Haselmeier GmbH

About Haselmeier GmbH

Haselmeier, a part of medmix, has been established in the healthcare marketplace for over 100 years. Starting as a family-owned business with approximately 240 employees, Haselmeier has been pioneering the development of injection pens for subcutaneous application since the 1960s. We continue to drive innovation in self-injection pens from design and manufacturing to packaging and delivery. We have developed solutions in scalable volumes for numerous pharmaceutical partners, always following state-of-the-art engineering practices – and we aim to envolve even further. 

We empower safe self-administration of liquid drugs through the patient-centric development and manufacture of intelligent injection devices that improve the efficiency and efficacy of therapy.

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. We support you at every stage – from technology to therapy.




The products shown on this website are under development and some of them may not yet have been approved for sale under applicable medical devices regulation. The content provides general information about these products, their field of application and intended use, and their function, performance and specification are subject to customer specific development and may deviate from those shown herein. All information contained herein is directed at medical devices manufacturer and pharmaceutical companies. This information shall not constitute a promotion for use in a way which conflicts with any applicable medical devices regulation nor is it directed at patients or intended to replace professional medical advice.  


Haselmeier GmbH Showcase
Certifications

Haselmeier GmbH

  • DE
  • 2021
    On CPhI since
  • 2
    Certificates
  • 100 - 249
    Employees

Products from Haselmeier GmbH

  • D-Flex™ Injection Pen

    Product D-Flex™ Injection Pen

    The D-Flex™ is a fixed-dose pen system for multiple injections based on 3 ml cartridges. Users can easily adjust the dose to the titration scheme of a  given treatment simply by replacing one component. With between 1 and 10 clearly separated, fixed doses in just one pen, the D-Flex™ bridges the gap between fixed and variable-dose pens. This innovative product platform also paves the way for connected commercial devices.

    The products shown on this website are under development and some of them may not yet have been approved for sale under applicable medical devices regulation. The content provides general information about these products, their field of application and intended use, and their function, performance and specification are subject to customer specific development and may deviate from those shown herein. All information contained herein is directed at medical devices manufacturer and pharmaceutical companies. This information shall not constitute a promotion for use in a way which conflicts with any applicable medical devices regulation nor is it directed at patients or intended to replace professional medical advice.

  • D-Flex™ Ecosystem

    Product 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.

    D-Flex™ Pen - Easy adjustable: The D-Flex™ is a fixed-dose pen for multiple injections based on a 3 ml cartridge. Clearly separated, fixed doses on just one pen, giving you flexibility during your dose-finding phase. This innovative product platform can be customized by changing only one component of the pen, reducing the time for R&D. Patients benefit from significantly reduced choice of doses.
    D-Flex™ Connected CapSeamless data collection: The connected solution with a digital cap operating with patented, Bluetooth (BLE)-enabled dose-sensing technology, the digital cap measures the dispensed dose, time and temperature, enabling seamless data collection at the point of care. D-Flex™ Connect is based on a proven technology that can be adapted to your needs.

    Health AppData capture atthe point of care: Patients can replace the standard cap with the new connected cap enabling automatic data capture at the point of care. Collected data is immediately transferred to the Haselmeier™ data platform via an app. This customizable app can remind patients manage their appointments with physicians and provide help or training.

    Health Platform- A data-transfer Ecosystem: The Haselmeier™ data platform provides data storage within the cloud, in compliance with all regulatory and safety requirements. The platform can transfer data to any existing clinical trial infrastructure (eCRF), minimizing additional IT resources. Advanced analytics, dashboards and CE certification are further customizable options.



    The products shown on this website are under development and some of them may not yet have been approved for sale under applicable medical devices regulation. The content provides general information about these products, their field of application and intended use, and their function, performance and specification are subject to customer specific development and may deviate from those shown herein. All information contained herein is directed at medical devices manufacturer and pharmaceutical companies. This information shall not constitute a promotion for use in a way which conflicts with any applicable medical devices regulation nor is it directed at patients or intended to replace professional medical advice.
  • Our Product Platforms

    Product Our Product Platforms

    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. We support you at every stage – from technology to therapy. 

    The D-Flex™ technical platform is a disposable pen platform for the usage with 3ml cartridges. Its design covers a freely selectable regular or irregular dose regimen. The platform can be set to deliver just one single dose or a number of fixed doses. An adaption to a number of pre-selected doses is possible too. The pen system is equipped with a proprietary mechanism to prevent unintended dose selection. D-Flex™ is the ideal and flexible platform designed for easy customisation of preset dose volumes. This platform accompanies and supports you from dose escalation studies to commercial product and adds potential to reduce „Time to Market“ and „CAPEX“. The dynamic D-Flex™ pen platform is available in a high quality plastic version.

    The Axis-D™ pen platform is a disposable, variable dose injection device system designed for the use with a 3 ml cartridge. The elegant and compact Axis-D™ pen platform is available as a high quality plastic version with a large range of ergonomic options for an attractive and colorful design.

