Instructions for completing this form (Delete all instructions in red before submission):
The project description should be maximum six pages (Garamond 12pt for all free text and Garamond 10pt for all
information in tables) in either Swedish or English.
For Mac-users: To check tick-boxes in the table below, please highlight the box and then press spacebar/space key.
ELIGIBILITY AND CLASSIFICATION
Project partners:
Name all project partners.
Minimum 2 different sectors required.
☐ Academia
Name:
☐ Industry
Name:
☐ Healthcare
Name:
Technical Readiness Level (TRL) at project start
TRL definitions available in Appendix 1.
A minimum TRL level of 2 is required to be eligible
for this application.
Marketing activities will not be supported.
Technical Readiness Level (TRL) expected at
end of project
Requested funding from SWElife/VINNOVA
(SEK)
Co-financing level (SEK and %)
Minimum 50% required.
Focus Area
Please indicate what area is most representative for
the project.
1☐
2☐
3☐
4☐
5☐
6☐
7☐
8☐
9☐
1☐
2☐
3☐
4☐
5☐
6☐
7☐
8☐
9☐
SEK
SEK resulting in a co-financing of
%
☐ Imaging method
☐ Early diagnosis
☐ Prognosis
☐ Prediction
☐ Other……………………………………
PROJECT INFORMATION
Project title:
Coordinator
(organisation):
Project leader (person):
Specify date for project
start (151201 - 160301):
Specify date for project end
(maximum 2 years):
Maximum 100 characters (including spaces)
(YYYY-MM-DD)
(YYYY-MM-DD)
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PURPOSE AND RESULTS
Please specify:



Describe the purpose of the project including the impact for the patient and what challenge or difficulty the
final innovative solution will overcome
Describe the current status of your project proposal including the science behind the project idea, motivate
actions/results performed to reach the actual Technical Readiness Level (TRL) and other relevant
information. See attachment 1 for definitions of TRL levels.
Present expected deliverables at the end of the project
CUSTOMER NEED AND BENEFITS
The long-term goal is to make a solution available that benefits the patient, healthcare or society in general. The
project will thus be evaluated on its potential to become a real-world application i.e. to determine feasibility. Hence
please provide information on the following:



Who will use the solution and how will it benefit each individual? (Think about patients, healthcare
professionals and careers – explain the benefit for each relevant individual.)
What would be the benefits of your solution in general healthcare terms? (Think about cost efficiency,
reduced time in hospital, more effective treatment etc.)
How will this solution be implemented for the benefit of the patient?
COMMERCIAL POTENTIAL



Who might be interested in taking your verified idea through to the market and why would they be
prepared to invest money and time? (Think about private healthcare providers, industrial suppliers,
investors etc. and how they might benefit.)
To the best of your knowledge, define the size of your first target market for the final solution. (Think
about who would use or purchase the product or service and where it would be used.) Describe potential
competitors.
Describe your Intellectual Property (IP) strategy for your potential solution. (Do you have patents? Have
you applied for patents? If not, what is your strategy? Are there patents from others that hinder you? Do
you need licenses from others for your final product?)
NEXT STEPS AFTER PROJECT COMPLETION
After completion of the project, what do you see as the next step in the process (e.g. start a company, license out the
technology, sell the idea to someone else, continue product development with a partner or continue in research)?
What are the potential sources of new funding, what partners may need to be involved, what would be the roles of
current partners in the next step, etc.
PROJECT ORGANISATION AND MANAGEMENT




Give a brief description of the project leader including earlier experiences and competence relevant to succeed
in coordinating the project.
Describe how the project partners will add strength to the project
Give a brief description of the project team organisation (steering committee? internal and external
communication, project meetings, etc.)
Describe the working relationship and any previous collaboration between partners.
2


