Constantly
working on the
future of therapy
Join us in Barcelona at CPHI Worldwide, October 24-26
Where? Fira Barcelona Gran Via, Spain
When? October 24-26, 2023
Our experts Klaus Schmid, Stéphane Singer, Sabrina Jauch, John Tinner, Dominik Vonier, Ines Schlenker, Katharina Venerius and Stefanie Manger are looking forward to meeting you in Barcelona!
Make an appointment today: info.drugdelivery@medmix.com
You are looking for more information about the conference? Click here to go to the event webpage.
Haselmeier at PDA Universe in Gothenburg, October 17-18
Where? The Swedish Exhibition & Congress Centre – Gothia Towers Hotel
When? October 17-18, 2023
Highlight: "Use of Life Cycle Assessment (LCA) to inform design and manufacturing of the PiccoJect autoinjector" – Don't miss the lecture of Thomas Thueer, Program Lead AI and Syringe Technology at Haselmeier.
This presentation aims to provide a short introduction to the methodology of Life Cycle Assessment (LCA) and to demonstrate how it can increase your understanding of the environmental impact of your product. Based on examples, it will be explained how the outputs of an LCA can support smart decisions in design and manufacturing to develop more sustainable drug delivery devices. The most important contributing factors to the environmental impact of the PiccoJect autoinjector will be highlighted and it will be shown how a significant reduction of the carbon footprint can be achieved.
Our experts Klaus Schmid, Stéphane Singer, John Tinner, Chris Muenzer, Thomas Thueer, Frank Leipold, Ines Schlenker, Katharina Venerius and Stefanie Manger are looking forward to meeting you in Gothenburg!
Make an appointment today: info.drugdelivery@medmix.com
You are looking for more information about the conference? Click here to go to the event webpage.
Join us at PODD in Boston – October 16-17
Where? The Westin Copley Place, Boston
When? October 16-17, 2023
Our experts Terry O`Hagan, Munir Panah and Joachim Keitel are looking forward to meeting you there!
Make an appointment: info.drugdelivery@medmix.com
You are looking for more information about the conference? Click here to go to the event webpage.
Enter the code HASELMEIER20 when registering and you will receive 20% discount on your ticket!
Successful compatibility testing of PiccoJect™ with Nipro's D2F™ pre-fillable syringes
The compatibility in terms of fit, performance and safety were proven between Piccoject 100 and Nipro's PFS (D2F syringes, 1 ml long, staked-needle with RNS). The syringes were subjected to different characterization tests to determine relevant force values and robustness limits. The capability of PiccoJect 100 to meet required dose accuracy and injection time performance was confirmed with fill volume and fluid viscosity at the specification limits.
Haselmeier at InnoPack Pharma Confex in Mumbai, June 21-22
Where? Hotel Sahara Star, Mumbai
When? June 21-22, 2023
Highlight: "The Case for Reusable Injection Pens for Global Generic Drugs" – Don't miss the lecture of Chris Muenzer, Vice President Innovation and Development at Haselmeier and learn more about:
Make an appointment: info.drugdelivery@medmix.com
You are looking for more information about the conference? Click here to go to the event webpage.
Click here to get your FREE delegate pass and join us in Mumbai!
Join us at Pre-Filled Syringes West Coast Conference in San Diego – June 12-13
Where? Horton Grand Hotel, 311 Island Ave, San Diego, CA 92101, United States
When? June 12-13, 2023
Highlight: Lecture on Day 2 from 13:50 – 14:20pm: "Go Digital" – The Solution to a Problem or a Problem without a Solution? Don't miss the lecture of Frank Leipold, Vice President Product and Portfolio Management at Haselmeier and learn more about:
Make an appointment: info.drugdelivery@medmix.com
You are looking for more information about the conference? Click here to go to the event webpage.
GOING GOLD: Haselmeier site in Dnešice, CZ, received EcoVadis Gold Medal
We are proud to announce that our site in Dnesice, CZ, received once again an EcoVadis medal – we improved from silver to gold!
Haselmeier SRO is in the top 3% of companies rated by EcoVadis in the manufacture of medical and dental instruments and supplies industry. This overall score is calculated by assessing four separate categories: Environment, Labor & Human Rights, Sustainable Procurement and Ethics. And we're working to keep improving!
Haselmeier & DCA Design International receive Red Dot Award for PiccoJect™
PiccoJect™, the disposable, two-step autoinjector, designed for subcutaneous injection, has now been recognized for another prestigious design award, the Red Dot Award: Product Design 2023. The award will be presented to Haselmeier and DCA Design at the Red Dot Gala on June 19 in Essen, Germany. This is the second design award that medmix, global leader in high-precision delivery devices, and DCA Design International Limited, one of the world's leading product design consultancies, have received for PiccoJect™. By the end of 2022, PiccoJect™ had already been awarded with the Good Design Award.
