Organizing Medtech Innovation with Concept Maturity Levels

Mathias Béjean

and Eliziane Siqueira

Institut de Recherche en Gestion (EA 2354), Université Paris Est, Place de la Porte des Champs, 94000, Créteil, France

MS Innovation by Design, ENSCI Les Ateliers, 48 rue Saint Sabin, 75011, Paris, France

Keywords: Medical Devices, Medtech, Innovation, Concept Maturity Levels.

Abstract: This paper presents an integrative approach to the maturation of concepts in the field of Medtech Innovation

by using Concept Maturity Levels (CMLs). CMLs have been introduced by JPL (NASA-Caltech) during the

last decade to cope with the early phases of space mission concept development. Extending well-known TRLs,

their strength is to evolve an innovative concept guided by an incremental set of assessment needs. The article

draws on an on-going research led in France where CMLs are being tested as a methodology for structuring

Medtech Innovation complexity. Exploratory results provide an emerging framework showing what could be

CMLs for Medtech Innovation. They also provide insights of why and how they could be implemented as a

solid basis to stimulate more formative and adaptive design and evaluation methods.

1 INTRODUCTION

The Medtech sector is a highly diversified and

complex one. According to MedTech Europe (2016),

it includes more than 500,000 medical technologies

ranging from familiar, everyday products such as

blood glucose meters, sticking plasters, syringes or

latex gloves, to high-tech medical technologies

including molecular diagnostics, total body scanners,

ultrasounds, life-supporting machines, implantable

devices (i.e. heart valves pacemakers),

neurostimulators and replacement joints for knees

and hips. Likewise, the industry structure brings into

play various economic actors ranging from small and

medium-sized companies to big technological firms

and high ranking research laboratories.

Another important characteristic of the medical

devices market is its dynamic nature. In average, a

medical device product has a life cycle ranging from

18 to 24 months, which forces companies to invest

constantly in research and development. This leads to

an increase in the relevance of development upstream

phases, where many Medtech experts try to anticipate

the different risks emerging from the complexity they

face. However, medical devices projects often fail or

result in products with no market-fit, for not having

sufficiently integrated the perceptions and insights of

end-users early enough (Habib et al., 2017).

https://orcid.org/0000-0001-6818-3008

Despite their strategic importance, the upstream

phases of medical devices development are still

insufficiently understood and documented. Available

approaches for exploration and evaluation often tend

to offer a sole snapshot of the product at the end of its

development cycle, neglecting the activities required

to incorporate the habits and needs of end users,

especially the patients. These facts and the complex

context mentioned above call for new approaches

which do not only evaluate the quality of a new

medical device and its market fit, but also clarify the

path to transform a promising idea into a solution that

is financially viable and easily adopted by patients

and their healthcare ecosystem.

This paper aims to fill this gap by studying an

integrative approach using “Concept Maturity

Levels” (CMLs) (Ziemer et al., 2013). CMLs are a

new metric inspired by Technology Readiness Levels

(TRLs) developed by NASA in the 80s. Allowing the

evaluation of knowledge robustness for a given

technology at a given moment, TRLs have become a

world-wide tool for project organization and

communication. CMLs extend TRLs by both adding

divergent phases to TRLs convergent orientation and

integrating needs (value proposition, end-users…) as

well as organizational aspects (costs, organization…)

to the technological ones.

To do so, the paper draws on an on-going research

led in the French context, where CMLs are being

Béjean, M. and Siqueira, E.

Organizing Medtech Innovation with Concept Maturity Levels.

DOI: 10.5220/0007697006210626

In Proceedings of the 12th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2019), pages 621-626

ISBN: 978-989-758-353-7

621

introduced to cope with Medtech innovation

complexity. After having provided the theoretical

background of the research, the article presents the

research context and methods used. Exploratory

results are then presented, leading to discuss the

opportunities and potential risks of implementing

CMLs for Medtech Innovation.

2 THEORETICAL

BACKGROUND

This section provides basic elements on the literature

on concept maturation activities in both management

and engineering sciences.

