Image guided surgery innovation with graduate students - a new lecture format

1 Introduction and motivation

Medical engineering students are supposed to work on creating exciting and useable new technologies and systems that are used by physicians for more accurate, faster, and cheaper diagnosis and therapy.

The graduate curriculum teaches them a lot about the imaging technologies and tools used, how they work, how to manipulate them, and should also give them some medical insights.

What is very often lacking during their university education is the actual interaction with clinicians, active participation in medical procedures, comprehension of healthcare economics, and a structured engineering approach to innovation creation in that field.

Figure 1

The innovation process based on Design Thinking in medical technology — and our technology focus [2, 7].

Medical technology innovation delivered to the clinicians (technology push) at the moment is very often not developed together with the clinicians, but comes predominantly from the engineering or business side.

Developments however that are based on medical needs by observing the clinical use and environment [1, 2], and that are done in close cooperation with the actual users (technology pull) may not be as disruptive, but are easier to recognise and implement (see figure 1 for the design thinking process in medical technology), provide a relatively quick feedback, and can be used as teaching tool for interdisciplinary innovation generation.

While it seems obvious that medical technology innovation is something that should be done in very close cooperation between clinical users, engineers, and scientists the reality in the university curriculum is different.

New devices, procedures, systems are only innovative, if the actual invention (the “new” stuff) is perceived valuable by the clinical user and translated to a commercial product. With that in mind basic knowledge of health economics seems inevitable knowledge for future medical technology innovators.

Design thinking, value proposition canvas, lean engineering [3, 4] are innovation techniques that these students should be exposed to before they start their final thesis.

2 Lecture format

We designed a new lecture format that would give the students some basics in the area of image guided surgeries [5] and combined that with innovation development techniques, basics on healthcare economics and subsequently send them out in small teams (max. 3-4 students) to see, experience, observe, and analyse an actual surgical intervention with the goal to identify some medical and innovation needs and work on a solution (teams were send to interventional radiology, laparoscopic surgery, bronchoscopy, orthopaedic surgery, cardiac intervention, vascular surgery).

These solutions had to be checked towards ease of implementation, possible gain to the stakeholders and resolution of associated pains (see figure 2 for an example of a Pain/Gain analysis).

A block format was used with 5 days of 6 academic hours each (with another 80-120 hours for preparation of the documentation and the innovation project - 6 ECTS) [6].

Figure 2

Pain / Gain analysis of the stakeholders as identified by observing an image guided surgery procedure - taken from an actual student project.

Figure 3

Example of a Value Proposition Canvas of an identified Image Guided Surgery problem with solution proposal - taken from an actual student project [3].

• – BLOCK 1: Basics on diagnostic imaging, image guidance, radiation protection – BLOCK 2: Basics on navigation, segmentation, –image processing, tracking, image fusion, hybridisation, reconstruction and registration

• – BLOCK 3: Basics on surgeries, engineering approaches, general expectations, preparation for surgery visit, minimal viable product design and lean engineering

• – BLOCK 4: Innovation games, conceptual blockbusting, project management and economics basics, initial presentations and individual project coaching

• – BLOCK 5: Final presentation and test – next steps?

Between Block 3 and 4 (4 to 6 week break in between) we expected the teams to visit the surgeries and present a summary impression during block 4 containing the observations, identifying the stakeholders and their Pains and Gains (see figure 2 for an example of a Pain / Gain analysis) and suggest the project work using the Value Proposition Canvas as a base ([3] and see figure 3 for an example of such a student canvas).

Two SKYPE conferences with the individual teams between blocks 3-4 and 4-5 were held to discuss the findings and to jointly decide on the actual project to be worked on.

For the final lecture (block 5) we picked a remote mountain hut and combined lecture, presentation, final examination with team building and innovation games over a period of 2 days.

The lecture was not considered completed without proof that the findings and the documents were communicated to and discussed with the hosting clinicians.

It was difficult enough to find clinical groups that were willing to accept the student teams and that were open enough for these innovation projects that basically implied that their operation was not perfect.

3 Results

The lecture “Image Guided Surgeries - from Bed to Bench.. and back to bench . .. plus beyond” at the TU München was held 2 times now, with lectures titled “Medical Technology Entrepreneurship” and “Translational Technology Entrepreneurship” preceding that one with related content and goal.

