DEMONSTRATION OF THE MECHANISM OF ACTION
In this analysis a causal path will be drawn to clarify how the innovation will result in the intended positive effects. These pathways are crucial to determine consecutive studies and relevant outcomes to study to eventually demonstrate the benefits of the innovation.
CONTEXT & CURRENT PRACTICE ANALYSE
During this analysis, an independent portfolio will be built that clarifies which (unmet) needs will be addressed with the innovation. Using literature research, interviews and focus groups it will be assessed which problems can be addressed by the innovation, and how this compares to the current standard.
APPLICATION IDENTIFICATION
What would be the best context to apply the innovation? In which patient group or care pathway will the innovation generate the most impact? During this application identification we will introduce the innovator to experts in potential application areas to understand how they would welcome this type of innovation in their care processes and to eventually identify the most favorable context of application.
LITERATURE REVIEW
Using a systematic literature review, we will identify the current scientific evidence that can substantiate the mechanism of action of the innovation. This will provide the innovator an idea of the theoretical chance of the innovation to be effective and as such to further build the business case. Additionally, it provides valuable input for what studies are needed to fill the identified gaps in the knowledge base to further substantiate the mechanism of action.
PROBLEM/NEEDS ANALYSE
Needs, perceptions and capabilities of the intended end user need to be clear. We will consult experts and intended users to demonstrate how the innovation will bring effect to a certain target group. This analysis is an important step as it reveals the user requirements, which are crucial for successful development.
IDEATION / DESIGN THINKING
After careful consideration of the mechanism of action and the end-user’s expectations, several potential solutions will be identified. This is a creative and hands-on exercise.
PAPER PROTOTYPING
Here we introduce a paper prototype of the innovation to small groups of end-users. Patients or other end-users are challenged to interact with the paper prototype, e.g. by doing a task. This exercise gives essential input in R&D decisions.
EARLY HTA
In an early Health Technology Assessment (HTA) we will research the minimal economic requirements for the innovation to bring added value, compared to the current standard of care. We will focus on the intended costs and the intended effects of an innovation. An early HTA provides an early estimation of the change in healthcare costs after implementing the innovation.
USABILITY TESTING
In a usability test we evaluate the usability and user friendliness of an innovation with end users. Using for example (video) observation and qualitative research, we will be able to quantify how users actually interact with and experience the innovation. This study will give recommendations for optimization and further implementation.
FEASIBILITY TESTING
A feasibility study assesses the acceptance of an innovation for a longer period of usage, in the intended context. Using a mixed method of qualitative and quantitative methods, several aspects will be measured, such as: acceptance, interest, implementation, practicability, adaptation, integration, expansion and preliminary effectiveness.
EARLY HTA
In an early Health Technology Assessment (HTA) we will research the minimal economic requirements for the innovation to bring added value, compared to the current standard of care. We will focus on the intended costs and the intended effects of an innovation. An early HTA provides an early estimation of the change in healthcare costs after implementing the innovation.
METHODOLOGY CLINICAL STUDY
We offer consultancy and advisory activities in setting up a clinical study and writing a study protocol. We can help to answer questions like: What would be the most efficient and appropriate design for the study to validly answer my research question? What aspects need to be covered by the study protocol to comply with rules and regulations? How many participants do I need?
CLINICAL STUDY
In a clinical study, the (clinical) performance, efficacy, effectiveness and/or efficiency of the innovation will be studied. In designing and performing the clinical study, several elements need to be addressed such as the need for a control group, randomization, follow-up time. We will consider the regulatory and ethical requirements as well as the logistics.
HTA
In this extensive quantitative analysis, we will use prospective study data, literature data and expert opinion. Optionally we develop a model to answer several cost effectiveness questions or scenarios. For example: what are the additional costs per gained life year? Does the prevention of a complication result in cost savings?
POST-MARKET SURVEILLANCE
Post market surveillance is a set of activities to monitor the safety and performance of an innovation, once implemented. THINC. has the research and data management techniques (European Guidelines: 93/42EEG) to determine the usability, safety and vigilance of an innovation after implementation. These analyses come with extensive recommendations on product and process improvement.