    The Pentek™ pen platform is a multi-dose, fixed dose injection device platform designed for use with a standard 3 ml cartridge. The Pentek™ pen platform features Haselmeier‘s hidden needle design which hides the needle from the patient before and during the injection. Pressing the clip on the pen causes the needle to automatically enter the subcutaneous tissue, followed by delivery of the fixed volume of the solution. 

    The i-pen product platform is the basis for a compact, patient-centered solution for easy subcutaneous self-application. Designed based on extensive research and patient testing, the i-pen technology can help improve safety, convenience and quality of life. The i-pen product platform features an attractive design and an extensive range of customization and different color examples.

    The i-pen² product platform is the basis for a reusable injection pen for use in diabetes treatment and other areas of care. Specifically created to provide a high-quality pen at an affordable cost, this innovative pen product platform is available in standard Haselmeier design or can be customized to your specific requirements.
    The products shown on this website are under development and some of them may not yet have been approved for sale under applicable medical devices regulation. The content provides general information about these products, their field of application and intended use, and their function, performance and specification are subject to customer specific development and may deviate from those shown herein. All information contained herein is directed at medical devices manufacturer and pharmaceutical companies. This information shall not constitute a promotion for use in a way which conflicts with any applicable medical devices regulation nor is it directed at patients or intended to replace professional medical advice.











  • Certified drug manufacturing

    Product Certified drug manufacturing

    As a full-service provider, Haselmeier can support you with a lot more than just R&D and product development. We also provide certified pharmaceutical manufacturing services, and so are able to offer pharmaceutical and biotechnological companies a comprehensive assembly, labeling and packaging service.


    A complete solution offering for pharmaceutical companies and biotech start-ups

    We are able to offer pharmaceutical and biotechnological companies an assembly, labeling and packaging service. In practice, this means we can assemble cartridges for therapies together with the injection pens, and we also label and package the combination projects. We also manufacture batches for stability testing. This comprehensive solution could deliver real benefits for pharmaceutical companies in the production of small and medium-sized series for clinical studies, as well as for biotechnological start-ups.


  • D-Flex™ Connect

    Product D-Flex™ Connect

    D-Flex™ Connect allows smart data management for therapy efficiency, offers great opportunities to develop customized solutions for clinical studies and supports a fast pathway to connected commercial devices.


    THE D-FLEX™ CONNECT IS SMART-HEALTH READY

    Haselmeier's D-Flex™ Connect solution comprises the disposable D-Flex™ injection pen, a smart cap and innovative technology platform. Using integrated optical sensors in the pen, D-Flex™ Connect provides valuable feedback, not only confirming that the patient has taken the medication but also indicating the precise amount administered each time. This information on the time and dose of each subcutaneous application is automatically documented, giving a clear picture of the patient's current therapy status. Connectivity via smart phone app means patients receive a reminder if they forget to take a dose. Moreover, they can view details themselves, for example to check whether they have already administered the drug. This innovative combination of state-of-the-art disposable injection pen and future-proof connected platform provides peace of mind for patients and medical professionals alike and helps to enhance patient safety. What's more, clearer insights can help improve compliance and therapy effectiveness.





    The products shown on this website are under development and some of them may not yet have been approved for sale under applicable medical devices regulation. The content provides general information about these products, their field of application and intended use, and their function, performance and specification are subject to customer specific development and may deviate from those shown herein. All information contained herein is directed at medical devices manufacturer and pharmaceutical companies. This information shall not constitute a promotion for use in a way which conflicts with any applicable medical devices regulation nor is it directed at patients or intended to replace professional medical advice.

  • D-Flex™ LOGBOOK

    Product D-Flex™ LOGBOOK

    The D-Flex™ LOGBOOK covers your needs from clinical testing to commercial launch. It allows utilization of a commercially viable injection pen already during dose ranging trials. Its Dose Selector Technology enables quick adoption to different dose settings and once reaching commercial launch there is no need for additional human factor or equivalence studies. Furthermore, its connectivity allows you to collect real world evidence at the point of care, complementing your clinical outcome data.
  • For speed and flexibility in clinical trials

    Product For speed and flexibility in clinical trials

    Haselmeier's D-Flex™ platform is the ideal choice for use in clinical trials and beyond, supporting you from drug development, through clinical trial, to commercial market launch.

    A complete solution offering for pharmaceutical companies and biotech start-ups

    To be deemed suitable for use in clinical trials, injection pens must be safe and simple to use, as well as supporting flexibility in the adjustment of the dose in phases 2 and 3. In addition, these devices must support continuous use with minimum adjustments for all phases of the clinical study up to drug approval. The D-Flex™ product platform can be configured for several fixed doses and values can be freely selected, making the device especially useful in dose-escalation studies, for example. The pen system does not allow any intermediate steps between the set doses, significantly reducing the risk of an incorrect dose and therefore supporting patient safety. Moreover, the D-Flex™ product platform pen can be quickly and cost-efficiently adjusted to meet customer requirements in terms of clinical-trial design, by replacing just one single part of the device. Modifications after phase 2 are possible and the drug delivery device can be adjusted to the requirements of other products in the drug development pipeline.