Pre-Filled Syringes East Coast Conference in Boston, April 24-25
Where? Hyatt Regency Boston, 1 Ave de Lafayette, Boston, MA, 02111, USA
When? April 24-25, 2023
Make an appointment: info.drugdelivery@medmix.com
You are looking for more information about the event? Click here to go to event webpage.
Join us at Swiss Biotech Day in Basel, Switzerland – April 24-25
Where? Congress Center Basel, Messeplatz 21, 4058 Basel, Switzerland
When? April 24-25, 2023
Make an appointment: info.drugdelivery@medmix.com
Click here to have a look at the event webpage and get more information.
Join us at CPHI Japan in Tokyo from 19-21 April, 2023
Register for free and visit us at booth #6C-14!
CPHI Japan celebrates its 20th anniversary and Haselmeier is part of it. What about you? Visit our booth #6C-14, learn more about our products – especially about our fully-featured 2-step autoinjector PiccoJect™ – and celebrate the anniversary of CPHI Japan!
Where? Tokyo Big Sight, Tokyo, Japan
When? April 19-21, 2023
Make an appointment: info.drugdelivery@medmix.com
Haselmeier at Pharmapack 2023 in Paris, booth #C70
Register now and receive a FREE attendee pass!
Be part of an exclusive group that is allowed to enter the halls before the other visitors. You have the advantage of being the first to talk to the exhibitors of your choice! Just use the promo code PRT30 at checkout.
February 2nd, 13:50-14:20 PM
Advanced Delivery Device Technology to Simplify the Reconstitution of Lyophilized Drugs
Don't miss the lecture of Chris Muenzer (Vice President of Innovation and Development at Haselmeier) in the Learning Labs area!
We look forward to your visit!
Make an appointment: info.drugdelivery@medmix.com
PiccoJect™ wins Good Design Award
With a focus on patient centric design and a commitment to sustainability, PiccoJect is composed of only eight parts and features an ergonomic shape and a large wrap-around drug window. Haselmeier is offering PiccoJect as a full-service platform including combination product development, design verification, final assembly, secondary packaging, labeling and serialization. This is the second time that Haselmeier – a medmix brand, wins the Good Design award after the D-Flex™ Ecosystem won the award in 2020.
Pre-Filled Syringes and Injectable Drug Devices in London, UK – January 10-12, 2023
Where? Copthorne Tara Hotel, Scarsdale Place, Kensington, London, United Kingdom
When? January 11-12, 2023 (main conference)
Make an appointment: info.drugdelivery@medmix.com
Join us at CPHI / PMEC in Delhi, India from 29 NOV - 1 DEC
Where? IEML, Greater Noida, Delhi NCR, India – Booth #15A.B73
When? 29th November until 1st December
Make an appointment: info.drugdelivery@medmix.com
Haselmeier & AARDEX Group join Forces to Improve Self-Injection of Drugs in Clinical Trials
Clinical testing during new drug development is costly and time intensive for pharmaceutical and biotech companies. The need for solutions, helping them to shorten testing time and increase data quality are two of the main factors determining overall cost and success of newly developed drugs. As a result, the future of clinical trials is becoming more reliant on connected medical devices, collecting data at the point of care, reducing the need for costly patient visits and cumbersome manual data acquisition. Therefore, Haselmeier, a medmix Brand, and AARDEX Group have joined forces to tackle the challenge of managing patient adherence during clinical trials.
Haselmeier at CPHI Worldwide in Frankfurt, November 1-3
Where? Messe Frankfurt, Ludwig-Erhard-Anlage 1, 60327 Frankfurt am Main, Germany
When? November 1-3, 2022
Make an appointment: info.drugdelivery@medmix.com
Join us at PODD in Boston, 24-25 October
Where? The Westin Copley Place, 10 Huntington Ave, Boston, MA 02116
When? October 24-25, 2022
WHEN YOU BUY YOUR TICKET, USE CODE HASEL20 FOR A 20% DISCOUNT!
Make an appointment: info.drugdelivery@medmix.com
Visit our booth #800 at PDA Universe in Palm Springs, 18-19 October
Where? Palm Springs Convention Center, 22 N. Avenida Caballeros, Palm Springs, CA
When? October 18-19, 2022
Make an appointment: info.drugdelivery@medmix.com
Join us at InnoPack in Hyderabad, 9-10 August
We are looking forward to your visit at InnoPack in Hyderabad, one of the most important Pharma Packaging Meet in India. Learn more about our self-injection devices D-Flex, Re-Vario and Re-Vario A as well as our connected solutions and our new autoinjector PiccoJect. Let's talk about your needs and how we can support you!
Where? Novotel HICC Convention Centre in Hyderabad
When? August 9-10, 2022
Make an appointment: saibal.sengupta@medmix.com
Meet us at "Pre-Filled Syringes West Coast" in San Diego, June 13-14
Visit our booth #10 at the "Pre-Filled Syringes West Coast" Show and find out more about our new autoinjector PiccoJect™ and our self-injection devices. Let's talk about your needs and how we can support you!
Our experts Terry O'Hagan and Munir Panah are looking forward to your visit!
