Haselmeier Self-Injection Devices
Haselmeier specialises in the development and manufacture of innovative self-injection devices with proprietary designs and technology.
The company covers all of the steps in the creation of its award-winning devices from design, to planning and industrialisation.
Haselmeier also offers a range of early-stage development activities to ensure all products are high quality. The company conducts human factors studies and consults with user focus groups to provide successful administration. This is combined with a qualified design control process, certified quality system, regulatory expertise, a solid network of partners, and strong manufacturing operations designed to meet and exceed client expectations.
Self-injection devices for the pharmaceutical industry
Haselmeier has a world-class design and development team that works in compliance with regulatory requirements. The company creates, designs and industrialises self-injection systems used by pharmaceutical and biotechnology companies worldwide.
Haselmeier creates products to enable a convenient and comfortable experience, which is why patient feedback is integrated into device designs.
Concept and prototype evaluations for pharmaceutical devices
Early concepts are prototyped for testing to ensure high-quality products, while human factor studies capture the handling needs and skills of potential users.
This knowledge is integrated into the design of pharmaceutical devices to provide successful administration of drug products and optimal user experience.
Haselmeier offers a range of early stage activities, including:
- Think-tank discussions and paper concepts for medical devices
- Detailed product concepts and industrial designs for pharmaceuticals
- User handling review and risk-analysis
- Prototyping initial concepts up to functional devices for patients
- User focus groups and human factor studies for concept and prototype evaluations
- In-depth user requirements and design specifications based on a selected medical concept
Development of pharmaceutical devices depends on the understanding of technical, regulatory and operational requirements.
Design-to-manufacturing transfer services
Haselmeier offers integrated design, development and industrialisation services to help clients bridge their serial product into the market.
The company’s qualified design control process, certified quality system, regulatory expertise, network of partners and manufacturing operations are designed to help clients achieve their goals.
Haselmeier’s commercial development and industrialisation services include:
- Concept transfer into user requirements and product design specifications for the pharmaceutical industry
- Design verification, product and process validation processes
- Regulatory expertise to support an approval strategy
- Controlled design-to-manufacturing transfer, verification and validation of self-injection devices
Haselmeier applies the highest standards for manufacturing drug delivery devices to ensure reliable manufacturing and quality processes. The company works with customers to identify product improvements at all stages of its lifecycle, to provide a safe drug delivery device.
Haselmeier provides flexible manufacturing and lifecycle management, including:
- Certified production facilities and manufacturing processes
- Qualified and trained personnel
- A strong network of sub-suppliers and manufacturing partners in the pharmaceutical sector
- Continuous engineering and product improvement programme for medical devices
- Innovation meetings to identify next product generation
The Haselmeier Group is headquartered in Switzerland and employs 200 team members globally, with a presence in Europe, the US, India and China.
All products are manufactured at sites in Buchen im Odenwald (Germany), Dnesice (Czech Republic) and Bangalore (India). The company’s customers benefit from its extensive expertise in developing and manufacturing safe and state-of-the-art drug delivery devices.
Haselmeier works continuously with its customers on improvement, factoring in individual and specific requirements and providing flexible and reliable lifecycle management.
Products and Services
Axis-D Disposable Variable-dose Injection Devices
The Axis-D pen system is a device, which uses 3ml cartridges for variable dose injection.
The D-Flex is a disposable injection pen that uses 3ml cartridges. It is available in two versions that are designed to cover a freely selectable, regular or irregular dose regimen.
i-pen Reusable, Variable-dose Injection Device
The i-pen injects standard 3ml cartridges of insulin in variable doses.
i-pen² Variable-dose Injection Device
The i-pen² is an injection device, designed for 3ml cartridges.
Penlet Disposable Multi-Injection
The Penlet is an auto-injector, which is suitable for injecting Enoxaparin or for the treatment of deep vein thrombosis.
Konrad Betzler was appointed the new chief quality officer (CQO) of the entire Haselmeier Group in October 2017, with responsibility for quality management, quality assurance, and all regulatory matters worldwide.Read more
The new Pergoveris® Pen by Haselmeier has received a positive assessment by Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA).Read more
Haselmeier has announced Paul Jansen has been appointed as its senior advisor and member of the board of directors.Read more
Haselmeier has announced that its new product the D-Flex Just one has won the GOOD DESIGN™ Award.Read more
Following approval by the European Medicines Agency (EMA), GONAL-f® 2.0 was launched by Haselmeier and Merck following its original release in 2011.Read more
Vaihinger Straße 48
Vaihinger Strasse 48
126 John Street
Lowell, MA 01852
United States of America
J.R Tech Park, Building No.1, Sy No. 27/4 A2
Yarandahalli, Bommasandra Indl Area 4th Phase
Jigani Hobli, Anekal Taluk
Bangalore – 560 105