Empowering Translation of New Ideas - A EIT Health ClinMed

Summer School Overview

Sofia Ribeiro

1,2*

, Mariachiara Ricci

, Albert Von Der Lieth

, Yves Bayon

, Dimitrios I. Zeugolis

2,5

Sylvia Pelayo

, Isabelle Marque

and Lionel Pazart

Medtronic, Sofradim Production, Trevoux, France

Regenerative, Modular and Developmental Engineering Laboratory (REMODEL),

National University of Ireland Galway (NUI Galway), Galway, Ireland

Department of Electronic Engineering, University of Rome “Tor Vergata” (Rome), Rome, Italy

Medical Center Hamburg-Eppendorf (UKE), University of Hamburg, Germany

Science Foundation Ireland (SFI), Centre for Research in Medical Devices (CÚRAM),

National University of Ireland Galway (NUI Galway), Ireland

Univ. Lille, INSERM, CHU Lille, CIC-IT 1403 - Centre d'Investigation Clinique, EA 2694, F-59000 Lille, France

Inserm CIC 1406, F-38000 Grenoble, France

Inserm CIC1431, University Hospital of Besançon, EA481 - Integrative and Clinical Neuroscience Laboratory,

University of Burgundy-Franche Comte, France

Keywords: ClinMed Summer School, Innovation by Design, EIT Health, Medical Device, Training.

Abstract: Translational research training is crucial to convert academic research ideas into efficient real-life solutions.

In this paper a summer school supported by EIT Health is presented. Its main goal is to integrate clinical

knowledge in the development of new medical devices, from ideas to post-market approval, in the clinics.

Students were immersed in clinical centres where they had close contacts and engaged discussions with

clinicians and patients to identify and assimilate clinical unmet needs. From this immersive stage resulted

innovative solutions that were further investigated with the support of plenary lectures and by interaction with

experts of the medical field, from clinicians to Medtech company representatives. This experience proved to

have a positive impact on the student’s understanding of the clinical development life cycle from research

findings or new ideas into medical devices.

1 INTRODUCTION

Despite the ground-breaking innovations that have

been made in many clinical indications less than 5 %

of all medical findings made in academia are

translated into commercially available solutions, such

as new medication, diagnostics or devices. And with

each passing year the gap between the biomedical

research and the clinical applications fields increase

(Gehr and Garner, 2016). The reason for the low rate

of translation comes down to the struggle to transform

innovative ideas from publicly founded academic

research into commercially available products

manufactured by the industry (Duda et al., 2014). A

medical device must be conceptually

designed to

These authors contributed equally to this work.

satisfy a real clinical need identified by end-users in

the field. Its product development must be aligned

with the market expectations and be realistically

designed, producing a scalable, manufactory robust,

cost-effective and user-friendly product while

fulfilling its intended clinical function (De Pieri et al.,

2018).

While clinicians and academic researchers have their

competence in identifying clinical needs and finding

conceptual and technical approaches, companies have

an established experience in product development,

large clinical trials, regulations and manufacturing.

Already at this background collaborations and

exchanges of knowledge between the private and

public stakeholders seem to be reasonable and

Ribeiro, S., Ricci, M., Von Der Lieth, A., Bayon, Y., Zeugolis, D., Pelayo, S., Marque, I. and Pazart, L.

Empowering Translation of New Ideas - A EIT Health ClinMed Summer School Overview.

DOI: 10.5220/0007696606030610

In Proceedings of the 12th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2019), pages 603-610

ISBN: 978-989-758-353-7

603

Figure 1: Valleys of death in translational research. The figure illustrates the two valleys of death that can occur during

medical device new product development.

necessary to improve translation. A study from 2016

showing the relative contribution of industry,

academia and private-public-partnerships in

regulatory approvals of medical devices underlines

this idea. With 82% of the medical devices obtaining

approval after clinical trials, the majority were

developed by the industry. However, the importance

of collaborations between academia and industry

showed to be relevant since they had a better

regulatory approval rate (13%) than the devices

developed by academia alone (5%) (Marcus et al.,

2016).