WeQare
WeQare
SmartQare develops weQare, a portable multisensor solution for 24-hour remote monitoring of at-risk groups. In addition to monitoring vital signals, it can detect a fall incident and has supports manual alarms. A tool that helps healthcare professionals to organize the healthcare process around patients effectively and efficiently. The solution consists of: 1) a comfortable portable medical device with various sensors. 2) an online platform (CDSS) that receives the measured values and processes them securely in pseudonymised form. 3) a mobile app. THINC. SmartQare supports in two mandatory steps towards obtaining a CE marking within the Medical Device Regulation (MDR): Formative and Summative usability testing.
USABILITY TESTING
In a usability test we evaluate the usability and user friendliness of an innovation with end users. Using for example (video) observation and qualitative research, we will be able to quantify how users actually interact with and experience the innovation. This study will give recommendations for optimization and further implementation.
PhoenixDX
PhoenixDX
PhoenixDX, a biotech company from Manchester in the UK, has developed the GenixDX innovation. GenixDX is a rapid, point-of-care diagnostic device to detect pathogens causing infection. Despite being a small device, it contains a platform technology which combines nucleic acid extraction, amplification, and detection into a single step. This diagnostic device is easy to use, and delivers rapid and accurate results. The current version is intended for the detection of nucleic acid from SARS-CoV-2, Influenza A, and Influenza B in nasal swabs from individuals suspected of COVID-19. The technology can be extended to other viruses, but also for the detection of bacteria. For more information, see their website https://www.phoenixdx.co.uk/ THINC. will assist PhoenixDX in identifying the most promising clinical uses for their innovation. Key deliverables include: (a) logic models summarizing technical features, working mechanisms, and potential benefits; (b) an inventory of the main intended uses with experts’ views on the need, fit and requirements for PhoenixDX to become successful; (c) estimation of potential market sizes for the main intended uses.
POST-MARKET SURVEILLANCE
Post market surveillance is a set of activities to monitor the safety and performance of an innovation, once implemented. THINC. has the research and data management techniques (European Guidelines: 93/42EEG) to determine the usability, safety and vigilance of an innovation after implementation. These analyses come with extensive recommendations on product and process improvement.
METHODOLOGY CLINICAL STUDY
We offer consultancy and advisory activities in setting up a clinical study and writing a study protocol. We can help to answer questions like: What would be the most efficient and appropriate design for the study to validly answer my research question? What aspects need to be covered by the study protocol to comply with rules and regulations? How many participants do I need?
Untire
Untire
Tired of Cancer heeft een app (Untire) ontwikkeld die (ex)kankerpatiënten helpt om te gaan met extreme vermoeidheid. Untire is door ORCHA (gerenommeerde organisatie waar het gaat over beoordelen van digitale zorg) uitgeroepen als 1 van de beste 5 apps binnen de oncologie wereldwijd, uit een totaal van 3603 beoordeelde apps. THINC. adviseert bij en ontwerpt een klinische gerandomiseerde trial voor het evalueren van het effect van de Untire app in Duitsland om vervolgens voor Untire (via BfArM) toegang te kunnen krijgen tot de Duitse markt.
METHODOLOGY CLINICAL STUDY
We offer consultancy and advisory activities in setting up a clinical study and writing a study protocol. We can help to answer questions like: What would be the most efficient and appropriate design for the study to validly answer my research question? What aspects need to be covered by the study protocol to comply with rules and regulations? How many participants do I need?
BreasTel®
BreasTel®
BreasTel® is a small handheld ultrasound device in development by a Dutch startup IDS International B.V, that assists in characterizing a palpable lump in the breast. The BreasTel® device is a single-purpose scanner for pre-hospital screening that is specifically designed to be used by untrained doctors, primary care personnel or women. The purpose of the BreasTel® project is to develop a low-cost user-friendly modality that allows first for Point-of-Care testing of palpable breast lesions. BreasTel® is based on ultrasound technology combined with an intelligent algorithm that, without needing a personal interpretation, distinguishes between benign and suspicious tumors, which may indicate breast cancer. BreasTel® is intended to support breast examination and to better determine when a woman should be referred to hospital for radiological examination. THINC. will be exploring the market opportunities and potential of BreasTel® in countries and settings with reduced access to mammography through desktop research and expert interviews.
