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Page 1 Version 6 October 30th, 2012
Holland High Tech Healthcare 2013 Roadmap
Contents Scope ................................................................................................................................................. 2
Authors ............................................................................................................................................... 2
1. Societal and economic relevance ................................................................................................ 3
Connection with the key societal theme Health ........................................................................................ 3
World-wide market size for this roadmap, now and in 10 years .................................................................. 3
Competitive position (in market and know-how) of the Dutch ecosystem .................................................... 3
2. Applications and technology challenges ....................................................................................... 4
1 Diagnostics ....................................................................................................................................... 4
1.1 Medical Imaging/signal processing .......................................................................................... 4
1.2 Patient-specific modeling ........................................................................................................... 5
1.3 New Modalities for diagnostics .................................................................................................... 6
2 Interventions and therapy .................................................................................................................. 6
2.1 Minimal Invasive Techniques ...................................................................................................... 6
2.2 Image-guided intervention and treatment (IGIT) and intervention labs ............................................ 7
2.3 Nuclear medicine ...................................................................................................................... 7
2.4 Radiotherapy ............................................................................................................................ 8
2.5 Rehabilitation techniques ........................................................................................................... 8
2.6 Neurostimulation ....................................................................................................................... 8
3 Home and community care (0-line and 1st-line) ..................................................................................... 9
3.1 Wellness of citizens ................................................................................................................... 9
3.2 Home and nomadic monitoring, alarm, management ..................................................................... 9
3.3 Diagnostic systems at community healthcare (1st-line) support ......................................................10
4 Enabling technologies .......................................................................................................................10
4.1 Micro- and nanotechnology ........................................................................................................10
4.2 ICT .........................................................................................................................................12
4.3 Ease of use, user experience and beyond ....................................................................................13
4.4 Cooperative systems ................................................................................................................14
4.5 Mechatronics and Robotics ........................................................................................................14
4.6 Biomaterials ............................................................................................................................15
4.7 Photonics ................................................................................................................................15
3. Priorities and implementation ....................................................................................................17
Selected priority areas for execution of this roadmap ...............................................................................17
(a) Diagnostic and interventional data acquisition and therapy (CMI-NEN, MDII, NIMIT, Quantivision, IDII, Neurocontrol) ........................................................................................................................17
(a1) High Definition Medical Imaging (from 1.1 and 1.3) ..................................................................17
(a2) Minimal Invasive Techniques (from 2.1) ...................................................................................17
(a3) Image Guided Intervention and Therapy (from 2.2) ..................................................................18
(a4) Integrated interventional lab (from 2.2 and 1.3) ......................................................................18
(a5) Diagnostic instrumentation with photonic technologies (from 1, 2.2 and 3.3) ..............................18
(b) Patient modelling & phenotyping (NeuroControl, MDII, IDII, Quantivision) (from 1.2) .....................18
(c) Nuclear medicine (from 2.3) .....................................................................................................19
(d) Home care (CCTR, SPRINT, NeuroControl, ICT for brain, body & behaviour) (from 3) ......................19
(e) Medical networks/Healthcare IT/Clinical decision support (MDII, IDII) (from 4.2, 3 and 1.2) ...........19
Page 2 Version 6 October 30th, 2012
(e1) Trusted medical networks for data sharing and remote care .........................................................19
(e2) Healthcare IT solutions for clinical decision support .....................................................................20
(f) Personalized medicine (from 4.1 & longterm 2) .........................................................................20
(g) Robotics for rehabilitation and other healthcare applications (from 4.4 and 2.4) ............................20
(h) Biomaterials (from 4.6) ...........................................................................................................20
(i) Healthcare handheld diagnostic device of the future (from 1.3 and 4.3).........................................20
Proposed implementation in public-private partnerships ...........................................................................21
Transition of connected program institutes (e.g., M2i, ESI) .......................................................................21
SME activities .....................................................................................................................................21
Linkage with other innovation instruments (e.g., innovation funds, innovative purchasing) ...........................21
3.1 TKI program .................................................................................................................................22
Committed and expected R&D activities contributing to the TKI program ...................................................22
Implementation of TKI grants, connection with other roadmaps ................................................................22
3.2 Alignment with European programs and policy instruments .................................................................23
3.3 Implementation in European and multi-national programs ............................................................23
4 Partners and process ........................................................................................................................25
Engaged partners from industry, science, and public authorities ................................................................25
5. Investments ............................................................................................................................26
Scope
This High-Tech systems & materials [HTSM] Healthcare innovation contract comprises of
healthcare systems, equipment, instrumentation and (technical) models. It focuses on
the industrial and technological innovation of Healthcare in the areas of home care,
diagnostics and interventions and therapy. In the Netherlands, a number of world
renowned key technological strengths exist in the healthcare domain. These strengths, in
HTSM related to nanoelectronics, embedded systems and mechatronics as well as
photonics serve as foundation for this contract.
Effective and efficient new technologies can only be developed and implemented in close
collaboration with medical professionals, and tested in a clinical environment. Therefore,
the roadmap of HTSM/Health is complimentary to the roadmap of the Topsector Life
Science & Health.
Authors
For the original 2012 version, we have received a large number of contributions via an
own email address ([email protected]) from many people across
academia, institutes and industry (including SME contributions):
Hans Reiber, Peter Luijten, Arjen Brinkman, Wiro Niessen, Jenny Dankelman, Johannes
de Boer, Bart Verkerke, Vinod Subramaniam, Max Viergever, Marcel van Herk, Ton van
der Steen, Jan-Leen Kloosterman, Jos Huisken, Freek Beekman, Bob Goedhart,
Bergmans, Henk Leeuwis, Michiel Jannink, John Lapre, Frans Beenker, Rene Collier,
Fokko Wieringa, Nicole Papen, Myra Kilitziraki, Miriam Verhees, Willem Nerkens, Peter
Martens, Ton van der Weelden, Lucas Nolden, Huub Rutten, Arjen van Rhijn, Rogier
Receveur, Eline van Beest, Jan-Marc Verlinden, Nico van Meeteren, Maurits van der
Heiden, Anton Duisterwinkel, Hans Hofstraat, Frank van der Linden, Lodewijk Bos, Petra
van den Elsen, Alex Koers, Mark van Rijnveld, Ronny van ‟t Oever, Casper Garos, Frans
van der Helm, Egbert-Jan Sol and Peter de With.
For this 2013 version, some updates have been included. All input has been processed
and edited by the HTSM healthcare editing team: Casper Garos, Frans van der Helm,
Egbert-Jan Sol and Peter de With.
Page 3 Version 6 October 30th, 2012
1. Societal and economic relevance Connection with the key societal theme Health We face tremendous societal challenges due to an aging population, more chronic
diseases, and a rapidly rising shortage in staff. In 2040 4.3 million people will be older
than 65 against 2.5 million today, resulting in more cancer treatments, hearing aids,
Alzheimer, etc. Consequently, in 2025 an additional 470,000 health professionals are
needed (+40%). The already high costs of healthcare, will increase every year by 6% (in
2010 88 B€ was spent on healthcare).1 To reduce healthcare costs in the Netherlands,
national policy2 stipulates to specialize and concentrate hospitals (2nd line care), to
decentralize and intensify extramural centers (1st line care), and to promote individual
self-management. From an economic point of view, the concentration trend enables the
more widespread use of highly advanced and more efficient medical equipment.
Decentralization at the 1st line and support for individuals is made possible through
technological enabled solutions suited for those markets.
The goal of the HTSM partners is to bring new applications to the health market to cope
with our healthcare challenges. Focusing on the consumer/patient, technologies will be
developed for use in the hospital, extramural centers and at home to prevent, screen,
diagnose, treat and monitor diseases as well as rehabilitate or cope with disabilities.
Preferably with improved user comfort and enhanced treatment effectiveness.
World-wide market size for this roadmap, now and in 10 years In the medical imaging equipment, global spending exceeded $21 billion in 2010. It is
expected to grow to $26.6 billion by 2016 (at a CAGR of 4.2%). Including services
provided to hospitals or other care centers, which normally are part of consolidated
market figures, the 2010 global spending figure increases from $21 billion to $28 billion.
In 2010, X-ray constituted the largest share of market with around 34%, followed by
Ultrasound with 21%, CT with 19.5%, MRI with 18.5%, and Nuclear Medicine with 7%.
The United States represents the largest market with around 37% of the global market,
followed by Europe with 27%, and Asia with 27% as well3. Some segments of the
medical imaging market show a much higher annual growth rate than the average, e.g.
the interventional imaging market grows by 8% p.a.
The total market for healthcare IT professional services market in Europe was valued at
$1.68 billion in 2011, a growth of 3% compared to 2010. The growth in IT services is
estimated to lead the market value to $1.86 billion in 2016. Healthcare IT is linked to
information and workflow management, but also to e.g. clinical decision support as well
as home health applications. Certain areas enjoy high growth figures. E.g. image-based
software applications that support intervention processes (3D/4D image processing and
visualization software) has a CAGR of 14% from 2004-20144.
The home healthcare market is still small today, but expected to grow significantly.
Precise market figures are not available today.
