Surgical instruments on their long way to Africa

Meet CASE, a small firm with large ambitions: producing tools for global health. The two women behind CASE are biomechanical engineer Julie Fleischer and her colleague Dr Roos Oosting. They specialise in designing surgical instruments for low and middle income countries (LMIC) like Kenya and India.

Oosting presented a dummy of an electrical surgical knife. She estimates that an electro surgical unit (ESU) for LMIC could be made for EUR 1,000. Her colleague Julie Fleischer developed a video laryngoscope (for intubating anaesthetised patients) that could cost less than EUR 200. After graduating, they now face the hard part: getting their instruments produced and exported to Africa.

International impact
“PhD students focus on publishing and on their theses,” says Oosting, who had her defence on 12 December last year. “The impact of their technology is often a secondary concern. People think any Tom, Dick or Harry can do that.” A notable exception to this rule is the Delft Global Initiative that strives for local impact of scientific findings. Full disclosure: Oosting’s PhD research was funded by the Delft Global Initiative.

Oosting first visited the African continent on a trip to an orphanage in Rwanda in her teens. The poverty as well as the pure joy of life she saw there made a lasting impression. The title of her thesis, ‘Towards increased global availability of surgical equipment’, reflects the direction of her PhD research. She went back to Africa and lived in Kenia for five months. Through contacts at Kenyatta University in Nairobi she got in contact with local health workers.

‘Well intentioned donations of Western medical equipment may actually be redundant’

Culture shock
To a western observer, hospital practices in many African countries are often shocking. There are frequent power cuts; disposable instruments are washed and used again and again; new equipment – often made in China – is of poor quality and often lack both manuals and service. Equipment from European countries or the United States is either incompatible or broken and piles up outside on verandas.

“Well intentioned donations of Western medical equipment to African hospitals may actually be redundant and is often dumped and ends up being unused,” Oosting observes.

The dozens of surgeons that she interviewed agreed that a reliable electro-surgical unit (ESU) could improve their surgical practices. So what would be needed to make an ESU for Africa? Oosting developed design guidelines at the end of her thesis that listed the requirements: reusable accessories; clear user interface; robust enough to withstand power failures; battery operable; and portable.

She even had a dummy made of the ESU to facilitate the exchange of ideas about it. She estimates that a reliable functional unit could be produced for a fraction of the cost of an ESU found in an average European hospital.

Julie Fleischer is in a comparable situation. Fleischer developed a video laryngoscope – an instrument that is inserted through the mouth down the patient’s throat to keep the tongue in place and feed a tube down into the lungs.

The video laryngoscope contains a simple battery powered USB camera. The video, which can be watched on a smartphone, guides the anaesthesiologist down the right track. Parts of the instrument may be removed and disinfected in a Cidex solution – as is the local practice.   

So there we are: an electro surgical unit that can be sold for about EUR 1,000 and a video laryngoscope for about EUR 150-200. Plus a screaming need for affordable and reliable surgical instruments in middle and low-income countries. And yet, why aren’t they being produced?

Obstacles abound
It turns out that there are numerous obstacles that stand in the way of developing a specific medical instrument and getting it into the hands of local practitioners.

• PhD research is primarily an academic affair, aimed at the training of  academic researchers, not at implementing practical solutions.
• A long-term local partner is required to provide a testing ground.
• Technology that cannot be patented (because it is an adaptation of existing technology for example) is not attractive to investors since it may easily be copied.
• Producers of medical instruments don’t want to undercut their own markets by producing a cheap version (i.e. for low-income countries) that basically does the same thing.
• Cheap medical instruments face strong competition from China.

Investors
Is there a way around this? If there is, Sustainable Surgery research leader Dr Tim Horeman, Assistant Professor at the Biomechanical Department, should know. He was appointed ‘Dutch engineer of the year 2016’, and he has earned himself a solid reputation for getting new technology into the operation theatre.

‘You’d need quite some investment (EUR 500,000 – 1 million easily) for the development of an electro-surgical unit,’ Horeman writes. ‘Without a solid business case, that’s often too much for non-governmental organisations. It may be noble to develop technology for places with few or no facilities where there will be no or limited returns, but as development is capital-driven, it still happens in places that have capital. Can you see the dilemma?”

Horeman mentions a ‘trick’ to make healthcare cheaper and thus generally more affordable: innovation. Asked for an example, he writes: ‘Take the new Surge-on SATA technology for cableless steerable keyhole surgical instruments. By steering without cables, this technology reduces the number of moving parts by 50-70% compared with standard steerable instruments. These instruments are thus detachable, thinner, cleanable, and are the only reusable instruments that comply with the latest Food and Drug Administration (FDA) standards for endoscopic instruments. As soon as they become popular in wealthy hospitals, the instruments will become cheaper, and hence affordable in middle and low-income countries as well.”

Finding funding
CASE favours a more direct approach. Fleischer and Oosting will start looking for funds in February. Fleischer mentions the following funding bodies: the EIT Health programme (although it has a strong focus on European healthcare); the Bill & Melinda Gates Foundation (provided it fits one of the grand challenges); the Yes!Delft investors network; and, health tech venture builder NLC. “I hope we will have find a working formula within three years,” says Fleischer.

She is convinced that “there is money to be earned in Africa, if only you get the match right. We should stop treating the continent as a dumping ground and start regarding it as an emerging market.”

• Roos Marieke Oosting, Towards Increased Global Availability of Surgical Equipment, promotor prof.dr.ir. Jenny Dankelman (3mE), 12 december 2019