Where? Hyatt Regency Mission Bay, 1441 Quivira Road, San Diego, California, USA
When? June 13-14, 2022
Make an appointment: info.drugdelivery@medmix.com
Haselmeier is Gold Partner of this year's InnoPack Pharma Confex in Mumbai, India
Visit our booth #B1 and discover our first, fully featured autoinjector platform PiccoJect™, the D-Flex™ Logbook or our product platforms D-Flex™, Re-Vario™ and Re-Vario™ A.
Don't miss the lecture of Chris Muenzer, Vice President of Innovation & Development at Haselmeier! Join his speech about "Importance of Simulation and Modeling in Autoinjector Development" on June 9th from 14:30 to 15:00.
We are looking forward to seeing you at InnoPack!
Where? InnoPack Pharma Confex, Sahara Star, Mumbai, India, booth #B1
When? June 9-10, 2022
Make an appointment: info.drugdelivery@medmix.com
Visit our booth at the PDA in Basel, 2-3 June 2022
Find out more about our first, fully featured autoinjector platform PiccoJect™, which is flexible and easily customizable. Convince yourself of its extremely low part count, unique flat shape and small size! Or let us explain the D-Flex™ Logbook, which collects injection data at the point of care without the need for a patient mobile app. The D-Flex™ Logbook makes patient compliance transparent and helps to identify and address issues already during the ongoing trial.
If you are looking for a proven pen platform (disposable/re-usable) for subcutaneous self-injection, we are pleased to introduce you our product platforms D-Flex™, Re-Vario™ and Re-Vario™ A.
We are looking forward to seeing you at the PDA!
Where? Congress Center Basel, Messeplatz 21, Basel, Switzerland
When? June 2-3, 2022
Make an appointment: info.drugdelivery@medmix.com
Haselmeier launches its first fully featured autoinjector at Pharmapack in Paris
medmix Drug Delivery introduces PiccoJect™, a disposable two-step autoinjector designed for subcutaneous injection. The device is being developed in two variants (PiccoJect™ 100 and PiccoJect™ 225) for a standard 1 ml long or 2.25 ml pre-filled glass or plastic syringes. With a focus on patient centric design and a commitment to sustainability, PiccoJect™ is composed of only eight parts and features an ergonomic shape and a large wrap-around drug window. Haselmeier is offering PiccoJect™ as a full-service platform including combination product development, design verification, final assembly, secondary packaging, labeling and serialization.
Chris Muenzer, Vice President of Innovation and Development at Haselmeier, explained: “It was important for us to offer a product that both met the needs of our pharmaceutical customers, and also of their patients. With this in mind, we focused on three key aspects during the development of PiccoJect™: consistent and repeatable performance, patient-centric design and a commitment to sustainability.”
PiccoJect™ is specifically designed to have a significantly reduced part count of only 8 components. This improved device design reduces manufacturing and scale up challenges that can impact performance. The autoinjector platform is fully customizable based on customer needs including support for different fill volumes and drug viscosities, color options for the cap and an adjustable size of the drug window. “In addition, the design of PiccoJect™ includes a number of connectivity options that are either integrated or provided as an add-on module, without modifying the core mechanism or compromising handling.”, Chris adds.
The PiccoJect™ design features an ergonomic shape and a large wrap-around drug window which provides a simple and consistent user experience. This was confirmed in a recent study in which 83% of the participants rated the visibility of the PiccoJect™ drug window as superior and 75% reported that they preferred the wide cross-section of PiccoJect™. A colored status indicator provides an easy-to-understand binary information about the usage status of the autoinjector. Audible clicks at the start and end of injection also help to ensure that the user holds the device in place until the full dose has been injected.
Reflecting its commitment to sustainability, medmix has designed PiccoJect™ based on the eco design principles, taking a conscious view to reduce its carbon footprint including utilizing materials with sustainable feedstocks, investment in green electricity, and development of regional supply chains for the US and Europe market. “From the start of the project, sustainability has been a focus of our development. Reduction of the carbon footprint has been a key design goal for the entire team” explained Chris.
“With PiccoJect™, Haselmeier are committed to offering a full-service platform to its customers. This includes combination product development, design verification, final assembly, secondary packaging, labeling and serialization. This allows pharma companies, particularly small to medium companies with limited device experience, to receive a ready to file device, including necessary supporting documentation.” Chris explained further.
PiccoJect™ is designed for patients and non-professional care givers to administer an injection in a home setting and can also be used by nurses and other health care professionals in the clinic. The device is applicable for the use in any drug product that is packaged in a prefilled syringe. This includes novel biologics for indications such as arthritis, asthma, cancer, cardiovascular disease, diabetes, autoimmune diseases, genetic disorders, and some viral diseases such as hepatitis. In addition, the use in biosimilars of existing drugs like adalimumab and etanercept is also a focus.
Both variants of the PiccoJect™ support small round or cut flange syringes. The autoinjector platform supports fill volumes from 0.2 ml to 2 ml and is designed to inject formulations with a viscosity up to 20 cP in less than 15 seconds.