Competitive position (in market and know-how) of the Dutch ecosystem In the market described above, the Dutch industry has a global strength, while for all
application areas the combined knowledge base of players in the HTSM ecosystem is of
world class. Areas with anticipated high growth are related to advances in more
comprehensive diagnostics, more precise and less invasive image-guided intervention
and treatment, personalized medicine, healthcare informatics and decentralized
healthcare, bridging hospital and home. 1 Source: CBS 2 Gezondheid dichtbij – Landelijke nota gezondheidsbeleid, mei 2011, VWS 3 TriMark Publications, “Medical Imaging Markets”, 2011; COCIR Market Figures 2012 4 Frost & Sullivan, 2008; Millennium Research Group IGS-RAS US Market 2008
Page 4 Version 6 October 30th, 2012
Market indicators (2010) Global market (B$) Dutch industry (B€) R&D (M€)
Medical imaging 28 2.8 220
Healthcare informatics 6 0.6 45
Home healthcare NA NA NA
There is an urgent need for a speedy implementation of this roadmap. For example, PwC
Health Research Institute emphasizes the importance for accelerating innovation and the
need for public-private partnerships in its HealthCast 2010 report as follows: “Healthcare
will soon become more patient-friendly and tailored” …”the greatest progress is being
made where governments are accelerating innovation and seeking public-private
partnerships around outcomes-based care.”
2. Applications and technology challenges 1 Diagnostics
1.1 Medical Imaging/signal processing
(a) Image acquisition
Several innovation directions are taking place in the medical imaging market to improve
image quality for better and earlier diagnosis to reduce healthcare costs and improve the
quality of life.
The continuous improvement of transmit and detection technology increases image
spatial temporal and parametric resolution, which means more detail, less motion
artifacts and better ways to discriminate different tissues. Furthermore, it reduces
ionizing radiation dose for the patient and medical staff. It also allows for faster
availability, real-time of the images, 3D/4D-rendered, including artificial colors and other
enhancements. New imaging technology will both increase sensitivity and specificity for a
comprehensive disease assessment, e.g. using further improved detectors and imaging
markers like e.g. organ specific coils for high field (7T) MRI, for ultra high field MRI
(11.7T) and dedicated SPECT systems. New developments exist on advanced optical
imaging of individual cells like TIRF, confocal microscopes, advance light microscopy,
cryo-transmission electron microscopy and diffuse optical imaging. A key trend is
combining imaging techniques to improve diagnostics in non-invasive applications, as
well as enhance tissue identification, using multimodality and a very broad wave
spectrum from X-ray to CT, MRI, optical, IR toward Terahertz, PET/CT, PET/MRI,
SPECT/CT, SPECT/PET/CT&MRI, ultrasound, opto-acoustic and hyper/multi-spectral
imaging. Another trend is the miniaturization of detectors, which allows intra-luminal
imaging on e.g. catheters and endoscopes.
(b) Image processing
New algorithms for clinical analysis and interpretation are required. Medical imaging data
are becoming increasingly more high-dimensional and multi-spectral, creating a need of
user-friendly visualization techniques, and new, robust, and quantitative computer vision
algorithms. Combining different modalities leads to more comprehensive diagnosis, in
turn leading to more evidence-based medicine. Developing new analysis algorithms and
models for these complex data may be accelerated/ inspired by high-tech research in
functional brain mechanisms of visual perception (e.g. opto-genetics)
Another trend is the combination of diagnosis and treatment (theragnostics), i.e. image-
guided interventions. To improve these intervention techniques, both in hardware and
software we need to:
Page 5 Version 6 October 30th, 2012
Obtain evidence of the value of use of a combination with optical, genetic and
molecular techniques, e.g. combining optical tissue identification, ultrasound, opto-
acoustic, optical fluorescence and optical coherence tomography imaging by
combining these techniques with established clinical modalities. A particular
advantage is offered by new developments in (digital) pathology that enables full
integration of imaging data across multiple dimensions (from cell to organ)
Ensure MR compatibility of medical devices and radiotracer detection
Exact dosimetry and tissue motion tracking when combining MRI and radiation
therapy, and other ablative and drug release techniques
Next generation (digital) detection and magnet technology
Increasing resolution to 1 nm of cryo-transmission electron microscopy to enable
monitoring of individual molecules, e.g. for development of pharmaceutical products
Tracking of moving tumors as in lungs, kidneys, cervix, prostate and livers during
radiation therapy and radiological interventions (dealing with deformations and
changes in the anatomy in images prior to and after an intervention)
Monitor and steer (local) drug response to optimize selection and dosage
Functional imaging to assess flow, elasticity, and contractility out of signal
processing, as well as finite element modeling to assess biomechanical properties of
vessels, atherosclerosis and tumors
Above innovations lower the threshold of entering new market segments like wider
preventive population screening and image guided intervention, all within reasonable
cost levels. The Netherlands has a particular strength in population imaging studies,
currently leading the European effort of the ESFRI project EuroBioImaging. These studies
will allow the construction of reference image databases, which can be used for improved
computer-aided detection, diagnosis, and prognosis, by comparing patient imaging data
with reference models encoding for population variability.
In addition, correlative imaging techniques or near-simultaneous with different
modalities in hybrid imaging are needed for validation of diagnostics and treatment.
Finally, closer cooperation between the medical imaging industry and the pharmaceutical
industry will expedite the development of molecular diagnostics and targeted and
personalized therapy.
1.2 Patient-specific modeling
To make the right diagnosis and perform the right treatment we need patient-specific
modeling - more precisely: body system modeling based on patient specific data -
enhanced by biological data (genetic profiling). With accurate insight, the most
applicable imaging or detection modality can be used. Functional patient data from
electrophysiological, force and motion recordings need to be compared with image data,
both recent and stored images of the same patient or others based on disease
characteristics. Multi-array EMG electrodes, high-density EEG for EEG source localization
and advanced ECG recordings can provide a profound insight in the control function of
the central nervous system. Moreover, the study of motion and forces, both statically
and dynamic, of the human body provides rapid insight in functioning and the control
properties of the CNS, muscles and tissues. Further dimensions may be added by
including patient-specific molecular data on patients and their response to specific
treatments, as well as genetic information. This process will raise the abstraction level of
the information, leading to biomedical models of the patient‟s condition and providing
the basis for patient-specific treatment planning, based on the anticipated response to
therapy. For screening and epidemiological research, patient data of cohorts need to be
compared, and deviant data need to be separated from normal ones.
The integration platform of these data will result in biomedical models detailing normal
and abnormal characteristics for body systems such as the brain, musculoskeletal
systems, bone, cardiovascular system, digestive system, immune system, etc.
Page 6 Version 6 October 30th, 2012
Integration of molecular data to effectively treat complex diseases such as cancer is
essential. Without integration of data, the function of these systems will never elucidate.
Systems biology requires the combination of models from cell to organ to organism.
Modeling needs data gathering using many sources. Quantitative functional imaging
across multiple dimensions is part of the modeling process. A range of physical
properties, including the natural movement of fluids and organs, but in other cases
mechanical modeling of gait and balance, are important elements in the modeling. In the
area of imaging for validation, similar challenges and solution directions exist; often at a
much more detailed level of individual markers or deviant molecular structures in cells.
The trend is to integrate diagnostic data to determine the functionality of patients, and
derive objective data for a diagnosis. Phenotypes will be compared to genetic
information in order to better understand the course of a disease. Patient models will be
made for specific diseases, e.g. for cancer treatment, bone adaptation (osteoporosis),
neurological disorders (stroke, Alzheimer, Parkinson‟s disease, schizophrenia, ADHD,
ALS), musculoskeletal disorders (sarcopenia, muscular dystrophia), personalized cancer
care (breast, head/neck, gastrointestinal, liver, cervix, prostate) and can be used to
evaluate the effect of treatment. 1.3 New Modalities for diagnostics
Introducing new diagnostic methods in healthcare is only possible after thorough
investigations. Specialized equipment is needed to validate methods, protocols and e.g.
markers. Imaging and diagnostic modalities need to be linked to more detailed
understanding of genetic and molecular profiles for understanding of the interplay
between structure and function on a cellular level (radio genomics) or proteomics as
another example of molecular level investigations. Processes within patient‟s cells are
often done using pathology or histology, i.e. outside the patient. Different analytical
techniques are being developed to advance this process, i.e. improve the molecular
specificity, such as various types of spectroscopy, NMR based cyclotrons, optical and soft
X-ray microscopy and (cryo) electron microscopy, and diffuse optical imaging, including
the combined image processing to yield spatially resolved functional information such as
OCT (Optical Coherence Tomography).
Challenges in this area are similar to those of imaging equipment for healthcare in
general. Many of the same enabling technologies as discussed in section 4 apply to this
equipment as well. Two are of specific importance: obtaining sufficient throughput and
sensitivity to get statistically significant results and combining various methods (imaging
modalities) into an integrated system (e.g. SPECT/CT, SPECT/PET/CT&MRI, PET/MRI,
EEG/fMRI) and EM/LM. Options for measuring cell‟s processes, without extraction of the
tissue are based on small optical imaging devices placed on slender long devices that
can be navigated intuitively into the patient‟s body in a minimally invasive way. Accurate
navigation of these devices is an important step to merge the data with macroscopic
imaging so that the “whole picture” is available for planning interventions. New
developments in pathology, like digital pathology, expanding into digital molecular
pathology, enable the expansion across multiple dimensions and patient-specific
diagnosis.
