March 08th, 2017
OPENING REMARKS & OVERVIEW ON THE MEDICAL TECHNOLOGY MARKET IN BADEN-WÜRTTEMBERG
SMART Implants and Customized Medical Devices
Failed operations, inflammatory reactions, implant loss and resulting re-operations burden the German health system with 1,000,000,000 euros annually: Chronic inflammatory reactions and poor ingrowth of implants are the reason for the above described complication rates. Clinical investigations show clearly that surfaces of implants used must be cell-attractively functionalized and engineered. MIMICKING BONE TECHNOLOGY (MBT), developed by stimOS GmbH, works like a "stealth cap", a “magic hood” for the implant. The patient's organism perceives the implant no longer as a piece of artificial material, but recognizes the implant as bone-identic material - implants are better integrated, inflammations are avoided. This unique refining method (MBT) can be used on all implant materials. In addition, different active substances can be embedded in the modified implant surface. They can be released and accurately dosed at the desired location in the patient's body after operation.
MedTech Report 2016
Presentation of the current MedTech Report 2016 and its history as well as a discussion with the participants. It involves major changes in the purchasing behavior of customers (essentially hospitals that are exposed to high cost pressures) which have an impact on the growth of the medtech industry as a whole as well as implications for the entire innovation process and business models.
Process Technologies for Future Intervention Rooms
Individualized, precise and gentle interventions deep inside the body of the patient are the buzz words of medical treatment today. The clinical methods, e.g. from intervential radiology, radiotherapy but even from biotechnology, have been developed in this way recent years and are now available. However the complexity of the procedures in intervention rooms grows extremely at the same time. Performing diagnosis and therapy straight or the need of intra-operative imaging and multi-modal data acquisition etc. require the change from a workshop to integrated, controlled and semi-automated processes in the intervention room. This talk will give an overview of the first results of the architecture of this new generation of intervention room.
Medical Device Requirements to OEM Manufacturer - an OEM view with examples for Endoscopy and Ophthalmology
A real partnership for the development and the fabrication of medical devices and IVDs becomes more and more important with the view to safe and efficacious solutions in a regulated environment. The workshop illustrates on one hand the customer requirements with a view to the technical as well the regulative aspects, on the other hand the needed OEM support for the technical file with a view to solutions to protect the know-how in the development and fabrication phase also. That leads to a partnership for a fast and reliable market entrance under regulated conditions. Realization examples will be shown in the field of endoscopy and ophthalmology, production technologies for small and high volume production will be discussed as well as solutions under the roof of the necessary implementation of the specific medical device regulations at the manufacturer side.
WhatsApp vs. mobile medical (device) apps
Digital radiological images are essential in modern traumatology, orthopedic surgery, oncology and may other medical fields. Access to this imaging data is however often limited due to a restricted number of workstations. An approach to overcome this limitation is to make use of mobile devices, like tablets and smartphones. This talk tries to give an overview of state-of-art methods used to simplify image access for physicians, and to discuss the challenges and problems that come along with mobile devices in daily clinical workflows.
REVISION OF THE EUROPEAN MEDICAL DEVICE REGULATION FROM A GERMAN PERSPECTIVE
Safety Requirements are being increased for manufacturers, with effects on notified bodies and hospitals. This presentation provides an overview of the approaching changes.
Challenges 2017 for medical device reimbursement in the inpatient setting in Germany
In 2015 two new laws were passed which have an impact on specific medical devices used in the inpatient setting in Germany. On the one hand, from 2016 onwards, therapeutic or diagnostic methods using high risk medical devices, if fulfilling specific criteria, have to undergo a Health Technology Assessment process at the Joint Federal Committee (G-BA). On the other hand, German DRGs will be differently calculated for 2017 and beyond, targeting a monetary reallocation from material cost intensive to personnel and infrastructure intensive case constellations. Both developments may put pressure on specific devices and their market access, from different directions. The presentation will summarize the new processes, highlight the challenges for affected devices and outline considerations from an industry perspective.
Technologies for ultra-miniaturized implants
The challenge of integrating an increasing number of functionalities into always thinner and smaller implants requires the combination of several integration and packaging technologies. We will present some of the custom integration processes we developed among others for die-stacking. Our examples will include the design of an ultra-compact multi-die class III implant - starting from a proof of concept that had the size of a sheet of paper, we used die stacking to integrate all required functionalities and provide electrical feedthrough connection in an extremely reduced volume. We ended up with a packaging no bigger than a one-cent coin.
