and describes the importance of working for an employer that sees patient safety as the top priority and recognises that it goes hand in hand with commercial success.

Content

I started out my career as a critical care nurse and was seconded quite early on to specialise in extracorporeal membrane oxygenation (ECMO). I received excellent training and felt really fortunate for the opportunity to be working in that specialty, one which is highly complex and has a critical focus on patient safety. Within a couple of years of practice, I was seconded from my role nursing critically ill adults and asked to join another hospital where I received further intensive training to become a clinical perfusionist.

As a perfusionist in theatre I was in charge of maintaining the patient's life during surgery. Operating the artificial heart and lungs, I supported the surgeons while they performed open heart procedures on babies. It was a demanding and rewarding role, and it required absolute focus on what I was doing and a total awareness of my patient’s every single metric, at all times. I loved looking after the most vulnerable patients and felt so privileged to play a critical part in improving lives.

Several years into my career, I had the opportunity to move into the medical device industry. At that stage of my life, I had different personal priorities and medtech offered a range of options to allow me more flexible work while still advancing patient care. I also had a passion for medtech, as companies don't often invest in developing products for the most vulnerable patient groups unless there is a commercial gain. So I was keen to take my advocacy, skills and expertise to the commercial world to make a difference. I worked for a number of companies that aligned with my values, clinical skills and really enjoyed my new career, which often involved interesting conversations and finding creative solutions to problems in partnership with clinicians.

At one point, an opportunity arose to join a start-up company that was developing a digital version of a critical piece of equipment for use in cardiac surgery. I couldn’t have been more excited—the idea of having a modernised, digitally-connected machine with automated safety features was amazing and very much needed, as no one had innovated in this space for a very long time. I could see how transformative it could be in improving safety and efficiency for patients undergoing bypass surgery. 

I began working at the company and in the first couple of weeks it became clear to me that their objective was to get their new device ready for market at pace. I could ask lots of questions as ‘the new person’ and enquired about how the product would be tested when we launched it and who would be looking after the process. I was told not to worry about it, and to focus only on managing the product to the point where it had everything the clinicians needed. I fully trusted that process. 

The day finally came when the device got the CE mark, which the company had managed to deliver just days before new medical device regulations came into force. Huge celebrations followed and the management team announced that we were going to commence using the device on patients in the coming weeks. I thought, “Hang on a minute, I haven’t even seen this device used in testing yet!” I asked whether there were plans to run a pilot or use it for research purposes first and I was told this was not needed and not going to happen. I had concerns that some safety features we had discussed in the initial plans for the device weren’t ready yet. I was told not to worry about them—and the priority was getting the device into the clinical space immediately.

Running a bypass case has often been likened to flying a plane. The most critical time points are running on, maintaining flow, temperature and pressure and then safely disengaging at the end of surgery. Safety protocols are well defined and I had reservations at this point about the device, as I could see that in its current iteration, it did not meet typical safety standards.

Two weeks after the CE mark was granted, my line manager informed me that a hospital had identified a patient and wanted to use the machine, and I was being sent to assist. I was appalled, the machine wasn’t even completely built yet. I raised my concerns in an email as I knew that the device was missing a critical safety feature that I knew would in normal circumstances meant the procedure would not go ahead. The safety feature that was missing was responsible for ensuring safe levels of blood were in circulation at all times. Without this feature there is the very real risk of causing a patient’s death or major brain damage during the procedure. There’s no going back from that, and if the patient were to be harmed, it would be the perfusionist who would be held professionally and legally responsible. There have been historical negligence cases that have referenced this feature and highlighted how essential it is to patient safety. I knew that there were a number of other safety features that were also not at the standard you would want them to be as a clinician.

At this point, I had been working at the company for two months and I realised that we did not share the same values. I walked into the theatre where the surgery was to take place to find one of my clinical colleagues who also worked for the company shaking their head. They were unsure how we were going to get through the procedure as the device wasn’t functioning to a standard they felt comfortable with. However, management said we had to go ahead with the case as the surgical team was ready and the patient had consented. 

I again told them how uncomfortable I was and emailed my line manager expressing my concerns that going ahead was unethical and unsafe, and highlighted that my reputation as a clinician was also on the line. I told them we needed further testing on the device before it could be used on a patient. The answer was simply, “No, we’re doing it.” 

So I watched as they operated on this patient—I didn’t sign in as a member of the team or touch the patient. During the procedure, I saw multiple safety mechanisms that were not calibrated or ready for use. Three times I saw the blood level drop below the acceptable limit, which increases the risk of small air bubbles entering the brain. This would have been mitigated if the safety sensor was in place. Low circulating blood volumes can cause embolisms; even if the patient doesn’t have a complete stroke, micro bubbles entering the brain can cause patients to wake up and be not quite right. After the procedure, I had no idea whether that patient recovered well, all I heard was the celebration of a job well done.

The following week, I found myself without a job. I was told that my performance was substandard and would no longer be employed by the company. As an experienced subject matter expert brought in to advise a fledgling company on how to create and deliver a device that meets the standard of excellence required, it’s devastating to be told that none of what you know matters. What I experienced was the ultimate gaslighting in a toxic work environment. The company had no concept or real care for patient outcomes. It was a really difficult time personally and it was difficult to find another job opportunity. The medical device industry can be fairly ruthless, and a gap on your CV looks bad. I had to really lean into my network during that time and the more people I spoke to about my experience, the more I realised that what I had lived through wasn’t an uncommon occurrence. 

When I got back on my feet, I started my own clinical consultancy. It focused on giving medtech companies that were really invested in safety the best possible opportunity and access to get it right, first time. Eventually I found myself in a role where safety is invested in from a commercial perspective. It was a surprise to me that such roles existed, but on my journey I discovered some companies do have a strong and real sense of purpose, and a just culture. A focus on patient safety can and does coexist with commercial success, in fact it relies upon it. I am now thriving and confident in an organisation that is values-based, purpose driven and strives to be better every day. 

The company where I lost my job is still operational. It has had to deal with many problems to get the product right. A lot of skilled people’s knowledge has finally been accepted into making it work better. However, many people have been unnecessarily harmed along the way, both patients and healthcare workers. 

Medtech is on a bit of a journey at the moment in terms of ethics and compliance—although things have improved we’re not quite there yet. At the moment, we still have non-experts designing products for therapy areas they don’t truly understand. Without clinicians in the room we won't get the context and human factors aspects right. The goal is to close the gap so that clinicians are co-designing and co-delivering to ensure patient safety. At its core, any solution needs to be focused on the patient and their experience, and how it will help clinicians to do their job better. As healthcare professionals, we are the experts to safely deliver innovation that makes a difference.

When you live through an event like this, you do lose confidence and start to question your own judgement. But now in retrospect, I’m more sure than ever that you have to trust your gut when you feel that something isn’t right. When you find yourself working for an employer that empowers you and creates the psychologically safe space to speak up, it’s worth holding on to that. Because the medical device industry is embedded in healthcare, greater opportunities to be more collaborative will drive and support the safe future of healthcare.