2.1 Innovation and concept maturation

In the field of innovation management, the streams of

“radical innovation” (O’Connor, 2008), “open

innovation” and “collaborative innovation”

(Chesbrough, 2003) have paid attention to the new

organizational forms of innovation, their strategies,

their processes, their business models. An important

aspect of recent literature concerns the more

“upstream” phases of exploration, including the

maturation and formulation of innovative concepts

(Markovitch et al., 2017).

During these maturation activities, it no longer

consists of evaluating and selecting ideas, as

advocated by “new product development” inspired by

project management (Cooper, 1994), but also of

structuring complete management systems intended

to “mature” concepts and the organizations which

sustain them to transform the starting intention into a

value proposition implemented into a new ecosystem

of uses (Hooge et al., 2016).

In this context, the strategic challenges are that of

formalization and instrumentation of new “upstream”

processes which are more agile and participative,

integrating a wide range of stakeholders, both internal

and external, including the end-users. Contemporary

approaches therefore call for novel approaches to

evolve and enrich innovative concepts throughout

their design process; CMLs are one of these.

2.2 Concept Maturity Levels (CMLs)

CMLs are a special metric developed by the JPL

Innovation Foundry (Caltech/NASA) for dealing

with the most early formulation phases of space

mission concept development. They are inspired by

Technology Readiness Levels (TRLs) already

developed by NASA in the 80’s. Allowing the

evaluation of knowledge robustness for a given

technology at a given moment, TRLs have become a

world-wide tool for project organization and

communication. CMLs aim at extending TRLs by

adding a divergent phase to their convergent

orientation and adding two more “drivers” to

technological maturity: the maturity of needs

understanding (value proposition, end-users…) and

the organizational maturity (costs, organization…).

Conceived as a generic language, CMLs aim to

assess a concept’s maturity making it possible to

select and prioritize the ones to support. JPL has

defined 8 different CMLs:

- CML 1: Cocktail Napkin

- CML2: Initial feasibility

- CML3: Area of application (Trade space)

- CML4: Design components (Point Design)

- CML5: Reference concept

- CML6: Integrated concept

- CML7:Preliminary referential implementation

- CML8: Integrated referential

3 RESEARCH CONTEXT AND

METHODS

3.1 Research Context

3.1.1 Context

This study emerged in the context of a partnership

between the French Forum of Living Labs in Health

& Autonomy (LLSA) and the INSERM CIC-IT

Network. Forum LLSA is a non-profit organization

which federates a community of over 30 Living Labs

and about 20 other members interested – and

generally involved – in codesign and living lab

approaches. CIC-IT Network brings together

Research Centers specialized in clinical research for

MedTech projects, providing support in clinical

protocols design, regulatory constraints and solution

assessment to project manager and enterprises.

The diversity of LLSA and CIC-IT members

reflects the one of the health ecosystem:

professionals, researchers, patients, manufacturers.

Recently, they formed a working group, named

“EVAL”. These members were both practitioners and

academics involved in use and/or clinical evaluation

before, during and after the design process of a

medical device. In February 2018, the group EVAL

decided to launch an intervention research based on

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the idea of implementing CMLs in the Medtech

sector. A research project team was set.

3.1.2 Case Selection

Regarding the case selection, the research goals were

to deepen the understanding of co-creation,

evaluation and project management best practices

applied in the lifespan of a concept maturation

process. Three criteria were established: organization

maturity, case maturity and trust relationships with

potential interviewees:

- Organizational Maturity: it was decided to

investigate cases managed by Living Labs and

CIC-IT with a well-established practice in the co-

creation and evaluation of medical devices. This

choice was based upon two rationales: the need to

clarify current design and management practices

and, as previously mentioned, to serve as a

stepping stone for the construction of a

methodology of evaluation.

- Project Maturity: it was agreed to study projects

that were further advanced in the development

cycle, i.e. that had already passed or were near to

pass regulatory certification (CE marking in these

cases). This characteristic would allow the study

to be based upon longitudinal cases, with rich

steps of development cycle and potentially a wide

range of relevant tools and best practices.

- Trust Relationships: more active members

regularly take part in the working group sessions.

As a consequence the suggested case studies were

those under direct or indirect responsibility of

those members. A potentially positive

consequence of this fact is that the trust

relationship between the Forum and the chosen

structures could allow the informants to feel more

at ease during interviews, possibly sharing project

pain points that would not otherwise been

communicated.