2 Interventions and therapy
2.1 Minimal Invasive Techniques
The developments in minimally invasive techniques are considered as one of the most
important and necessary innovations in the healthcare industry. The quick recovery after
treatment is economically very attractive as it implies shorter hospitalization, early
rehabilitation, a rapid return to normal daily activities, and reduced labor time for the
Page 7 Version 6 October 30th, 2012
nursing staff. Catheter based imaging and treatment is currently extensively used in
interventional cardiology, where it is rapidly developing. However, minimally invasive
diagnosis and treatment is still not possible in many body parts due to the limited
functionality of current instruments.
The next step is the to expand the range of minimally invasive options by developing
new devices for multiple clinical disciplines such as interventional cardiology, image
guided surgery, radiology, anesthesiology, arthroscopy, cardiology and cardiac surgery,
oncology, eye surgery, surgical instrumentation for intraluminal interventions
(colonoscopy), minimal invasive ventilation techniques and otorhinolaryngology
(neurosurgery via the nose). Devices may be combined with other disciplines such as EM
- or focused - ultrasound based hyperthermia for oncology treatment/diagnostics. The
new devices will also allow for the minimally invasive treatment of very ill or very old
patients, a patient group that consumes a large portion of the current health care
budget. 2.2 Image-guided intervention and treatment (IGIT) and intervention labs
Image guided intervention is an application domain in which the innovations mentioned
above are of crucial importance.
Now we make the transition from invasive, open surgery to minimally invasive, image
guided intervention and treatment (IGIT). IGIT seeks better clinical outcome of the
treatment, a predictable procedure time, fewer complications, shorter hospital stay,
better patient service, and lower morbidity and mortality rates, faster recovery times –
most elements directly lead to lower costs and increased patient well-being.
The technical challenges to be solved are: treatment planning, decision support and
simulation, resolution improvement, exact positioning of invasive devices relative to
deforming anatomy by means of needle/catheter steering devices/robotics, extend
application to other modalities than X-Ray (like CT, MRI, US, photo-acoustic and optical
imaging), development of catheter based imaging and endoscopes, more precise tissue
identification or tumor localization and tracking (needing real time imaging and feedback
loops, modeling), techniques for (image-based) instrumentation tracking technologies
for local and focused treatment (e.g. with light or with focused ultrasound), next
generation navigation as well as multiple actuators (including robotics) and sensors,
including MRI compatible instruments such as photonic sensors. We will need integrated
intervention labs in which highly focal, fast treatment delivery systems are connected to
the image-guidance tools for real-time IGIT. 3D-display technologies rapidly evolve and
progressively play an enabling role in image guided intervention and treatment. For
these new display technologies it is important to gather and apply specific ergonomic
insights to obtain optimal results. Most of the innovations mentioned will have impact in
the way IGIT provides a solution to the healthcare professionals.
2.3 Nuclear medicine
Radioisotopes are indispensable for diagnostics and therapy of cancer. Breakthroughs in
diagnostics and treatment of patients will be attained by developing new radionuclides
and innovative radioisotope generators using high tech materials providing an almost
continuous supply of such radioisotopes (e.g. small reactors for continuous production of
radionuclides). New radioisotope targeted delivery systems with increased specificity,
based on tailor-made radionuclide chemical transport systems (e.g. nano-cages,
polymersomes for the transport of alpha-emitters) will result in more effective
treatment. Fluorescent labeling of targets (e.g. monoclonal antibodies) opens a new era
of high resolution diagnostics; targeted ultrasound contrast agents, consisting of
microbubbles with nano shells can be used for molecular imaging, or, when loaded with
drug or genes, for local drug and gene delivery, just as radioisotopes deal with
Page 8 Version 6 October 30th, 2012
innovative applications of bionanomaterials in nuclear medicine. It opens business
opportunities for the production of new nanoscaled targeted drug delivery and detection
systems, and contributes to the growth of the industry providing fluorescent and
radioisotope generator kits.
2.4 Radiotherapy
More than half of the cancer patients are treated by radiotherapy, a technique based on
the destructive power of ionizing radiation (X-rays, photons, electrons). Unfortunately,
radiations cause damage in the healthy tissue surrounding the cancer. Particle therapy is
considered the next generation of radiotherapy. In this new technique charged particles
such as protons are used instead of X-rays. Charged particles deliver their destructive
dose to a more localized area so that tumors can be treated with less damage to
surrounding healthy tissue. Particle therapy is based on linear energy transfer (LET)
which limits the delivery of energy beyond the tumor. To reach the tumor particles will
still travel through healthy tissue with possible damaging effects. Highly focal radiation
techniques like internal radiation with brachytherapy (minimal invasive technique) limits
damage to healthy tissues. Research is necessary in finding alternative ions (such as
12C), and in improving particle therapy by image guidance, robotics, accelerator physics,
improved transport calculations for protons and system design.
2.5 Rehabilitation techniques
A shortage of care workers is foreseen in the near future. We need advanced technology
to enhance the amount of therapeutic hours and reducing the cost and presence of care
workers. A new generation of rehabilitation robots is needed to replace the activities of
physical therapists, while increasing the practicing hours of the patients. Intelligent
treadmills (robots) are designed and built for assisting stroke patients to regain their
walking ability, the strength and coordination of upper extremity motions and hand
rehabilitation. The ideal robots are impedance controlled, and assist the patients were
needed, and challenge the patients to improve their skills. Motion should be trained with
as much variety as possible in order to sustain. Early and functional training may help in
finding alternative neurological paths. Novel techniques based on virtual reality can help
to overcome cognitive problems in e.g. stroke patients. Visual and haptic cues and game
interfaces are imperative to stimulate patients to spend more time for rehabilitation
practices.
2.6 Neurostimulation
Neurostimulation devices can enhance the function of malfunctioning system. Examples
are the cochlear implants, which have changed the life of deaf people considerably.
Novel directional acoustic transducers may improve the performance of such cochlear
implants or microphone based hearing aids substantially. Devices that measure the
acoustic impedance of a vocal tract can be used as a speech trainer for people who can‟t
hear. Other stimulation devices are Functional ElectroStimulation (FES) for paralyzed
patients, e.g. in case of a drop foot of stroke patients and Deep Brain Stimulation (DBS)
for Parkinson‟s disease patients. Implantable devices are now being developed which
sense brain states for epilepsy and for paralyzed people (Brain-Computer Interfaces),
and for increasing battery life by sensing when stimulation is needed (e.g. Parkinson).
There is also interest in the use of Transcranial Magnetic Stimulation to enhance the
learning and adaptation processes in the cerebrum.
Page 9 Version 6 October 30th, 2012
3 Home and community care (0-line and 1st-line)
3.1 Wellness of citizens
Besides the aging society, people‟s lifestyle (sedentary lifestyle, eating and drinking
habits, and stress) is another factor entailing more chronic diseases. Applications and
services to change and maintain a healthy lifestyle are important means to reduce the
risks for chronic diseases and play a key role in the area of prevention. Monitoring
lifestyle, coaching and behavior change applications and services are important tools in
this respect. Furthermore, improving the health and wellbeing of citizens through the use
of light-based treatments will provide a non-invasive therapeutic route for skin diseases,
pain relief, sleep and mental disorders, and more. Technology can help to keep people at
home (or visit a closeby 1st line or primary support) instead of going to costly institutions
such that they and society benefit.
Wellness is strongly related to cognitive functioning. Significant advances can be made
by integrating mental training techniques in people‟s lives, with modern techniques (e.g.
serious gaming, web-based training).
3.2 Home and nomadic monitoring, alarm, management
Due to the demographic changes, we face a major challenge in keeping the healthcare
system affordable and accessible, while simultaneously increasing the quality of life and
prolonging the independence of elderly people. Diseases that were once incurable
become chronic conditions and the aging of the population makes the overall prevalence
of chronic conditions rise fast. The cost of care delivered at home or, in general, low
acuity settings, is much more affordable than the acute care in hospitals. It can even
create a consumer market were costs are not paid by health insurances but from
wellbeing/consumer sectors.
Early diagnosis and intervention allow for effective home care, whereas home monitoring
and disease management services result in better care after hospitalizations and can
prevent future hospitalization. Part of the rehabilitation treatment, performed in
hospitals, can be transferred to the home situation. And finally prevention programs will
decrease or delay hospitalization.
E-Health or telemedicine incorporates useful technologies and services that empower
patients to self-manage their health much more effectively at home while being in
contact with remote physicians. It will increase the quality of life, it will keep care
affordable and accessibility, as the increased efficiency will help to resolve the shortage
of staff. The technology enablers have to be embedded in innovative care models in
which integration and co-ordination of care among primary, and secondary care is key.
Technical progress will result in affordable (wearable) devices that provide simple, yet
effective feedback to the patient (e.g. monitoring systems for diabetic patients, non-
invasive (continuous) blood pressure, glucose and spO2 measuring systems). If clinical
decision support or other forms of expert systems are included, this feedback can have
an increasingly clinical nature and subsequently a bigger impact on the care model and
work flow.
