Innovatie

ForceSense

Opschaling

Since many years training in laparoscopy is done with simple box-trainers and Virtual reality systems. These systems are used by educators to asses surgical performance of their students and staff. As only instrument handling and task time are used for objective assessment, true indicators that predict safe tissue handling (e.g. tissue rupture or pinch damage) are not part of the assessment. With ForceSense, interaction forces are measured and evaluated because rushing a training task may lead to a fast time score but increases the risk of tissue damage. As in the OR careful tissue handling increases the safety of the procedure. ForceSense is the only training system to reward careful tissue handling in its scoring metrics.

Digitalisering

Informatie-uitwisseling

Medisch technologische innovaties

(Tele)monitoring

Regio Zuid-Holland

Tim Horeman

http://www.ForceSense.net

Probleemstelling

In laparoscopy, long and slender instruments are inserted into the abdominal cavity through small 5 mm incisions to manipulate, cut and repair tissue under view of a scope. Due to scaling and mirroring effects, intensive training is needed to manipulate tissues safely as damaged or punctured tissue can be very painful and even life threatening. Currently, steerable hand-held instruments are entering the market that are far much more difficult to control and therefore increase the risk of undesired tissue damage during surgery. As there are no training and assessment methods available that show young surgeons the risks related to manipulation of organs and tissues with complex (robotic) steerable laparoscopic instruments inside the abdomen, nothing holds unskilled surgeons back from using those instruments in practice. This problem was addressed and recognized at the technology committee of the European Association of Endoscopic Surgery resulting in full support for this initiative.

Oplossing

ForceSense measures & evaluates interaction forces during laparoscopy training. Rushing a training task may lead to a fast time score but increases the risk of tissue damage. As in the OR careful tissue handling increases the safety of the procedure. ForceSense is the only training system to reward careful tissue handling in its scoring metrics.

Doelgroep

This system aims at training of young surgeons in endoscopic surgery (laparoscopy, Arthroscopy). Training is done at leading conferences, skills labs and individual hospitals

Verdienmodel

As this platform is developed by scientists and surgeons for training of Residents on an international level the goal was to keep costs low to allow most hospitals to integrate this system in their curriculum. Therefore a combination is used of fixed fee for the hardware, a threshold fee and license agreement for the software and a pay per use if the threshold value of the standard contract is exceeded. Depending on the chosen setup, the hardware costs around 12kEuro

Geïnvesteerd vermogen

€ 100 duizend-1miljoen

Concurrentie

To train outside the patient Virtual Reality (VR) systems (e.g. Simendo) for or standard Box-trainers (e.g. 3D-Med) are used. VR trainers are mainly used for training of abstract tasks or training of simple procedures. Those commonly used systems do not make use of real instruments and do not provide any haptic feedback. In the upper segment, some systems were developed that provide haptic feedback that are not used anymore. Besides the significant costs (simbionix 60k + maintenance) important tissue manipulation tasks as suturing (used for technical skills assessment in all educational programs) remains impossible due to the complexity of the internal haptic models and limited control systems. Most importantly, none of those systems asses performance based on metrics that reflect safety in terms of tissue manipulation handling. Soft tissue handling is now mainly learned during costly cadaver studies (800-1200 Euro per cadaver) and through proctorship in surgery.

Unieke kenmerken

- Highly validated with 6 PhD trajectories, 46 publications, 40 conference presentations. this is the only system that is considered to be fully validated in the field.
- Small Delft Medtech company (100% owned by original founders) that fundamentally changed the vision on training of laparoscopy worldwide.
- reached a Technology Readyness Level (TRL) 10 status last year by becoming mandatory in Germany for Gynecologists. The Netherlands is running up.
- Only system that certify laparoscopic skills based on real live objective data (i.e.Tissue interaction force, instrument motion and task time)
- Use real surgical instruments to increase transfer of trained skills to medical practice.
-Sales in 3 continents, over 2000 registered users since introduction and used in 20+ hospitals

