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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.