During the commercial development of a medical

device it is common to reach a stage referred to as

‘valley of death’ at an early point when the idea

begins to be translated into potential clinical solutions

(Figure 1). The main hurdle to overcome at that point

is the lack of financial resources, mainly for very

innovative projects (Farragher et al., 2015). A second

valley of death may come after pre-clinical and

clinical validation of the product and the completion

of the regulatory approval process. This second valley

comes from the difficulty to gain market acceptance

and reimbursement and it is the main cause for the

failure of 42% of start-ups in the medical devices

area. To overcome both valleys of death is it crucial

to precisely define the unmet need and to pave out a

clear path to both clinical acceptance and

reimbursement (Murphy and Edwards, 2003).

Therefore, paying a great attention to unmet clinical

needs and the product usability and acceptance from

the very early stages improves the chances of success

and allows for a reorientation of product development

early if needed. Nowadays there is an increased

difficulty to develop an innovative solution due to an

increased number of regulations and the fact that

complex solutions require more and more

sophisticated technology and knowledge.

New translational research programs have been

created in the last decade with the goal to educate

scientist and clinicians on product development and

how to make their research attractive to warrant

further development and commercialization (Gehr

and Garner, 2016). In the US several project-oriented

educational programs have emerged inside the

universities to install entrepreneurship in academia,

an understanding of drug development in industry and

project-management skills. In one of these

educational programs, SPARK-Stanford, the success

rate is high with more than 55% of projects/year being

licensed, entering the clinic or becoming

commercialized (Gehr and Garner, 2016).

In the EU similar programs, educational

curriculums and summer schools have been

developed. European Institute of Innovation &

Technology (EIT) Health is responsible for

innovative collaborations between research,

education and industry with over 140 partners. EIT

Health has supported 122 start-ups that have attracted

€27.9M in investment, has trained over 8 thousand

graduates, professionals and executives and has

launched 10 products or services on the market. It is

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based in three program areas. Accelerator supports

innovation and business, Campus was designed for

education and Innovation Projects is to build new

ideas and collaborations.

The European regulation 2017/745 imposes the

obligation to produce clinical data for the CE marking

of any type of medical device. But during the year

2016, more than 13,000 new medical devices were

registered with the CE marking, while only 1,600

clinical studies were registered on a medical device in

Europe. In 95% of the cases, European medical

device companies are SMEs and start-ups. They lack

the skills and resources to respond to this increased

regulation. Filling this gap is an integral part of the

EIT Health core mission.

ClinMed summer school is a project developed

with support of EIT Health to address the gaps

previously presented regarding the need for

translational research program derived from the

heavier regulation imposed on medical devices

development in the present time.

2 METHODOLOGY

2.1 The Genesis of the Summer School

To maintain the competitiveness of European medical

device companies, the challenge of this summer

school is to strengthen internal skills of companies

and/or to recruit knowledgeable staff on the clinical

evaluation. A needs analysis focusing on the market

of Medical Devices and e-Health applications was

performed at European level during the FP7 European

ITECH project (2014-2016) co-lead by INSERM

CIC-IT network. The ITECH project describes the

process of going from research to market; identifying

the gaps and barriers existing at all stages. The

summer school benefits from results and

recommendations of the ITECH project; specifically,

to quickly reinforce clinical study capacities and

Human Factors Engineering.

Within the Tech4Health network of F-CRIN (the

French branch of European Clinical Research

Infrastructure Network) French partners of this

proposal have organized 3 annual training sessions

(2015, 2016 and 2017) on "Specificities of clinical

research for medical devices". Two-days training

courses were designed for academics, hospital staff

and industrials. But these short courses unfortunately

didn’t trigger the opportunity to set up formal

collaborative projects.

ClinMed is a summer school of EIT Health co-

organized by public and private partners: INSERM

(Public, France), Karolinska Institutet (Public,

Sweden), University of Grenoble-Alpes (Public,

France), University of Lisbon (Public, Portugal),

Medtronics (Private, Ireland), Becton Dickinson

(Private, France) and Madopa (Private, France). The

great variety of clinicians, academics and industry

representation from start-up and large companies is a

unique aspect to the ClinMed summer school. It was

intentional from the part of the committee to make

sure the participants had interactions and knowledge

from all players of the medical device sector.

This summer school is extending these initiatives

with an action-based training and the use of

innovative educational methods, tools and

pedagogies such as experiential learning, co-design

and teamwork based on mixed-skills. EIT Health

would give credibility and open up this international

training, especially for all European stakeholders.

The ClinMed summer school aims to train

participants on the technological innovation in health

care by providing a global vision of the maturation

cycle of a medical device, i.e. from the idea to the

market, using the concept of experiential learning.