REQUIREMENTS AND CLASSIFICATION OF PCBS FOR MEDICAL APPLICATIONS - IPC Medical Standard for PCB
Electronics for Medical applications are today made without a standardized requirement to the Printed Circuit Board (PCB). The manufacturer decides himself which standard and reliability class, to use in his PCB specification. Elmatica suggested in 2016, to create a Medical addendum to the existing PCB standards IPC-6012d for rigid PCB, and IPC-6013C for PCB with Flexible materials. At Electronica 2016, Elmatica and IPC started a task group, to develop a standard requirement for PCBs used in Medical applications. This presentation will show current status, how the standard will relate to Medical reliability and Risk assessments, and give a frame description of the new standard. The new standard will be mandatory for all Electronic devices, used in Medical Applications.
Cloud-based training for medical product advisers
In Germany and Austria medical product advisers have to be trained on a regular basis according to national law. In cooperation with a globally active industrial medical technology company, IMC, a leading digital training provider, developed a standardised e-learning concept, which will be presented.
DORA orchestrates your hospital workflow and logistics
The surgical pathway is a complex, cost-intensive activity within a hospital that should be managed efficiently. A Digital Operating Room Assistant (DORA) manages the scheduling of the operating theatre through real-time monitoring of all critical steps in the perioperative process and presents this information in a structured and understandable fashion to the personnel. DORA optimizes the operating room (OR) planning and scheduling by predicting OR time using the information that is available in the preoperative and perioperative phase. This includes both patient characteristics (e.g., age, gender, co-morbidity), and information that can be extracted from the OR environment in real-time, like the use and status of instruments and equipment.
3D Printing in Healthcare - Driving Innovation for Medical OEMs
It is a pleasure to introduce our Vision for 3D Printing within Healthcare. We will focus 3D-Printing Applications within the Product Life Cycle of a Medical Device and will highlight market requirements, challenges and drivers for the Medical device industry. Stratasys will provide a clear picture on how 3D Printing technology can help the industry to create own success stories.
March 09th, 2017
Immunomodulatory Biomaterials: Hydrogel based Systems to Control Foreign Body Response
Hydrogels are versatile structures for cell encapsulation due to their similarity to the hydrated environment of extracellular Matrix (ECM). Several crosslinking methods are possible to obtain cell-laden hydrogels; including physical, enzymatic and photocrosslinking. They are not only a strong tool for in vivo cell therapy and tissue engineering applications, but they also provide a reliable platform for 3D modelling of cellular interactions and cell response to biological events in vitro. In recent years, our research unit has focused on the utilization of hydrogels for immunomodulation around implants and spatially controlled incorporation of cellular components to titanium implants via development of fast gelling hydrogel/ porous titanium hybrid structures for tracheal replacement. The physicochemical characteristics of the hydrogels are crucial for their successful application in a given clinical condition. For example in order to have a precise control over cell phenotypes (such as macrophage phenotype), the composition of the hydrogel should provide a microenvironment conducive to the desired phenotype. This requires modified, crosslinkable ECM components such as Hyaluronic Acid (HA), Collagen or macromolecules that contain aminoacid sequences or biological signals that are recognized by the cells such as Gelatin and Polyarginine . In this talk, the hypothesis driven selection of hydrogel components will be explained for the specific example of macrophage phenotype manipulation. Potential clinical applications of immunomodulatory systems in medical device industry will be covered.
Dermaject® intradermal injection device
We present dermaject® intradermal injection device, a novel intradermal injection device for using the intradermal or intracutaneous route. The underlying injection technology of dermaject® intradermal injection device was tested in numerous ex vivo and in vivo experiments, demonstrating safety, easy handling and leak tightness. The design is user-friendly, small and considered for single use in humans. Specific immune response of vaccines was shown using the technology. dermaject® precisely and easily inserts a thin cannula (e. g. 30 Gauge) into the dermis at a well-defined angle, mimicking the Mantoux method. Wrinkle formation usually occurring during the insertion process is effectively compensated for by partial retraction of the cannula. Handling of the device is simple. A specially developed mechanism shall protect against needlestick injuries. Intradermal drug delivery, compared to subcutaneous drug delivery, provides numerous benefits, such as significantly more effective vaccine and immunotherapy action, faster bloodstream absorption and higher bioavailability. With the newly introduced, economical dermaject® intradermal injection device, intradermal injections can be performed reliably. Therefore, it is supposed to be a highly clinically relevant solution for all parenteral substances and fluids suitable for administration into the skin.
