March 7th, 2018
OPENING REMARKS & OVERVIEW ON THE MEDICAL TECHNOLOGY MARKET IN BADEN-WÜRTTEMBERG
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.
Functional glass encapsulation for micro-systems
GlencaTec’s hermetic glass encapsulation service makes miniaturized transparent packaging real. The two encapsulation technologies allow combining functions of the device with the purpose to protect sensitive electronics from the harsh environment. Come and listen to the company’s history, the technology and the benefit of GlencaTec’s long-term solutions for in-body and in-process application.
Practical solutions for the implementation projects
In this presentation Stefan Menzl will go through the key steps of the EU-MDR, including the scoping, gap assessments, portfolio assessment and impact on rest of world certification, the roadmap to compliance, training needs, implementation phasing and final reflections to prepare for full MDR compliance assessments. He will bring information derived from numerous ongoing projects.
Patient Access and Patient Engagement and why it impacts on Regulatory, HTA and market success
Patient Access and Patient Engagement – what does it mean? Regulatory authorities and HTA request ever more data (e.g. Patient Reported Outcome Measures PROMS, QoL or Real World Evidence RWE), that can only be generated in direct collaboration with patients, their caretakers and representatives. More and more companies get under pressure late in the process to market launch and reimbursement negotiations since they have not created sufficient evidence for patient benefit over existing diagnostic and therapy options. The presentation gives a first introduction to the subject and demonstrates the practical daily relevance via case studies.
March 8th, 2018
SOLUTIONS ON ASSISTIVE ROBOTICS AT CESTER-LARM
Agewell project approaches an open problem in healthcare for the aging population of Europe, committing to provide a viable solution of the (sub)acute therapy for stroke patients. The implementation team aims to deliver a solution that can be extended towards robotic assisted rehabilitation in different phases of the post-stroke therapy/rehabilitation as well as an exercise/training devices for healthy aging of the elderly population. Some proposed solutions shall be outlined as referring to LAWEX, ASPIRE, and PaRReX patent pending designs. The structure of LAWEX is a non-conventional cable-driven open architecture, which allows accessibility of patients under treatment. Using wristbands, cables are connected to the end-effector which covers the limb to be trained. ASPIRE is a spherical parallel architecture intended for shoulder assistance as it can perform multiple feasible shoulder motion ranges. PaRRex can be seen as a wearable exoskeleton with modular structure, consisting of two parallel modules, one for the forearm mobilization (elbow flexion) and the pronation/supination, the second parallel module is designed to mobilize the wrist (flexion/extension and abduction/ adduction).
Electronic Challenges in Medical Devices
Innovation in medical device is mainly driven by electronics with always more challenges ahead such as multiple connectivity, efficient power management, wireless, reducing complete system size while increasing the number of functionalities and respecting tighter regulations. Lowering development and industrialization risks is more than ever crucial and requires the choice of a partner specialized in miniaturization, from R&D to manufacturing.
Hoax or Fact –Teleradiology officially with WhatsApp?
One in three physicians sends patient data via apps " - the title of an article published in the Ärzte-Zeitung in early 2016 probably does not capture the actual extent of unauthorized use of smartphones and tablets for exchanging patient data - usually via WhatsApp.
For many doctors, one thing is of particular importance: the quick and easy exchange of information - mainly through pictures. Data protection and data quality are usually not sufficiently taken into account here.
Professional, certified apps, however, meanwhile enable quick and easy, but also secure access to the relevant information. The successful implementation of a tele-radiology solution via mobile devices will be presented in this talk.
Market Access Challenges for Medical Devices in Europe: Combining clinical trial data for CE marking and reimbursement
One of the key challenges for medical device companies is meeting the requirements for clinical data from a regulatory as well as a reimbursement perspective. On the one hand, clinical data needs to gain CE mark have been limited so far. With the new Medical Device Regulation (MDR) becoming effective by end of May 2020 and the implementation of the scrutiny process for high risk devices, this will likely change to a yet not fully known degree. On the other hand, the far bigger challenge so far has been passing health technology assessment (HTA) processes in different EU countries to gain reimbursement. In an ideal world, clinical trial efforts would be combined for the purpose of gaining CE mark and reimbursement at the same time. The presentation will highlight basic needs in terms of clinical data for these purposes, shed a light on the behavior of the most important HTA players in Europe and outline necessary considerations from an industry perspective.
New Medical Device Regulation (EU) 2017/745
- Evolution or revolution?
- New obligation of manufacturers
- New aspects in classification
- Transitional period
Needle positioning system – a new development in the field of an MRI compatible needle placement system in the field of prostate cancer
When prostate cancer is suspected, biopsies of the questionable tissue are taken. This has to be done using MRI imaging, in the limited area available between the patient’s legs. In the current, manual procedure, the doctor inserts the biopsy needle rectally; the patient is given preventive antibiotics because of the risk of infection. On average some four attempts are needed before the needle reaches exactly the right position.
For this reason, DEMCON developed the MIRIAM robot. It can introduce the needle through the external skin based on the MRI-image. The doctor indicates the point of interest, and the operating system recognises the robot and the patient’s position. The system positions the robot in the correct orientation, and the robot then introduces the needle gradually into the prostate, autonomously. This makes the procedure faster, more accurate, more sterile and more patient-friendly.