LITERATURE REVIEW
Using a systematic literature review, we will identify the current scientific evidence that can substantiate the mechanism of action of the innovation. This will provide the innovator an idea of the theoretical chance of the innovation to be effective and as such to further build the business case. Additionally, it provides valuable input for what studies are needed to fill the identified gaps in the knowledge base to further substantiate the mechanism of action.
APPLICATION IDENTIFICATION
What would be the best context to apply the innovation? In which patient group or care pathway will the innovation generate the most impact? During this application identification we will introduce the innovator to experts in potential application areas to understand how they would welcome this type of innovation in their care processes and to eventually identify the most favorable context of application.
Spreekuur.nl
Spreekuur.nl
Spreekuur.nl is an initiative of DigiDok and Topicus and the first to make fully online general practitioner consultations available for Dutch patients. With Spreekuur.nl, patients prepare for a consultation themselves by completing triage and anamnesis questions and adding a photo and/or video. General practitioners are then presented with this information in a clear manner via a digital system and can easily handle the consultation via a chat or videocall. In collaboration with THINC., the questionnaires were validated during several individual sessions with triagists and general practitioners. The triage and anamnesis questions were assessed for completeness, relevance and unambiguity, among others.
USABILITY TESTING
In a usability test we evaluate the usability and user friendliness of an innovation with end users. Using for example (video) observation and qualitative research, we will be able to quantify how users actually interact with and experience the innovation. This study will give recommendations for optimization and further implementation.
DEMONSTRATION OF THE MECHANISM OF ACTION
In this analysis a causal path will be drawn to clarify how the innovation will result in the intended positive effects. These pathways are crucial to determine consecutive studies and relevant outcomes to study to eventually demonstrate the benefits of the innovation.
Mind Mansion
Mind Mansion
Over 1 million people in in the Netherlands suffer from an anxiety disorder. An anxiety disorder can have a significant impact on someone’s daily life. Exposure therapy can effectively treat anxiety disorders. The startup Mind Mansion developed an intervention to help people deal with their anxiety through virtual reality exposure therapy. THINC. performs an early feasibility study to gain insight into the usability, ease of use and implementation opportunities of Mind Mansion’s innovation.
DEMONSTRATION OF THE MECHANISM OF ACTION
In this analysis a causal path will be drawn to clarify how the innovation will result in the intended positive effects. These pathways are crucial to determine consecutive studies and relevant outcomes to study to eventually demonstrate the benefits of the innovation.
FEASIBILITY TESTING
A feasibility study assesses the acceptance of an innovation for a longer period of usage, in the intended context. Using a mixed method of qualitative and quantitative methods, several aspects will be measured, such as: acceptance, interest, implementation, practicability, adaptation, integration, expansion and preliminary effectiveness.
Haermonics Flush
Haermonics Flush
Haermonics built an investigational device that is able to flush the pericardial space with a warm saline solution in order to stop the bleeding after open heart surgery, called the Haermonics Flush. Haermonics technology allows controlled infusion of a warmed liquid solution into the pericardial cavity after the operation while the system monitors blood loss and pressure in the pericardial cavity. Continuous flushing will result in a lower viscosity mixture that will prevent chest tubes from clogging and promote the evacuation of blood and clots from the pericardial cavity. THINC., in collaboration with Haermonics and clinical experts, has developed a randomized clinical trial to determine the effects of the use of Haermonics Flush in the reduction of blood loss and associated complications.
METHODOLOGY CLINICAL STUDY
We offer consultancy and advisory activities in setting up a clinical study and writing a study protocol. We can help to answer questions like: What would be the most efficient and appropriate design for the study to validly answer my research question? What aspects need to be covered by the study protocol to comply with rules and regulations? How many participants do I need?
CLINICAL STUDY
In a clinical study, the (clinical) performance, efficacy, effectiveness and/or efficiency of the innovation will be studied. In designing and performing the clinical study, several elements need to be addressed such as the need for a control group, randomization, follow-up time. We will consider the regulatory and ethical requirements as well as the logistics.