Facts and figures about PiccoJect™:
medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from a dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 13 production sites worldwide together with our highly motivated and experienced team of 1,900 employees provide our customers with uncompromising quality, proximity, and agility. medmix is headquartered in Zug, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX). www.medmix.swiss
medmix is a trademark of medmix AG, and transcodent, MIXPAC, COX, and MK are trademarks of medmix Switzerland AG, a company of the medmix group.
This document may contain forward-looking statements including, but not limited to, projections of financial developments, market activity, or future performance of products and solutions containing risks and uncertainties. These forward-looking statements are subject to change based on known or unknown risks and various other factors that could cause actual results or performance to differ materially from the statements made herein.
Meet us at the Pharmapack Europe 2022 in Paris, May 18-19
This year, exciting and up-to-date information awaits you:
On our booth (#B79) you can discover our first, fully featured autoinjector platform PiccoJect™, which is flexible and easily customizable. Convince yourself of its extremely low part count, unique flat shape and small size! You can see the PiccoJect™ also in Pharmapack's Innovation Gallery.
In addition, we will present the D-Flex™ Logbook, which collects injection data at the point of care without the need for a patient mobile app. The D-Flex™ Logbook makes patient compliance transparent and helps to identify and address issues already during the ongoing trial.
If you are looking for a proven pen platform (disposable/re-usable) for subcutaneous self-injection, we are pleased to introduce you our product platforms D-Flex™, Re-Vario™ and Re-Vario™ A.
Chris Muenzer, Vice President of Innovation & Development at Haselmeier, will give a lecture on the second day of Pharmapack. Join his speech about "Importance of Simulation and Modeling in Autoinjector Development" on May 19th from 13:50 to 14:20.
Have a look at Chris' teaser video for his lecture!
We welcome all fair attendees to visit us at our booth and to learn more about our products and services in a one-to-one conversation.
Where? Paris Expo, Porte de Versailles, Paris, France, booth #B79
When? May 18-19, 2022
Make an appointment: info.drugdelivery@medmix.com
Haselmeier at the CPhI Japan, 20-22 April 2022 in Tokyo Big Sight, Japan
This year we will have a booth at the CPhI show in Japan and are looking forward to your visit!
Join us and get up-to-date information about our innovative product platforms and related service portfolio which assist you every step of the way – leading to an advanced combination of drug and device that is safe and convenient in therapy. Meet Saibal Sengupta, Head of Sales & Business Development APAC, and John Tinner, Vice President Commercial.
Interested in learning more about CPhI Japan and the program, just follow the link.
Haselmeier and plus10 win the Microsoft Intelligent Manufacturing Award for "Innovate!" 2021
At a press conference on February 24, Haselmeier and plus10 were announced as winners of the Microsoft Intelligent Manufacturing Award 2021 for the "Innovate!" category and were able to present their winning use case to the audience. The project of Haselmeier and plus10 won for their implementation of AI-based software on an automated assembly line for injection syringes to increase productivity in GMP compliant production.
Implementation of Shannon® on an automated assembly line for injection syringes to increase productivity in GMP-compliant production at medmix Drug Delivery. Source: medmix Drug Delivery (Haselmeier).
AI-based software – process optimization in the assembly of medical devices
Medical products such as self-injection syringes are manufactured on fast and highly automated assembly lines. Process optimization is a complex undertaking, with AI-based software helping to find the most effective measures. medmix Drug Delivery (Haselmeier) leverages technology such as the GMP-compliant Shannon® software from plus10, to identify technical problems of the production line and understand their causes in real time, enabling appropriate solutions to address the specific situation. In this winning joint project between Haselmeier and plus10, the assembly line was analyzed to identify the causes of technical availability and performance losses. While the initial overall equipment efficiency (OEE) was already relatively high (70-80 %), this project successfully uncovered additional productivity potential of over 10 %.
plus10-Shannon®: Learning and GMP-compliant optimization control loop for production plants from Haselmeier™ a medmix Brand. Source: plus10
Microsoft and Roland Berger honor innovative ideas and digital solutions
The Microsoft Intelligent Manufacturing Award, jointly organized by Microsoft Germany and consultancy Roland Berger, recognizes companies in the manufacturing industry that are actively helping to drive the transformation to Industry 4.0.
Haselmeier at the virtual PODD 2021, Boston, October 28 & 29
Boston, October 28 & 29 2021 - Haselmeier at the virtual PODD 2021: Partnership Opportunities in Drug Delivery (PODD) is offered as a virtual program and promises to uphold its ten year tradition of combining partnering with access to cutting-edge business and scientific content in the field of drug delivery with loyal support from a top notch speaking faculty. PODD offers access to a wide range of drug delivery technologies and opens partnering before during and after the event.