Considering these three criteria, five projects were

selected: Hemogyn 2 (CIC-IT, Grenoble), Motio

(Kyomed, Montpelier), Careware (Infoautonomie,

Nancy), Connected Glass (Evalab, Lille) and Modu-

Lab (CHL, Castres).

3.2 Data Collection

3.2.1 Selecting Informant’s Profile

Following guidelines suggested by Eisenhardt

(2007), the research team opted for interviewing

multiple informants for each case, preferably from

different organizations and having different roles in

the case. This approach limits biases, since the same

situation is described from different perspectives.

According to each project ecosystem, a list of

interviews was set to include the project manager, the

organization responsible, the operational team and

partners of development.

For each project, the responsible organization had

to contact participants of the project and arranged an

interview. Strategy during the interview was to assign

all investigators with slightly different roles.

According to Eisenhardt (1989), this allows the case

to be interpreted from different, sometimes divergent

perspectives, which has the potential to enhance

richness of the study. The lack of representation of the

voice of patients could consist in a source of

weakness of this research, and should be accounted

for in similar future studies.

3.2.2 Exploratory Phase

This paper presents an on-going research. At this

stage, it only concerns the exploratory phase of the

research, consisting of 17 interviews carried out

between June and July 2018, lasting from 30 min to

more than 2hours.

All interviews, except for two, followed a semi-

directive protocol. During the interview, a member of

the research team would introduce the purpose and

the process of the study, as well as the general goal of

the interview. During the interview, all of the

investigators would ask questions; however, the lead

of the interview was taken by the scientific

responsible of the study. The two other investigators

would take notes according to their own perspectives

of the case.

After obtaining consent, all the interviews were

registered by using a voice recorder.

3.3 Data Analysis

The first round of data analysis consisted of the

following steps: Interviews summary, Interviews

transcriptions, Defining CML criteria, Coding

interviews according to criteria:

- Interviews Summary: we consolidated our

impressions and notes in form of an interview

summary, produced shortly after the field study.

The aim was to serve as a quick reference to the

team, offering a way of recovering essential

information quickly, which proves to be useful in

studies composed of large amounts of interviews.

- Interviews Transcriptions: all interviews were

entirely transcribed, following sound recordings

by using the software o-transcribe.

Organizing Medtech Innovation with Concept Maturity Levels

623

- Confronting Field Data to CMLs: three

representative interviews were confronted, in

extenso, to the CML framework.

During data analysis, the main findings were

organized to elaborate a generic model that defines

the maturity of an innovative concept in the sector of

medical devices, as well as a generic process to

transform an initial concept idea into a functional

proven concept. In the following we refer to this

emerging framework as the “CML-FS framework”

(FS for “Forum Santé”). As already mentioned, this

is an on-going research and further research is needed

to strengthen and enrich this model. The next section

presents the CML-FS framework.

4 RESULTS

4.1 The CML-FS Framework

At this stage, the CML-FS framework defines 6

progressive levels, which describe the increasing

maturity of a healthcare concept:

- CML1-Framing the Idea: this includes the

understanding of social and health care

background to contextualize and prove solution’s

relevance. Building project team is another key

step in CML 1.

- CML2-Understanding Usage Requirements:

this includes that rapid prototyping and financing

plan have been identified as the main validation

steps in CML 2.

- CML3-Shaping the Design: this maturity level

requires listing the platform concept, regulatory

affairs and definition of usage scenarios as

essential milestones to give shape to the chosen

concept design.

- CML4-Fine-tuning the Design: this maturity

level must achieve pre-clinical trials and help

building clinical trials as well as use test

protocols.

- CML5-Clinical Trials, use Tests and

Certification: this maturity level consists of

preparing and executing clinical trials, if

applicable, as well as leading user tests.

Certification is the last critical step to this level.

- CML6-Planning Implementation: this maturity

level is achieved after completing activities

needed to consolidate product and commercial

specification to the industrial development of the

solution.

The division into six maturity levels is not arbitrary.