FrankySpeaking
FrankySpeaking
FrankySpeaking combines a new invention with an already existing therapy, EMDR. By stabilizing the jaw, the oral cavity is calmed and EMDR neutralizes negative memories. THINC. has conducted an innovation assessment in which the innovation and its components have been fully screened, the mode of action has been determined, clinical experts have been consulted, current literature has been mapped to identify knowledge gaps, and suggestions have been made to fill these gaps with additional research . In addition, a pilot study was designed together with FrankySpeaking and experts in the field of EMDR to gain more insight into the usability, feasibility and early effectiveness of FrankySpeaking, whether or not in combination with EMDR.
CLINICAL STUDY
In a clinical study, the (clinical) performance, efficacy, effectiveness and/or efficiency of the innovation will be studied. In designing and performing the clinical study, several elements need to be addressed such as the need for a control group, randomization, follow-up time. We will consider the regulatory and ethical requirements as well as the logistics.
METHODOLOGY CLINICAL STUDY
We offer consultancy and advisory activities in setting up a clinical study and writing a study protocol. We can help to answer questions like: What would be the most efficient and appropriate design for the study to validly answer my research question? What aspects need to be covered by the study protocol to comply with rules and regulations? How many participants do I need?
Sapien 3
Sapien 3
Edwards developed a Transcatheter Aortic Valve Implantation (TAVI) that can be used in patients with severe aortic stenosis. TAVI is expected to be associated with a reduced risk of complications and associated admission duration and costs. Yet, little is known about early discharge and whether this can be predicted reliably. THINC. identified prognostic factors for early vs. late hospital discharge in TAVI patients, and developed and internally validated a prognostic model to predict early vs. late discharge in these patients.
METHODOLOGY CLINICAL STUDY
We offer consultancy and advisory activities in setting up a clinical study and writing a study protocol. We can help to answer questions like: What would be the most efficient and appropriate design for the study to validly answer my research question? What aspects need to be covered by the study protocol to comply with rules and regulations? How many participants do I need?
DeltaScan
DeltaScan
The DeltaScan, developed by Prolira, is world's first objective medical device to detect and monitor delirium, acute brain failure. The DeltaScan enables early detection of delirium and intends to minimize the negative impact of delirium on a patient's life. Together with Prolira, THINC. performs a cost-effectiveness study, a full-scale literature review (systematic review) and provides Prolira with methodological support in the design and execution of clinical studies needed for CE-/FDA approval.
METHODOLOGY CLINICAL STUDY
We offer consultancy and advisory activities in setting up a clinical study and writing a study protocol. We can help to answer questions like: What would be the most efficient and appropriate design for the study to validly answer my research question? What aspects need to be covered by the study protocol to comply with rules and regulations? How many participants do I need?
HTA
In this extensive quantitative analysis, we will use prospective study data, literature data and expert opinion. Optionally we develop a model to answer several cost effectiveness questions or scenarios. For example: what are the additional costs per gained life year? Does the prevention of a complication result in cost savings?
LITERATURE REVIEW
Using a systematic literature review, we will identify the current scientific evidence that can substantiate the mechanism of action of the innovation. This will provide the innovator an idea of the theoretical chance of the innovation to be effective and as such to further build the business case. Additionally, it provides valuable input for what studies are needed to fill the identified gaps in the knowledge base to further substantiate the mechanism of action.
Nightwatch
Nightwatch
The Nightwatch is a detection system for patients with severe epilepsy. In a collaboration with UMC Utrecht, SEIN and Kempenhage, we work on a feasibility study for this device. We research if and how the Nightwatch can be used to support parents of children with epilepsy.
DEMONSTRATION OF THE MECHANISM OF ACTION
In this analysis a causal path will be drawn to clarify how the innovation will result in the intended positive effects. These pathways are crucial to determine consecutive studies and relevant outcomes to study to eventually demonstrate the benefits of the innovation.
USABILITY TESTING
In a usability test we evaluate the usability and user friendliness of an innovation with end users. Using for example (video) observation and qualitative research, we will be able to quantify how users actually interact with and experience the innovation. This study will give recommendations for optimization and further implementation.
