Home Risk management for medical devices in research projects
Article Open Access

Risk management for medical devices in research projects

  • Christian Sauter EMAIL logo , Marion Heinloth , Andreas Tobola , Nadine Pensky and Christian Weigand
Published/Copyright: September 12, 2015
Download Article (PDF)
Become an author with De Gruyter Brill
Author Information Explore this Subject
Current Directions in Biomedical Engineering
From the journal Current Directions in Biomedical Engineering Volume 1 Issue 1

Abstract

In applied research for medical devices exists a conflict between effective research and regulations. While researchers need sufficient freedom the regulations require a complex technical documentation for a medical device. One relevant aspect of the regulations is risk management which takes time and therefore is ignored in many research projects. With adoptions to the standard the effort can be reduced: Identifying of risks can be focused on critical risks, measures can be categorised and only some categories need to be implemented. Research teams using this method can provide results which can be transferred into commercial products easier, cheaper and faster.

Keywords: Risk management; 14971; research; time to market; regulatory affairs; efficiency

1 Introduction

Today many research projects can be categorised as “applied research” which is also known as Research and Development (R&D) (BPB; Forschung und Entwicklung (FuE): Finanzierung und Ausgaben; 2012; www.bpb.de). The goal of those projects is to transfer recent research findings in products.

When developing medical devices for the EU-market, one of three European directives is applicable (94/42/EWG (Medical Device Directive - MDD), 98/79/EG (In Vitro Diagnostica Directive - IVDD) and 90/385/EWG (Active Implantable Medical Devices Directive)). The MDD is the most common one. As all of them have the same structure the thoughts of this paper are relevant for all of them. The most important aspect of those European directives is that essential requirements have to be fulfilled before placing devices on market. The first essential requirement contains: “The devices must be designed and manufactured in such a way that [...] they will not compromise the clinical condition or the safety of patients [...]” (MDD - Annex I), which is usually fulfilled by a risk management following ISO 14971.

To proof that all essential requirements were fulfilled a technical documentation is needed. Such a technical documentation requires great effort (the amount of overhead is not be quantified in literature, but mentioned, e.g. [4]).

The literature agrees that is important to integrate, practise and learn safety in projects throughout the complete life-cycle. [1–3, 5] Nevertheless in many projects this aspect is ignored [2]. Even if safety considerations are made they are usually not documented in a risk management file. Researches need flexibility, creativity and sufficient time to generate results and this is why research teams usually try to minimise documentation effort. Due to this development needs to start over from scratch to transfer the results into a product. This conflict between safety considerations and efficiency needs to be resolved by scaling risk management to an helpful and effective level.

2 Decision about the necessity and extent of risk management

As mentioned above, risk management should be performed in all projects researching and developing medical devices. Since medical devices are not the only products that are regulated, but all products need to be safe (see also 2001/95/EG (General Product Safety Directive)), a basic risk management is recommended for most kinds of projects.

If a decision in favour of risk management is made, the extend of risk management is scalable. Influencing factors are:

Product related work: If the final development of a product is planed directly after the actual research project the risk management activities should be elevated in comparison to a very basic proof of concept with many more steps of research.

General risk of the project: If the intended use of the project is obviously harmless (a completely harmless product is usually not possible, but some software has only very indirect and low influence on the health of humans), less risk management is necessary than in a high risk project (e.g. devices that are life-sustaining or devices with high voltages, radiation or mechanical functions).

3 Risk management method

The already mentioned standard ISO 14971 (the actual version is EN ISO 14971:2012 ”‘Application of risk management to medical devices”’) requires several steps; the following chapters show profound ideas how some important steps can be included into research projects efficiently. Nevertheless, this is not a complete listing of all necessary steps. Furthermore it is important to mention, that there are two kinds of risk management. The standard focuses on humans and their safety (“this International Standard deals with processes for managing risks, primarily to the patient, but also to the operator, other persons, other equipment and the environment.” Introduction of EN ISO 14971:2012). The other category, the risks for the project itself (e.g. financial risks due to higher amount of time, loosing know-how due to a leaving employee), is not covered by the mentioned standard. The techniques are basically the same.

3.1 Risk policy

The standard ISO 14971 requires a risk policy which usually does not exist explicitly in research projects. The risk policy can be depicted in a matrix showing how often an “accident” of a certain severity is accepted. (See example in table 1) (it is strongly suggested to replace qualitative descriptions like “sometimes” by quantitative values fitting to the project like “between 2 % and 10 %”). It is suggested to define a risk policy already for research projects. It helps to have specific numbers for discussions and decisions concerning risks. In order to minimise unnecessary overhead and due to the fact that many probabilities are not easily definable in early stages, the number of columns should be reduced to general classes. For example, the NACA-Score [6] consists of seven severities, usually the four severity-categories shown in table 1 are sufficient for research projects. Normally the risk policy is defined by the management. However, for research projects this can be carried out by the project team or the project manager. It is time saving if an experienced person makes a suggestion, since depending on the intended use, each project needs to define its own risk policy (example: The risk policy for a device for measuring blood pressure differs from the risk policy for surgery equipment).

