Design for Manufacturing
Industrial design, concept and product development

What results from the connection of creative design and competent industrialization? Products that not only look good, but also progress to mass production quickly and smoothly.

The Gerresheimer item company was founded at the beginning of 2012 as a result of the merger of the successfully owner-operated service company item medical device design with the plastic specialists Gerresheimer Medical Systems. Particularly our customers profit from the linking of strategically oriented product development and industrial design with the industrialization know-how of the market leader in plastic processing in the fields of pharmaceuticals and medical technology.

Our customers appreciate the many years of experience and many realized design projects. Through our base in the university city of Münster, we are closely networked with the faculties of medicine, pharmaceuticals technology, and medical technology. Because Gerresheimer item is organized as an independent limited company, our customers maintain maximum freedom following completion of the product development. You alone decide whether your product will be manufactured at a location of Gerresheimer Medical Systems or at another producer of your choice. 

Your PLUS with Gerresheimer

Complete service: from concept development to the series production-ready product

Product design, concept development, product development, drug delivery systems, medical devices
We offer our customers complete service: from concept development to the ready for series production product

The service spectrum of the Gerresheimer item GmbH extends from the concept development to the series production-ready product. Consultation and support in early project phases with services such as the design development or the ensuring of the freedom to operate are as much part of our service portfolio as are engineering, prototyping, or studies and the manufacture of clinical samples. Our 20-member team of designers and product developers look at a product concept from the most varied perspectives. The needs and requirements of the users are thereby in the foreground, but functional and technical requirements and practicability in plastic also define the design.

Our goal at Gerresheimer item is to also equip complex medical devices with functionally compatible ergonomics. We are only satisfied when the end product contributes to the quality of life of patients.

Design: from the strategy to the optimal product

Concept development, usability engineering
Concept development and optimization of a handling device for a catheter system

Our product designers work with a clear vision: Form follows function. The design must improve the functionality of the products, consider the needs of users, manufacturers, and patients, and design the production processes to be as efficient as possible. At the same time, however, the product design should reflect the unmistakable image of our customers and ensure easy recognizability.

We combine market requirements with the functional and technical requirements of the product. This encompasses not only an attractive form, but also and especially, functionally compatible ergonomics. Especially in the case of products for the pharmaceuticals and medical technology area, the intuitive and easy handling of the product is of great importance. The Gerresheimer item GmbH evaluates several alternative design concepts in the framework of usability studies. The most promising design variants are then further optimized and realized as clinical samples.

Usability engineering according to ISO/IEC 62366

Concept development for inhaler
Design and concept development of drug delivery device

The focus of our development is always on future users: Patients, doctors, or pharmacists, with their daily tasks, needs and sensibilities. As a result of direct contact with them, we acquire extremely valuable information from daily practice, in order to later transfer this to the requirements of our products.

The user also remains our point of reference during continuous tests until development is completed and beyond. That gives us (and our customers) a sense of security that all potential risks for later use have been recognized and minimized. Our customers receive this process in the form of standard-compatible documentation, which enormously accelerates the approval process for medical and pharmaceutical products.

Product development: thinking ahead to production

Design for manufacturing, product development of medical devices
We ensure design for manufacturing

What good is an innovative concept if it isn't suitable for industrial production? Gerresheimer item customers can be certain that designs have been conceived of as compatible with plastic and can be robustly manufactured in large series. This is ensured by the close cooperation with the Technical Competence Centers of Gerresheimer Medical Systems in Wackersdorf (Germany), Peachtree City (USA), and Dongguan City (China). This means that the central requirements like producibility in plastics, assembly and testing capability are already considered during the conception of a new product.

Together with the customer, we define the key data for the new product, create a user requirements specification as needed and derive appropriate specifications from this, which cover all aspects of a plastic and production-compatible conception. The results of all development phases are tested and validated on the basis of handling samples, test models, prototypes and pilot run products.

Product development by Gerresheimer item provides our customers with advantages:

  • short development time
  • minor development costs
  • reduced project risk through plastic-compatible optimization during development
  • high level of brand knowledge
  • many years of experience in design and engineering

Patent management: recognizing trends

Industrial design of medical devices
Recognize trends and systematically utilize all chances – that's how we realize a permanent market advantage

Strategic patent management is of essential importance in product development for the pharmaceuticals and medical technology branch. In the process, this does not only concern the securing of all occurring ideas in accordance with patent law. Through targeted patent research, Gerresheimer item is in a position to be able to recognize trends and to systematically utilize all chances for converting the innovative competence of our customers and our company into a permanent market advantage.

Quality management: systematic reduction of risks

Circumspect quality management in product development reduces systematic risks – in every project phase, step-by-step. Quality management at Gerresheimer item encompasses both the internal processes and the quality of the products to be developed.

Permanently anchored processes include: Project phase model (design control), product specification, risk analysis and documentation of development. All tools of quality assurance pursue the goal of minimizing the risks for investors, distributors, and users. Gerresheimer item maintains a structured product development process that is divided into five phases. Our phase model guarantees you all-round maximum safety, forms the foundation of successful cooperation and generates the respective documents of relevance for approval. This development process is synchronized with the process at Gerresheimer Medical Systems and thus guarantees loss-free transfer to the industrialization there.

Gerresheimer item certified according to DIN EN ISO 9001:2008 and ISO 13485. This distinction was awarded following detailed testing by experts of DQS. Tested, among other things, were the quality goals, all important work instructions and process sequences, training and continuing training of employees, determination of customer satisfaction and reactions to customer wishes.

Certification according to ISO 13485, product development medical devices
Gerresheimer item certified according to DIN EN ISO 9001:2008 and ISO 13485.
Certification according to ISO 13485, product development medical devices
Certification according to ISO 13485, product development medical devices

Projects: core competence in the pharmaceutical and medical technology market

What generates trust in a development partnership? The experiences and the clearly defined processes speak in favor of Gerresheimer item.

Sophisticated companies seek out the most competent partners. 

This is why Gerresheimer item concentrates completely on its core competence in the pharmaceuticals and medical technology markets. Our customers can therefore be sure that Gerresheimer item can provide the standards-compatible documentation of relevance for approval during any project phase. We also possess medical-specific material knowledge with regard to biocompatibility, migration, and permeation.

Gerresheimer item offers its customers one-stop shopping with regard to electronic hardware and software development, market research and production through close cooperation with strategic partners and the access to the industrialization competence of Gerresheimer Medical Systems.

Fresenius Medical Care

Product name: VenACC
Product: Wetness detector for the quick detection of blood loss during dialysis
Contribution of item: Industrial design, design, prototyping for clinical samples

Industrial design and product development


Product name: Cathlete plus
Product: Catheter system 
Contribution of item: Optimization of the handling device

Industrial design and product development of medical device


Product name: Tuloc
Product: Tumor marking system
Contribution of item: Industrial design, mechanical design, prototyping
Remark: The challenge was to design a product burdened with a great deal of fear in such a way that it preserves human dignity, to represent a high level of functionality ergonomically and to realize a disposable product economically.

Industrial design and product development of medical devices


Each innovation pursues its own strategy. And every development poses new challenges resulting from ambitious technical and economical conditions.

For this reason we are proud of the experience we have been able to build up in the most varied projects with sophisticated clients.

Industrial design, concept and product development for medical devices, drug delivery systems and medical devices
Contact us!
Carsten Bank
Sales Europe
+49 (0)251 490944 122
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