Please indicate if there are any competences or skills needed that would strengthen the project and if you have
any plans to include these during the project.
Please also present whether any of the partner(s) may contribute to the commercialisation of the concept, and if
so, how they will contribute.
PROJECT PARTNERS
Describe the different partners in the project. Briefly describe each party’s competence and role in the project in the
table below. If needed please add more lines.
Project partner
(organisation)
Competence of project partner
(for more details, refer to CV)
Role in the project
PROJECT PLAN
The project should define at least three work packages (WPs). For each WP please specify the project activities,
deliverables, the scope of the activities and decision point for the project leader to decide how to proceed with the
project as well as the contribution from each partner. The deliverables will be the basis for evaluation and should
reflect the progress of the project as a whole. Several activities may be run in parallel.
One WP must address business development (for example business strategies, bench-marking analysis,
reimbursement etc.). If needed you may add more WPs
Work
package
(Title)
WP1
Ex Business
development
WP2
Time
(start and
end)
Detailed description
Activities:
Ex.
1) Regulatory requirements – Find out the demands for CE marketing for
product
2) Market analysis – verify the market including competitors
Deliverables (quantifiable where possible):
Ex.
1) Report classification and relevant guidelines
2) Report of market analysis
Decision point (STOP/GO):
Ex.
Window in market verified for potential product.
Participating partners and their respective contribution:
Ex.
1) Partner A via their regulatory experts
2) Consultant – responsible for contact project leader
Activities including and the scope of the activity:
Ex.
3
Ex. Technical
verification of
diagnostic product
1) Measure human samples on first prototype of product – confirm
research data on a larger number of samples
2) Documentation - write instructions for use of product – to be tested by
other technical personnel
Deliverable (quantifiable where possible):
Ex.
1) 80 % of the samples shall be positive for the diagnostic biomarker
2) A final instruction for handling the product to be used by several
technical personnel with same results
Decision point (STOP/GO):
Ex.
Target % of positive samples reached.
Participating partners and their respective contribution:
Ex.
1) Partner A
2) Partner B
Activities including the scope of the activity:
WP3
Deliverable (quantifiable where possible):
Decision point (STOP/GO):
Participating partners and their respective contribution:
WP4
Activities including the scope of the activity
Deliverable (quantifiable where possible):
Decision point (STOP/GO):
Participating partners and their respective contribution:
WP5
Activities including the scope of the activity:
Deliverable (quantifiable where possible):
Decision point (STOP/GO):
Participating partners and their respective contribution:
RISK ANALYSIS
Describe the major risks in the project. Please consider the following areas


Business/market (market need cannot be verified, new competitive landscape, customer limitations, etc.)
Technical (research not mature, uniqueness cannot be verified, etc.)
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

