End-user Need based Creation of a Medical Device: An Experience of

Co-design to Struggle Pathological Scars

Thomas Lihoreau

, Brice Chatelain

, Gwenaël Rolin

1,3

, Chrystelle Vidal

, Nadia Butterlin

Emmanuelle Jacquet

, Aflah Elouneg

, Jérôme Chambert

, Xavier Bertrand

, Christophe Meyer

2,7

and Aurélien Louvrier

2,3

CHU Besançon, INSERM CIC 1431, Centre d'Investigation Clinique, Besançon, France

CHU Besançon, Department of Maxillo-Facial Surgery, Besançon, France

Univ. Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Besançon, France

Univ. Bourgogne Franche-Comté, Institut Supérieur d'Ingénieurs de Franche-Comté ISIFC, Besançon, France

Univ. Bourgogne Franche-Comté, FEMTO-ST Department of Applied Mechanics,

CNRS/UFC/ENSMM/UTBM, Besançon, France

CHU Besançon, Hygiène Hospitalière, UMR 6249 Chrono-Environnement, Université de Bourgogne-Franche-Comté,

Besançon, France

Univ. Bourgogne Franche-Comté, Nanomedicine Lab EA 4662, Besançon, France

Keywords: User-need, Keloid Scars, Medical Device, Innovation Cycle, Clinical Investigation.

Abstract: Scar is a common visible mark of human tissue healing. Sometimes pathological phenomena lead to abnormal

hypertrophic or keloid scars, with evolutions varying depending on different conditions: origin of the tissue

barrier disruption, concerned body area, or ethnic origin. Based on these statements, care procedures have

been developed to avoid aesthetical or functional impairments: drugs injection, surgery, cryotherapy or

mechanical compression. The story will relate the matching of a multi-disciplinary team that focused on

covering an unmet need for ear lobe keloid treatment, providing patients an optimal and holistic care. The

benefits researched lied in improving the understanding of the disorder, avoiding the recidivism of the scars,

diminishing the frequency and duration of care, and in end improving patients’ quality of life. The paper will

not only narrate the building of a health innovation, on technological, clinical, user points of view, but will

also try to detail the evaluations planned at the different stages of development, as well as the challenges,

conditions and prerequisites allowing to produce concrete solution.

1 INTRODUCTION: THE

MEDICAL PROBLEM

The keloid scar is defined as a pathology of tissue

healing resulting from a proliferation of fibrous

tissues that extend beyond the limits of the initial

wound (Butler et al., 2008). This pathology, described

as “pseudo-cancerous”, does not put the patient's vital

prognosis into threat, but could constitute a severe

aesthetic disturbance in addition to inducing serious

functional problems, pain and itching, seriously

impacting the quality of life of the patients, especially

for scars on visible areas of the skin. Available

epidemiological data indicate an incidence that can be

very high (16%) in subjects with ethnic skin (Bayat et

al., 2003).

The management of this pathology by the sur-

geons is difficult and seems randomly addressed.

Indeed, different treatments are proposed, ranging

from the injection of corticosteroids, to cryotherapy

and the administration of anticancer molecules (Ud-

Din et al., 2013). At present, no treatment, or

combination of treatments, have been described as

effective. The main classical management remaining

intra keloid resection, it too often leads to a more

serious recurrence of keloid in 45 to 100% of cases

(Andrews et al., 2016).

The lack of standard and effective treatment is

mainly due to the poor understanding of the cellular

and tissue mechanisms involved in the appearance

and evolution of keloids. For many years homemade

compression techniques have been described in the

literature to prevent recurrence of keloids after

surgery. Especially the handiworks were dedicated to

the ear, area of frequent occurrence of this type of

Lihoreau, T., Chatelain, B., Rolin, G., Vidal, C., Butterlin, N., Jacquet, E., Elouneg, A., Chambert, J., Bertrand, X., Meyer, C. and Louvrier, A.

End-user Need based Creation of a Medical Device: An Experience of Co-design to Struggle Pathological Scars.

DOI: 10.5220/0009369403170322

In Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2020) - Volume 1: BIODEVICES, pages 317-322

ISBN: 978-989-758-398-8; ISSN: 2184-4305

317

pathology, often developed after piercing (Brent et

al., 1978, Vachiramon et al., 2004, Chang et al., 2005,

Yigit et al. Coll., 2009; Park and Chang, 2013;

Tanaydin et al., 2016). The effectiveness of these

means of compression relies on the reduction of the

post-surgical relapse of the earlobe keloid, observed

to a range of 10 to 30% (Vachiramon et al., 2004, Park

and Chang, 2013, Tanaydin et al. 2016).

