By Teresa Murray, freelance writer for healthech and writer for the Giant Health Conference

Over the last few decades, popular culture around innovation has shaped the idea of the lone, but brilliant innovator/disruptor figure (usually a man), equipped with a visionary idea and the smarts to build a well-funded, stellar company.

This is not the reality for most innovators.

Katarina Hedbeck and Dr. Rebecca Bejhed of Tada Medical AB talk about how they designed their clinical innovation – ReLink. A journey as compelling as the innovation itself.

Katarina, Rebecca and Christopher Blacker MD, the co-founders of Tada Medical AB didn’t even know each other before coming together as a team in the Clinical Innovation Fellowship (CIF) programme.

This CIF programme is based on the Stanford Bio-Design Process, which starts with the formulation of a solid needs statement, rather than leading with a solution. The programme puts a multidisciplinary team of four together. Diverse thinking and complementarity drive team formulation. Each person goes through rigorous testing of intelligence, personality, and stress resilience.

This team then works in a designated clinical environment.

Rebecca, Katarina and Christopher were put on the same team. That’s how the story of Tada Medical AB and their clinical innovation, ReLink, started.

Katarina Hedbeck comes from an engineering and business background. Dr. Rebecca Bejhed from the academic and highly technical world of solid state physics and nano technology, and Christopher Blacker is a medical doctor.

An interesting aspect of the CIF programme is its approach to team dynamics. Teams are prepared in advance for conflict and crashes, and support is built into the process. Teams have regular group and individual sessions with a therapist throughout the 9-month programme.

Perhaps something all corporate teams should have!

The team started with an observational phase lasting several months in a children’s oncology clinic, their objective simply to observe.

Eight pairs of eyes day after day watching and noting, each from their unique perspective. The value of multidisciplinarity.
For the team, it was not easy to sit for hours on end in a children’s oncology clinic, witnessing daily, children suffering and parents in distress. On the flip side, this exposure increased the team’s drive to find innovative solutions.

Once the observational stage ends, the team compile a restricted number of observed needs and produce a comprehensive report. The Tada Medical team’s report was of such high quality that it was subsequently adopted by the Swedish Childhood Cancer Foundation (Barncancerfonden), and shared with other child cancer clinics across Sweden to bring about improvements in set ups and quality of care.

The CIF process only lets teams work on one need from the list. To receive post-programme funding a jury must approve it. For this, they had to build a strong enough business case, and a solid needs statement which justified the rationale behind their selection and the potential impact of finding a solution.

The team wanted to ensure that their need resolution would have maximum impact in as many clinical settings possible.

So, what was the need they chose?

During the observation period, the team had noticed that intravenous therapy lines risked becoming dislodged. This was a problem because the reconnection of lines took up a lot of nurses’ valuable time. Also, in the context of chemotherapy, spills from IV breaks are toxic and present significant health risks to nurses. The team took the time to check whether this dislodgement problem was prevalent in other clinical settings.

It was.

To illustrate the dimension of the problem is the team’s analysis of one ward which revealed that the number of dislodgements and replacements were the equivalent of one nurse dedicated full-time to reconnecting dislodged IV lines.

In fact, Intravenous therapy is the most common invasive procedure in healthcare. An incredible 16 billion IV tubes are consumed globally per year. Studies point to a 10% dislodgement rate.

Just do the maths!

Children, who dislodge their IVs a lot, are rarely alone so a nurse is quickly alerted and the IV replaced.

However, it is a different story with adults or the elderly.

Elderly patients on IV lines are often alone for long periods of time. In the case of dementia, they may not even realise their IV has become dislodged. Covid-19 patients suffering delirium often dislodge their IVs too.

Amid a pandemic, with nurses already over-stretched and in short supply, too much time dedicated to Iv reconnections is a problem.

A problem Tada Medical AB is solving with their innovative solution ReLink.

The team researched the sector to see what solutions already existed but found no good one. Most were attempts to prevent the dislodgement in the first place; taping extra gauze to make it harder to dislodge, or wrapping the patient’s hands until they looked as if they were wearing boxing gloves. If that isn’t bad enough, in some cases, patients with confusion disorders are tied to the bed to prevent them from pulling the line.

A relatively new solution is using hook-like devices, but these still dislodge when pulled hard enough. This causes tissue tears which hurt like hell.

The team saw the opportunity to bring a better solution, dug deeper and spent hours talking to nurses in different clinical settings about the problem.

The team then moved onto the ideation phase, which followed the Stanford Biodesign rationale that the first solutions proposed aren’t necessarily the best ones, and forces teams to dig deeper.

The Tada team came up with the ReLink solution relatively quickly.

So, what exactly does ReLink do?

ReLink is a patented breakaway connector, designed and engineered to increase safety and reduce the harm caused by these accidental dislodgement incidents. The device has double-sided, self-sealable valves which protect the catheter site and prevent fluid loss.

The team tested the device rigorously to ensure that the amount of force required to separate the two ReLink parts was lower than the force that usually separates the catheter from the patient. For nurses, when dislodgement occurs, instead of having to replace everything, with ReLink, as the name suggests, they simply need to swab the device and quickly reconnect it.

No need to replace the whole line, as is the case now.

Though the device looks simple, it was by no means easy to engineer. It is very small and complex. But, as is the case here, it is great engineering design that makes the hardest things look easy.

The CIF post-programme funding gave the team the means to embark on their journey as entrepreneurs and further grants from the Sweden’s Innovation Agency, Vinnova, helped them to take their idea forward, perfect the design and manufacturing process and continue to build a solid business case and model.

ReLink has already been both winner and runner up in several innovation pitch contests, including runner up as Giant Health’s Most Promising Healthtech Innovation. There is also a forthcoming article soon to be published in the prestigious British Journal of Nursing which will acknowledge the impact of their innovation for nursing staff.

It also brings substantial cost savings to healthcare systems and providers. Remember that 10% of 16 billion.

But ReLink helps patients too.

Many will be familiar with the pain of getting an IV ripped from the arm. Tada Medical AB never forget their time in the children’s’ cancer clinic and other wards. The ReLink technology has been presented to hospitals and veterinary clinics in Sweden, and they have achieved the milestone of obtaining their CE mark, the European Commission’s health, safety and environmental protection standards.

On the business side, the team itself have come a long way in the last five years. They have built platform technology and a growing company replete with talent and diversity.

Katarina and Rebecca too have had an intense autumn travelling around Europe to meet with project partners, potential customers and investors and to size up sales distribution options. The time for critical commercialisation decisions has arrived, but Tada Medical are confident because, as always, they have done their homework well.

The team’s innovation journey is a timely reminder that there are many paths to innovation. The Tada Medical team survived the tough CIF programme. Many do not. Their goals achieved whilst juggling child rearing and other life priorities. Having kids though proved advantageous in providing ready-made test subjects for ReLink.

Don’t worry, no real IVs were used!

When looking at innovation from the side-lines, we are at times unaware of all the factors that make an innovation successful or we think success is about the big idea. Brilliance. Magic even!

And, though there is no doubting the brilliant minds behind Tada Medical’s ReLink, their success is marked too by their ability to work together as a team, and respect each other’s ideas and viewpoints without judgement or dismissal.

Behind every innovator there is a long road of hard work, grind, perseverance, and risk-taking.

The idea is just the first step. Making it happen, staying the course, not giving up.

Now that’s the real magic!