As declared by the operational committee, the

summer school was organized “to identify new

challenges on unmet needs, to co-design new

solutions and to implement realistic and feasible

projects to solve important health problems”.

The link to other CAMPUS activities is bi-

directional: the ClinMed project can benefit from the

Innovation and Accelerator EIT Health pillars, and

those pillars can also take advantage of the summer

school. More particularly, projects arising from the

summer school can be implemented either in the

VALIDATE EIT Health program if the project is

already well defined, or within the Innovation

Journey program for innovative ideas that have

emerged from the summer school. The participants of

ClinMed also have the possibility to register in the

EIT Health Alumni network, which connects alumni

from the different EIT Health programs of Campus,

Accelerator and Innovation projects with one another,

partners and entrepreneurs.

2.2 The Pedagogical Logic Adopted

and Main Goals

ClinMed summer school was based on the

pedagogical concepts of experiential learning (Kolb,

1984), design thinking (Plattner, 2011) and

competency-based approach (Frank, 2010); concrete

ideas of innovative products from a first observation

was developed by teams through workshops with the

contribution of coaches and experts. It begun with an

Empowering Translation of New Ideas - A EIT Health ClinMed Summer School Overview

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unprecedented immersive experience in a healthcare

service: subgroups of participants were invited to

have a fresh look, to identify problems, and needs that

innovative solutions could meet and later share their

ideas within the clinical setting, through meetings

with healthcare professionals and patients, and direct

observations.

The aim is twofold. The first one is to provide

multiple knowledge and skills necessary to develop a

new medical device into the market by giving lectures

in several thematic sessions. The second one is to

allow the different teams of participants to confront

their ideas and discuss problems with the clinicians

and potential users, to work on a project using the

knowledge acquired during the lectures and to carry

the project towards EIT Accelerator or within the

INSERM structures that supervise this school.

Another unique aspect of ClinMed summer school

was to communicate not only theoretical information,

but also practical accompaniment from the lecturers

after their session. The lecturers were encouraged to

go through the teams and give advice on the

development of their specific product. Moreover, the

teams benefitted from regular meetings with the

coach belonging to the immersive site.

The participants are supposed to learn, at the end

of the program, how to assess the clinical and market

need for the development of a new medical device;

understand the rules for protection and property;

know how to find the adequate regulations; define a

development plan; recognize the state of the art,

understand the objectives and methods of usability

studies, clinical investigations and post-marketing

follow-up studies and work in a multidisciplinary

team.

2.3 Summer School Organization

The ClinMed summer school was organized between

the 21

and the 31

of August 2018. The attendees

were divided in team of 4 to 6 participants and hosted

for 3-day in a hospital or living lab where they

interacted with healthcare professionals and patients

in order to understand unmet needs in a specific field

that requires technological innovation. Afterwards,

all the participants gathered at the main site of the

summer school, located in Villard de Lans, a village

located in the French Alps near Grenoble (France), to

develop the projects through lectures and coaching

from professionals in academic and industrial sectors.

2.3.1 Online Session

Students were invited to attend courses offered on a

private e-learning platform on the theme of Health

Technology Innovation before the beginning of the

summer school. These courses, exclusively in

English, have been developed by the CIC-IT network.

They are part of teaching since 2011 in 4 master's

courses in France (Besançon, Bordeaux, Grenoble

and Nancy), with more than 700 graduate students.

The first part focuses on translational research, the

core business of CIC-ITs, explained in the form of 2

conferences filmed during international congresses

and illustrated by 5 videos of 6 minutes each showing

examples lived in CIC-ITs (with testimonies from

clinicians, researchers and industrialists). A very

concrete example of a DM (insufflation mask) which

led to the creation of a start-up is developed more

precisely. The other courses explore different

innovative topics in the world of medical devices:

Computer Assisted Medical Interventions,

Biomaterials, evaluation of medical device safety in

MRI and Usability.

2.3.2 Immersive Stage

The ClinMed summer school began with an

immersive experience in a healthcare service or a

living lab. This unique experience allowed the

participants to share their ideas within the clinical

setting, through direct observations and meetings

with healthcare professionals and patients. This

exceptional contact between students and real-life

situations permitted to grasp a real-life clinical

problematic presented to them by the healthcare

providers.

Each location had a specific theme. The locations

and themes are displayed in Figure 2 and are: Lyon,

Garches Lisbon, Lille, Besaçon, Grenoble, Tours and

Nancy.