Even if these works have been presented, there is

no current consensus or shared “gold standard”

practice for the treatment of the ear, particularly its

compression lobe. One of the causes being the lack of

solid clinical trials on the subject (Louis and Gracia,

2010). We proposed then a work assembling from the

beginning different experts around the development

of a quite unpretentious medical device, which

materialize in fact the center of complex

considerations.

2 THE ADVENTURE OF

EMERGENCE OF THE IDEA

In 2014, a surgeon from our university hospital,

contacted the clinical investigation research center for

a need related to his clinical practice, in fact the

medical problem announced in part 1 of this abstract.

His difficulty concerned then the reccurrences of

keloid scars on an important proportion of his

patients, which he yet treated consciensioulsy with

intralesional resection plus corticosteroids -

triamcinolone acetonide injection.

Meeting the research engineers, he explained his

needs in a system to add to the current care, relatively

to the litterature arguments in favor of a compression

of these specific tissues on one point, and to the

existing proposed solutions on another point.

At the beginning the deal seemed to be fairly

simple:

the possibility of adjustment of the pressure by the

patient himself (within a limit of the maximum

number of magnets imposed by the clinician) would

favorize the observance of the device and its comfort.

For the few existing studies on the subject, correlation

between keloid recurrence of the ear and discomfort

in wearing a device has been proved to be correlated

(Tanaydin et al, 2016), which may be related to poor

adherence to the application of pressure procedure.

Following works in collaborations with other

clinicians (to confort the shared property of the

expressed need), engineering and business local

schools (bibliographic, research & development,

clinical, and market analysis successive training

periods), as well as with engineering research center,

permitted to formalize a state of the art, and the first

drafts of the value analysis and specifications of the

innovation, in terms of ergonomy, adaptability, cost,

aesthetic...

The collaborations led then to the design of a

product as well as evaluations all along the

progression.

3 TECHNOLOGICAL

DEVELOPMENTS: THE “SCAR

WARS” PROJECT

Based on brainstorming and on the kind of “Santa

letter-writing” desires from the clinicians, but also

from the specific anatomical area, and from the

technical constraints, the prototypes were first

computer-aided designed (Figure 1 left) to format,

modelize the idea and project the skateholders into a

first view of the possible object.

From that, discussions led - beginning of 2015 -

to adaptations before an agreement on the general

shape and on primary dimensioning options.

The next step consisted in a 3D printing thanks to

stereolithography: few samples of different sizes

where produces, manipulated and confronted to the

ear lobes of healthy volunteers (from the

team…Figure 1 right).

It permitted to define then the size, but also to

determine the fact that our idea would need to be

constitued of a clip on which magnets could be easily

inserted. We had our proof of concept definition

prototype.

Figure 1: Digital and first physical version of the clip.

At the same time, bench lab tests on magnets

figured out their sizing - and in fact the possible

applied strengths.

A support associated with a dynamometer system

measured the forces in work with different magnets

and depending of the distance between.

According to the results, for a coherent lobe

thickness plus a pressure to be applied (from the

litterature) of 25 to 35 mmHg, we defined that we

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would need 2 to 8 neodymium-iron-bore magnets

with nickel coating magnets (1mm thickness,

diameter 12mm) to be placed on ear lobe.

We needed then to securize the product before

thinking of a first use in human. The contact with an

industry allowed to produce a mold from which the

first clips made with flexible medical grade silicone

were manufactured on February 2016 (Figure 2).

In terms of idea protection, an anteriority mark

tool was used in December 2016.

It was then the time to think about testing it on

targetted concerned patients with keloid scars.

Figure 2: The Scar Wars clip.

4 THE REAL LIFE TEST

4.1 Requirements

In order to provide a product that could be tested

during a clinical trial, the responsible manufacturer

need to follow regulatory requirements, centralized

by the european Medical Device Regulation MDR

2017/745 (repealing Council Directive 93/42/EEC).

Our ambition was to test a product which was not

yet CE marked. As a reminder, the CE mark is obtain

by a procedure in which notified bodies examine the

conformity of the product. On this particular situation

(without yet industrial part identified as a owner), our

hospital assumed the responsibility as a regulatory

manufacturer, for the clinical trial. Actually to obtain

the authority agreement to perform the clinical study,

we had to provide a file quite similar to the one that

would be presented for CE mark obtention.

