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Kick Off new Working Group PHARMACEUTICS

Additive Manufacturing (AM) for pharmaceutical applications, parts and tools becomes more and more attractive due to its individualized production. Several pharmaceutical companies use this technology for spare and format parts or for personalized medications.

What is your experience regarding Additive Manufacturing in the field of pharmaceutics, development and optimization of medications, tools, spare parts and techniques, or training of employees?
We offer the international platform for meeting experts from leading pharmaceutical sector, for connecting and planning of joint projects and many other opportunities to further increase awareness of AM in pharmaceutical settings. PHARMACEUTICS is aimed at different fields of interests to bring them closer together via the common interface AM.

Leading experts from
Takeda
Merck

And suppliers such as

Marchesini
Syntegon
Körber
Uhlmann

and many others will participate in PHARMACEUTICS.

Within our network Medical goes Additive (MGA) we establish new ideas and find technical solutions for challenges for which there currently are none.
The result-oriented work is our top priority! Our aim: to lower the barriers for 3D printing in accordance with authorities and notified bodies and generate new business models plus economically optimized solutions.

We are very committed to involving all players in the value chain in order to open up the mindset for additive manufacturing. In MGA more than 130 members throughout the whole AM value chain are organized.
We look forward to your participation at our offices on October 28 2021 11:00 – 15:00 CET in the Marienpark in Berlin!

Please note that the kick off will be held as a pure “2G” (vaccinated, or recovered) event.
For more information and to join the working group, please contact Dr Cora Lüders-Theuerkauf.

AM Medical Days 2021 – premier of a new event series!

Additive manufacturing is considered as the future technology. Especially in medicine, 3D printing can provide innovations and patient-optimized care in a wide range of areas. Customized products made from different types of materials can provide better regeneration. These are just a few examples of the importance and positive impact of additive manufacturing in medicine.
Together with KUMOVIS, ottobock and the University hospital Basel, MGA is a founding partner of AM Medical Days. Celebrate the premiere with us and enjoy exciting content!
Over 750 conference visitors are part of the Medical Days, discussing the possibilities of 3D printed medicine in the future, in a wide variety of formats. The event will take place as a hybrid session, where attendees can participate physically, as well as virtually.
Physicians, hospital chains, medical technology manufacturers, regulatory authorities and health insurance companies can make new connections and exchange ideas about the technological shift towards additive medicine. These topics will be highlighted together with AM solution providers, such as printer manufacturers, material suppliers and service providers.
The event will be rounded out by the Innovation Exhibition with 40 inspiring show cases as a break-out area. Among the speakers are Stefanie Brickwede, Cora Lüders-Theuerkauf, Olivier Cynamon, Güngör Kara, Sonja Rasch, Özlem Weiss and many others.
We are excited and looking forward to meeting you there.

Working Group Hospitals welcomes Jonathan Morris

When talking about implementing AM technologies in the medical sector, hospitals are one of the biggest and most important players. That is why we established a working group exclusively for employees in hospitals like physicians, nurses, technicians and the administrations – with an option to later open the group for suppliers and consultants.
Hospitals is also aimed at different medical fields to bring them closer together via the common interface AM.
In January 2021 at the first Hospitals meeting, we welcomed 34 participants from 6 nations. Since then members of this working group are engaged in discussions on quality management, change management and the general AM requirements and needs hospitals have.

At the next meeting on October 13 at 4.30 pm we are now opening our doors to everyone interested in the topic of AM in Hospitals and are happy to welcome one of the pioneers of this field as a speaker: Jonathan Morris (Medical Director – Anatomic Modeling Lab, Department of Radiology, Mayo Clinic) has more than 20 years of experience in the field of medical AM and is one of the leading experts in in house printing who has successfully established clinical 3D printing services at Mayo Clinic. His expertise is in the use of point of care 3D printing/additive manufacturing for preoperative planning and custom surgical guides. Additionally, Dr. Morris is focused on the development and deployment of extended realities, VR/AR in medical education, intraoperative guidance, and medical capital equipment training. Clinically, he focuses on minimally invasive thermal ablation of tumors in the neuroaxis.
Dr. Morris will be talking about “Point of Care Manufacturing: Looking at the Big Picture” at the virtual meeting in October and the working group under the lead of Dr. Cora Lüders-Theuerkauf would like to invite you to participate in the following discussion on Change Management.

Prüfverfahren 3D-gedruckter Medizinprodukte

30. September 2021 · 14:00 – 18:00 Uhr

Ein Workshop für Mitarbeiter aus Orthopädie-technikunternehmen, Krankenhäusern, Arztpraxen und wissenschaftlichen Einrichtungen.