Legal/Regulatory (IPR, dependencies, need for standardisation, etc.)
Project execution (lack of necessary competences, need for further financial investments, etc.)
Likelihood and Consequence will be ranked on a scale 1-5 (1=none, 2= small, 3=intermediate, 4= high, 5=very
high)
Risk
Likelihood
Consequence Action to manage/mitigate risk
BUDGET
The budget is divided into two steps
Step 1. Use the table below and specify the costs of each work package.
Step 2. On VINNOVA’S portal, fill in, for each project part: the costs per year and how much that will be cofinanced. Include also the project partners that do not apply for money from VINNOVA: The value of the cofinancing will be in SEK but may well be in-kind resources in practice.
BUDGET FOR EACH WORK PACKAGE
Cost (SEK)
Salary
Equipment,
land, buildings
IPR, cost for
consultant etc.
Other direct
costs incl.
travel costs
Indirect cost,
incl. overhead
Sum (SEK)
Cost (SEK)
Total sum (SEK)
WP1
WP2
WP3
WP4
WP5
If relevant
If relevant
Salary
Estimated hours
(in total)
Equipment
Material
Other
IPR
Consultant
Other
Services
Travel costs
Other direct
costs
Indirect cost,
incl. overhead
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Appendix 1.
Please use the following definitions to indicate TRL level reached during the project. Please delete this table before
submission.
Technological Readiness Level (TRL) Definitions
TRL
General
description of
TRL
Basic principles
and research
data observed
and reported
Pharmaceuticals
Med Tech including diagnostics
e-Health
(research based)
e-Health
(concept based)
Scientific research findings are
reviewed and assessed, and beginning
of translation into applied research.
Potential targets and disease
mechanisms evaluated. Focus is still
on discovery.
Scientific research findings are
reviewed and assessed, and
beginning of translation into
applied research and new
technologies.
TRL2
Technology
concept and/or
practical
application
formulated
Hypothesis, research ideas, protocols
and experimental designs are
developed. Potential therapeutic
targets for intervention are identified.
TRL3
Analytical and
experimental
Proof of
Concept of
critical function
and /or
characteristics
Active R&D initiated. Hypothesis
testing and target identification and
potential candidates characterization,
data collection, exploration of
alternative approaches and early proof
of concept in a limited number of in
vitro & in vivo models.
Hypothesis, research ideas,
protocols and experimental designs
are developed. The potential ability
of particular technologies,
materials, and processes to address
certain health problems identified.
Active R&D initiated. Hypothesis
testing, data collection,
identification and evaluation of
critical technologies and
components and early proof of
concept in laboratory models
including in vivo studies.
Scientific research begins
to be translated into
applied R&D activities.
Concepts evaluated that
can be implemented in
development of e/mtechnology (software,
sensors, devices,
infrastructure or process).
Invention of potentially
practical e/m-technology
solutions addressing
particular needs.
Observed need for either
improved treatment
procedure (process
efficiency) or novel
solution where e/mtechnology (software,
sensors, devices,
infrastructure or process)
can be advantageous.
Invention of potentially
practical e/m-technology
or novel setup of existing
technology solutions
addressing particular
needs.
Active development
initiated. Studies to
validate predictions of
separate e/m-technology
components of the
concept that satisfy a
need. System application
tested in laboratory
environment
TRL4
Validation of
the technology
in the laboratory
TRL5
Validation of
technology in a
relevant
environment
TRL6
Demonstration
of technology in
relevant
environment
Preclinical R&D. Optimization of
candidates and in vivo demonstration
of activity and efficacy. Identification
and integration of critical technologies
(animal models, biomarkers, assays,
etc.) in continued characterization of
and development of potential
candidates. Initiation of GMP process
development and manufacturing of
non-GMP material and drug
formulations. Evaluation of safety,
pharmacodynamics and
pharmacokinetic properties.
Formulation of a Target Product
Profile initiated.
Further characterization of candidate,
i.e. absorption, distribution,
metabolism and elimination. A
manufacturing process established
amenable to large scale GMP
manufacturing and consistent with the
intended use of the drug.
Development of in process controls
and relevant analytical assays.
Continued development of animal
models for efficacy and dose-ranging
studies. Selection of candidate drug.
GLP safety studies for IND
submission and Phase 1
Clinical development. GMP
production, IND submission and
Phase I clinical evaluation performed
proceeding to Phase II. Appropriate
safety evaluations conducted to
support further development
TRL1
Preclinical R&D. Laboratory
testing of critical components and
processes. Proof of concept of
device demonstrated in relevant
laboratory and animal models.
Active R&D initiated.
Analytical studies to
validate predictions of s
e/m-technology
components of the
technology that satisfy a
need – forming the system
application. System
application tested in
laboratory environment
System components
integrated and tested
regarding preliminary
efficiency and reliability.
Software architecture and
other system components
development to address
reliability, scalability,
operability, security etc.
Other system components
development
System components
integrated and tested
preliminary efficiency
and reliability. Software
architecture, and other
system components
development to address
reliability, scalability,
operability, security etc.
Further development of device
candidates and system solutions.
Validation of system components
and processes in relevant
laboratory environment.
Classification of device by
appropriate regulatory body and
when appropriate an
Investigational Device Exemption
(IDE) prepared and submitted for
review.
System component
architecture established.
System tested in relevant
testing environment as
expected in the
operational environment.
Verification, validation
and accreditation when
appropriate initiated.
System component
architecture established.
System tested in relevant
testing environment as
expected in the
operational environment.
Verification, validation
and accreditation when
appropriate initiated.
System/device prototype
demonstrated in an operational
environment. Clinical testing to
demonstrate safety may be
required. Depending on the
classification of the device
Representative model or
prototype system
demonstrated in relevant
live or simulated
environment. System
component releases are
“beta” versions and
Representative model or
prototype system
demonstrated in relevant
live or simulated
environment. System
component releases are
“beta” versions and
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TRL7
Technology
prototype
demonstrated in
an operational
environment
Phase II clinical study is completed.
Manufacturing process scale-up and
process validation initiated and
stability testing ongoing. Continued
safety studies to support further
clinical testing. The TPP refined when
necessary. Phase III clinical plans
defined and approved by regulatory
authorities.
TRL8
Technology
system
completed and
qualified
through test and
demonstration
Manufacturing processes validated.
Pivotal clinical Phase III testing and
safety studies completed. NDA or
BLA prepared and submitted. And
approved by appropriate regulatory
authorities.
TRL9
Technology
system in its
final form ready
for full
(commercial)
deployment in
relevant
operating
environment
Product launched.
Post-marketing studies (Phase IV) and
surveillance
Premarket approval or Premarket
notification (510(K)) apply.
configuration controlled.
Support structure in
development and
verification and validation
and when needed
accreditation for safety
reasons in progress.
Clinical safety and effectiveness
trials conducted using a fully
integrated prototype version of the
medical device in an operational
environment. Data evaluated to
support further development The
final product design validated and
final prototype and/or device
intended for commercial use
produced and tested.
Premarket application or premarket
notification submitted and
approved
System tested in an
operational environment.
Support structure in place
and System component
releases in distinct
versions. Verification,
validation and when
appropriate accreditation
completed.
configuration controlled.
Support structure in
development and
verification and
validation and when
needed accreditation for
safety reasons in
progress.
System tested in an
operational environment.
Support structure in
place and System
component releases in
distinct versions.
Verification, validation
and when appropriate
accreditation completed.
Development completed.
System demonstrates to
work under real life
conditions. Testing of
design specifications.
System component
releases are production
versions. Support
structure in place to
resolve technical issues.
Development completed.
System demonstrate to
work under real life
conditions. Testing of
design specifications.
System component
releases are production
versions. Support
structure in place to
resolve technical issues.
Product launched.
Post-marketing studies and
surveillance
Product launched.
Product launched.
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