Further progress in the area of domotics facilitates patients in being self-supported much
longer, thereby increasing their quality of life and independence, with e.g. WII gaming
type of devices. Also software training programs in combination with monitoring devices
can facilitate rehabilitation at home, while progress can be monitored remotely by the
therapist. Intelligent camera systems can be used to continuously monitor patients,
specially nursed children and elderly at home. Cameras would be very obtrusive to the
privacy of the people, therefore the camera images are not to be sent out, but are
interpreted using pattern recognition algorithms or avoided altogether using fall-
detectors, detecting irregular movements (as e.g. no frig open/closing) Based on this
interpretation, e.g. that the patient has fallen, help from care workers is being
Page 10 Version 6 October 30th, 2012
requested. Home robotics will provide „arms and legs‟ to the computerized world of many
disabled and elderly, enabling them to effectively manipulate the home environment or
allow prolonged moving about the house. This technology will help these patients to live
to some extent independently from the caregivers, which will substantially decrease
home care costs. Ambulant monitoring devices based on inertial measurements and
derivation of interactive forces can be used to monitor the activities of patients at home.
E.g. after the patient has received a hip or shoulder implant, the physician can monitor if
the patient is walking symmetrically, or using the arm, which may result in adaptation of
the physical therapy.
In order to create and validate the aforementioned option of home care and remote
monitoring, it is important to build a large living lab based on broadband communication
between various cities across the country. The network should be a trusted and secure
system where data can be shared and enabled for experiments between academic
centres and connected institutes. Involvement of all stakeholders across the medical and
care profession, as well as patients, is essential. This platform enables the gradual
introduction of novel remote care and monitoring equipment, preventive care and
constrained testing and evaluation.
3.3 Diagnostic systems at community healthcare (1st-line) support
Diagnostics at 1st line influences 60-70% of further medical decisions and indirectly
subsequent costs. At 1st line or primary level, healthcare support of the general
practitioner a person is considered healthy, unless otherwise proven. At 2nd line, i.e. in
the hospital, the individual is considered ill, until proven to be healthy again. New
improved equipment for generic diagnostics at 1st line can avoid huge subsequent costs.
While more advanced medical equipment at specialized hospitals will be installed and
used, a new market emerges of local health centers (or extramural care centers in the
1st line) which requires easier, general, more affordable diagnostic equipment to enable
e.g. general practitioners to make proper medical decisions. Examples are simplified
equipment, lab-on-chip/point-of-care analysis equipment, tissue recognition equipment,
etc.
4 Enabling technologies
4.1 Micro- and nanotechnology
Micro- and nanotechnology contributes to all kinds of (implantable) bio-devices for
diagnosis or treatment of different pathologies that partly benefit from the use of active
materials as actuators and sensors. In addition, nanotechnology promises the
development of much more sensitive imaging markers for diseases such as cancer. Such
active or "intelligent" materials are capable of responding in a controlled way to different
external physical or chemical stimuli by changing some of their properties. These
materials can be used to design and develop sensors, actuators and multifunctional
systems with a large number of applications for developing medical devices. An example
of such an approach is the use of microgas bubbles as contrast agents to support high-
precision ultrasonic measurements, or polymer nanoparticles for transport and local
release of drugs with focused ultrasound. Another example that fits here is the concept
of “Lab-on-a-chip” where bio-sensing is combined with the subsequent sensed data
processing and actions according to the outcomes of the diagnostics. Novel sets of clean
room materials with steeper temperature coefficients can be explored to optimize
acoustic directional sensors for use in hearing aids, optimizing between signal to noise
ratios of sensors and their power consumption.
Further improvement needs a shift from single parameter diagnosis to multi parameter
or array analysis. This involves experimenting with new forms of nanotechnology for
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sensing to be combined with existing nanotechnology such as CMOS for the data
processing. The intervention may be initiated by embedded micromechanics or special
(bio-)materials. Furthermore, this involves experimenting with high miniaturization and
ultra-low power designs for these systems. The health market requires circuits and
components to be packed in special (bio-)materials. Especially the introduction of
sensors and lab on chip systems next to other circuits and components poses an
additional challenge not only for the applied materials but is also a challenge on the
packaging process. On one hand the sensor must be exposed to the material it should
sense, but should not lead to a malfunction of the other circuits and components.
It is foreseen that by 2015, many IVD analyses, both lab-based and those designed for
point-of-care testing, will use some variation of miniaturization and „(bio) chip‟
techniques („„lab-on-a-chip‟‟ as indicated above). Several trends are promising for the
development of biosensors, including the developments in functional genomics and
proteomics (understanding the functions of the genome and the information derived
thereof), personalized medicine, imaging biomarkers for early diagnostics, for prognosis
and for measuring disease progression or treatment response, pharmacogenomics (the
influence of genetic variation on individualized drug response), bioinformatics, test
device miniaturization and other microelectronics enabled features (such as wireless
capacity and parallel processing) and, lastly, integrated detection technologies such as
nanophotonics and radar technology (up to THz).
The area of „personalized medicine‟ will be a new area for the micro and nano technology
based the above lab-on-a-chip technology. Personalized medicine is a medical model
emphasizing in general the customization of healthcare, with all decisions and practices
being tailored to individual patients in whatever ways possible. Recently, this has mainly
involved the systematic use of genetic or other information about an individual patient to
select or optimize that patient's preventative and therapeutic care. This development will
be a paradigm shift in the pharmaceutical industry towards development of patient
groups‟ targeted drugs by high-tech biotech (SME) companies, spinning off from
research at universities and institutes, and by partnerships established between
pharmaceutical and medical technology companies. On the one hand, these targeted
drugs and therapies will ask for more dedicated instruments for patient screening and
monitoring („companion‟ diagnostics). On the other hand, Lab-on-a-Chip technologies
will be applied in „flow chemistry‟ equipment which allow the required flexible
development and (scaling up of) production of the targeted drugs. This development will
be founded on the collaboration between biotech and micro/nanotechnology based
companies, with a key role for the innovative high-tech SMEs. The integration of new
insights in imaging biomarkers in relation to cellular processes will lead to developments
in molecular pathology, providing the basis of personalized treatment of complex
diseases, such as cancer. In the Netherlands many micro/nano and biotech SMEs,
backed by world-renowned research groups at universities/institutes, have emerged,
which fits perfectly in the EU R&D Framework Programme strategies for a sustainable
Europe, aiming at „convergence‟ of synergetic technologies.
Finally, there is a strong trend of consumer home use of medical electronics. This can
contribute to lower healthcare spending and increase the quality-of-life of individuals at
home. Implantable devices need energy autonomy. This can be done either by wireless
recharging or energy harvesting, and should not dissipate too much heat to the
surrounding tissue. The same holds true for non-implantable devices, wearing on your
body, although here (rechargeable) batteries can be replaced. In either case energy
efficiency calls for very low-power signal processing of an order of magnitude higher
energy-efficiency.
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4.2 ICT
ICT in the healthcare environment can be categorized in three major areas: (1)
Healthcare infrastructure IT, (2) Medical data IT and (3) Embedded ICT. Healthcare
infrastructure IT concentrates on data processing and networking of the technical data
(always consistent, raw data from a device, etc.). Medical data IT aims at processing at
another level, in particular the processing of medical data with specific medical
knowledge data, the analysis on patient records and so on. The third category is
embedded ICT within devices, more or less around the human body at home or in a
healthcare centre and it incorporates the embedded software systems hidden in both
mobile and large systems as e.g. image processing software. For healthcare, ICT
standards as ISO/NEN13606 are applicable.
(1) Healthcare infrastructure IT
The explosive growth of mobile smart phones, mobile computing & communication,
(wireless) computer networks and the Internet changes the healthcare infrastructure to
larger networks of cooperating hospitals with clusters of (joint) field labs and groups of
people connected to these field labs in a mobile flexible way. This development requires
effective, large data sharing and managed access as well as interoperability with IT
solutions, massive data fusion, storage and transport, and similarly it needs fast
extraction of the right information, preferably from a very large data base of biomedical
relevant models. It requires the digitization of vast amounts of biomedical data, from
general practitioners, vaccine programs, pharmacists, clinical practice as well as clinical
research, and advanced IT solutions to find the right information at the right moment,
also from a remote perspective, based on various types of fixed and mobile Internet
connections. This remote perspective crossing organizational borders requires that
specific attention is given to security and privacy for patient data and the setup of
trusted networks. Another extension to such networks will be the safe, secure and
smooth integration with mobile communication and visualization devices, leading to
optimized medical data transmission, modeling and visualization applications for mobile
devices.
A growing problem in medical imaging involves the increasing amount of data generated
by modern scanning equipment. These data, which often is 3D, need to be accessed in a
robust and secure way and stored for future use. Consequently, the need arises for
standardized and open data formats, independent of the storage method and/or
medium, media integrity, manufacturer, and networking technology. These open formats
will ensure interoperability and an efficient insertion of security and protection protocols
at the appropriate layers in the architecture and its data users.
(2) Medical data IT
The advancements in ICT and the growth of reliable data sets enable the use of Clinical
Decision Support systems, to significantly increase the required overall productivity and
quality. This implementation of such support systems becomes more challenging when
data have to be accessed or updated from a remote location using (reliable) Internet
connections. Low-latency high-volume data mining and decision support algorithms in
massive image bases enable better understanding of the cause and evolution of
diseases, enabling better patient-oriented treatment planning before and after
intervention. Another type of medical data IT is the expert data processing of data model
output that is gathered by analysis of individual people. The model description results
from a patient and associated disease analysis systems, but overall expertise grows from
modeling the results for a large group of people and finding correlation factors to
other/related domains and patient conditions.