Organs-on-a-chip: Next generation in vitro tissue models as alternatives to animal testing
There is an urgent need in pharmaceutical industry to effectively and efficiently screen potential drug compounds during early stages to assess both effectiveness and toxicity. Drug discovery and development today is hampered by high failure rates attributed to the reliance on non-human animal models employed during safety and efficacy testing. In recent years, microphysiological organ-on-a-chip systems have developed from a conceptual idea to a feasible alternative for animal models, recognized by academic researchers, pharma industry, and regulatory agencies. Organ-on-a-chip systems combine the advantages of traditional cell assays (human genetic background) and animal models (3D tissues and complex circulation), and have the potential to significantly reduce animal testing and increase the overall predictivity of pre-clinical testing. In the Department of Cell and Tissue Engineering at Fraunhofer IGB, our interdisciplinary team of experts develops advanced organ-on-a-chip systems by integrating human iPS cell derived tissues into microfluidic environments
Plasma-technical solutions for tailoring medical device surfaces
The challenge for materials to be designed for interaction with biological systems is to induce the appropriate reaction of the biological system in contact. It is well known that the surface structure and the chemical composition will influence the biological response. A lot of research has been done to understand and modulate the processes occurring between cells and surfaces (mediated by the extracellular matrix) by varying the structure and composition of the surfaces in a well-defined way. Nevertheless, this field is far away from a quantitative understanding due to diversity of parameters like the kind of surface functional groups, their amount and distribution at the surface as well as the partial electrical charges due to their presence. Tailoring the latter properties opens a wide field of releasing/absorbing systems to modulate the interaction with biological systems. Considering the requirements there are several methods available to modify surfaces. For this purpose e.g. plasma-based techniques are used at Fraunhofer IGB, because their interaction with materials is restricted to the outer surface only, and with such treatment almost all polymeric surfaces can be finished with the appropriate chemical composition. Examples will be given.
Therapy Planning in Oncology by Using Biomarker Information
Beside surgery and irradation the drug treatment is the major tool to treat cancer patients. In order to find the best treatment regimen there are approved and new diagnostic options available. This is of particular interest since the costs especially for the new targeted drugs are high and the preselection of the susceptible patient population is of health economic interest. The approved diagnostic tests are companion diagnostics and other biomarkers which help to predict the efficacy of drugs. Most of the biomarkers are based on DNA data and some on protein data. In addition there is also the biomarker information available that can be obtained from viable tumor tissue samples. All approaches will be introduced and discussed for their advantages and disadvantages.
Smart and lean medical device development
The successful development of a medical device is guaranteed with a comprehensive interdisciplinary system architecture. Avoid unnecessary development loops by misleading and untraceable labels. Focus instead on the implementation of your ideas and wishes, the standard-compliant documentation is self-evident.
Telemedicine - How it can work
With the changing demographic situation, longer living expectation, less doctors in rural areas, faster acting drugs and new technology there is no doubt, that the way of medical treatment for patients will and has to change. Telemedical treatment can be one solution to solve the challenges, however the way and process how this is done is a preliminary factor for the success and the reliability for the improved outcome. Professional delegation models is one way to go forward. The presentation will give an example what and how it can be done, also showing today’s existing limitations.
Time- and material saving laser microtomy for hard tissue and implants
Histological analysis often is a mandatory, yet laborious part of preclinical study design in regenerative medicine. Especially the preparation of hard tissue samples or samples containing implants requires specialized technicians to perform sections with either microtomes or ground section technology. Quality of the cutting result is limited using ground section technology, or bone has to be decalcified before cutting. Laser microtomy is a novel method to prepare thin sections for histological analysis. Thin sections of non-decalcified hard tissue or implanted tissue (e.g. stented vessels) can be generated in adequate thickness and quality. Almost serial sectioning at 10 μm is possible. So the tremendous material loss associated with ground sectioning is significantly minimized. A further big advantage is time saving, both, the overall processing time and the technician working time. Thereby, laser microtomy works very economically and efficiently at equal quality.
Latest advancements in microfluidic flow control and microfabrication technologies for Diagnostic, Organ-on-Chip and MEMS applications
Micronit microtechnologies provides innovative solutions for Lab-on-a-Chip and MEMS applications. After a brief company update, this presentation will focus on the latest advancements in active and passive microfluidic flow control, and give more insight into Micronit’s platform technologies that are used in customized product development for Point-of-Care, Organ-on-Chip and MEMS. Various examples in these application areas will be discussed. Microfabrication strategies will be shown which do not require adhesives for the integration of materials relevant to the above mentioned fields.