Today's neurosurgical operating suites are filled with technological advances - making surgery safe that was deemed too risky until recently.
Yet, the required devices often operate independently from one another, do not fit well in existing rooms and end up taking away focus from the surgical field.
Our solution is surgeon-driven - we're product owners not of a single device but the entire OR. This approach differs from what we have experienced with device manufacturers.
Prof. Regelsberger is a pioneer in exoscopic neurosurgery as the first person in Europe using the a device of its kind. As head of a neurosurgical department he is familiar with the decision-making process in purchasing decisions.
We're using commercial off the shelf components wherever possible to create a device that allows updating existing technology with new capabilities, fixing known ergonomic issues with multi-screen workflows and tackling problems that might not sound like features that we should have to implement.
In a first step we're bringing a modular system to the OR that can be enhanced in the future.
Despite all technology: micro-neurosurgery remains a deeply manual task. Yet, many devices make it harder to focus on it and perform optimally.
Everyone who has beed to a modern surgical suite sees many devices with screens around the patient, cables on the floor and in general just a cramped space. Combine this with sub-optimal positioning of screens, leading to problems with posture, optimal viewing angles and keeping all relevant information in view and it distracts from the intricacies of operating. Real progress is allowing the surgeon to focus optimally.
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We want to solve many of these challenges with our Flensburg Exoscopic Neurosurgery System (FLENSS) through its four components:
Firstly, we're integrating up to eight different image sources and allow for flexible image-compositions as needed by the surgeon for the specific task. The images - especially from the Exoscope - will receive additional processing to improve the view into the situs and will then be displayed on a comfortable and semi-transparent Head-Mounted Display whose image can spatially be anchored.
We're routinely iterating each component with the ultimate goal of a short time to set up in the OR.
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We have carefully reviewed and discussed two topics that seem to be on everyone's agenda at the moment:
Many approaches to these look interesting in principle and may be helpful in some cases, yet do not meet the bar of "everyday usefulness". For this we have come up with a solution (we cannot share yet) incorporating both that we believe better meets the demands of practicing surgeons and less of marketing experts.
Jan Regelsberger and Roman Rotermund have extensively consulted on med-tech innovations in their field. At this stage however, only minor revisions could usually be made to incorporate their feedback.
That's why we're turning this on its head and build a device that works the way they need it and not vice versa. In their surgical practice they need devices that adapt to their surgical workflow and improve it without major learning curves and hassle in setting up.
Jan has been practicing as an academic neurosurgeon for 30 years and teaches as Professor at University Hospital Hamburg-Eppendorf (UKE) – Germany's 2nd largest department right after Charité Berlin.
There he was vice-chairman of the department prior to his current role as chairman at DIAKO Flensburg.
He has had major involvement in many devices, especially in exoscopic surgery as the first user of Orbeye in Europe.
Roman followed Jan from UKE Hamburg (he's an Associate Professor [PD] there) to Flensburg as senior physician, where he mainly focuses on cranial neurosurgery; he's a leading expert in the field of pituitary surgery.
On the flip side - working in a major trauma center means that his small son says "Daddy work" when he sees a helicopter.
Especially between cases when he's on call, is when Nils comes in or he goes over to our provisional lab to check out the latest progress and further customize it.
We're not entirely sure when he catches some sleep - as during the precious moments outside the hospital he's always either chopping up wood in his yard, keeping up with art, socializing or with his family.
Nils has a legal background but found that following his interests in technology more and more interesting than merely its intersection when advising on data privacy over time. He has alway been a tinkerer with a keen interest in the underlying technologies - a transferable skill to solving this challenge. As such he's in charge of the technical development.
Having been responsible for quality management, IT and Occupational Health and Safety in a previous role has sharpened Nils' eye for processes and systemic inefficiencies (my partner jokes about my joy in setting up a clean database as a single source of truth).
Having that view and trying to genuinely help (and not from a business consultant's perspective) made him a welcome guest in the OR.
That and he really tried not to get close to anything sterile or snack too much in the lounge.
There are three parts to the name:
And to state the obvious: We have no affiliation with Flens, our local brew.
No worries: Roman and Nils's dogs were adequately compensated in treats for introducing them to one another.
After having talked quite a bit about surgery and the devices Roman uses, with the announcement of Apple's Vision Pro they started to think: Could this be useful? While we don't think pass-through video will widely be used in the OR in the future, it did open up the conversation about "what if".
Once we had something and discussed its merits, we were hoping that Jan wouldn't see major issues when we pitched the idea to him. See section above for your answer to this.
We started to get to work on more technical details, refined their unmet needs in the OR, looked at what avenues had been explored previously and why they might not have worked out. We went through lots and lots of papers (as anyone who has ever looked at the barrage of publications in MDPI etc. knows), discarded many ideas and approaches, thought about required effort and expected return, sorted needs in the OR, discussed details with subject-matter experts and finally landed on a solution.
That's what we're building now.