Philips Healthcare
Philips Healthcare
Philips is a health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. In collaboration with Philips, THINC. combined prediction modelling results with clinical outcomes and cost data to document the clinical and monetary benefit from innovations. Outcomes of these studies are used for management decisions on future investments in research and development. THINC. also partners in Philips HealthWorks. HealthWorks creates collaboration opportunities between Philips and early-stage companies, as well as ecosystem partners, to accelerate innovation in healthcare.
METHODOLOGY CLINICAL STUDY
We offer consultancy and advisory activities in setting up a clinical study and writing a study protocol. We can help to answer questions like: What would be the most efficient and appropriate design for the study to validly answer my research question? What aspects need to be covered by the study protocol to comply with rules and regulations? How many participants do I need?
Docly
Docly
Docly, known as Min Doktor in Sweden, is the driving force towards digitalisation of primary care in Sweden. Docly has treated 400.000 patients so far. It offers an online service where patients have access to a General Practioner via a mobile phone. Docly offers a solution for a complete care pathway: automated triage, anamnesis, interaction between patient and doctor (videocall or chat), diagnostics (incl. decision support) and doctor's referral. THINC. performed a Content Validity Study for Docly - in which the content of the digital care pathway was validated for the Dutch care context. Secondly THINC. performed a feasibility study in cooperation with HAP Eemland in the Netherlands (out of office primary care) to focus on solid implementation. In this study interactive sessions with professionals, questionaires for patients and professionals, qualitative and quantitative research were all combined to assess the impact of Docly on the Dutch healthcare system.
FEASIBILITY TESTING
A feasibility study assesses the acceptance of an innovation for a longer period of usage, in the intended context. Using a mixed method of qualitative and quantitative methods, several aspects will be measured, such as: acceptance, interest, implementation, practicability, adaptation, integration, expansion and preliminary effectiveness.
CONTEXT & CURRENT PRACTICE ANALYSE
During this analysis, an independent portfolio will be built that clarifies which (unmet) needs will be addressed with the innovation. Using literature research, interviews and focus groups it will be assessed which problems can be addressed by the innovation, and how this compares to the current standard.
Philips Image Guided Therapies
Philips Image Guided Therapies
"Philips Image Guided Therapies developed a new software package for their angiography and percutaneous coronary intervention products, the Philips Dynamic Coronary Roadmap (DCR). With this software package an image of the coronary arteries made with x-rays and a contrast agent is projected over the x-ray images made during the subsequent procedure. The rationale is that cardiologists and/or radiologists will be able to perform complex coronary interventions with lower volumes of contrast agent. The use of contrast agents in intervention cardiology is associated with acute kidney injury and in some cases long lasting kidney failure requiring dialysis. The question therefore was whether a reduction in contrast volume is likely to lead to a decrease in acute kidney injury (AKI) and dialysis incidence. Furthermore, Philips was interested to assess whether a possible decrease in AKI and dialysis incidence would also lead to cost savings for performing institutions. Based on these questions THINC. to peformed (i) a systematic review to identify the most valid and applicable prediction models relating contrast volume and other clinical variables to acute kidney injury and other relevant outcomes and (ii) a health economic model in which the best model(s) identified from the literature were used to determine the costs and effects associated with current care and with care after the implementation of DCR. "
EARLY HTA
In an early Health Technology Assessment (HTA) we will research the minimal economic requirements for the innovation to bring added value, compared to the current standard of care. We will focus on the intended costs and the intended effects of an innovation. An early HTA provides an early estimation of the change in healthcare costs after implementing the innovation.
Proton Therapy
Proton Therapy
Since 2018, Dutch cancer patients are potentially eligible for proton therapy. Proton therapy is a radiation therapy that results in less side effects than the current standard of radiation therapy, photon therapy. In collaboration with a radiation oncologists from proton and non-proton centers, THINC. validates and optimizes prediction models to select patients who would benefit most from this new type of radiation therapy. This model-based patient selection is unique and is an optimal combination of existing knowledge and transparent substantiation of patient selection.
METHODOLOGY CLINICAL STUDY
We offer consultancy and advisory activities in setting up a clinical study and writing a study protocol. We can help to answer questions like: What would be the most efficient and appropriate design for the study to validly answer my research question? What aspects need to be covered by the study protocol to comply with rules and regulations? How many participants do I need?