Table 1

Risk policy - a red field indicates that the combination of probability and severity is critical while a yellow field represents a combination that can be tolerated, but ISO 14971 requires to reduced them as far as possible.

3.2 Initial risk management workshop

As research teams want to know all influences of the risk management on their project as early as possible they should identify those influences as soon as possible. An initial risk management meeting before the architecture is defined ensures that obvious risks and their countermeasures are known early enough. This initial risk management team should consist (like required by the standard) of experts of all affected parties. This includes technical experts as well as medical specialists and professionals for risk management. They should analyse each part of the project systematically and start identifying risks. In research projects it is sufficient to identify risks in different levels of detail. It is possible to focus on those risks that are somehow “critical”, meaning they are in the “red area” of the risk policy or they might have an influence on the architecture or other project decision. In this case the details of the risk should be explored in more details. If any area is identified as “not critical” it is sufficient to mention this without listing many details. This is sketched in Fig. 1.

Figure 1 This figure shows Depending on the risk categorisation, it is necessary to put more or less focus on it. This figure shows an example for focusing on critical aspects: Aspects with very low risk (green) need less effort than aspects with medium risk (yellow) or high risk(red).
Figure 1

This figure shows Depending on the risk categorisation, it is necessary to put more or less focus on it. This figure shows an example for focusing on critical aspects: Aspects with very low risk (green) need less effort than aspects with medium risk (yellow) or high risk(red).

3.3 Documenting risk management

In the later development phase everything needs to be documented according to the defined procedures (ISO 13485 describes a quality management system (QMS) for medical devices, but in some cases manufacturer do not need a complete QMS. In this case they need to define procedures for development.). However, it is important to recall that details in research projects usually are subject to many changes. This is why the documentation should be easy to change and not too extensive. Therefore the results should be digitalised, to ease changes. Possible tools will be presented later on.

3.4 Updating risk management

The standard requires a continuous risk management. This means on the one hand that any identified risk, independent from the context, should be added immediately to the risk management and on the other hand that the complete risk management should be reviewed regularly. In research projects this is even more important than in regular projects, since numerous changes in the project can result in new or changed risks. In this case two possibilities exist: a) risk is not critical, then it is just documented, without bureaucracy, but very efficient; b) risk is critical, then relevant persons need to be informed and measures (actions to reduce risks are called “risk control measures” (ISO 14971 chapters 2.19, 6.1.3) . In the following the expression “measure” is used) have to be defined together.

3.5 Measures

One of the main focuses of risk management is to control risks by implementing measures. In many cases the implementation of measures is not necessary during research phase. Therefore, the measures are the main aspect, in which the risk management can be much more efficient than in development projects.

3.5.1 Influencing aspects for implementation of risk management measures

Basically there are four aspects that should help to decide when the measure needs to be realized:

Risks for humans during research phase: If the risk during the research phase for persons is too elevated, the corresponding measures have to be implemented. But if the demonstrator is only handled by a small group of persons who know how to avoid the risk the implementation can be postponed.

Example: The device does not need an enhanced usability during research since all persons using the demonstrator know its functionality.

Influence on the architecture: If the measure has an influence on the architecture, the measure should be considered during the definition of architecture, even if it is not necessary to implement it during research phase.

Example: If the measure is “sending an alarm”, it is necessary to provide an architecture for software and hardware that provides all necessary interfaces, even if no alarm is implemented during research.

Obviousness how the measure can be realized: If it is obvious how a measure is realized, it does not need to be implemented at once. If research is needed to verify the effectiveness of a planned measure, at least an implementation of a “proof of concept” can be helpful to decide if the measure is sufficient.

Necessity for the research project: Many measures do not only affect the risk management but are also a solution for another requirement. In this case the measure should be implemented.

3.5.2 Decision for implementation

After having checked all aspects of the previous chapter it should be decided for each measure if it will be considered in the planning and architecture as well as in which time or project phase the implementation is done (e.g. month/year or “in a following development phase”). Especially if the implementation is postponed to a phase beyond the project it helps to minimise the effort of risk management in research projects.

3.6 Risk management report

A risk management report is generally not necessary during research. That is why this document usually does not need to be written. Nevertheless there are cases, where a risk management report is helpful. Some are listed here:

  1. A customer or someone else wants to use the results

  2. The device is used in some kind of study – then the risk management report needs to address at least the risks that can affect the participants of the study.

4 Risk management tools

The most important aspect of risk management is to list all known risks together with their relevant data (relevant data of a risk includes description, causes, effects, assess-ment(probability and severity according to the risk policy), measures and reassessment).

Neither the standard or the law require a special form and there exist special tools, which are normally quite expensive. Some of them are specialised on risk management and others try to depict the complete “life cycle” of the product. Nevertheless, one of the most used tools are spreadsheets that are available in each office software. Those do not provide special help, but are easy to edit, mostly available and most scientists are familiar with them. Furthermore, at least a basic evaluation can be realized easily.