(3) Embedded ICT
A specific class of ICT systems and devices deal with all signal processing functions for
monitoring body functions, tele-monitoring and diagnostics, (neuro-)feedback and
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revalidation, etc. This can be summarized as ICT for brain, body and behavior (Dutch
SME initiative), or the processing that is embedded as software in large high-tech
systems such as MRI of X-ray equipment. Due to the growth in mobile devices and
remote and home care, the signal processing functions in personal mobile sensing
equipment/devices is fully included here. As already mentioned above, data sets are
becoming increasingly available in 3D. For the involved signal processing functions, this
involves the gradual inclusion of 3D object segmentation, visualization and 3D image
reconstruction.
Besides the signal processing ICT, a complementary type of ICT here is the control and
operation software for the smooth operation of the system or device. System qualities
such as performance, simplicity, reliability, interoperability, are key factors in medical
equipment systems. Architecting these system qualities demands decisions on multi-
objective trade-offs, involving power, cost, accuracy and speed. See separate HTSM
embedded systems roadmap.
The field of telemedicine is also part of this section on ICT. Telemedicine is defined as
healthcare performed where patient and care provider are not located at the same place.
The typical use case is that the patient has a personal sensing device, which
communicates with a remote care centre. Hence, telemedicine is a combination of
Embedded ICT and Health infrastructure ICT.
Two aspects, related to ICT in healthcare, are Ease of Use and Cooperation of Systems.
They are separately discussed below.
4.3 Ease of use, user experience and beyond
Human factor engineering and design for usability are crucial ingredients for design
processes in healthcare systems. Ease of use is an important requirement for two
categories of users: for the professional operator of complex medical equipment and for
the patient as a consumer of innovative e-health services (even to the level of self
management, prevention or even supporting daily physical exercises/sport to remain
healthy). Technological enabled innovations are needed, but their ultimate success is
also, even largely determined by the (social/economic) acceptance. Ease of use is
therefore essential.
The complexity factor of modern technological systems results in the requirement of
well-trained users. Novice users cannot use systems such as MRI scanners, electron
microscopes and operating robots. The recognition of this complexity has caused a shift
from technology-driven innovation towards human-centric innovation. This human-
centric innovation reinforces the importance of „ease-of-use‟, including items such as
context-awareness, human-device interaction, remote peer-to-peer interaction, user-
configurable behavior of systems, 3D-rendering, etc. Furthermore, the surgeon should
be supported by intuitive sterile interaction with the increasing number of information
systems present in the OC for improved feedback efficiency and system complexity
management. A key result of this approach will be a significant increase in quality of the
healthcare system and reduction of medical errors.
In this context (surgical) training is a vital factor in safety. The market for surgical
simulators, spread over 1400 training centers, is valued at 105 M Euro. The complexity
factor of modern technological systems, despite the drive towards more ease of use, still
requires continuous training of users in order to perform operations in minimal time. In
particular, not only instrumentation movement should be trained, but also the tissue
handling skills based on the instrument interaction forces (haptic feedback).
E-health services have a broad application scope, from prevention to rehabilitation. They
are typically implemented as „smart systems‟ that collect data, extract information from
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them and take decisions about appropriate actions. The technology needed for such
services is largely available, but their (commercial) success ultimately depends on their
acceptance, individually and socially. They have to meet basic usability requirements,
but they also need to answer concerns about the autonomous behavior of intelligent
systems: reliability, trustworthiness, end-user control, privacy, internet access, etc.
Therefore, a user/patient-centered approach is indispensable in the implementation of
the Home Care scenarios sketched in the previous paragraphs.
4.4 Cooperative systems
Proactive cooperation between many healthcare applications is crucial. Especially this
holds for sharing data and forwarding triggers, between equipment with different
hardware characteristics. Interoperability of systems in a network requires acquiring,
communicating, merging, interpreting, storing, and securing of medical information. This
has to align with hospital workflows, patient planning, patient treatment and the
corresponding decision support.
This shared data from multiple sources is important for decision support, visualization,
feedback provision and dynamic model building (e.g.):
Making data from different sources (laboratory data, data from rehabilitation)
available for treatment selection, planning and monitoring, and for analysis by
applications supporting a multi-disciplinary care team
Support of multidisciplinary virtual teams to perform complex medical treatments.
This reduces time and sterilization needed for several team members
Support for virtual teams having instant access to the same set of patient data and
models, for diagnosis purposes, but also for a second opinion during treatment itself
Sending a trigger to appropriate care givers when a telemonitoring/telemedicine
application detects an undesired trend in vital signs
Making data from wellness applications such as activity monitoring available to the
care team for chronic diseases
Activity monitoring can also be used for the training of medical personnel and
advanced simulators will be necessary and offer a proven value for learning critical
situations on small and larger scale (same holds for children such as in perinatology)
Using results from analyzing data collected by monitoring activities of daily life from
elderly persons to inform the relevant care giver in case of mental decline.
Crucial to the success of interoperability is implementation of international standards
(like HL7, DICOM, IHE, ISO/NEN 13606 and other open data standards) in medical
systems. This will extend the possibilities, increase performance and efficiency, and
guarantee security of the complex medical systems and increase quality of cure and
care. These standards should be further developed and their implementation should be
mandatory.
4.5 Mechatronics and Robotics
Cost effective and high level healthcare requires improvements in various ways:
Automate routine jobs, reduce costs by introducing industry standards for none time
critical add-ons (patient infotainment, ward ventilation, generic IO, motion control)
Use of “mechanical imaging”: fast and cost-effective screening of patients based on
their movement and response to disturbances, using system identification and gait
analysis. Balance and gait issues (e.g. tripping) are among the most disabling threats
to elderly, which should be diagnosed and trained as early as possible
Improve ergonomics for healthcare providers (e.g. haptic feedback for surgeons and
hospital personnel), so that their performance and employability is increased
Improve quality of interventions such as improved trade-offs between speed,
accuracy, reproducibility, pollution, sterility, intuitive steerability, by development of
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new tools, including hybrid technology such as (haptic) feedback and instrument
maneuverability in image-guided interventions, MRI assisted OR
Encourage development of devices that make care receivers less dependent on care
providers, such as domestic monitoring, exo-skeletons, therapeutic and intelligent
exercise machines and treadmills, emergency warning
Encourage patient-driven development of devices instead of technology-driven to
increase the applicability of them. Especially prostheses and orthoses often are
hardly used, because the patient has to adapt himself to the device instead of the
device adapting to the patient
More specifically for robotics, a typical HTSM topic, we identify the following areas:
- Robotics for medical interventions
- Robotics for rehabilitation treatment
- Robotics supporting professional care
- Robotics assisted preventive therapies and diagnosis
- Robotic assistive technology
4.6 Biomaterials
Novel materials can be used for a broad spectrum of biomedical applications such as
implantable devices, drug and gene delivery, tissue engineering, imaging agents,
theranostics, and biosensors. Traditionally, biomaterials are mostly integrated into
medical devices or implants in, for example, orthopedic and cardiovascular devices, and
drug delivery systems. The present and future developments in medical technology
highlight the essential role of biomaterials in regenerative medicine, i.e. to restore lost or
damaged organs and tissues, using cells, scaffolds required to settle in the body and cell
growth factors. Biodegradable gels, specifically hydrogels, will act as key enabling
materials for minimal invasive (arthroscopic) treatment. Biodegradable metallic
biomaterials such as magnesium and iron with controlled porosity have most of the
characteristics needed for bio-resorbable, osteo-inductive and -conductive, chondro-
inductive and –conductive, multi-component scaffolds for bone and cartilage tissue
engineering. 3D fiber-deposited/printed biomaterials for biomedical use are also
appearing. In the HTSM printing roadmap some remarks are made on their activities in
this field.
Another trend in the development of advanced biomaterials is the integration of multiple
functionalities into medical devices and systems; biomaterials act as carriers of drugs,
genes, radionuclides, imaging agents, anti-bacterial agents, etc. Based on current and
future trends in the research field of biomaterials, four niche areas where the
Netherlands has a strong industrial base and a great potential to stand at the forefront of
technological advances, have been identified:
- Materials for advanced vascular devices
- Antimicrobial surfaces for implants, medical instruments and systems
- Medical devices for enhanced osseo-integration
- Biodegradable medical devices
- Materials for local drug delivery
Within the HTSM Healthcare domain only the (more or less) metallic implantable devices
aspects as coating, antimicrobial surfaces, etc. are included. Tissue engineering,
regenerative medicine, etc. belong to the Topsector LS&H.
4.7 Photonics
Photonics is crucial in many areas of healthcare. A wide variety of techniques in
biomedical research, diagnosis, and therapy are based on the interaction of light with
matter (e.g. optical imaging and tomography, (superresolution) microscopy,
fluorescence lifetime imaging microscopy, Raman and fluorescence spectroscopy,
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photodynamic therapy, optofluidics). Moreover, photonic components form key enabling
technologies in many advanced (bio-) medical devices such as X-ray and PET imaging
systems, minimal invasive surgical equipment, laser therapeutic systems, lab-on-a-chip,
etc.