Safe@home
Safe@home
Zwangere vrouwen die in een eerdere zwangerschap een complicatie hebben gehad zoals zwangerschapsvergiftiging, hoge bloeddruk of vrouwen die zwanger zijn en hartproblemen hebben moeten extra in de gaten gehouden worden. In het huidige zorgsysteem wordt deze risicogroep gevraagd om met regelmaat poliklinisch onderzocht te worden. Deze controles zijn belastend voor de vrouwen en gaan gepaard met hoge kosten. Safe@home is een thuismonitoring systeem. Met Safe@home kunnen vrouwen thuis gebruiken maken van meetapparatuur en op afstand (door de arts) in de gaten worden gehouden. Dit biedt zwangere vrouwen een comfortabeler zorgpad, en artsen de kans om eventuele afwijkingen tijdig te signaleren. Voor deze innovatie hebben wij een nul-meting in zorgverbruik (poliklinische bezoeken, echo’s etc.) gedaan. Deze meting geeft antwoord op de vraag: hoeveel zorg is er momenteel nodig om deze risicogroep goed te monitoren? Deze nulmeting stelt de onderzoekers in staat om bij implementatie van Safe@home het verschil in zorggebruik vast te stellen.
EARLY HTA
In an early Health Technology Assessment (HTA) we will research the minimal economic requirements for the innovation to bring added value, compared to the current standard of care. We will focus on the intended costs and the intended effects of an innovation. An early HTA provides an early estimation of the change in healthcare costs after implementing the innovation.
Fast Focus
Fast Focus
FastFocus is a Wireless Patient Monitoring System: a device specially developed for the wireless and continuous measurement of the vital functions, posture and movement activity of hospitalized patients. The device is an earsensor (see image). After exploring the areas of application for FastFocus, THINC. mapped out what the clinical potential or mechanism of action of FastFocus could be. Through a rapid scoping review of the literature on the monitoring of vital functions and (group) interviews with experts (scientists, pulmonologists, nurses and a physiotherapist) THINC has. collected information and identified four applications areas (for example continuous monitoring, self-management or replacement of manual measurements).
LITERATURE REVIEW
Using a systematic literature review, we will identify the current scientific evidence that can substantiate the mechanism of action of the innovation. This will provide the innovator an idea of the theoretical chance of the innovation to be effective and as such to further build the business case. Additionally, it provides valuable input for what studies are needed to fill the identified gaps in the knowledge base to further substantiate the mechanism of action.
USABILITY TESTING
In a usability test we evaluate the usability and user friendliness of an innovation with end users. Using for example (video) observation and qualitative research, we will be able to quantify how users actually interact with and experience the innovation. This study will give recommendations for optimization and further implementation.
Release
Release
Various challenges hamper capitalizing the real potential of eHealth in heart failure patients: insufficient evidence, heterogeneity of technologies and a lack of guidance in quality control and quality improvement. The aim of RELEASE-HF (REsponsible roLl-out or E-heAlth through Systematic Evaluation - Heart Failure) is to realize a responsible and safe rollout and continuous quality improvement of eHealth / telemedicine in Heart Failure patients. THINC. developed a evaluation-model based on maximum use of routine care data, creating a continuously learning environment in order to shed more clarity about which intervention components (WHAT) work for which profile patients (WHO) and in which type of care model / context (HOW and WHERE). This constant flow of knowledge in parallel with the natural roll-out of eHealth provides essential input for quality improvement and is also a catalyst for new innovations
METHODOLOGY CLINICAL STUDY
We offer consultancy and advisory activities in setting up a clinical study and writing a study protocol. We can help to answer questions like: What would be the most efficient and appropriate design for the study to validly answer my research question? What aspects need to be covered by the study protocol to comply with rules and regulations? How many participants do I need?
MRIguidance
MRIguidance
MRIguidance is a spin-off company of the UMC Utrecht, developing the medical imaging technique BoneMRI. BoneMRI is a software solution that generates a CT-like image to complement the soft tissue images derived from an MRI scan, it adds 3D bone visualization to MRI . This innovation is designed to offer better diagnostic information, no radiation and an efficient care pathway for patients and professionals. THINC. partnered with MRIguidance in the methodology for the clinical study.