Join our speakers at the PODD 2021
28 October 2021 - Terry O’Hagan
Value of Smart Drug Delivery Systems in Clinical Testing
The challenges in clinical testing of subcutaneous drugs, relying on patients to self-inject at home will be explored. In addition, the value of a non-real-time connected drug delivery systems (i.e. without the need of a patient app & mobile phone) in the clinical setting will be outlined.
29 October 2021 - Chris Muenzer
D-Flex™ Dose Selector Technology: A solution for accurate delivery of peptides and other injectable small molecules
Review device options for subcutaneous injection of peptides. Learn how Dose Selector Technology can bring your molecule to market faster with lower capital investment
Interested in learning more about PODD 2021 and the Agenda, just follow the link.
We are there - InnoPack Pharma Confex 2021
We are there - InnoPack Pharma Confex 2021. Visit us on October 21 and 22, 2021 in Hyderabad, India at InnoPack Pharma Confex 2021. We will be happy to present our solutions for pharma and healthcare.
India's Premier Pharma Packaging Event is now Back to being held in Face to Face mode! Innopack Pharma Confex this October will be held in Hyderabad. With Packaging Innovation at its core, the theme will focus on powering Industry's growth. This year's face-to-face and hybrid event will have 2 days full of panels, roundtable discussions, and celebrations of innovations & excellence by industry front runners.
Meet us online at the Pharmapack Europe 2021
This year we will be part of the digital conference program from September 27 to October 15. Meet us online at the Pharmapack Europe 2021.
Exciting and up-to-date information awaits you in our online Company Portal: We will be presenting our innovative product platforms and related service portfolios assist you every step of the way – leading to an advanced combination of drug and device that is as time-saving and economical for your company as it is safe and convenient in therapy.
In the Networking Area, our global team of experts will be happy to present our integrated solutions for pharma and healthcare. Take the opportunity to make appointments or simply chat in the Networking Area. We look forward to meeting you.
This year we are also represented in the Learning Lab with two exciting presentations by Chris Muenzer, Vice President Innovation & Development and Frank Leipold, Business Development, on the topics: Trends in Injection Device Development and Networked Medical Devices in Healthcare.
The focus is on options and opportunities to shorten time-to-market and reduce capital expenditures for the development of injection devices from clinical trials to commercial product. Rapid drug development, smooth clinical trials, and speed to market are high priorities for the pharmaceutical industry. For drugs intended for subcutaneous use, our self-injection pens can help reduce risks and shorten time to market. Our D-Flex™ platform and our digital solution, the D-Flex Ecosystem™, are central to this.
We are all very excited about this year's event format and look forward to welcoming you to the digital conference program at Pharmapack 2021.
Good Design Award for the D-Flex™ Ecosystem
Stuttgart, 01.03.2021: We are pleased to have received the Good Design Award 2020 in the medical category for our D-Flex™ Ecosystem.
The D-Flex™ Ecosystem consists of the D-Flex™ injection pen, a connected cap, a mobile app and the Haselmeier™ data platform. The connected cap collects data at the point of care, securely transferring it to the mobile app and from there to any platform. In this way D-Flex™ Ecosystem enables real-time monitoring and advanced analytics in clinical trials.
Meet our D-Flex™ Ecosystem. It collects treatment data at the point of care, automatically transferring it to any platform, giving controlled access to various stakeholders.
Good Design Award: The Chicago Athenaeum continues the organisation of the program to create an awareness about contemporary design and to honor both products and industry leaders in design and manufacturing that have chartered new directions for innovation and pushed the envelope for competitive products in the world marketplace. Good Design® was founded in Chicago in 1950 by Edgar Kaufmann, Jr., Eero Saarinen, and Charles and Ray Eames. Mort Goldsholl also created the iconic Good Design logo in 1950.
Contact at Haselmeier
Silvia Wilkes, Marketing
Vaihinger Straße 48
70567 Stuttgart, Germany
Phone: +49 711 71978-158
silvia.wilkes@sulzer.com
D-FLEX™ ECOSYSTEM – FROM DATA TO VALUE
OnDrugDelivery Magazine, December 2020: Here, Fred Metzmann, PhD, Vice-President Sales and Marketing, and Frank Leipold, Business Developer Digital Solutions, at Haselmeier, discuss the benefits of connected medical devices in clinical trials and describe the advantages of Haselmeier's D-Flex™ Ecosystem for improving adherence and reducing the dropout rate in clinical trials.
In recent years, interest in, and adoption of, connected technologies has grown significantly within the drug development industry, due to their potential for improving healthcare delivery, research and the patient experience. The use of connected digital products, such as those that capture physiological and behavioural metrics, in formal clinical research has also been steadily gaining in prevalence and importance for several years.
Currently, many pharmaceutical companies are exploring how connected digital devices can be incorporated into their clinical trials to improve the data foundation and, potentially, to assist in securing a faster time to market and improve patient retention. However, one of the biggest challenges that remains to doing so is the creation of a work structure that is robust enough to allow the output data from connected devices to be accepted as evidence for the trail.