5 Discussion

Even though the importance of risk management is widely accepted, there are many research projects ignoring it. One reason might be the funding policy of research calls. In those calls applied research is funded but not the developing of a product. And therefore in research proposals seldom resources for risk management and other quality related aspects are considered. So it is understandable that those aspects do not get sufficient consideration. Therefore a balance has to be found between effectiveness in the next stages, freedom of research and financing efforts used for risk management.

6 Summary

Since safety considerations are indispensable, at least a basic risk management is beneficial in research projects. During the several steps of risk management there are many possibilities to scale the effort compared to a full risk management while the main advantages of risk management can be used during research and the results are usable for a later transition to a product.

It is important to identify risks as early as possible and decide which risks are relevant and need measures during research. Especially important is to consider risks affecting the definition of the architecture to reduce expensive changes in later phases. The results should be documented in a form that is already adequate for the technical documentation although the extent can be reduced in earlier stages and detail content can be supplemented in later stages.

Including a scaled risk management in early stages reduces time to market as well as costs and improves the chance of commercialization.

Acknowledgment

Fraunhofer IIS is specialised on applied research. During the last years in the ”Department of Image Processing and Medical Engineering BMT” a method was developed how research and quality management can be combined effectively. This method was tested and improved in several research projects. Some of the results focusing on risk management are presented.

Author's Statement

  1. Conflict of interest: Authors state no conflict of interest. Material and Methods: Informed consent: Informed consent is not applicable. Ethical approval: The conducted research is not related to either human or animals use.

References

[1] BVMed (GER). Risikomanagement für Medizinprodukte. Berlin 2009.Search in Google Scholar

[2] Dössel, O. Patientensicherheit in der medizintechnischen Forschung. Bundesgesundheitsblatt-Gesundheitsforschung-Gesundheitsschutz, 2009, 52. Jg., Nr. 6, S. 579-583.10.1007/s00103-009-0848-ySearch in Google Scholar PubMed

[3] Gärtner, A. Medizinproduktesicherheit-Band 1: Medizinproduktegesetzgebung und Regelwerk. Köln: TÜV Media, 2008.Search in Google Scholar

[4] Imhoff, Michael. Risk management for medical networks in intensive care and emergency medicine–a joint position paper on IEC 80001-1, 2013Search in Google Scholar

[5] Regan, G., et al. Medical device standards’ requirements for traceability during the software development lifecycle and implementation of a traceability assessment model. Computer Standards & Interfaces, 2013, 36. Jg., Nr. 1, S. 3-9.10.1016/j.csi.2013.07.012Search in Google Scholar

[6] Schlechtriemen, T., et al. Der Münchner NACA-Score. Notfall & Rettungsmedizin, 2005, 8. Jg., Nr. 2, S. 109-111.10.1007/s10049-005-0719-5Search in Google Scholar

Published Online: 2015-9-12
Published in Print: 2015-9-1

© 2015 by Walter de Gruyter GmbH, Berlin/Boston

This article is distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Articles in the same Issue

