Development and design of drug delivery systems, medical products, diagnostic products, medical devices
Contract development for large series

We have been developing drug delivery systems, medical and diagnostics products focussing on people on behalf of leading pharmaceuticals and medical technology companies for more than 35 years now. This results in solutions that combine functional safety with easy handling and that are perfectly oriented to the specific requirements of material, patient and user.

Your PLUS with Gerresheimer

New development, further development, plastic-compatible opimization for large series

Contract development, product development, drug delivery systeme
Contract development of drug delivery systems

For large series projects, whether new development, continuing development of an existing development project or plastic-compatible optimization – our development teams in the Sales und Engineering Centers in Wackersdorf (Germany) and Peachtree City (USA) are at your disposal. Here, more than 50 specially trained employees formulate the product innovations of tomorrow at the most modern CAD workplaces. Production and assembly-oriented aspects flow into the development.
Through calculations and simulations, we ensure the producibility in plastics and the subsequent assembly and testing capability.

Design for manufacturing

contract development of drug delivery systems, medical devices, diagnostics devices manufactured by injection molding
The design for manufacturing is already considered in the development phase of drug delivery systems, as well as of medical and diagnostics devices.

We address the high requirements of the pharmaceuticals and medical technology companies typical of the branch with regard to quality and development speed through holistic project support in our Sales und Engineering Centers, as well as in our Technical Competence Centers in Wackersdorf (Germany), Peachtree City (USA), and Dongguan City (China). Here engineers and technicians of the areas of product and process development, as well as mold making and automation engineering work hand in hand and formulate new concepts for products, manufacturing processes and manufacturing equipment. In this way we ensure that production and assembly-oriented aspects flow into product design and product development. Plastic-compatible optimization is dispensed with following product development. Your advantage: reduction of the development time, development costs and the project risk.

Flexible entry and support for your project

The development of a product goes through many phases. You decide how many you need our support for – from the start as of the product idea, the entry at an existing stage of development to the further development of an existing product. Our development team is happy to assist you in all project phases upon request.

Our service offering for phase I: concept phase

contract product development, medical device, lancing devices
Product development lancing device with lancet magazine

In the first project phase we develop ideas and product concepts for drug delivery systems, medical and diagnostics devices. We define product requirements, draft the industrial design, assume responsibility for patent management, develop operating concepts, consider critical sub-functions and create models. In addition to this, we evaluate design concepts in the framework of usability studies and carry out concept evaluations and feasibility studies. The result of the concept phase is a preferred concept with risk analysis and defined product requirements.

Our service offering for phase II: design and development phase

contract product development of drug delivery systems, inhaler, plastics
Plastic-compatible optimization of an inhaler

In the following project phases we detail the industrial design and develop medical and diagnostics products, drug delivery systems and pharmaceutical primary and secondary packaging in accordance with regulations (e.g. MDD 2007/47/EG, ISO 13485, FDA). We develop the process necessary for the production of the product, analyze the processes for potential patenting, carry out simulations and tests and create functional samples. Our service package thereby also contains the preliminary selection of suppliers and the material selection. Result of the design and development phase is a completely developed product.

Our service offering for phase III: pilot series development

Contract product development, mold design
In phase III of product origination, our experts for mold design and automation engineering develop small series molds and special purpose machinery.

Design verification and the preparation of product validation takes place in phase III. Our experts in mold design and automation engineering develop the small series molds and special purpose machinery. Mold and automation solutions are thus not formulated first for series production, but instead in a time-saving fashion in the prototypes and pilot series phase. Quality planning develops the measuring equipment in the quality lab. When necessary, we produce development samples, clinical samples or stability batches and small series in our small series production with clean room in accordance with ISO 14644-1 class 8. The result of this phase is a verified product.

Our service offering for phase IV: series development

Development of the manufacturing equipment for large series production
Manufacturing equipment design: complex assembly system for an inhaler.

Industrialization, manufacturing equipment validation and the preparation of the product launch takes place in phase IV. Our experts from mold making and automation engineering develop and build the high-cavity molds and complex automated systems and systems for the large series. We qualify the manufacturing equipment, plan the worldwide mold and special machinery procurement and create the Product Master File. The results of phase IV are the series production resources and a validated series product.

Computer-aided engineering: Product-specific calculations/simulations

Contract development and product development, mold flow analysis
Mold flow analysis of a laboratory disposable

With upstream injection molding simulations like mold flow we eliminate weak points and material accumulations and determine the optimal injection points, as well as process-stable injection parameters for the plastic parts. With the help of the finite element method we already determine and optimize the structural behavior of the components during the design phase. Statistical tolerance analyses show the influence of deviations of production parameters on the function of products. Multi-body simulations and flow simulations round off our service portfolio. If test results and simulations lead to adjustments of the design or material, these improvements are realized hand in hand with mold making and automation engineering.

Computer-aided engineering: measuring methods

Contract development and product development, computer tomography
Computer tomography enables a look into the interior of an inhaler.

In our TCC-internal quality lab, injection molding mold parts or assembly-units can be measured extremely precisely in the product origination process. With the Zeiss Metrotom 800 computer tomography, complex individual parts and complete modules can now be examined non-destructively and evaluated with regard to their dimensions and functionality. Besides components of plastics, thin-walled metal components like springs, for example, can also be measured. Computer tomography enables a look into the interior of objects or entire modules, without them having to be dismantled or even destroyed, as is usually the case. In a single pass, a three-dimensional image of the examined object is created, with which dimensional deviations or hidden errors, like, for example, blowholes can be read and measured.

Own development lab

Contract product development
Analysis of the pressure progression

Our development department has its own development lab, in which initial tests are already carried out at the commencement of product origination. The equipment, including workbench, milling machine, compressed air and high voltage current is selected in such a way that the most important system elements can be simulated. We also cover connection technology with the help of ultra welding machinery and a heat seal system. When preliminary treatment is to be simulated, we have an atmospheric plasma station at our disposal. With our special light and dispensing equipment, we can also test UV gluing technologies for a product in advance. Our product development works hand in hand with our engineers from the quality lab in order to coordinate all geometrical measurements and functional tests carried out on plastic parts, assembly-units and finished products during the product development process.

Contact us!
Alexander Schiessl
Sales Europe
+49 9431 639 6292
Shane Anderson
Sales North America
+1 609 369 1679
Rafael Kollofrath
Sales South America
+49 9431 639 6162
Mike Nie
Sales Asia
+86 769 8851 7100 317