To this end, Haselmeier has developed the D-Flex™ Ecosystem, a flexible digital solution that works with Haselmeier's D-Flex™ disposable injection pen. The D-Flex™ Ecosystem presents significant advantages for improving the robustness and data quality of clinical trials.
Pharmapack Europe in Paris is postponed to October 2021
Stuttgart, Germany, December 7, 2020: Pharmapack Europe in Paris is postponed to October 2021
Due to the current situation, Pharmapack will not take place in January 2021 as planned. The event will now take place from 13 to 14 October 2021 at the same location, Hall 7.2, Paris Expo, Porte de Versailles. We look forward to welcoming you in in Paris at our booth, L 66. Please, for further information follow the link https://www.pharmapackeurope.com/en/home.html
Dr. Marco Linari becomes new CEO of the Haselmeier Group
Stuttgart, Germany, May 5, 2020: We are pleased to inform you that Dr. Marco Linari has been appointed Chief Executive Officer (CEO) of the Haselmeier Group effective May 1, 2020.
In addition to his role as Chair of the Executive Team, Dr. Marco Linari will be responsible for Marketing and Sales, Project Management, Quality Management and IT. As Executive Team Dr. Marco Linari and the Chief Operations Officer (COO) Matthias Meissner are leading the Haselmeier Group.
Dr. Marco Linari studied chemistry and economics and holds a doctorate in biochemistry. After a successful track in strategy consulting, Dr. Marco Linari held national and international leadership roles within the Merck Group in the last 15 year, lastly as CEO of Allergopharma. Through his experience and knowledge of the pharmaceutical and med tech sector, he knows the requirements and needs of the pharma and Med Tech industry.
The Haselmeier Group will benefit from his expertise and will have an excellent perspective for its successful further development.
The D-Flex™ from Haselmeier wins Red Dot for outstanding design quality
Stuttgart, Germany, May 5, 2020 - The Red Dot Jury has made its decision: The D-Flex™ emerged victorious from the Red Dot Award: Product Design 2020 and won a Red Dot for its good design quality. This means that the Haselmeier Group is one of the winners in the world’s most renowned design competition.
D-Flex™ - The Innovative Injection Pen from Haselmeier
The D-Flex™ from Haselmeier is a product platform of a new generation of disposable injection pen systems for subcutaneous self-injection. The patented D-Flex™Technology is bridging the gap between simple fixed dose pens and normal variable-dose pens as known in the Diabetes or Hormone-Therapy. This innovative technology allows easy adaptation to the titration requirements of drugs for specific therapies where multi distinct fix doses are required. All essential fix doses can be realized on just one D-Flex™Pen. These doses can be flexible selected by the customers according to their specific requirements on the titration-scheme of the special drug. It just needs the modification of just one part of the D-Flex™ Pen Platform. Thus, the customers save time and money in the development of the combination product. Furthermore, the special D-Flex™ Technology creates additional value for the patient by preventing injection errors and unintended dosages, thus resulting in an improved patient safety.
Red Dot CEO Professor Dr. Peter Zec on the laureates
“The winners of the Red Dot Award have proved that they have created excellent products worthy of winning an award. The products won over the jury not only through their aesthetic, but also thanks to their incomparable functionality. With their designs, the award winners are setting new standards in their industry. I wish to congratulate them most sincerely on their success,” said Professor Dr. Peter Zec, founder and CEO of Red Dot.
Detailed evaluation of the products entered
The Red Dot Award: Product Design offers designers and manufacturers from all over the world a platform for assessing their products. In 2020, designers and companies from 60 countries entered more than 6,500 products in the competition. The international jury comprises experienced experts from different disciplines and has been convening for around 65 years in order to select the year’s best designs. The adjudication process lasts several days and is based on two essential criteria: The jurors test all of the entries in order to assess not just the aesthetic but also the materials selected, the level of craftsmanship, the surface structure, ergonomics and functionality. After intensive discussions, they make a decision on the design quality of the products. True to the motto “In search of good design and innovation”, only the best designs receive an award.
D-Flex™ in exhibitions, online and in the yearbook
On 22 June 2020, D-Flex™ will be added to the exhibition “Design on Stage” in the Red Dot Design Museum Essen, where all of the award-winning products will be on show. The museum will thus be a hot spot for best-in-class industrial design. From that date, the winning product from Haselmeier will also be presented in the online exhibition on the Red Dot website. The Red Dot Design Yearbook 2020/2021 comes out in July 2020.
About Haselmeier
Haselmeier, a part of Sulzer AG, is a leading provider of solutions for subcutaneous injection systems for the safe self-administration of liquid drugs. As a reliable development partner, Haselmeier offers customer-specific solutions from design and conception with prototype construction, engineering and product development to industrialization in modern production facilities. Additional services such as lifecycle management, pharmaceutical packaging, packaging design and regulatory support complement the range of services. The customized development is always based on patented proprietary platform technologies for injection devices.
