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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, the Chief Financial Officer (CFO) Mark Bleckmann 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, headquartered in Switzerland, 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
Marketing Haselmeier Group
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, headquartered in Switzerland, is a 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 Coordinator
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 Exclusive 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.