Dr. Cora Lüders-Theuerkauf Mobility goes Additive e.V. und Simon Schlagintweit TÜV Süd sprechen über:

  • Prüfverfahren
  • Testmethoden
  • Normung, Standardisierung
  • Zulassung (MDR, FDA)

Teilnahmegebühr: 49,- €
Für MGA-Mitglieder kostenlos

cora.lueders@mga-net.com
+49 (0)152 031 980 22

MGA Mobility | MGA Medical
Mobility goes Additive e.V.
Im Marienpark 22
12107 Berlin

 

MGA Medical Working Group Approval Result: MDR Decision Tree

Anyone who has ever dealt with medical approval procedures knows the difficulties and mountains of questions and approval paths one is confronted with in this regard. 

But no matter what you do, there is one thing you can’t avoid: 

The Medical Device Regulation came into force on May 25, 2017, and is now finally applicable as of May 26, 2021. It comprises of 10 chapters, 123 articles and 17 Annexes, on more than 175 pages.  

It is used for the risk classification of medical products, whereby the 22 classification rules from Annex VIII in particular must be observed. The MDR is formulated in comprehensive legal jargon and is difficult for non-specialists to understand and apply.  

To break down this extensive construct, the experts from our Approval working group, lead by Simon Schlagintwelt (TÜV Süd Product Service GmbH) and Dr. Cora Lüders-Theuerkauf (Mobility goes Additive e.V.) have jointly developed a simplified procedure. The decision tree, which they have designed, is arranged in a clear structure, which guarantees an easy and quick orientation.  

Here, the 22 classification rules are simplified and structured in a way that by answering simple “Yes”/” No”-Question one can find the associated risk to one’s device.  

The user is being navigated through the questions automatically and arrives at a result by simply following the path. 

It is available to MGA members free of charge in the internal members’ area of the MGA website as a PDF file. External interested parties can also purchase it, for more information please contact us directly at info@mga-net.com. 

MGA Medical goes Additive: Medical Potential Studies

Additive manufacturing is being used widely in the medical sector. In particular, the various departments of hospitals often access its extensive applications. The major advantages here are the individual fit, freedom of design, speed of production, and cost savings. But how great is the actual potential of medicine and medical technology in terms of using additive manufacturing in Berlin? To answer this question, we at Medical goes Additive conducted a potential study: For this purpose, research was conducted and expert discussions were held over several months to determine the specific needs in the medical sector and to get to know the most important players of said sector in Berlin. It became clear that most representatives of the industry would like to see more networking within the Berlin 3D printing community and that there is a great need for cooperation and alliances. The Industrial Additive Manufacturing (IAM) Hub, which opened in October 2020 on the Marienpark site in the south of Berlin, provides a suitable basis for a central contact point for establishing Additive Manufacturing in the medical sector in the capital: In Berlin-Mariendorf, a dedicated micro-ecosystem with campus character is being created. The topics of co-working, training, research and development, as well as AM events, find a new home here. Check out our medical potential study and find out which areas of the medical industry are particularly promising for the use of Additive Manufacturing.

Two Years Medical goes Additive

The Annual Meeting on September 16 & 17, 2019 was not only the first time we gathered in front of the backdrop of the Brewdog Brewery, but also marked the first Annual Meeting with a separate Medical Track.

Since then, our Medical Division, led by Dr. Cora Lüders-Theuerkauf, has been growing steadily and now works in four separate working groups:

Materials, led by Dr. Özlem Weiß (Expertants GmbH), provides insight into the materials jungle through informative guest contributions from a wide range of experts and interviews with industry representatives. In addition, the group trains interested parties on existing standards (e.g. . ISO 10993) and, together with the Mobility working group Materials, populates the WeBoostAM knowledge base.

The Approval working group already has a workshop in December 2019 on MDR, DRG, inclusion of AM manufactured medical devices in health insurance catalogs, and liability issues. Led by Simon Schlagintweit (TÜV Süd), a decision tree on Annex VIII of the MDR (risk classes) has since been developed and during the working group meetings with exciting keynotes on approval issues, including UK MDR.

Specifically in light of the Corona pandemic, the Use Cases working group rose above and launched the “3D printing fights Corona” initiative. The highlight of this initiative was the fundraising campaign in which more than 5,000 face shields were handed over to Johanniter Unfallhilfe. Currently, the focus of the work is on development aid while the meetings are still characterized by highlighting new application fields of AM in medicine through keynotes.

In January 2021, a fourth working group was initiated: At the first Hospitals meeting, we welcomed 34 participants from 6 nations. Members of this working group are engaged in discussions on quality management, and workshop on “make or buy”, SOPs and QM are also scheduled for summer 2021. The next meeting will take place under the title Change Management.

But this is far from the end of our Medical Division: we are planning the next working group with Pharmaceuticals for fall 2021.