In addition, the company actively develops innovative digital solutions that help shape the future of smart medical healthcare. Haselmeier currently employs 240 people in six countries with sales offices in Europe, the USA and India and state-of-the-art production facilities in Buchen (DE), Dnešice (CZ) and Bengaluru (IND). Haselmeier has over 100 years of experience in the health care sector and has always contributed to reliability and success in therapy.
About the Red Dot Design Award
In order to appraise the diversity in the field of design in a professional manner, the Red Dot Design Award breaks down into the three disciplines of Red Dot Award: Product Design, Red Dot Award: Brands & Communication Design and Red Dot Award: Design Concept. With more than 18,000 entries, the Red Dot Award is one of the world’s largest design competitions. In 1955, a jury convened for the first time to assess the best designs of the day. In the 1990s, Red Dot CEO Professor Dr. Peter Zec developed the name and brand of the award. Ever since, the sought-after distinction “Red Dot” has been the revered international seal of outstanding design quality. The award winners are presented in the yearbooks, museums and online. More information is available at www.red-dot.de.
Press Contact at Haselmeier
Silvia Wilkes, Marketing
Vaihinger Straße 48
70567 Stuttgart, Germany
Phone: +49 711 71978-158
silvia.wilkes@sulzer.com
Press contact at Red Dot
Julia Hesse
Manager PR & Communications
Red Dot GmbH & Co. KG
Gelsenkirchener Str. 181
45309 Essen, Germany
Phone: +49 201 30104–58
j.hesse@red-dot.de
www.red-dot.org/press
Haselmeier receives Medical Device Master File number for D-Flex™ product platform
Stuttgart, 17.03.2020: Haselmeier officially announces that it has received Master File Number MAF3202 from the Food and Drug Administration (FDA) of the United States for its D-Flex™ product platform, a new generation of injection pen systems for subcutaneous self-administration.
A device master file provides regulatory authorities with proprietary data about a material, component or manufacturing process. It enables the company submitting the information to the FDA to comply with regulatory requirements for trading in the USA while protecting its intellectual property from potential partners, competitors and customers. Moreover, it facilitates combination product approvals for multiple applications using the same device.
Haselmeier formally submitted the MAF for D-Flex™ in late 2019, following productive discussions with the FDA. Pharmaceutical customers can now refer directly to the master file number MAF3202 when submitting their own products based on the D-Flex pen for approval, greatly simplifying and streamlining the FDA clearance process.
With this documentation in place, customers worldwide will be able to leverage the patent-registered D-Flex™ disposable pen system for their combination product development. This versatile, reliable platform is configurable for several fixed doses, bridging the gap between fixed and variable-dose pens, and can support pharmaceutical customers from clinical trials through to commercial use.
Konrad Betzler, Vice President Quality and Alexander Ball, Vice President IT, were involved in the FDA talks. As Mr Betzler comments, “We are delighted that global pharmaceutical customers can now benefit from this device master file submission. The file is a ‘living document’ that will evolve over the months and years ahead, in line with the latest D-Flex™ capacity and capability enhancements.”
In addition to the D-Flex™ injection system, Haselmeier also presented its D-Flex® Connect system to the FDA. D-Flex™ Connect comprises the D-Flex® pen, a smart cap and an innovative, future-proof software platform. This development illustrates Haselmeier’s active commitment to digitalization. Following positive initial conversations with the FDA, Haselmeier plans to compile the data for either 510(k) or IDE submissions by the end of 2020, with the goal of enabling its customers to deploy D-Flex™ Connect in clinical trials.
As Mr Ball remarks, “We are grateful to the FDA for their active and encouraging participation in the meetings held so far. This is an important step for Haselmeier’s expansion into smart data management for therapy efficiency by building the D-Flex™ Connect platform.”
About Haselmeier
Haselmeier, a part of Sulzer AG, ia leading provider of subcutaneous injection system solutions. As a reliable development partner, Haselmeier provides customized solutions from concept design and prototyping to engineering and industrialization, including pharmaceutical packaging solutions. Haselmeier empowers safe self-administration of liquid drugs through the development and manufacture of intelligent injection devices that improve therapy efficiency. Moreover, the company is actively developing innovative connected solutions that will help shape the future of smart healthcare. Haselmeier currently employs 240 staff members in six countries with distribution offices in Europe, the US and India, and state-of-the-art manufacturing plants in Buchen, Odenwald, Germany, Dnešice, Czech Republic and Bengaluru, India. Haselmeier unites 100 years of experience in medical technology. For further information, please visit www.haselmeier.com.
Contact
Silvia Wilkes, Marketing
silvia.wilkes@sulzer.com
Information on Covid-19
Stuttgart, 2020: Information on Covid-19
We are viewing the development around the coronavirus (Covid-19) from both a human and business perspective with concern, attention and prevention. The coronavirus pandemic has changed the way we live and operate and poses many challenges for us as individuals, our families and communities and businesses. The Haselmeier Group focuses on the health and safety of its employees, implements strict protective measures and hygiene regulations and continues to strengthen containment measures to reduce the risk of transmission. We are committed to ensuring the usual responsiveness to answer to customer inquiries. From today's perspective, the supply of raw materials and supplies to our plants is assured for the near future. We are therefore optimistic about the supply and delivery from our plants. We are closely following the developments and effects surrounding the new coronavirus. We are in constant communication to ensure the health and safety of all our stakeholders.