  1. Research Article
  2. Development and characterization of superparamagnetic coatings
  3. Research Article
  4. The development of an experimental setup to measure acousto-electric interaction signal
  5. Research Article
  6. Stability analysis of ferrofluids
  7. Research Article
  8. Investigation of endothelial growth using a sensors-integrated microfluidic system to simulate physiological barriers
  9. Research Article
  10. Energy harvesting for active implants: powering a ruminal pH-monitoring system
  11. Research Article
  12. New type of fluxgate magnetometer for the heart’s magnetic fields detection
  13. Research Article
  14. Field mapping of ballistic pressure pulse sources
  15. Research Article
  16. Development of a new homecare sleep monitor using body sounds and motion tracking
  17. Research Article
  18. Noise properties of textile, capacitive EEG electrodes
  19. Research Article
  20. Detecting phase singularities and rotor center trajectories based on the Hilbert transform of intraatrial electrograms in an atrial voxel model
  21. Research Article
  22. Spike sorting: the overlapping spikes challenge
  23. Research Article
  24. Separating the effect of respiration from the heart rate variability for cases of constant harmonic breathing
  25. Research Article
  26. Locating regions of arrhythmogenic substrate by analyzing the duration of triggered atrial activities
  27. Research Article
  28. Combining different ECG derived respiration tracking methods to create an optimal reconstruction of the breathing pattern
  29. Research Article
  30. Atrial and ventricular signal averaging electrocardiography in pacemaker and cardiac resynchronization therapy
  31. Research Article
  32. Estimation of a respiratory signal from a single-lead ECG using the 4th order central moments
  33. Research Article
  34. Compressed sensing of multi-lead ECG signals by compressive multiplexing
  35. Research Article
  36. Heart rate monitoring in ultra-high-field MRI using frequency information obtained from video signals of the human skin compared to electrocardiography and pulse oximetry
  37. Research Article
  38. Synchronization in wireless biomedical-sensor networks with Bluetooth Low Energy
  39. Research Article
  40. Automated classification of stages of anaesthesia by populations of evolutionary optimized fuzzy rules
  41. Research Article
  42. Effects of sampling rate on automated fatigue recognition in surface EMG signals
  43. Research Article
  44. Closed-loop transcranial alternating current stimulation of slow oscillations
  45. Research Article
  46. Cardiac index in atrio- and interventricular delay optimized cardiac resynchronization therapy and cardiac contractility modulation
  47. Research Article
  48. The role of expert evaluation for microsleep detection
  49. Research Article
  50. The impact of baseline wander removal techniques on the ST segment in simulated ischemic 12-lead ECGs
  51. Research Article
  52. Metal artifact reduction by projection replacements and non-local prior image integration
  53. Research Article
  54. A novel coaxial nozzle for in-process adjustment of electrospun scaffolds’ fiber diameter
  55. Research Article
  56. Processing of membranes for oxygenation using the Bellhouse-effect
  57. Research Article
  58. Inkjet printing of viable human dental follicle stem cells
  59. Research Article
  60. The use of an icebindingprotein out of the snowflea Hypogastrura harveyi as a cryoprotectant in the cryopreservation of mesenchymal stem cells
  61. Research Article
  62. New NIR spectroscopy based method to determine ischemia in vivo in liver – a first study on rats
  63. Research Article
  64. QRS and QT ventricular conduction times and permanent pacemaker therapy after transcatheter aortic valve implantation
  65. Research Article
  66. Adopting oculopressure tonometry as a transient in vivo rabbit glaucoma model
  67. Research Article
  68. Next-generation vision testing: the quick CSF
  69. Research Article
  70. Improving tactile sensation in laparoscopic surgery by overcoming size restrictions
  71. Research Article
  72. Design and control of a 3-DOF hydraulic driven surgical instrument
  73. Research Article
  74. Evaluation of endourological tools to improve the diagnosis and therapy of ureteral tumors – from model development to clinical application
  75. Research Article
  76. Frequency based assessment of surgical activities
  77. Research Article
  78. “Hands free for intervention”, a new approach for transoral endoscopic surgery
  79. Research Article
  80. Pseudo-haptic feedback in medical teleoperation
  81. Research Article
  82. Feasibility of interactive gesture control of a robotic microscope
  83. Research Article
  84. Towards structuring contextual information for workflow-driven surgical assistance functionalities
  85. Research Article
  86. Towards a framework for standardized semantic workflow modeling and management in the surgical domain
  87. Research Article
  88. Closed-loop approach for situation awareness of medical devices and operating room infrastructure
  89. Research Article
  90. Kinect based physiotherapy system for home use
  91. Research Article
  92. Evaluating the microsoft kinect skeleton joint tracking as a tool for home-based physiotherapy
  93. Research Article
  94. Integrating multimodal information for intraoperative assistance in neurosurgery
  95. Research Article
  96. Respiratory motion tracking using Microsoft’s Kinect v2 camera
  97. Research Article
  98. Using smart glasses for ultrasound diagnostics
  99. Research Article
  100. Measurement of needle susceptibility artifacts in magnetic resonance images
  101. Research Article
  102. Dimensionality reduction of medical image descriptors for multimodal image registration
  103. Research Article
  104. Experimental evaluation of different weighting schemes in magnetic particle imaging reconstruction
  105. Research Article
  106. Evaluation of CT capability for the detection of thin bone structures
  107. Research Article
  108. Towards contactless optical coherence elastography with acoustic tissue excitation
  109. Research Article
  110. Development and implementation of algorithms for automatic and robust measurement of the 2D:4D digit ratio using image data
  111. Research Article
  112. Automated high-throughput analysis of B cell spreading on immobilized antibodies with whole slide imaging
  113. Research Article
  114. Tissue segmentation from head MRI: a ground truth validation for feature-enhanced tracking
  115. Research Article
  116. Video tracking of swimming rodents on a reflective water surface
  117. Research Article
  118. MR imaging of model drug distribution in simulated vitreous
  119. Research Article
  120. Studying the extracellular contribution to the double wave vector diffusion-weighted signal
  121. Research Article
  122. Artifacts in field free line magnetic particle imaging in the presence of inhomogeneous and nonlinear magnetic fields
  123. Research Article
  124. Introducing a frequency-tunable magnetic particle spectrometer
  125. Research Article
  126. Imaging of aortic valve dynamics in 4D OCT
  127. Research Article
  128. Intravascular optical coherence tomography (OCT) as an additional tool for the assessment of stent structures
  129. Research Article
  130. Simple concept for a wide-field lensless digital holographic microscope using a laser diode
  131. Research Article
  132. Intraoperative identification of somato-sensory brain areas using optical imaging and standard RGB camera equipment – a feasibility study
  133. Research Article
  134. Respiratory surface motion measurement by Microsoft Kinect
  135. Research Article
  136. Improving image quality in EIT imaging by measurement of thorax excursion
  137. Research Article