METHODOLOGY CLINICAL STUDY
We offer consultancy and advisory activities in setting up a clinical study and writing a study protocol. We can help to answer questions like: What would be the most efficient and appropriate design for the study to validly answer my research question? What aspects need to be covered by the study protocol to comply with rules and regulations? How many participants do I need?
Ares Analytics
Ares Analytics
Ares Analytics aims to develop a cheap, light, and non-invasive wearable that tracks exercise intensity continuously with the help of data science. Athletes are constantly searching for ways to assess and further improve their performance. Information about exercise intensity and fatigue are crucial for an athlete to train efficiently and reduce their chance of getting sports related injuries. The degree of fatigue also determines the length of the optimal recovery period before training is continued. This not only applies to athletes, but also to specific types of patients. THINC., in collaboration with Ares Analytics and clinical experts, has developed an early evaluation study that will further help select the most valuable components for further research and development.
CLINICAL STUDY
In a clinical study, the (clinical) performance, efficacy, effectiveness and/or efficiency of the innovation will be studied. In designing and performing the clinical study, several elements need to be addressed such as the need for a control group, randomization, follow-up time. We will consider the regulatory and ethical requirements as well as the logistics.
Wind Tales
Wind Tales
Wind Tales is a breath-controlled game (serious game) designed for children with Cystic Fibrosis. The digital game enables children to use breathing exercises to control an avatar to steer and overcome obstacles in a fantasy world. In close collaboration with Wind Tales, we performed a usability and a feasibility study for their serious game. The goal of these studies was to enable Wind Tales address the opportunities and threats as perceived by the end users with the goal to achieve a flawless implementation of the game.
FEASIBILITY TESTING
A feasibility study assesses the acceptance of an innovation for a longer period of usage, in the intended context. Using a mixed method of qualitative and quantitative methods, several aspects will be measured, such as: acceptance, interest, implementation, practicability, adaptation, integration, expansion and preliminary effectiveness.
GGZ Central
GGZ Central
Research has shown that mental healthcare patients with a long hospitalization are more likely to develop obesity and related disordes such as diabetes and cardiovascular diseases. GGZ Centraal developed a program to counteract these diseases, which has shown to have a positive effect on healthcare of these patients. THINC. is performing a Health Technology Assessment to determine the total costs of care of patients using this program, both short term and long term. Important data in this research are e.g. costs of the program, residential status of the patient, medication use, support by a dietician etc.
HTA
In this extensive quantitative analysis, we will use prospective study data, literature data and expert opinion. Optionally we develop a model to answer several cost effectiveness questions or scenarios. For example: what are the additional costs per gained life year? Does the prevention of a complication result in cost savings?
Leontienhuis
Leontienhuis
The Leontienhuis aims to be an accessible and safe walk-in center for people with an eating disorder. In addition to the low-threshold and non-committal stimulation of optimal coping with the eating disorder, the aim is to motivate people who normally remain out of treatment to take a first step towards treatment, to remain in treatment and not to revert to old behavior after treatment. THINC. conducted an innovation assessment to map out the working mechanism by which the Leontienhuis tries to achieve its goals, to test the plausibility that the Leontienhuis achieves the set objectives through the current activities, and to identify the possibilities for additional research, with which it can be demonstrated with greater certainty whether the Leontienhuis promotes health gains and reduces costs.
PROBLEM/NEEDS ANALYSE
Needs, perceptions and capabilities of the intended end user need to be clear. We will consult experts and intended users to demonstrate how the innovation will bring effect to a certain target group. This analysis is an important step as it reveals the user requirements, which are crucial for successful development.
POST-MARKET SURVEILLANCE
Post market surveillance is a set of activities to monitor the safety and performance of an innovation, once implemented. THINC. has the research and data management techniques (European Guidelines: 93/42EEG) to determine the usability, safety and vigilance of an innovation after implementation. These analyses come with extensive recommendations on product and process improvement.
