working on the
future of therapy
+49 711 71978 158
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. You can access these Presentations online or attend them in Paris in the Learning Lab on October 13 and 14, at 11:30 am.
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
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.
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
Press contact at Red Dot
Manager PR & Communications
Red Dot GmbH & Co. KG
Gelsenkirchener Str. 181
45309 Essen, Germany
Phone: +49 201 30104–58
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.”
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.
Silvia Wilkes, Marketing
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.