  138. A clustering based dual model framework for EIT imaging: first experimental results
  139. Research Article
  140. Three-dimensional anisotropic regularization for limited angle tomography
  141. Research Article
  142. GPU-based real-time generation of large ultrasound volumes from freehand 3D sweeps
  143. Research Article
  144. Experimental computer tomograph
  145. Research Article
  146. US-tracked steered FUS in a respiratory ex vivo ovine liver phantom
  147. Research Article
  148. Contribution of brownian rotation and particle assembly polarisation to the particle response in magnetic particle spectrometry
  149. Research Article
  150. Preliminary investigations of magnetic modulated nanoparticles for microwave breast cancer detection
  151. Research Article
  152. Construction of a device for magnetic separation of superparamagnetic iron oxide nanoparticles
  153. Research Article
  154. An IHE-conform telecooperation platform supporting the treatment of dementia patients
  155. Research Article
  156. Automated respiratory therapy system based on the ARDSNet protocol with systemic perfusion control
  157. Research Article
  158. Identification of surgical instruments using UHF-RFID technology
  159. Research Article
  160. A generic concept for the development of model-guided clinical decision support systems
  161. Research Article
  162. Evaluation of local alterations in femoral bone mineral density measured via quantitative CT
  163. Research Article
  164. Creating 3D gelatin phantoms for experimental evaluation in biomedicine
  165. Research Article
  166. Influence of short-term fixation with mixed formalin or ethanol solution on the mechanical properties of human cortical bone
  167. Research Article
  168. Analysis of the release kinetics of surface-bound proteins via laser-induced fluorescence
  169. Research Article
  170. Tomographic particle image velocimetry of a water-jet for low volume harvesting of fat tissue for regenerative medicine
  171. Research Article
  172. Wireless medical sensors – context, robustness and safety
  173. Research Article
  174. Sequences for real-time magnetic particle imaging
  175. Research Article
  176. Speckle-based off-axis holographic detection for non-contact photoacoustic tomography
  177. Research Article
  178. A machine learning approach for planning valve-sparing aortic root reconstruction
  179. Research Article
  180. An in-ear pulse wave velocity measurement system using heart sounds as time reference
  181. Research Article
  182. Measuring different oxygenation levels in a blood perfusion model simulating the human head using NIRS
  183. Research Article
  184. Multisegmental fusion of the lumbar spine a curse or a blessing?
  185. Research Article
  186. Numerical analysis of the biomechanical complications accompanying the total hip replacement with NANOS-Prosthetic: bone remodelling and prosthesis migration
  187. Research Article
  188. A muscle model for hybrid muscle activation
  189. Research Article
  190. Mathematical, numerical and in-vitro investigation of cooling performance of an intra-carotid catheter for selective brain hypothermia
  191. Research Article
  192. An ideally parameterized unscented Kalman filter for the inverse problem of electrocardiography
  193. Research Article
  194. Interactive visualization of cardiac anatomy and atrial excitation for medical diagnosis and research
  195. Research Article
  196. Virtualizing clinical cases of atrial flutter in a fast marching simulation including conduction velocity and ablation scars
  197. Research Article
  198. Mesh structure-independent modeling of patient-specific atrial fiber orientation
  199. Research Article
  200. Accelerating mono-domain cardiac electrophysiology simulations using OpenCL
  201. Research Article
  202. Understanding the cellular mode of action of vernakalant using a computational model: answers and new questions
  203. Research Article
  204. A java based simulator with user interface to simulate ventilated patients
  205. Research Article
  206. Evaluation of an algorithm to choose between competing models of respiratory mechanics
  207. Research Article
  208. Numerical simulation of low-pulsation gerotor pumps for use in the pharmaceutical industry and in biomedicine
  209. Research Article
  210. Numerical and experimental flow analysis in centifluidic systems for rapid allergy screening tests
  211. Research Article
  212. Biomechanical parameter determination of scaffold-free cartilage constructs (SFCCs) with the hyperelastic material models Yeoh, Ogden and Demiray
  213. Research Article
  214. FPGA controlled artificial vascular system
  215. Research Article
  216. Simulation based investigation of source-detector configurations for non-invasive fetal pulse oximetry
  217. Research Article
  218. Test setup for characterizing the efficacy of embolic protection devices
  219. Research Article
  220. Impact of electrode geometry on force generation during functional electrical stimulation
  221. Research Article
  222. 3D-based visual physical activity assessment of children
  223. Research Article
  224. Realtime assessment of foot orientation by Accelerometers and Gyroscopes
  225. Research Article
  226. Image based reconstruction for cystoscopy
  227. Research Article
  228. Image guided surgery innovation with graduate students - a new lecture format
  229. Research Article
  230. Multichannel FES parameterization for controlling foot motion in paretic gait
  231. Research Article
  232. Smartphone supported upper limb prosthesis
  233. Research Article
  234. Use of quantitative tremor evaluation to enhance target selection during deep brain stimulation surgery for essential tremor
  235. Research Article
  236. Evaluation of adhesion promoters for Parylene C on gold metallization
  237. Research Article
  238. The influence of metallic ions from CoCr28Mo6 on the osteogenic differentiation and cytokine release of human osteoblasts
  239. Research Article
  240. Increasing the visibility of thin NITINOL vascular implants
  241. Research Article
  242. Possible reasons for early artificial bone failure in biomechanical tests of ankle arthrodesis systems
  243. Research Article
  244. Development of a bending test procedure for the characterization of flexible ECoG electrode arrays
  245. Research Article
  246. Tubular manipulators: a new concept for intracochlear positioning of an auditory prosthesis
  247. Research Article
  248. Investigation of the dynamic diameter deformation of vascular stents during fatigue testing with radial loading
  249. Research Article
  250. Electrospun vascular grafts with anti-kinking properties
  251. Research Article
  252. Integration of temperature sensors in polyimide-based thin-film electrode arrays
  253. Research Article
  254. Use cases and usability challenges for head-mounted displays in healthcare
  255. Research Article
  256. Device- and service profiles for integrated or systems based on open standards
  257. Research Article
  258. Risk management for medical devices in research projects
  259. Research Article
  260. Simulation of varying femoral attachment sites of medial patellofemoral ligament using a musculoskeletal multi-body model
  261. Research Article
  262. Does enhancing consciousness for strategic planning processes support the effectiveness of problem-based learning concepts in biomedical education?
  263. Research Article
  264. SPIO processing in macrophages for MPI: The breast cancer MPI-SNLB-concept
  265. Research Article
  266. Numerical simulations of airflow in the human pharynx of OSAHS patients
https://doi.org/10.1515/cdbme-2015-0129
Keywords for this article
Risk management; 14971; research; time to market; regulatory affairs; efficiency
Creative Commons
BY-NC-ND 3.0