Emerging techniques in biomedical photonics are increasingly based on the generation,
manipulation, and/or detection of single optical photons. This may not be surprising as
single-photon technology is one of the most dynamic fields in contemporary physics and
electronics research today. For example, CMOS single-photon technologies, such as
digital photon counters based on single-photon avalanche diodes (SPADs), bear a still
untapped potential for massively parallel single-photon detection and generation. This is
expected to have disruptive consequences in e.g. microscopy, spectroscopy, and (time-
of-flight) PET In the coming years.
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3. Priorities and implementation
Addressing the applications and technological challenges the following topics are selected
as priorities based upon the strengths of the Dutch ecosystem of industrial players,
research institutes and users. In particular imaging is a Dutch strength. To further
enhance our multi-disciplinary capacity we combined the priorities in diagnostics and
intervention/therapy into one cluster of shared research programs. Secondly, applying
technology in the 1st- and 0-line care is considered important for the coming years.
Finally, several enabling technologies addressing prime healthcare needs are selected.
While the prior section addresses relevant enabling technologies – mainly
nanotechnology, photonics, (bio)materials, ICT, embedded systems, mechatronics - we
refer to other Topsector HTSM roadmaps for more details.
Selected priority areas for execution of this roadmap
Below reference is made to the relevant CoREs (Centers of Research Excellence) of the
ZonMW/STW initiative IMDI.nl (Innovative Medical Devices Initiative NL) commissioned
by ZonMW as well as to the sections from the previous chapter. IMDI-CoREs focus both
on high tech technology (HTSM) and on clinical implementation within Topsector LS&H.
(a) Diagnostic and interventional data acquisition and therapy (CMI-NEN, MDII, NIMIT,
Quantivision, IDII, Neurocontrol)
(a1) High Definition Medical Imaging (from 1.1 and 1.3)
Increased sensitivity and specificity of imaging will contribute both to early diagnosis
(prevention, prognosis) and personalized treatment selection (prediction) which in return
will result in better healthcare efficacy and improved patient comfort. This field e.g.
includes new, MR compatible radiotracer detection technology, broadband
radiofrequency transceiver systems, magnet technology, optical and photo-acoustics
devices and sensitive sensor technology, scanning technology and (optical) tracer
detection (both for diagnosis and image guided interventions). Multi-modal as well as
longitudinal imaging and quantitative image analysis form an integral part of this
program, e.g. supporting an individualized medicine approach. And next to tissues, also
fluids and molecular processes are increasingly better visualized. Lastly, integration with
digital pathology will enable personalized treatment based on cellular and molecular
characteristics. The image data sets for diagnostics and interventions become
increasingly available in 3D, so that 3D image analysis, segmentation, visualization or
related processing and 3D image reconstruction form an integral part of this section.
(a2) Minimal Invasive Techniques (from 2.1)
Therapy delivery has to be supported by navigation, non-graphic and non-touch user-
interfaces. Therapy specific „surgical cockpits‟ have to deal with planning, decision
support and (minimal invasive) therapy guidance and delivery. The range of minimally
invasive options should be expanded by developing new devices for multiple clinical
disciplines such as anesthesiology, arthroscopy, cardiology and cardiac surgery,
oncology, eye surgery, surgical instruments for intraluminal interventions, and
otorhinolaryngology (neurosurgery via the nose).
The interface systems should be self-explanatory and act according to physicians‟
procedures. In order to support the medical personnel in diagnosis and minimal invasive
procedures, it is essential that only relevant images are shown, and all relevant elements
are distinguished.
Advanced presentation is critical for feed-back to the physician during minimal invasive
treatments while he/she is lacking the traditional open surgery haptic feedback and
instrument maneuverability. Also, next-generation surgical robots will need multi-modal
interaction: visual information needs to be supplemented with tactile feedback; manual
control of the instruments needs to alternate with spoken commands. In addition to the
imaging aspects, also hardware development for needle steering, instrument tracking in
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deforming anatomy and other treatment delivery systems (e.g. as in brachytherapy)
including the needed sensors and actuators is needed. And, with all the above,
simulation equipment for training purposes is needed.
(a3) Image Guided Intervention and Therapy (from 2.2)
Images from X-ray, MRI, CT and increasingly optical, opto-acoustic, ultrasound and
nuclear imaging (SPECT, PET) play an important role for the planning of minimally
invasive interventions (surgical and especially non-surgical as radiological, cardiological
and radiotherapeutical). More accurate imaging and visualization tools are needed, either
to guide the intervention procedure directly (interventional radiology, image-guided
radiotherapy) or to improve manual maneuvering of instruments such as catheters,
steerable needles and other minimal invasive instruments. Also surgical guidance
systems and surgical robots rely on the availability of accurate navigation information.
Automated quantification, segmentation and pre-processing into a 3D representation of
the morphological structures are needed for clinical applications, in order to enable the
physicians to orient themselves and to avoid vulnerable areas, all supported by
automated registration of different imaging modalities
(a4) Integrated interventional lab (from 2.2 and 1.3)
Integration of new modalities in the interventional lab – next to X-ray, imaging
modalities such as ultrasound and MRI as well as catheter based optical imaging and
sensing combined with specific navigation technologies – with the ability to switch
between them or combine them, will increase outcome and productivity of the
interventional procedures. Local therapy delivery can be invoked by local application of
light, EM energy or focused ultrasound to provide targeted activation of tissue or drug-
releasing materials. Introduction of new – X-ray less - navigation techniques will enable
the reduction of radiation dose. The combination of all these techniques, such as X-ray,
MRI, US, EM tracking or optical shape sensing, will increase traceability/location of
devices in patients‟ body.
(a5) Diagnostic instrumentation with photonic technologies (from 1, 2.2 and 3.3)
The development of non-invasive and invasive biophotonic measurement technologies
for enabling diagnostic instrumentation needs better solutions to deal with measurement
environment and patient-to-patient variability, leading today to a wide variety in spectral
signals. A wide variety of techniques in biomedical research, diagnosis, and therapy are
based on the interaction of light with matter and/or require advanced photonic
components. Emerging techniques in biomedical photonics are more and more based on
the generation, manipulation, and/or detection of single optical photons. For example,
CMOS single-photon technologies such as digital photon counters based on single-photon
avalanche diodes (SPADs) bear a still untapped potential for massively parallel single-
photon detection and generation. Once current bottlenecks such as the required high
level of integration and sensitivity are solved, this is expected to have disruptive
consequences in e.g. microscopy, spectroscopy, and (time-of-flight) PET.
It is of great importance to understand how light interacts with tissues and fluids, and to
model these interactions for different types of tissues and pathologies. Validated models
will lead to a general methodology to measure differences in tissue types and/or fluids.
The resulting measurements will generate a library of data to be used for input and/or
validation of the biophotonic models. Besides modeling, also the further development of
optical measurement technologies is important for application in medical diagnostics.
Finally, the development of signal processing methods is of vital importance to optimize
information extraction from measurements and reduce or eliminate disturbances for
effective data interpretation.
(b) Patient modelling & phenotyping (NeuroControl, MDII, IDII, Quantivision) (from
1.2)
Increase of patients with age related diseases like stroke and Parkinson‟s disease
requires individualized treatment of patients at home or in a healthcare center.
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Integration of patient monitoring and treatment in a closed-loop approach is required to
fine-tune the treatment, i.e. the patient‟s response to treatment should load to
adjustment of the therapy if necessary. Advanced patient monitoring requires state-of-
the-art diagnostic instruments, combining functional information, electrophysiological
information and (neuro-)imaging, genetic information, and the development of patient
models for interpretation of the data. The combined use of (ambulant) motion recording,
EMG technology, EEG source localization and morphological images can be used to
visualize complex data structures which will represent a large step forward for diagnosis
of gait and balance disorders, allowing for early, more distinctive and more accurate
analysis of muscular, skeletal and neurological problems. Many of these monitoring
techniques should become available in the home situation. Personalized treatment will be
brought to the home situation as well, or in specialized centers, using rehabilitation
robots to increase exercise time per patient and the number of patients that a care giver
can look after. Special indications are for patients with neurological disorders like stroke,
who require much attention while their numbers will increase due to the ageing
population.
(c) Nuclear medicine (from 2.3)
Radioisotopes are indispensable for diagnostics and therapy of cancer. Breakthroughs in
diagnostics and treatment of patients will be attained by developing new radionuclides,
new radioisotope targeted delivery systems and the combination with fluorescent
labeling of targets. It opens business opportunities for the production of new nanoscaled
targeted drug delivery and detection systems, and contributes to the growth of the
industry providing fluorescent and radioisotope generator kits.
Particle therapy is considered the next generation of radiotherapy causing less damage
to surrounding healthy tissue, but needs to be improved by image guidance, robotics,
accelerator physics, improved transport calculations for protons and system design.
(d) Home care (CCTR, SPRINT, NeuroControl, ICT for brain, body & behaviour) (from 3)
E-health techniques and telemedicine use data from all sources to communicate with
care givers at a distance, who have, if necessary, a 24/7 view of the patient at home,
and can provide advice and treatment from a distance.
Home monitoring requires the development of intelligent camera systems, which
interpret the images and respond adequately. Advanced monitoring must be developed
such as multimodal monitoring of body functions and actions using ambulant monitoring
devices. Integration of the data of these systems provides a full picture of the status of
the patient, which will lead to more effective and cost-effective treatment.