The findings allowed for grouping activities

according to chronologic order of main milestones

revealed during the interviews. We found six to be the

minimal number of activities chunks to be

represented in order to mature a concept. Every CML

phase could be further divided, resulting in more

levels. Further research will serve to validate the

model and its levels or to modify it if needed.

4.2 Towards a New Design Process

Figure 1 depicts the design process model

corresponding to the progressive nature of CML-FS

framework. It provides structure in the form of a

“diamond” including milestones and corresponding

activities per level, enabling the definition of a

concept development roadmap.

The diamond background (fading grey shape)

illustrates the diverging and converging moments in

the framework: levels 1 to 3 consists in the divergent

phase aiming at exploring the field, opening up the

perceptions about the chosen healthcare problem, and

allowing for problem reframing, if necessary.

At the end of CML 3, however, design iterations

end once few preferred design solutions are chosen.

Starting a convergent phase, the preferred solutions

are further matured and tested with users in CML 4.

Figure 1: The evolution of an innovative healthcare concept

over time.

It is relevant to notice the role of design iterations

between CML 2 and 3. This iterative process is

inherent to the divergent phase of design. According

to our interviewees, it is an essential step to identify

the problem at stake and discover which ideas are the

most relevant to figure it out. In practical terms, it

allows ideas to be developed and tested a number of

times, with weak ideas dropped along the way. The

result, at last, is one concept that has been evaluated

and refined several times before its launch, by a wide

range of stakeholders.

4.3 Opportunities and Potential Risks

Interesting information shown by the CML-FS

framework is the level of financing requested before

entering each CML phase. As per the studied projects,

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the largest amounts of financing are needed in the

transition between CMLs 4 and 5 in order to execute

clinical trials, use tests and apply for product

certification. Likewise, our research suggests that

research work needed to go from CML1 to 3 is still

lacking, at least in the French context. Using CMLs

might be a way to better analyze and structure these

early financing phases.

However, the CML-FS design model is merely

illustrative, aiming at warning project owners to

account for such expenses beforehand. A quantitative

estimation of financial needs is not in the scope of the

current exploratory research, given the broad

spectrum of products that could make use of this

framework. Each one of these products, according to

certification classification, would present

considerable variations in development budget and

financing needs, one of the current perceived risks

being to overlook this diversity of products and

situations.

5 CONCLUSIONS

Our exploratory research thus suggests that CMLs

could provide an integrative approach to the upstream

co-design difficulties, by opening new ways of

combining real-life data with results of clinical

investigations, or even exploring complex

polymorphic therapeutic solutions at different levels

of maturity. One of the main interest could for

instance be avoiding the so-called “techno push”

phenomenon, as applicable to the spatial domain and

the Medtech sector.

Furthermore, health projects are highly supported

by public funds. At the end, they deliver products and

services which are subsidized to a large extent.

Therefore, evaluation of these projects concerns not

only project manager, stakeholders involved but also

public authorities and policy makers.

The interest of using the CML approach will be

enforced by adding to the process description some

indicators that are likely to be available at an early

stage rather than requiring evidence of final impact.

This could enable the “clock speed” of the evaluation

cycle to increase, bringing it more in line with the

policy cycle.

As quoted in (Warwick and Nolan, 2014): “The

developmental evaluation approach [...] is

particularly well matched to the modern conception

of industrial policy where policy makers engage in an

iterative process of dialogue with business and others,

and there is a combination of top-down and bottom-

up approaches. Experimental methods are

increasingly being used in the evaluation of some

facets of industry and innovation policies, but there is

potential to do more.”

The use of experimentation and the iterative

approaches of developmental evaluation fit well not

only with the CML approach, but also with the notion

of a “smarter state”, which seeks to learn from the

market and the discovery process of entrepreneurs in

selecting appropriate targets for public policy.

ACKNOWLEDGEMENTS

Authors thank all the interviewed experts from

Hemogyn 2 (CIC-IT, Grenoble), Motio (Kyomed,

Montpelier), Careware (Infoautonomie, Nancy),

Connected Glass (Evalab, Lille) and Modu-Lab

(CHL, Castres). Special thanks also to the Forum

LLSA, the CIC Network and Altran Research

Department which all made this research possible.

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