Thus the team formalize a technical file, including

conception plans, laboratory tests, risk analysis,

essential requirements answers (list of all applicable

standards and the way we addressed it), user manual,

labelling and packaging.

This technical file (or “investigator brochure” on

a clinical trial language) aim to present the product

that will be tested and the security measures taken by

the manufacturer to ensure its safety use.

The medical device under study was then defined

as related to a Class I according to the requirements

of the EC Directive.

On another side, the clinical trial running (or

“design”) needed to be described in study documents,

the master ones being the study protocol, the

informed consent and case report forms. A specific

budget had also been searched and obtained to

finance the clinical project (hospital internal research

call).

4.2 Design of the Clinical Trial

The building of the study protocol was an important

phase of our project, and its writing needed to

mobilize all the partners. It helped to define the

objectives, the criteria of evaluations, the targetted

population (characteristics and number), the progress

in terms of duration… all this taking into account the

data already availables (in the litterature and thanks

to our previous advances), as well as the previous

realized tests and obtained results.

The main objective was defined as the evaluation

of the effectiveness and safety of the compressive

device; the main endpoint being then the reccurence

(yes/no) of the pathology. The study concerned 27

male and female patients (more than 18 years old)

presenting keloid lobe ear scars that needed to be

treated by reconstructive surgery; it excluded patients

with known allergy to nickel (even if the magnets are

not in direct contact, silicone clip making the

interface).

After usual management of the keloid scar of the

ear (reconstructive surgery and injection of

corticosteroids - triamcinolone acetonide), the

concerned patients had to wear the compressive

device and to adjust the compression with the

magnets provided. By consulting the literature, which

proposes that the patient wears his compression

device 8 to 24 hours a day (Louis and Garcia, 2010),

it was decided to recommend to the patient to apply a

compression allowing him to wear the device at least

12 hours a day, daily and throughout the duration of

study, ie one year. The compression must be

sufficient, without being painful. The clinician will

rely on these data, individually for each patient, to

dictate the maximum number of magnets to be used

based on the measured thickness of the patient's ear.

The clinician may reduce the frequency of use of

the device, or even stop it according to the evaluation

of the quality of healing during visits.

End-user Need based Creation of a Medical Device: An Experience of Co-design to Struggle Pathological Scars

319

The patients were planned to be seen at 3, 6 and 12

months after intervention, in the traditionnal course

of visits during the usual care (no modification due to

the trial).

The secondary objectives of the Scar Wars trial

focused on a multimodal and interdisciplinary

assessment of scar tissues by (Chambert et al., 2019):

- evaluation of patient acceptance and satisfaction,

evaluation by the surgeon (specific scars evaluation

scales, Draaijers et al., 2004, Deslauriers et al., 2009),

- biometric characterization of the area of interest,

- non-invasive imaging assessment of tissue

evolution,

- analysis of the bacterial flora present at the level of

the keloid scar,

- the creation of a keloid cell bank, basis of a

biological ancillar study allowing our biologists to

focus on pathological healing process and anti-

fibrotic drug evaluation.

4.3 Official Agreements

The “pilot study evaluating the effectiveness and

safety of a compressive device intended to prevent

recurrence of keloid scars after surgical resection” file

was submitted on February 2017 onto French

authorities, with a final positive agreement by ethical

committee and national agency for health products –

ANSM Agence nationale de sécurité du médicament

et des produits de santé – obtained in August 2017.

The trial was recorded on official web platform

ClinicalTrials.gov, and the first patient was included

in October 2017.

To date, 10 patients have been included, without

presenting a reccurence.

5 NEXT STEPS

The enrolment of the last patients and results of the

study will feed the CE mark file, which is then already

initiated.

Apart for the CE mark class I obtention, the next

important stage will be to build the business model

and development associated to an official regulatory

manufacturer that will handle the responsibilities and

assure the distribution.

Concerning the material, the perspectives could

lie on the development of different sizes of the clip

and magnets, in order to fit as much as possible to

different morphologies, or even other area on ear or

even face. 3D printing technologies offer also

prefigure tailor-made medical devices.

Functionalization with specific drugs or molecules

could be the future of such innovations.