Home care robots will become available to reduce the time spend by home care givers.
These robots should be developed to provide the patient with an extra pair of hands,
enabling to manipulate the environment, i.e. opening the door, getting a cup of coffee or
some food, or getting a book of the newspaper. Robot companions are likely to replace
pets for patients with cognitive disorders.
(e) Medical networks/Healthcare IT/Clinical decision support (MDII, IDII) (from 4.2, 3
and 1.2)
(e1) Trusted medical networks for data sharing and remote care
Trusted and secure cross-organizational network for robust data storage, sharing and
exchange up to mobile agents, featuring efficient data mining, medical data analysis and
decision-support systems combined with patient identification, record and retrieval
options. In this context open data standard are needed in which also the source and the
quality of the sources is traceable (own home measurements, lab test, info on used
equipment, etc), all with the drive to avoid unnecessary retesting
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(e2) Healthcare IT solutions for clinical decision support
Integration of information from different sources (e.g. imaging modalities, diagnostic and
clinical information) and dedicated interpretation and presentation of the information to
the physician and patient will contribute to efficiency and quality of healthcare systems.
The increasing complexity of diagnostic and patient-specific information and the
necessity to bridge different stakeholders across healthcare settings both require
innovations in information sharing, access and interpretation (as ISO/NEN 13606).
Healthcare IT solutions provide an answer to these challenges, creating virtual
multidisciplinary teams and supporting clinical decision taking. The prime advantage is in
a significant increase of productivity and quality of care and cure, and a concomitant
reduction of medical errors. Healthcare IT can also support innovations in workflow and
way of working. In addition, high-volume data mining and decision support algorithms in
massive data bases; comprising genotypic and phenotypic information, enable novel
understanding of the cause and evolution of diseases, enabling effective treatment
planning and follow-up tailored to individual patients. Hence, clinical decision support will
depend on computer-aided decision systems trained on representative imaging and other
(biological, modeling) data. This will apply both to personalized diagnostic procedures
and in the various stages of personalized patient treatment. (f) Personalized medicine (from 4.1 & longterm 2)
Development of „‟Lab-on-a-chip concept‟‟ with new sensing technology and
microsystems, in combination with new, personalized pharmaceuticals. The existence of
the associations MinacNed, for micro/nanotech organisations (with a dedicated
microfluidics/lab-on-a-chip cluster) as well as NIABA and Biofarmind for med/biotech
organizations (with many drug developing SMEs), can facilitate a possible collaboration
between the HTSM and LS&H Topsectors.
(g) Robotics for rehabilitation and other healthcare applications (from 4.4 and 2.4)
Rehabilitation robots offer an opportunity to treat more patients with less care givers.
One paramedic can supervise multiple patients. Rehabilitation robots should be
impedance controlled, such that the assistance can be fine-tuned to the needs of the
patients. Other rehabilitation techniques are the use of virtual environments to stimulate
exercising patients. Besides the retraining of function through peripheral neural
stimulation of the robots, also central brain stimulation through TMS devices will be
developed. Also direct neurostimulation of the peripheral or central nervous system is an
effective way to regain function.
(h) Biomaterials (from 4.6)
The use and knowledge of biomaterials is indispensible for any implanted device. New
developments are the use of metallic degradable biomaterials such as magnesium and
iron with controlled porosity for use as scaffolds for (bone) tissue engineering and as
resorbable implants. Another trend in the development of advanced biomaterials are
antimicrobial coating of surfaces for implants, medical instruments and systems.
(i) Healthcare handheld diagnostic device of the future (from 1.3 and 4.3)
The X-price organization will launch in 2012 a 10 M dollar reward for the first tricorder: a
handheld healthcare diagnostic instrument, first visualized and named in the Startrack
movies. The criterion is a device that can better or equal diagnose patient to a panel of
certified physicians. The real ambition is to have an early diagnosis device that will bring
down healthcare curing cost by an order of magnitude and reduce the number of staff
dramatically. Dutch instrument makers are considering bringing together breath
analysis, remote sensing of respiratory and hearth functions and skin diseases using
improved (N)IR, Raman/Lib, and radar technologies.
Page 21 Version 6 October 30th, 2012
Proposed implementation in public-private partnerships
Fundamental research on healthcare is an essential area for NWO, covered by various
programs and projects. It is of critical importance to keep a solid NWO contribution in
the coming years. At STW several public-private „‟Perspectief‟‟ programs on healthcare
technology (e.g. CARISMA, NeuroSIPE, H-Haptics) are currently running. In addition, a
first IMDI call conducted by ZonMw is currently ongoing, with several new collaborations
between academia and companies being proposed. As the call is still pending, no
overview is available. At TNO activities on healthcare within the HTSM domain resulted in
2012 in the start of the van‟t Hoff shared research program on optical tissue
identification with one health-fund and two companies. This program is extended in with
at least 3 more companies and health-funds.
Internationally, the Healthcare domain of HTSM is embedded in a strong innovation
network. The excellent Dutch knowledge base - both at company and knowledge
institute level - plays a vital role in this context. In order for companies and knowledge
institutes to remain world class, international cooperation is crucial. Therefore, besides
R&D cooperation on a national level, the international ecosystem in HTSM Healthcare -
currently very well positioned within international cooperation schemes - requires special
attention. Most prominent international public funding R&D schemes include the EU
Framework Program 7 (FP7), the Joint Technology Initiatives (JTIs) such as Artemis and
ENIAC and Eureka‟s ITEA2 and CATRENE programs. The HTSM Healthcare roadmap is
also well tuned to the priorities of the EUs new Horizon 2020 program (further see
section 3.2).
Transition of connected program institutes (e.g., M2i, ESI) With regard to the program institutes within the HTSM sector, Holst centre, M2i and ESI,
there is a clear and important link with ESI. With the Holst centre and M2i some projects
exist in the healthcare domain. Both the Holst Centre and ESI describe in their roadmaps
on WATS and Embedded systems healthcare applications. The TKI part and contributions
from private companies is included into those roadmap contributions.
SME activities Chapter 4 shows an overview of the Healthcare ecosystem, which comprises a large
number of high-tech SMEs. Many of these SMEs have experience in collaborative R&D
projects and have benefitted in the past from international collaborative R&D
programmes, such as Eureka and JTIs. As an example, 30 Dutch SMEs have participated
in the ITEA2 program between 2007 and 2012, receiving Dutch funding5. These
collaborations are expected to provide a solid basis for future collaboration under the
umbrella the HTSM Healthcare roadmap.
For priority 3.i a group of SME is currently discussion to start under one of the TNO MKB
scheme an MKB driven program. This subject is also part of a possible instrumentation
roadmap that is currently in discussion.
Linkage with other innovation instruments (e.g., innovation funds,
innovative purchasing) Large companies increasingly rely on small firms and start-up companies to perform
certain initial development work. The added value provided by those smaller companies
are their pronounced innovativeness and short development cycle times. New medical
devices are more and more developed by smaller firms. In the Netherlands these smaller
firms often have no financial means and/or credit possibilities required to perform such
R&D activities. As a result, they rely on (regional) investment funds for more risky
5 @-portunity, Almende, CCM, Cyclomedia, Demcon, DevLab, Eagle Vision, Evalan, GravityZoo, KE-Works, Medis, Mextal, Noldus, Nucletron, Prodrive, Sopheon, Sound Intelligence, Technolution, TIE, VDG Security, Vector Fabrics, VicarVision, ViNotion, ZorgGemak.
Page 22 Version 6 October 30th, 2012
technology developments and benefit a lot from innovative purchasing to receive an
initial income. An example here is the medical robotic start-up from the TU/e. We expect
that this roadmap will provide these (SME) companies additional supportive material in
their request for funding. And in return for those funds we expect that at some point in
time they themselves can be in a position to contract knowledge institutes for joint
projects.
3.1 TKI program
Committed and expected R&D activities contributing to the TKI program
The application and technology challenges, as elaborated upon in this roadmap, result in
the following topics:
Topics
Application and technology challenges
Partners:
In principle all academia, institutes
and a large number of companies
mentioned below under 4.
1. Diagnostics
Medical imaging
Patient-specific modelling
New modalities for diagnostics
2. Interventions and therapy
Minimal invasive techniques
Image-guided intervention and treatment
(IGIT) and intervention labs
Nuclear medicine
Rehabilitation techniques
3. Home and Community Care:
Wellness of citizens
Home and nomadic monitoring, alarm,
management
Diagnostics systems
4. Enabling technologies for Healthcare:
Micro- and nanotechnology
ICT
Ease of use
Cooperative systems
Mechatronics and robotics
Biomaterials
The second column of above TKI table can be filled in when specific discussions on
collaborations between interested partners have been completed.