Assessing usability early for optimal injection pen design
OnDrugDelivery Magazine, 2019:
To meet the need for effective delivery systems that optimise the benefits of new drugs and the growth in patient self-injection, combination drug delivery represents a significant opportunity. However, it is important to undertake a full use-related risk analysis for these products to assess their usability and identify any risks.
Using the example of Haselmeier’s D-Flex™system, David Fink, Vice-President Strategic Development at Ximedica, and Stefan Gaul, Head of Strategic Product Management at Haselmeier, highlight the importance of considering usability right from the start.
Developments in self-injection devices for combination products
OnDrugDelivery Magazine, Oct 7th, 2019: In this article, Fred Metzmann, PhD, Vice-President Sales & Marketing, Haselmeier Group, reports on the latest state-of-the-art developments in innovative injection devices for combination products in subcutaneous self-application. He outlines Haselmeier’s product platform strategy for single-use (D-Flex™) and re-usable (i-pen²) injection-pen systems, and related services. He also looks at the company’s connected digital solutions, which support point-of-care data collection and transfer by patients, as well as data management by stakeholders in the care environment.
High cost-pressure in the healthcare sector means that to launch a new combination product successfully, a drug must not only be safe and effective, but the combination of drug and device must also guarantee reliable and beneficial therapy and, of course, be economical.
Many biopharma companies are currently looking for solutions that enable rapid drug development, smooth conduct of clinical trials and fast device development for commercialisation of their combination products. For drugs that require subcutaneous application, self-injection pens offer an ideal opportunity to reduce time and risk.
Haselmeier signs an Agreement with Stevanato Group to License Axis-D™ Pen-injector Technology.
Zurich, Switzerland – Oct 7th, 2019. Haselmeier, a Swiss- and German-based developer and manufacturer of innovative self-injection devices, and Stevanato Group, an Italian-based producer of glass primary packaging and global leader in providing integrated capabilities and solutions for combination products today announced an exclusive agreement to license the Axis-D™ pen-injector technology and intellectual property (IP) for Development, Manufacturing and Supply of the Axis-D pen-injector in the Therapeutic Area of Diabetes Care.
The Axis-D™ pen-injector was designed and developed by Haselmeier together with its partners, and a version of this pen-injector is currently on the market today having been launched by a major pharmaceutical company and approved for use, among others, by the European Medical Agency (EMA) and the US Food and Drug Administration (FDA). Stevanato Group plans to utilize this technology and IP to provide a new pen injector to support the needs of diabetes patients all over the world. Once the design for the device is finalized, it will be produced at one of Stevanato Group’s manufacturing facilities, based on extensive tooling and molding expertise. Sub-assembly and final assembly equipment will be provided by Stevanato Group operations in Denmark.
Frédéric Gabriel, Chief Innovation Officer at Haselmeier, said: “We are pleased and proud to have Stevanato Group as our strategic partner for Axis-D™ in Diabetes. Stevanato Group has demonstrated in past years a consistent development strategy coupled with unique integrated capabilities and is able to leverage Haselmeier’s pen injection platform to bring it to the next level. Such platform has already been proven in the market, from an IP, performance and user perspective. It also demonstrates Haselmeier’s strategic orientation to exploit its IP over various paths, either with own development and manufacturing capabilities or together with a strategic partner.”
“Consistent with its vision Stevanato Group always welcomes strategic agreements with key players in the market to broaden its global capabilities” said Paolo Patri, Chief Technology Officer at Stevanato Group. “We value our relationship with Haselmeier as a device technology partner. With this agreement, we continue to expand our portfolio of devices for patients suffering from diabetes. This complements ongoing work on our award winning 1ml cartridge-based wearable device, which will give our biopharmaceutical partners the opportunity to provide patients with both standard and alternative treatment solutions with such devices.”
Haselmeier has been in possession of an allowance to manufacture pharmaceuticals since December 2018, which is done at the production site in Buchen, Odenwald, in accordance with §13 of the Medicines Act (Arzneimittelgesetz – AMG) or according to Art. 40 of Directive 2001/83/EC. Haselmeier can now offer pharmaceutical and biotechnological companies an assembly, labelling and packaging service.
Konrad Betzler, Chief Quality Officer of Haselmeier: “I am pleased that, after extensive preparatory work and in close coordination with the responsible GMP supervisory authority, we have now received the manufacturing permit”.
Haselmeier will in future assemble the cartridges supplied by customers for the respective therapies with the injection pens as well as label and package the combination products. This service also includes the manufacture of batches for stability testing. Haselmeier thus offers important complete solutions, for example for pharmaceutical companies in the production of small and medium-sized series for clinical studies as well as for biotech start-ups.