Articles in the same Issue

  1. Research Article
  2. Development and characterization of superparamagnetic coatings
  3. Research Article
  4. The development of an experimental setup to measure acousto-electric interaction signal
  5. Research Article
  6. Stability analysis of ferrofluids
  7. Research Article
  8. Investigation of endothelial growth using a sensors-integrated microfluidic system to simulate physiological barriers
  9. Research Article
  10. Energy harvesting for active implants: powering a ruminal pH-monitoring system
  11. Research Article
  12. New type of fluxgate magnetometer for the heart’s magnetic fields detection
  13. Research Article
  14. Field mapping of ballistic pressure pulse sources
  15. Research Article
  16. Development of a new homecare sleep monitor using body sounds and motion tracking
  17. Research Article
  18. Noise properties of textile, capacitive EEG electrodes
  19. Research Article
  20. Detecting phase singularities and rotor center trajectories based on the Hilbert transform of intraatrial electrograms in an atrial voxel model
  21. Research Article
  22. Spike sorting: the overlapping spikes challenge
  23. Research Article
  24. Separating the effect of respiration from the heart rate variability for cases of constant harmonic breathing
  25. Research Article
  26. Locating regions of arrhythmogenic substrate by analyzing the duration of triggered atrial activities
  27. Research Article
  28. Combining different ECG derived respiration tracking methods to create an optimal reconstruction of the breathing pattern
  29. Research Article
  30. Atrial and ventricular signal averaging electrocardiography in pacemaker and cardiac resynchronization therapy
  31. Research Article
  32. Estimation of a respiratory signal from a single-lead ECG using the 4th order central moments
  33. Research Article
  34. Compressed sensing of multi-lead ECG signals by compressive multiplexing
  35. Research Article
  36. Heart rate monitoring in ultra-high-field MRI using frequency information obtained from video signals of the human skin compared to electrocardiography and pulse oximetry
  37. Research Article
  38. Synchronization in wireless biomedical-sensor networks with Bluetooth Low Energy
  39. Research Article
  40. Automated classification of stages of anaesthesia by populations of evolutionary optimized fuzzy rules
  41. Research Article
  42. Effects of sampling rate on automated fatigue recognition in surface EMG signals
  43. Research Article
  44. Closed-loop transcranial alternating current stimulation of slow oscillations
  45. Research Article
  46. Cardiac index in atrio- and interventricular delay optimized cardiac resynchronization therapy and cardiac contractility modulation
  47. Research Article
  48. The role of expert evaluation for microsleep detection
  49. Research Article
  50. The impact of baseline wander removal techniques on the ST segment in simulated ischemic 12-lead ECGs
  51. Research Article
  52. Metal artifact reduction by projection replacements and non-local prior image integration
  53. Research Article
  54. A novel coaxial nozzle for in-process adjustment of electrospun scaffolds’ fiber diameter
  55. Research Article
  56. Processing of membranes for oxygenation using the Bellhouse-effect
  57. Research Article
  58. Inkjet printing of viable human dental follicle stem cells
  59. Research Article
  60. The use of an icebindingprotein out of the snowflea Hypogastrura harveyi as a cryoprotectant in the cryopreservation of mesenchymal stem cells
  61. Research Article
  62. New NIR spectroscopy based method to determine ischemia in vivo in liver – a first study on rats
  63. Research Article
  64. QRS and QT ventricular conduction times and permanent pacemaker therapy after transcatheter aortic valve implantation
  65. Research Article
  66. Adopting oculopressure tonometry as a transient in vivo rabbit glaucoma model
  67. Research Article
  68. Next-generation vision testing: the quick CSF
  69. Research Article
  70. Improving tactile sensation in laparoscopic surgery by overcoming size restrictions
  71. Research Article
  72. Design and control of a 3-DOF hydraulic driven surgical instrument
  73. Research Article
  74. Evaluation of endourological tools to improve the diagnosis and therapy of ureteral tumors – from model development to clinical application
  75. Research Article
  76. Frequency based assessment of surgical activities
  77. Research Article
  78. “Hands free for intervention”, a new approach for transoral endoscopic surgery
  79. Research Article
  80. Pseudo-haptic feedback in medical teleoperation
  81. Research Article
  82. Feasibility of interactive gesture control of a robotic microscope
  83. Research Article
  84. Towards structuring contextual information for workflow-driven surgical assistance functionalities
  85. Research Article
  86. Towards a framework for standardized semantic workflow modeling and management in the surgical domain
  87. Research Article
  88. Closed-loop approach for situation awareness of medical devices and operating room infrastructure
  89. Research Article
  90. Kinect based physiotherapy system for home use
  91. Research Article