In projection, next evaluations could focus for

sure on safety aspects once devices will be on the

market and largely diffused (material vigilance), and

on aggregation and reinforcement of clinical

evidences of the innovation. Medico-economics

studies will aim to test and possibly prove advantages

of the invention relatively to the current costs for

patients, hospital, society.

6 DISCUSSION

Based on our experience of ideation from a clinical

uncovered need, formalization of an innovation,

development and testing, we would like to share

interesting points that guided us and seems conditions

of success for bringing innovation in care and in

medical devices field, which guid by definition to

complex projects.

6.1 Guiding Principles

Team effort was a key in our pathway to a concrete

solution: clinic, clinical research, technology,

regulations, ethics, usability, market / business

strategy, intellectual protection, project

management… are skills hardly or not often grouped

in the context of an hospital, or of medical devices

field which is oftenly represented by small medium

enterprise.

Contacts need to be actively researched outside,

and realized with experts motivated to answer the

questions and develop the specific project with

anticipation and relevancy. Else the innovation risks

to encounter the “death valley” located between

research and real life.

Related to that, the time and money are important

to anticipate. As we speak about little team, we can

imagine the consequences of timelines like the ones

we presented here, onto the survival of the start-up if

not planned with a strong and realistic vision.

6.2 Some Tools?

Developing innovation in health is a field on which

theory and models exist. Well known scales such as

Technology Readiness Level (TRL, Scar Wars being

today at a TRL 6-7), declined in Market RL, Financial

RL… can provide accurate marks for emergence,

development, maturity.

We can also refer to more dedicated ones to health

such as CREPS cycle (Concept, Research,

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Evaluation, Product, Care, Moreau-Gaudry A et al.

2010), Innovation RL, health tech innovation cycles

(Center for Integration of Medicine and Innovative

Technology - CIMIT, Boston) that take into

consideration the dimensions of technology,

regulatories, market, clinics…

Projects have also been provided on the subject,

let’s cite for example the European Itech “Roadmap

for Research and Innovation in Health Technology”

(FP7-HEALTH-2013-INNOVATION-1, CSA-SA –

https://cordis.europa.eu/project/id/602667/fr), that

describe 5 phases from need to industrialization,

leading to 5 outcomes from proof of concept (POC)

to reimbursment and commercialization.

Figure 3: Scar Wars cycle of development.

The idea is to try using the scales/tools to define the

project roadmap from the beginning, to anticipate the

stages, duration, money needed, and to evaluate its

progress regularly.

We proposed on Figure 3 the cycle of

development of our innovation, with 7 steps from idea

to industrialization, evaluations indicated in red, and

perspectives in green.

7 CONCLUSION

The aim of the SCAR WARS project was to evaluate

the effectiveness and safety of an innovation in the

treatment of specific pathology on a targeted body

location.

The device is proposed in addition to the usual

care of patients seen at surgery departments, and will

provide, at the level of the lesion, a controlled

physical compression, reported in the literature as

being a determining factor for the reduction of the

volume of the scars and the rate of recurrence after

reconstructive surgery.

The conclusions of the work carried out during the

project will make it possible to lay solid foundations

for the valorization of the device. Above all, the

original and multimodal approach of evaluation could

help identify new areas of improvement in the

pathology management, and provide to the

community new scientific data for a better

understanding of these scars, and possible successes

or failures of proposed treatments.

This first study will quickly provide the patient

with an inexpensive device, with targeted properties

of aesthetic, comfort and adjustability by the patient

himself (within the limit of the maximum number of

magnets imposed by the clinician). Those

characteristics are hoped to be source of better

compliance and therefore efficiency. The expected

decrease in recidivism rates could result in a

reduction in public health costs for resumption of

resection, which could be evaluated with specific

methodologies late. Adaptation closer to the

morphology of the patient, or to other areas of the

body by 3D printing can then constitute a potential

opening of this project.

In terms of a more global approach and for an

ambitious project, we tried to enhance the key

important guidelines; general schedule of the

pathway of innovation could be resumed by:

-writing of the project and the general objective: state

of the art, context (points to improve), positioning,

with clinicians and experts in the field;

-describing the solution (s) to be developed, broken

down into several lots (technical, regulatory, tests

(pre- and clinical, pre- and post-market…), business

marketing, etc.), and players to be brought up at each

stage.

-formalizing a consortium accordingly: do we have

all the internal or external actors identified for the

different stages ?

-establishing the budget (and means of search and

obtention) accordingly.

One of the first deliverable of any project could be

this master roadmap document, adapted and

improved all along the life of the project.

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