healthcare htsm innovation contract

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


(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.

mailto:[email protected]


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


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:


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.


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


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


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.


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


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


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.


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


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


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


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,


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.


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


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.


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


(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.


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.


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


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

http://www.agentschapnl.nl/sites/default/files/bijlagen/Nederlandse%20topsectoren%20in%20KP7%20-%202011.pdf

http://www.agentschapnl.nl/sites/default/files/bijlagen/Nederlandse%20topsectoren%20in%20KP7%20-%202011.pdf


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


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.


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

healthcare htsm innovation contract

Documents