Intellectueel eigendom

The knowledge obtained during the PhD research project from Tim Horeman (2014) was licensed to the startup company MediShield BV. Since the start, all software and firmware was developed by MediShield BV and never exposed. Also the data of around thousands of users is owned and stored by MediShield and accessible for research partners to develop assessment metrics and models on. Without this, competitors can maybe remake the hardware (never done so far) but do need a huge network to gather training data in order to set up a curriculum. As this is not likely, protecting the source software and training data, is one of the best ways to protect your innovation. As MediShield works together with the largest European skills Centers, technical universities Delft and many academic and general hospitals in the Netherlands and Germany on a scientific bases, copying an platform as ForceSence.NETthat has an established name in the (scientific) field of surgery can lead to bad reputation. Today, over 45 articles were published and 6 dissertations were written that shows the impact of the system.

Organisatie

ForceSense.NET is an initiative of mediShield Delft Bv that owns 100% of the rights. MediShield is a R&D company for surgical devices with a strong focus on Laparoscopic surgery and has a very strong relation with the BioMechanical engineering department of the Delft Universty of Technology. Within multiple consortia with many hospitals, the products are launched in the different markets. Most likely ForceSense.NET attracts new partners and gets its own identity under mediShield BV in 2021.

Beschrijving pilotfase

After the first scientific proof, curriculum implementation studies started at the Amsterdam medical Center for our arthroscopic PASSPORT system and Leiden medical center, + VUmedical center with our ForceSense system. in a parallel track instrument developers and research groups purchased the system to validate their own innovations (e.g. used our measurement system to claim that their instruments and training tasks work according to he specifications.) Today, the system is sold world wide to early adaptors (20+ hospitals and organisations) that all share their data with us for improvement of the curricula and technology.

Betrokken partners

Hospitals and skillslabs: Germany, Netherlands, china , Philippines, USA, Mexico and India
Organisations: EAES Europe, AGE Germany

Aantal gebruikers pilot

101-1.000

Onderzoeksresultaten

The system can be used to monitor skills developments of young surgeons and identify dangerous learning behavior during surgical tasks conducted with conventional and steerable laparoscopic instruments

Rapportage pilot

Hardon2018_Article_Force-basedLearningCurveTracki.pdf

Implementatiestrategie

In surgery, publication of scientific papers is the best way to market your innovation. after the proofs are made in an in conditioned setting, implementation and context research is needed to embed the innovation in the already excising structures, processes and protocols. Keep in mind that those variables differ between hospitals, regions and nations. therefore a risk in inventory need to be done to investigate what elements can hamper introduction. finally, make sure that the branch organisations are involved for further up-scaling of the innovation.

Behaalde prestaties of gewonnen awards

• Best research Award (PhD student), NVEC 2018
• Athanasiou Award for best submission ABME 2017-2018
• Best Technology Award (PhD student), EAES Frankfurt 2017
• Royal Prins Friso “Engineer of the year award”, The Netherlands 2016
• Finalist & Runner up 3-in-5 competition DMD USA 2015
• Public award - Entrepreneurial Scientist Award DESA 2012-2013, Delft 2013
• Runner up Delft Entrepreneurial Scientist Award DESA 2012-2013, Delft 2013
• Top 50 best young professionals, 4th place technology, The Netherlands 2011-2012 and 2012-2013
• 1st place sustainable healthcare challenge, Nijenrode 2013
• 2nd place Eureka Mega Challenge, Utrecht 2013
• Daniel F. Kott Award for the Best New Instrumentation - Las Vegas AAGL 2011
• SMIT Young investigator award, Trondheim 2011
• Best business idea New Venture & Best feasibility study New Venture, Nijenrode 2009
• Finalist Philips Innovation Award (PHIA), Rotterdam 2008

Productontwikkeling

We now aim for new and smarter functional training tasks that better represent organ tissue and better facilitate instrument-tissue interaction during surgery. Also the system becomes more dynamic and can handle more and different kind of sensor inputs to record more data that helps for better assessment of more complicated types of laparoscopic surgery

Internationale ambitie

We aim at becoming a standard for more international operating organisations in multiple fields of endoscopic surgery.

Omzet

€ 101k-1M