  92. Evaluating the microsoft kinect skeleton joint tracking as a tool for home-based physiotherapy
  93. Research Article
  94. Integrating multimodal information for intraoperative assistance in neurosurgery
  95. Research Article
  96. Respiratory motion tracking using Microsoft’s Kinect v2 camera
  97. Research Article
  98. Using smart glasses for ultrasound diagnostics
  99. Research Article
  100. Measurement of needle susceptibility artifacts in magnetic resonance images
  101. Research Article
  102. Dimensionality reduction of medical image descriptors for multimodal image registration
  103. Research Article
  104. Experimental evaluation of different weighting schemes in magnetic particle imaging reconstruction
  105. Research Article
  106. Evaluation of CT capability for the detection of thin bone structures
  107. Research Article
  108. Towards contactless optical coherence elastography with acoustic tissue excitation
  109. Research Article
  110. Development and implementation of algorithms for automatic and robust measurement of the 2D:4D digit ratio using image data
  111. Research Article
  112. Automated high-throughput analysis of B cell spreading on immobilized antibodies with whole slide imaging
  113. Research Article
  114. Tissue segmentation from head MRI: a ground truth validation for feature-enhanced tracking
  115. Research Article
  116. Video tracking of swimming rodents on a reflective water surface
  117. Research Article
  118. MR imaging of model drug distribution in simulated vitreous
  119. Research Article
  120. Studying the extracellular contribution to the double wave vector diffusion-weighted signal
  121. Research Article
  122. Artifacts in field free line magnetic particle imaging in the presence of inhomogeneous and nonlinear magnetic fields
  123. Research Article
  124. Introducing a frequency-tunable magnetic particle spectrometer
  125. Research Article
  126. Imaging of aortic valve dynamics in 4D OCT
  127. Research Article
  128. Intravascular optical coherence tomography (OCT) as an additional tool for the assessment of stent structures
  129. Research Article
  130. Simple concept for a wide-field lensless digital holographic microscope using a laser diode
  131. Research Article
  132. Intraoperative identification of somato-sensory brain areas using optical imaging and standard RGB camera equipment – a feasibility study
  133. Research Article
  134. Respiratory surface motion measurement by Microsoft Kinect
  135. Research Article
  136. Improving image quality in EIT imaging by measurement of thorax excursion
  137. Research Article
  138. A clustering based dual model framework for EIT imaging: first experimental results
  139. Research Article
  140. Three-dimensional anisotropic regularization for limited angle tomography
  141. Research Article
  142. GPU-based real-time generation of large ultrasound volumes from freehand 3D sweeps
  143. Research Article
  144. Experimental computer tomograph
  145. Research Article
  146. US-tracked steered FUS in a respiratory ex vivo ovine liver phantom
  147. Research Article
  148. Contribution of brownian rotation and particle assembly polarisation to the particle response in magnetic particle spectrometry
  149. Research Article
  150. Preliminary investigations of magnetic modulated nanoparticles for microwave breast cancer detection
  151. Research Article
  152. Construction of a device for magnetic separation of superparamagnetic iron oxide nanoparticles
  153. Research Article
  154. An IHE-conform telecooperation platform supporting the treatment of dementia patients
  155. Research Article
  156. Automated respiratory therapy system based on the ARDSNet protocol with systemic perfusion control
  157. Research Article
  158. Identification of surgical instruments using UHF-RFID technology
  159. Research Article
  160. A generic concept for the development of model-guided clinical decision support systems
  161. Research Article
  162. Evaluation of local alterations in femoral bone mineral density measured via quantitative CT
  163. Research Article
  164. Creating 3D gelatin phantoms for experimental evaluation in biomedicine
  165. Research Article
  166. Influence of short-term fixation with mixed formalin or ethanol solution on the mechanical properties of human cortical bone
  167. Research Article
  168. Analysis of the release kinetics of surface-bound proteins via laser-induced fluorescence
  169. Research Article
  170. Tomographic particle image velocimetry of a water-jet for low volume harvesting of fat tissue for regenerative medicine
  171. Research Article
  172. Wireless medical sensors – context, robustness and safety
  173. Research Article
  174. Sequences for real-time magnetic particle imaging
  175. Research Article
  176. Speckle-based off-axis holographic detection for non-contact photoacoustic tomography
  177. Research Article
  178. A machine learning approach for planning valve-sparing aortic root reconstruction
  179. Research Article
  180. An in-ear pulse wave velocity measurement system using heart sounds as time reference
  181. Research Article
  182. Measuring different oxygenation levels in a blood perfusion model simulating the human head using NIRS
  183. Research Article
