MITTWOCH 07. MÄRZ 2018
OPENING REMARKS & OVERVIEW ON THE MEDICAL TECHNOLOGY MARKET IN BADEN-WÜRTTEMBERG
Regulatory work is strategic planning - and standards are some useful tools
You may ask yourself: Do I really need an ISO 13485 certificate? Yes, you do! Of course, you can manage your business with EC type examinations and conformity assessments, but - from the experience of many other firms - one can confidently say that: You do NOT want to work this way. Working with standards makes your work much easier.
Approaches to customized healthcare
Customized piece one flow is digital process chains is key in many industries. Medical device industries has to face this issue for efficient treatment as well. Challenges and examples are being discussed. The new “Leistungszentrum Mass Customization” of Uni Stuttgart and Fraunhofer Stuttgart is presented.
Telemedicine and E-Health
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.
Structured data in radiology and its importance for personalized cancer medicine
Health care is changing. The better understanding of diseases and the availability of more valuable patient-specific parameters describing those diseases lead to tailor-made therapy approaches – especially in cancer. Different disciplines contribute to first in getting the right diagnosis and second in assessing the therapy response – so does radiology. The presentation will focus on an innovative approach of how to transfer radiological images into relevant data by discussing the buzzword “Personalized Medicine”, by showing new opportunities in cancer care and by introducing the importance of structured data in radiology.
The famous versus the inconvenient – or the dawn and the rise of 3D-culture systems
One of the greatest impacts on in vitro cell biology was the introduction of three-dimensional culture systems more than six decades ago and may be called the dawn of 3D-tissue culture. And although the advantages were obvious, this field of research was a sleeping beauty ever since the 1970s when multicellular spheroids were discovered as ideal tumor models. With this second starting signal the rise of organotypical culture systems began and is still continuing. The talk will give an overview of current 3D cell culture approaches for fundamental research as well as industrial screening applications.
CE certification of dermaject® intradermal injection device – regulatory experiences from a start-up perspective
Verapido Medical is the drug delivery medical device spin-off of Hahn-Schickard. The company focuses on developing innovative, safe, and convenient devices for injection and infusion of liquid drugs into or below the skin. Verapido’s most advanced product to date is the dermaject® intradermal injection device, a specialty device for intradermal injections into the uppermost layer of the skin at a depth of 0.77 - 0.8 mm perpendicular to the surface of the skin (intradermally or intracutaneously). dermaject® is a sterile, single use class IIa medical device and was regulated in the European Community using a conformity assessment procedure in collaboration with a notified body supervising the conformity assessment procedure. A quality management system according to EN ISO 13485 was established, according to which, and according to the essential requirements, dermaject® was developed. Compliance was demonstrated by the preparation of the technical documentation including risk management, usability dossier and clinical evaluation. Finally, production is carried out under supervision of the suppliers.
Reducing friction with an intelligent combination of design and coating
Many applications using an elastomeric material experience issues with friction. This problem is well known in syringes. Friction between the elastomeric seal and the barrel of the syringe requires relatively high pressure to move the piston, making it difficult for the physician to provide an accurate dose of medication. This problem is typically solved by using special lubricants, but they can have disadvantages during the manufacturing process as well as for the patient. This presentation demonstratesthat by combining an intelligent design withan innovative medical coating, a superior alternative can be developed to solve these challenges.
Certainty in 30 minutes: Detecting antibiotic-resistant bacteria during patient admission
Millions of hospitalized patients are infected unnecessarily every year by resistant pathogens that are brought in by other patients. SpinDiag is developing an easy-to-use, compact and automated point-of-care system for the screening for drug-resistant pathogens. The device detects the most prevalent antibiotic resistances. This allows targeted isolation of infected or colonized patients to avoid spread of resistant pathogens in hospitals.
To be confirmed
To be confirmed
Digitalisation – Is that The Resolution for Healthcare?
The healthcare sector is undergoing an unprecedented change: digitalization, automation and autonomization are accelerating a technological change offering a wide range of possible applications in healthcare. Already today, first digital initiatives are pushing the boundaries of medical and economic freedom. However, the digital transformation also forces traditional service providers to rethink their strategy. In his presentation, Christian Egle will guide the audience through the opportunities and challenges posed by the digitization in healthcare and will – by citing international best-practice examples – describe how healthcare companies can make use of the increasing connectivity to close the gap between the old and new reality.
DONNERSTAG 08. MÄRZ 2018
New Medical Device Regulation (EU) 2017/745
Evolution or revolution? New obligation of manufacturers New aspects in classification Transitional period