A total of 186 student completed these courses in the last 11 semester. All courses were always overbooked and filled within 1 day after opening and were consistently rated by the students among the best 5 lectures of the faculty.

Main positive responses were:

• – a course with real MedTec experience

• – presented innovation techniques are very valuable

• – soft skill improvements

• – team work (excitement+frustration)

• – interdisciplinarity is a key to MedTec innovation

• – understanding of healthcare innovation cycles

• – stakeholders and their thinking are now much clearer

On the negative side was the amount of work listed that was necessary to complete the assignments.

Table 1

Evaluation of Questionnaire used for the evaluation of selected knowledge of the students prior to and after the lecture as well as a some personal

Very importantly the clinical hosts were quite happy about the results and the interaction with the students. Several suggestions and observations that were provided by the student teams were implemented rather quickly.

Figure 4

Examples of proposed projects developed based on observations during Image Guided Surgery procedures - includes new way of navigating with a bronchoscope to biopsy devices and suture systems.

All in all 7 patents were filed by the teams and many of the identified solu tions were used subsequently for thesis or dissertation projects. And, three start-ups were founded!

Before and after the lecture a questionnaire was distributed to the students (see Table 1) consisting of 25 questions relating to innovation components, importance of certain factors, and also some personal grades on the value of the lecture.

It was very interesting to note that most students believed after completion of the lecture that innovation that is developed based on a medical need (technology pull) will be more successful (grade improved by +91%), that interdisciplinary teams are key to a meaningful innovation (+64%) and that the knowledge of healthcare economics is essential (+42%).

Looking at specific criteria for creating medical technology innovation “ease of use” was considered very important (+35%), understanding reimbursement (+44%) and reducing the footprint of products (+55%). The importance of “complexity” as important criteria went down (-17%), which the authors believe too little of a change, as complex systems are in reality very difficult to successfully introduce. It could very well be that some of the students misunderstood the rating direction of the question.

The format was rated excellent by the majority of the students, providing a good balance between theory, actual practical experience, team work, and the innovation project (figure 4), that had a real practical need.

4 Conclusion and outlook

Similar and even more formal and intense lectures were introduced several years ago by the Biodesign group of Stanford [7] with exceptional results and growing popularity.

Classes are now being offered by different institutions in Europe as well and a yearly congress (BME IDEA) is dedicated on programmes in the EU that deliver biomedical design and medical device entrepreneurship training based on the Biodesign process [2]. In the Biodesign process they focus on identifying huge numbers of medical needs that are then evaluated and filtered.

The Image Guided Surgery class that we developed is constantly being updated and changed, but the core content will stay as it has proven to provide insights for the students, results for the clinicians and also a lot of fun to the lecturer. It is quite a bit different from the Biodesign process, as its focus is on teaching the students innovation processes and asks for identifying and implementation of an actual development project that focusses on medical need.

Medical technology innovation very often needs to come incrementally rather than disruptive. Disruption means that clinicians need to change the way they do things right now, training is necessary, maybe large investments are needed, results need to be proven and shown using multi-year / multi center clinical trials, and take a lot of time and sometimes cost huge amounts of pre-investment money.

Regulatory issues also need to be considered, which are time-consuming, but obviously required and very important.

Innovation lectures within the graduate program of Medical technology / Biomedical engineers are important and essential basics for these incremental medical need based innovations.

Figure 5

Lecture Series offered – leading from INNOVATION GENERATION (mandatory) to an applied course (IMAGE GUIDANCE - elective), and further to an ENTREPRENEURSHIP lecture (elective).

In our university we have now started to introduce a “master” innovation class titled “Innovation Generation and Entrepreneurship in the healthcare Domain IGEHD” [9] that follows the “Image Guided Surgery” lecture. In that one (4 ECTS, 3 blocks of 8 academic hours each) we focus more intensively on the theory of the innovation generation process with several iterations in cooperation with the clinicians (see figure 5 for an overview of the lectures offered).

This is not only exciting for the students, but also for the academic and teaching staff and the hope is that we will see many more interesting and meaningful developments for and with the clinicians.