  • Our Service - Product Development

    Product Our Service - Product Development

    We offer two principal product development pathways: customized pens and platform pens.

    Platform pens – a fast, flexible development approach

    We work together with you to develop unique customized pen solutions that reflect the specific requirements of both you and your patients. We can develop these customized solutions from sketch to scale, from clinical trial to commercial production, and from manual applications to connected devices.
    Customized pens to suit your needs

    Our platform pen solutions – which include i-pen² technology and D-Flex™ – offer significant benefits. They provide an affordable, high-quality alternative to fully customized pens, and can easily be adapted to your specifications, greatly accelerating time-to-market. The platform approach also brings flexibility, as a single pen can be used with different pre-defined dosage values for different applications. This flexibility also reduces your manufacturing risks – helping you save time and money.



Haselmeier GmbH Resources

  • News Haselmeier is now a part of medmix.

    Haselmeier is now a part of medmix. Medmix is a global leader in high-precision delivery devices. Medmix occupy leading positions in the healthcare, consumer and industrial end-markets.
  • Video D-Flex™ Ecosystem - From data to value

    The D-Flex™ Ecosystem comprises hardware, software and services enabling data capture in clinical trials. In particular, the system consists of the D-Flex™ injection pen, a digital cap, a mobile app and the Haselmeier™ dataplatform. The digital cap captures data at the point of care and securely transfers it to the Haselmeier™ data platform.The platform allows controlled and secure access to the different stakeholders.
  • News Haselmeier acquires drug manufacturing license and now offers assembly, labelling and packaging services to pharmaceutical and biotechnology companies

    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.
  • Video Haselmeier D Flex™ Ecosystem

    The D-Flex™ Ecosystem is a smart drug delivery solution. It consists of the D-Flex™ injection pen and a smart cap, collecting injection data at the point of care. Haselmeier™ developed this ecosystem for the use in clinical trials and for commercial launch.
  • Video Video - Haselmeier Product Platform Overview

    Technology that changes lives: Since nearly 100 years we develop products that serve the needs of pharmaceutical partners, doctors and patients. Whether it´s your next clinical trial or a couple´s desire to have children – our innovative and customizable products are here to help and support. Always based on our own IP and striving for the highest therapy efficiency.
  • Brochure D-Flex™️ Connect - The connected solution with a digital cap

    Operating with patented, Bluetooth (BLE)-enabled, dose-sensing technology, the digital cap measures the dispensed dose, time and temperature, enabling seamless data collection at the point of care. D-Flex™️ Connect is a proven technology that can be adapted to a number of drugs and indications.
  • Video Manufacturing Site Dnesice, Czech Republic

    Haselmeier Manufacturing Site Dnesice, Czech Republic
  • Video Manufacturing Site Bengaluru, India

    Haselmeier Manufacturing Site Bengaluru, India
  • Brochure D-Flex™ Ecosystem - From data to value

    Here, Fred Metzmann, PhD, Director Business Development, 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. 
  • Brochure DEVELOPMENTS IN SELF-INJECTION DEVICES FOR COMBINATION PRODUCTS

    In this article, Fred Metzmann, PhD, Director Business Development, 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.
  • Whitepaper Whitepaper - INNOVATIVE INJECTION PEN - THE D-FLEX™

    The D-Flex™ closes a gap in the market: The D-Flex™ injection pen can do more than previous pens. D-Flex™ can be configured for several fixed dose values and is thus a variable fixed dose pen. It makes it possible to integrate a certain dosage value or several different fixed dosage volumes in one injection device.
  • Whitepaper Whitepaper - The D-FLex™ Injection Pen for GLP-1 Medication

    Type 2 diabetes is a global health problem – according to expert estimates, the number of patients worldwide will increase by 48 percent by 2045. constantly elevated blood sugar levels mean stress for the blood vessels,which can lead to feared complications,including life-threatening sequelae such as a heart attack, organ failure or stroke. A consistent treatment of type 2 diabetes as early as possible can significantly improve the quality of life for the patient and the course of the disease.All patients have in common that they have had to treat it on their own their whole lives. A patient-centered approach must be consistently developed so that the GLP-1 analogs treatment is efficient.The innovative D-Flex™ injection pen can make a significant contribution to this.
  • Whitepaper Whitepaper - Injection pens for osteoporosis therapy may contribute to greater compliance

    The International Osteoporosis Foundation cites figures of around 200 million osteoporosis patients worldwide.Numerous patients suffer not just one bone fracture, but several at once. Treatment does not appear to be having the best possible effect. As an experienced partner in the design and production of injection systems, Haselmeier is also well prepared in terms of injection pens for osteoporosis therapy.