Many thanks to all involved in our Medical Division, we are looking forward to the coming successful years!

Hospitals: A successful Kick Off

Thank you to the Parc Taulí Hospital Barcelona, Tel Aviv Medical Center, German Heart Center Berlin, Charité – University Clinic Berlin, Unfallkrankenhaus Berlin, Medical University Graz, University Clinic Eppendorf, University Clinic Basel and Hospital of the Armed Forces Berlin for joining us and enriching the kick off with you expertise.

Special thanks to Jonathan Morris, who gave a fantastic presentation about the wide scope of additive manufacturing at the Mayo Clinic, thus providing an inspiration for other hospitals.

In this first discussion, the following key topics for the working group were raised:

  • Change management: Decision makers need to know what to expect with the use of additive manufacturing technologies.
  • Quality management: Establishment of new standards. Standard Operating Procedures (SOPs( are often already regulated for in-house processes, but are regulated differently for external suppliers.
  • Increase awareness of materials, especially new materials
  • networking with industry
  • further training programs

In the next working group meetings, we would like to address the raised topics in more detail.

We will start on 2 March 2021 with the topic of quality management, inviting Simon Schlagintweit from TÜV Süd Service GmbH and Dr. Özlem Weiß, CEO of Expertants GmbH.
The speakers head our medical working groups Approval and Materials and are well-known experts on the topic of quality management in the medical sector.

In the following working group meeting, we will then address the topic of change management.

Working Student (Werkstudent) f/m/x for 3dprinting in Medical

From our office in the south of Berlin you will work with some of the leading professionals in the field of 3d printing and Additive Manufacturing. Along with other creatives, engineers and strategists, you’ll play an important role in field of Additive Manufacturing in the Medical Sector. You should have a keen interest and intuitive understanding of trends, especially in the technical and additive manufacturing fields. However, we would also be happy to support you as a newcomer in this field.

YOUR TASKS

  • Independent research on data and content of 3D printing in medicine
  • Maintenance of databases and support for the expansion of the website
  • Support for presentations, events, workshops, meetings etc.
  • Assistence of working group meetings

YOUR PROFILE

  • You are a registered student in the field of medical technology or other technical orientation (e.g. biotechnology). You are available as a working student for at least two semesters.
  • High commitment and enthusiasm for medical applications and digital technologies
  • distinguish yourself through your open-minded and proactive manner as well as your independent, conscientious and committed way of working.
  • You also have a very good knowledge of MS-Office as well as very good written and spoken German and English skills

WHY MGA

  • We rely on flat hierarchies and are respectful, loyal and appreciative
  • We offer a steep learning curve and opportunities of professional development within the network
  • Equipment with own laptop, remote working by arrangement
  • Modern flexible workplace with cosy and warm atmosphere, free coffee and softdrinks, located directly opposite brew dog gastronomy
  • Immediate entry possible

Introduce yourself to us if you like : Motivation letter, curriculum vitae, certificates, your salary expectations and possible starting date to : hr@mobilitygoesadditive.com . Your contact is Susann Mühler. We are looking forward to your application!

Announcement Kick Off Working Group Hospitals – MGA Medical

Additive manufacturing (AM) for medical applications/devices has been on everyone’s lips for quite some time, but the corona pandemic has once again demonstrated the special potential of this technology, such as the speed with which individualized products can be manufactured.
Within our network Mobility goes Additive (MGA) our division Medical goes Additive is working hard on establishing new ideas and finding technical solutions for problems for which there currently are none.
The result-oriented work is our top priority! Our aim: to lower the barriers for 3D printing in accordance with the Medical Device Regulation (MDR) and generate quality improvements plus economically optimized solutions.
Three successful working groups are already boosting this aim: “Use Cases”, “Materials” and “Approval”. Now, a new working group exclusively for employees in hospitals like physicians, nurses, technicians and the administrations is going to be established. In order not to influence the clinical, scientific and economic exchange of experience between the players from the start, suppliers and consultants will only be invited at a later time.

We aim for an open discussion regarding in-house printing versus external suppliers, development and optimization of materials, tools, spare parts and techniques, training of employees, planning of joint projects and many other topics to further increase awareness of AM in clinical settings. Therefore, the new working group Hospitals is also aimed at different medical fields to bring them closer together via the common interface AM.
Your ideas, visions and experiences are in demand! We offer the appropriate industry contacts and knowledge of the latest technologies.

This newest working group HOSPITALS will kick off on January 12 with the aim of finding AM solutions suitable for use in and by hospitals.
Join in with Mayo Clinic (USA), the University Hospital Basel (Switzerland), the Charité Berlin, the University Hospital Eppendorf in Hamburg, the Armed Forces Hospital Berlin (Germany) and many others and participate in HOSPITALS.
Contact us if you would like to know more….

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