  184. Multisegmental fusion of the lumbar spine a curse or a blessing?
  185. Research Article
  186. Numerical analysis of the biomechanical complications accompanying the total hip replacement with NANOS-Prosthetic: bone remodelling and prosthesis migration
  187. Research Article
  188. A muscle model for hybrid muscle activation
  189. Research Article
  190. Mathematical, numerical and in-vitro investigation of cooling performance of an intra-carotid catheter for selective brain hypothermia
  191. Research Article
  192. An ideally parameterized unscented Kalman filter for the inverse problem of electrocardiography
  193. Research Article
  194. Interactive visualization of cardiac anatomy and atrial excitation for medical diagnosis and research
  195. Research Article
  196. Virtualizing clinical cases of atrial flutter in a fast marching simulation including conduction velocity and ablation scars
  197. Research Article
  198. Mesh structure-independent modeling of patient-specific atrial fiber orientation
  199. Research Article
  200. Accelerating mono-domain cardiac electrophysiology simulations using OpenCL
  201. Research Article
  202. Understanding the cellular mode of action of vernakalant using a computational model: answers and new questions
  203. Research Article
  204. A java based simulator with user interface to simulate ventilated patients
  205. Research Article
  206. Evaluation of an algorithm to choose between competing models of respiratory mechanics
  207. Research Article
  208. Numerical simulation of low-pulsation gerotor pumps for use in the pharmaceutical industry and in biomedicine
  209. Research Article
  210. Numerical and experimental flow analysis in centifluidic systems for rapid allergy screening tests
  211. Research Article
  212. Biomechanical parameter determination of scaffold-free cartilage constructs (SFCCs) with the hyperelastic material models Yeoh, Ogden and Demiray
  213. Research Article
  214. FPGA controlled artificial vascular system
  215. Research Article
  216. Simulation based investigation of source-detector configurations for non-invasive fetal pulse oximetry
  217. Research Article
  218. Test setup for characterizing the efficacy of embolic protection devices
  219. Research Article
  220. Impact of electrode geometry on force generation during functional electrical stimulation
  221. Research Article
  222. 3D-based visual physical activity assessment of children
  223. Research Article
  224. Realtime assessment of foot orientation by Accelerometers and Gyroscopes
  225. Research Article
  226. Image based reconstruction for cystoscopy
  227. Research Article
  228. Image guided surgery innovation with graduate students - a new lecture format
  229. Research Article
  230. Multichannel FES parameterization for controlling foot motion in paretic gait
  231. Research Article
  232. Smartphone supported upper limb prosthesis
  233. Research Article
  234. Use of quantitative tremor evaluation to enhance target selection during deep brain stimulation surgery for essential tremor
  235. Research Article
  236. Evaluation of adhesion promoters for Parylene C on gold metallization
  237. Research Article
  238. The influence of metallic ions from CoCr28Mo6 on the osteogenic differentiation and cytokine release of human osteoblasts
  239. Research Article
  240. Increasing the visibility of thin NITINOL vascular implants
  241. Research Article
  242. Possible reasons for early artificial bone failure in biomechanical tests of ankle arthrodesis systems
  243. Research Article
  244. Development of a bending test procedure for the characterization of flexible ECoG electrode arrays
  245. Research Article
  246. Tubular manipulators: a new concept for intracochlear positioning of an auditory prosthesis
  247. Research Article
  248. Investigation of the dynamic diameter deformation of vascular stents during fatigue testing with radial loading
  249. Research Article
  250. Electrospun vascular grafts with anti-kinking properties
  251. Research Article
  252. Integration of temperature sensors in polyimide-based thin-film electrode arrays
  253. Research Article
  254. Use cases and usability challenges for head-mounted displays in healthcare
  255. Research Article
  256. Device- and service profiles for integrated or systems based on open standards
  257. Research Article
  258. Risk management for medical devices in research projects
  259. Research Article
  260. Simulation of varying femoral attachment sites of medial patellofemoral ligament using a musculoskeletal multi-body model
  261. Research Article
  262. Does enhancing consciousness for strategic planning processes support the effectiveness of problem-based learning concepts in biomedical education?
  263. Research Article
  264. SPIO processing in macrophages for MPI: The breast cancer MPI-SNLB-concept
  265. Research Article
  266. Numerical simulations of airflow in the human pharynx of OSAHS patients
Sign up now to receive a 20% welcome discount
Institutional Access
How does access work?
Have an idea on how to improve our website?
Please write us.
© 2025 De Gruyter Brill
Downloaded on 7.9.2025 from https://www.degruyterbrill.com/document/doi/10.1515/cdbme-2015-0129/html
Scroll to top button