NightWatch
NightWatch
The Nightwatch is a detection system for patients with severe epilepsy. The NightWatch detects seizures and alarms caregivers. THINC. partners with SEIN and Kempenhage in a feasibility study for this device. We research if and how the Nightwatch can be used to support parents of children with epilepsy.
FEASIBILITY TESTING
A feasibility study assesses the acceptance of an innovation for a longer period of usage, in the intended context. Using a mixed method of qualitative and quantitative methods, several aspects will be measured, such as: acceptance, interest, implementation, practicability, adaptation, integration, expansion and preliminary effectiveness.
Oncode Institute
Oncode Institute
The vision of Oncode is: ‘Outsmarting cancer, impacting lives’. Oncode is an independent institute dedicated to understanding cancer and translating research into practice. Along with performing vital fundamental research, Oncode specializes in cooperating with third parties to guide its scientists’ discoveries towards translational and clinical research for new diagnostics, drugs and treatments. THINC. partners with Oncode in several research topics in which we identify the added value of ideas and innovations in early stages of development.
EARLY HTA
In an early Health Technology Assessment (HTA) we will research the minimal economic requirements for the innovation to bring added value, compared to the current standard of care. We will focus on the intended costs and the intended effects of an innovation. An early HTA provides an early estimation of the change in healthcare costs after implementing the innovation.
Quarantaine coach
Quarantaine coach
In February 2021 Municipal Health Services, the Red Cross and the Ministry of Health, Welfare and Sport started a pilot with "quarantine coaches" in the Dutch regions Drenthe and Kennemerland. Quarantine coaches support people who experience psychological or practical objections during quarantine. The pilot with quarantine coaches has been evaluated by The Healthcare Innovation Center (THINC.). THINC. evaluated the need for the quarantine coaches and how the coached people experienced the help provided.
DEMONSTRATION OF THE MECHANISM OF ACTION
In this analysis a causal path will be drawn to clarify how the innovation will result in the intended positive effects. These pathways are crucial to determine consecutive studies and relevant outcomes to study to eventually demonstrate the benefits of the innovation.
USABILITY TESTING
In a usability test we evaluate the usability and user friendliness of an innovation with end users. Using for example (video) observation and qualitative research, we will be able to quantify how users actually interact with and experience the innovation. This study will give recommendations for optimization and further implementation.
STRIDE
STRIDE
The STRIDE innovation consists of two components: a prognostic algorithm and a functional in-vitro test. The STRIDE innovation is a decision-support tool to improve the matching between an available donor kidney and a potential recipient. By desk research and input from innovators THINC. performed a THINC. first assessment to gain insight into the Product & Use '(including claims and population),' CE certification '(including intended use and risk classification),' Stakeholders' (including which stakeholders are most relevant and what are their interests) , 'Evidence & Studies' (including what scientific evidence is there and what still needs to be produced), and 'Implementation' (including barriers and facilitators to successful implementation). After a round table discussion with relevant stakeholders (including patients, health insurers, clinicians, CE-exprt, National Health Care Institute), concrete recommendations for the future of STRIDE were formulated.
METHODOLOGY CLINICAL STUDY
We offer consultancy and advisory activities in setting up a clinical study and writing a study protocol. We can help to answer questions like: What would be the most efficient and appropriate design for the study to validly answer my research question? What aspects need to be covered by the study protocol to comply with rules and regulations? How many participants do I need?
FREE Bionics
FREE Bionics
Free Bionics is a Taiwanese company of scientists, engineers and technicians. Free Bionics developed the FREE Walk, an exoskeleton for patients with spinal cord injuries, nerve damage or limb weakness. The first FREE Walk in the Netherlands is currently in clinical trials at Hoogstraat Revalidatie. THINC. partners with Hoogstraat Revalidatie and Freebionics to ensure the research protocol and Dutch research guidelines are met in constructively gathering research results for the FREE Bionics in a Dutch study.
METHODOLOGY CLINICAL STUDY
We offer consultancy and advisory activities in setting up a clinical study and writing a study protocol. We can help to answer questions like: What would be the most efficient and appropriate design for the study to validly answer my research question? What aspects need to be covered by the study protocol to comply with rules and regulations? How many participants do I need?