Implementation of TKI grants, connection with other roadmaps
HTSM Roadmap
Healthcare Topic HTSM
Roadmap Healthcare Topic
Semicon
equipment
Packaging technologies,
power consumption Components &
Circuits
CMOS based imaging, HD medical
imaging, minimal invasive techniques, IGIT, (revalidation) robotics, lab-on-a-chip, sensor
technologies, RF technology wireless interfaces and power management, wireless energy transfer
Page 23 Version 6 October 30th, 2012
Printing Printed bio-implants ICT
Trusted medical networks, home care
Healthcare IT & clinical decision Support
Solar - Embedded Systems
Integrated interventional lab
Healthcare IT & clinical decision Support, power consumption
Lighting Light for health & wellbeing Advanced materials
Biomaterials
Security Real-time image processing, data fusion and (near) real
time analysis
Mechatronics & Manufacturing
Minimal invasive techniques, IGIT, (revalidation) robotics
Automotive Wireless technology Nanotechnology Minimal invasive techniques, IGIT,
molecular diagnostics
Aerospace - Photonics Medical optics / optical imaging light based therapies / photonic components
3.2 Alignment with European programs and policy instruments
For FP7, the Netherlands is among the largest beneficiaries in Europe (AgNL-publication
“Nederlandse topsectoren in KP7”, 20116). This was enabled by top-level R&D actors
active in the Dutch HTSM Healthcare domain. With return percentages for the
Netherlands well above investment levels, it can be concluded this Dutch ecosystem is
outpacing its international peers.
From the year 2014 onwards the European Commission proposes the “Horizon 2020”
program, integrating the Framework Program (FP7) with the CIP and EIT programs.
As is stated by AgNL, the HTSM sector will have a specific interest in the Horizon 2020
areas that require public-private partnerships. In particular, the HTSM Healthcare
roadmap is well tuned to the three main priorities of the Horizon 2020 program:
a) Excellent science
b) Industrial leadership
c) Societal challenges
In total € 80 billion has been earmarked for a period of seven years (2014-2020). For
the Health part specifically (belonging to the „‟Societal challenges‟‟ priority) an amount of
€ 8.5 billion has been reserved.
Finally, Dutch knowledge institutes play a key role in defining Euro-BioImaging (EBI), a
large‐scale research infrastructure project part of the European Strategy Forum on
Research Infrastructures (ESFRI) Roadmap. EBI‟s aim is to provide access to a complete
range of state-of-the art imaging technologies for scientists in Europe, partnering with
industry to realize this objective.
3.3 Implementation in European and multi-national programs
The Eureka programs ITEA2 and CATRENE and the JTIs Artemis and ENIAC –most
relevant to HTSM– enjoy prominent Dutch participation. The Dutch healthcare ecosystem
wants to continue the substantial collaboration that is established through these
projects, with a rapidly increasing involvement of Dutch SMEs. To illustrate this trend
below tables have been included. The tables show that Dutch SME participation in ITEA2
(in person years) has increased from 5% in 2007 to 25% in 2012.
6http://www.agentschapnl.nl/sites/default/files/bijlagen/Nederlandse%20topsectoren%20in%20KP7%20-%202011.pdf
Page 24 Version 6 October 30th, 2012
Therefore, the HTSM community calls upon the Dutch government to maintain the Dutch
commitment for international R&D in the framework of the EUREKA and JU programs in
order to avoid losing the international connection and additional funding (co-funding in
case of the JU programs) from Europe.
0
5
10
15
20
25
30
35
40
2007 2008 2009 2010 2011 2012
ITEA 2: SME participatie (PY-%)
ITEA 2 totaal
Nederland
0
50
100
150
200
250
2007 2008 2009 2010 2011 2012
ITEA 2: Participatie in PY
Research/Universities
SME
Large industries
Page 25 Version 6 October 30th, 2012
4 Partners and process
Engaged partners from industry, science, and public authorities At present below partners are collaborating in the healthcare eco-system. In Q4 2011,
when this roadmap was drafted for the first time, they have actively been involved. For
the current update, the previous version still proved to be highly accurate and only
minimal changes needed to be made.
Academia TU/e, TUD, Utwente, VU/VUMC, UvA/AMC, UU/UMCU, RUL/LUMC,
EUR/ErasmusMC, RUN/RUNMC, RUG/UMCG, UM/MUMC
Institutes ESI, Holst Centre, TNO, imec-NL NWO/FOM, NKI
Industry Personal Space Technologies, Sopheon, Technolution, Sioux, Frencken, CCM, MI-Partners, Zorggemak, Prodrive, Medis, Pie Medical, Microflown, Logicacmg, C2V,
NXP, FEI, Lionix, Maquette Netherlands, Medison, Orthoproof, Demcon, Mecon, Bruco, Baat Medical, Micronit, Noldus, Optel, Bronkhorst, Medspray, Wwinn-group, MMS International, Akeso Medical, Dolphys, ICMCC, Magnamedics, Collectotec, U-Needle, Nano4Imaging, MediCorporate, Chematronics, Inviso, Stamhuis Lineair, Exactdynamics, Honeywell, Miscea, De Koningh Medical Systems, Vither
Hyperthermia, Lavoisier, Biosenz, Scalene Medical, Alliance Medical, Canon Europa, D.O.R.C. International, Enraf-Nonius, Esaote Europe, Finapres Medical Systems, GE Healthcare, Getinge, GymnaUniphy, Lamboo Specials Sales, Macawi, Medtronic Bakken Research Center, NightBalance, Novymed Int., Nucletron, Oldelft Benelux, Philips Healthcare, Philips Research, RS TechMedic, Simed Int., Smit Mobile Equipment, Technomed Europe, The Surgical Company Int., VDL
Groep From IMDI-CoREs not yet included above: 2M Sensors, Abbott Vascular, Allergan, Ambroise, AtosOrigin, aXion, Ayton, Bayer
Healthcare, BG Medicine, Biomet, Blanxx, Boston Scientific, Bracco, BrainLAB, Cardialysis, Centre for Human Drug Research, Cofely West Utiliteit, Cruden, D&L Graphics, De Koningh Medical Systems, DEAM, Delft Prosthetics, DoubleSense,
Durea, Elekta, Eriks aandrijftechniek, Eurocept, Evocare, FLIR, ForceLink, GBO-Design-engineering, Grendel Games HemoLab, IMDS, Indes, InfraReDx, Ipsen Farmaceutica, Jalaco, , Lantheus Medical Imaging, Lavoisier, Lode, LogiMedical, Luminostix, McRoberts, Medical Field Lab, MediShield, Meditas, Microline, MOOG, Motek Medical, Motion Projects, New Compliance, NewComNoppe, O2View, OIM Orthopedie, Össur, Otto Bock, Peters Metaalbewerking, Pezy, PR Sys Design, Saint Joseph's Translational Research Institute, Sense IT, SensorTagSolutions, Siemens
Nederland, Simendo, Sonosite, Stryker, STT, Technobis Fibre Technologies, Technologies88, TMS International, Toshiba MedSyst Europe, Umaco, Variass, Verathon, Virtual Proteins, Visual Sonics, Vita Care, Vitalis, Volcano, Xsens
Above table shows an extensive industry network with a lot of SMEs. More companies
are expected to join. Several organizations within the HTSM healthcare domain have
actively promoted this roadmap with their members, such as Holland Health Tech,
Medical Delta, Health Valley, Microcentrum and Brainport.
Process followed in creating this roadmap This 2013 roadmap is based on the long (10.000 words) roadmap 2012 version. As
indicated above, it has been adjusted to cover some recent developments. This 2013
version will serve as basis to (1) rank joint projects for TKI funding and to (2) serve as
roadmap for the TKI projects at knowledge centers. Those TKI projects are funded with
the 25% TKI scheme and are bound to the conditions as specified in the TKI
„‟Staatscourant‟‟ ruling. In essence that implies that a knowledge institute that acquires
private funding for joint projects in the context of this roadmap, is eligible for funding to
supplementary projects in the same context.
Page 26 Version 6 October 30th, 2012
5. Investments
The following tables indicate the public-private partnership R&D investments according
to the best estimates currently available.
Roadmap program 2013 2014 2015 2016
Industry 77.8 77.8 77.8 77.8
TNO 4.5 4.5 4.5 4.5
NLR 0 0 0 0
NWO 30.4 32.0 32.0 32.0
Universities 40.1 40.1 40.1 40.1
EC 10.0 11.0 12.1 13.3
EL&I 10.7 11.8 13.0 14.3
Other institutes 0 0 0 0
Other government 0.1 0.4 0.4 0.5
Grand Total (in M€) 173.6 177.6 179.9 182.5
TKI program 2013 2014 2015 2016
Industry, cash 2.0 2.0 2.0 2.0
Industry, in-kind 3.7 3.7 3.7 3.7
TNO 1.5 1.5 1.5 1.5
NLR 0 0 0 0
NWO 0.5 0.5 0.5 0.5
Universities 5.0 5.0 5.0 5.0
Other institutes 0 0 0 0
Other government 0.1 0.4 0.4 0.5
TKI grant 0.5 0.5 0.5 0.5
TKI Total (in M€) 13.3 13.6 13.7 13.7
European program 2013 2014 2015 2016
Industry 55 55 55 55
TNO 0.5 0.5 0.5 0.5
NLR 0 0 0 0
FOM 0 0 0 0
Universities 10 10 10 10
Other 0 0 0 0
EU Total, projects (in M€) 65.5 65.5 65.5 65.5
European program 2013 2014 2015 2016
EC 10.0 11.0 12.1 13.3
EL&I 7.0 7.7 8.5 9.3
Other 0 0 0 0
EU Total, grants (in M€) 17.0 18.7 20.6 22.6