The participants’ goals were:

 Observe the current situation;

 Identify problems and needs;

 Prioritize the issues to be addressed;

 Formalize the technical specifications to be

achieved with a solution;

 Gather information on the problem and existing

solutions.

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Figure 2: Location and corresponding themes for the

immersive stages possible during the ClinMed summer

school.

2.3.3 Plenary Sessions

After the immersive stage, participants met up at the

main site of the ClinMed summer school in Villard de

Lans to develop their projects through lectures and

coaching from lecturers and mentors.

The lectures were divided into thematic sessions

which were new product life cycle development,

regulation of CE marking, essential requirements,

risk analysis, pre-clinical testing, clinical

investigation, suitability for use, post-market

monitoring and the “market approach” (business

plans, protection and property management).

The daily agenda consisted of a first session of

lectures in the morning, followed by a period of time

dedicated for the participants to work on the project

assisted by the invited speakers and mentors. A

second session of lectures followed after lunch.

Before dinner the participants were encouraged to

continue the elaboration of their work or to participate

in social activities organized by the committee and

the participants to stimulate the networking between

participants.

During this second part of the summer school

students worked on the conceptualization phase of

their solution to the unmet need refining the problem

to be solved and identifying the missing skills if

necessary.

The participants’ goals at this stage were to get a

clear idea on the key components of clinical

translation process, such as:

 Define the broad outlines of the development plan

for their new medical device;

 Perform a state of the art;

 Describe the market, the competition and the

means to afford the market;

 Assess the possibility of technical, biological and

clinical equivalence of the innovation with an

existing product;

 Define the class of the new medical device and

find the regulations and essential requirements

needed;

 Perform the risk analysis of the product;

 Define tests and experiments;

 Precise the business plan, protection and property

management.

2.4 Lecturers, Mentors and Clinicians

Lectures and mentors were invited to share their

knowledge and expertise with the students. This

unique opportunity allowed the students to have a

close interaction with experts that are in the top of

their field and enhance their project.

The ClinMed summer school had 25 lecturers and

mentors, from 9 different countries, who are

professionals from hospitals, companies and

academia (Figure 3A). They have expertise in diverse

fields such as medicine, sociology, biomaterials,

Figure 3: Speakers background, A- distribution in percentage of professional backgrounds, B- distribution of speakers’ fields.

Empowering Translation of New Ideas - A EIT Health ClinMed Summer School Overview

607

medical imaging, engineering, health informatics,

ergonomics, marketing and economy (Figure 3B),

which guaranteed a comprehensive approach.

It was also made possible to obtain a feedback

from clinicians within the EIT Health network. Each

group developed an idea to satisfy a clinical need.

This solution was shared with clinicians and their

feedback was taken into account for the development

of their projects.

2.5 Recruitment Procedure and

Participants

The summer school accepted 37 participants. A

selection committee evaluated the participants’

experience, academic performance and motivation.

The evaluation was based on their curricula and

motivation letter.

The aim of the selection committee was to put

together a group of attendees that came from diverse

educational and professional backgrounds with high

motivation in developing new solution in the medical

field.

The participants had Bachelor’s or Master’s

degree in the fields of biomedical engineering,

medicine, biology, ergonomics, health informatics,

economy and pharmacy. Most of them came from

university whereas five students came from industry

(Figure 4A).

The participants came from all over the world,

with a total of 17 different countries, with the

majority coming from European countries (Figure

4B). The participants were divided in the following

groups at the start of the program: 4 students in Lyon,

4 students in Garches, 4 students in Lisbon, 6 students

in Lille, 5 students in Besaçon, 5 students in

Grenoble, 4 students in Tours and 5 students in

Nancy.

2.6 Evaluation

After the immersive stage and after an initial lesson

on how to pitch, the participants made their first day

in Villars de Lans a first pitch to an audience to

present their idea. Feedback was given regarding the

content and the efficiency of the pitch by other

participants and mentors. Afterwards it was

encouraged for the groups to keep working on the

pitch.

The participants performed another pitch to two

mentors with experience in industry in order to obtain

a more detailed and constructed feedback.

As a final evaluation each group presented a written

report and an oral presentation, in form of a pitch, in

front of an international jury of experts in the field

followed by Q&A session. Each group project was

evaluated according to the criteria used for the

assessment of European projects, i.e. excellence,

impact, quality and efficiency of the implementation,

quality and efficiency of the pitch.

3 LESSONS LEARNED

During the ClinMed Summer School 8 projects were

developed in the fields of home assisted health, self-

monitoring devices, rehabilitation solutions and

diagnostic products. All projects originated from a

Figure 4: Background of the participants of the ClinMed summer school. A- Distribution in percentage of the participants’

background; B- Countries of origin of ClinMed summer school participants.

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clinical need suggested by the clinicians involved and

further developed during the course of the summer

school.

The evaluation process gave an overview of the

quality of the projects based on criteria related to i)

excellence (eg. relevance of the proposal, innovation

potential, credibility of the proposal, accuracy of risk

analysis);

ii) impact (eg. presentation of market, economic

viability, potential to improve healthcare);

iii) quality & efficiency of the implementation (eg.

co-design and interdisciplinary approach, clinical

impact, intellectual property management,

exploitation and dissemination of results);

iv) quality & efficiency of the pitch (eg. presentation

quality and answers to the jury’s questions, team’s

ability to convince).

3.1 Feedback

At the end of the summer school, students were asked

to fill a feedback survey. The questionnaires covered

topics of satisfaction of the program, organization,

accommodation, quality of lectures, educational point

of view (i.e. immersive experience, common core and

team project), social events and general aspects

related to the understanding gained through the

summer school. The questionnaires had both scale

questions (1. Very Satisfied-2.Satisfied-3.Rather

Satisfied -4.Indifferent -5.Rather Disappointed-

6.Disappointed-7.Very Disappointed) and free

commentaries.

In Figure 5A is represented the overall

satisfaction expressed by the participants. 55.6% of

the participants replied that they were very satisfied,

while 41.7% were satisfied and the remaining

percentage (2.8%) were rather satisfied. Some of the

positive comments refer to the high quality of

lectures, the comprehensive overview of the medical

devices field, the unique opportunity to work and

interact with people with diverse backgrounds, as a

few examples. A few more negative comments refer

that the time of the year (end of the summer) was not

ideal for the immersive stage due to the limited

number of people available, some of the lectures were

too detailed and extensive for the type of summer

school and there was not enough time to work on the

final report.

In Figure 5B is represented the satisfaction from

an educational point. 94.5% of the participants stated

they were very satisfied or satisfied. While from a

Scientific point of view (Figure 5C), 83.7% of the

participants were very satisfied or satisfied, 11% were

rather satisfied while 5.6% were indifferent.

When asked if the participant had a better

understanding of the maturation cycle of an

innovative medical device, the majority of the

participants replied yes (97.2%) (Figure 5D).

From the different concepts presented during the

summer school, the students singled out some as the

most difficult ones to comprehend, such as business

model and regulatory affairs. It is to be expected that

students that have different backgrounds would find

specific biomedical topics more difficult to grasp.

4 CONCLUSIONS AND FUTURE

PERSPECTIVES

Looking at the present view of translational research

it is clear that there are many challenges left to

overcome. Using research findings for improving

clinical medicine needs the combined expertise of

basic researchers, clinicians and the industry. At the

initial stage of the development of a medical device it

Figure 5: Representation of data (in percentage) obtained from the participants’ reply to a survey. A- Overall satisfaction; B-

Satisfaction from an educational point; C- Satisfaction from a scientific point; D- If the participant had a better understanding

of the product maturation.

Empowering Translation of New Ideas - A EIT Health ClinMed Summer School Overview

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is crucial to clearly identify an unmet need and to

optimize the product usability in order to improve the

chance of success. This notion, as simple as it may

seem, needs to be thought through and put into

practice by young researchers and developers.

In this paper a report of the ClinMed summer

school was given. This program gave an up-to-date

general perspective of the life cycle of a medical

device: from the initial concept until it reaches the

European market. Its uniqueness came from the

immersive stage and the close contact between

participants and experts of the medical field. It main

goal was to empower students to become developers

and innovators.

According to the feedback obtained at the end of

the summer school, students believe that the

experience improved their knowledge of the medical

device field, broadened their comprehension of

possibilities for the development of devices. The

participants believe that the impact of this summer

school will be presented to them only in future

projects of innovation in medical devices.

ACKNOWLEDGEMENTS

This work received funding from EIT-Health campus

call (Project Grant Agreement n°18497).

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