Product development for medtech

Close cooperation with our customers is at the heart of every development project. We can enter a project flexibly at any stage of development - from the initial idea through design and prototyping to serial production. You decide how intensive our support should be for you. Each customer is assigned a personal NICOLAY project manager as a point of contact who steers the project through all phases and ensures clear communication. Our structured stage-gate process model with defined phases (requirements analysis, design, industrialization, design verification and process validation) forms the framework for every project. In each phase, there are milestones and coordination points (gates) at which we review the progress of the project together with you and make decisions. Through this collaborative development approach with continuous feedback, we ensure that the project is optimally managed from early concept development to final product maturity - in a targeted, transparent and successful manner.

A solid product specification is the foundation of every successful development. We support you in formulating clear technical requirements from initial ideas. In the requirements and specification phase, we record all relevant aspects: desired product functions, performance data, operating conditions and regulatory requirements. Thanks to our experience, we take all the important factors of ISO 13485, the international quality standard for medical devices, into account right from the start. This results in complete requirement and functional specifications that serve as a common roadmap and avoid misunderstandings. Thorough specification development saves time and costs, as it identifies the need for changes at an early stage and creates the basis for design, verification and approval. It is important to us that your requirements are not only understood, but also translated into feasible technical specifications - for a product design that meets expectations right from the start.

As early as the development process, we pay specific attention to the manufacturability of your product. Design for Manufacturing (DfM) means optimizing the design of individual parts, components or the entire product in order to make production as simple and cost-effective as possible. Our development teams therefore carry out DfM analyses at an early stage in order to identify and eliminate potential manufacturing problems before a product goes into production. The aim is to achieve stable and technologically feasible processes that ensure reliable series production. Aspects such as material selection, part geometry and assembly processes are taken into account in the design to avoid reworking or unnecessary complexity. Because manufacturability and quality are an integral part of our development approach right from the start, products can be transferred to production more quickly - with robust processes, high yields and a low error rate. The result: a well thought-out design that not only works on paper, but can also be implemented smoothly and efficiently in production.

In addition to technical performance, we always keep an eye on the cost-effectiveness of your solution. Design to cost means developing a product in such a way that all target costs are met without compromising quality. Our declared aim is to work with the customer to define the optimum product solution that both meets all technical requirements and complies with the planned cost structure. As early as the concept phase, we analyze cost drivers - such as material selection, production steps or supplier parts - and look for potential savings. Through clever design decisions (e.g. standardization of components, simplification of assemblies or selection of cost-efficient manufacturing processes), we optimize the design in monetary terms without compromising functionality. This design-to-cost approach pays off particularly in series production: Lower manufacturing costs mean competitive advantages for our customers. Ultimately, we deliver solutions that are both high-quality and cost-effective - so that your innovation is not only a technical success, but also a commercial one.

If existing products or assemblies are to serve as a starting point, we resort to reverse engineering. This involves analyzing an existing device or component and breaking it down into its design features in order to understand and digitally reconstruct design and functional principles. Reverse engineering - i.e. extracting information from existing objects or systems - has proven its worth in product development. NICOLAY uses state-of-the-art tools such as 3D scanning and CAD modeling to derive exact virtual models from physical samples. For example, we can re-roll a customer's proven product, optimize it or adapt it to changed requirements, even if original drawings or files are missing. The process is also used to develop compatible replacement parts for older devices or to examine competitor products - always within the scope of permitted methods. Through reverse engineering, we gain valuable insights that lead to an improved new design. Our customers benefit from shorter development times because existing know-how does not have to be developed from scratch, but is efficiently transferred into innovative solutions.

Before a project goes into full development, we carry out thorough feasibility studies. In these technical feasibility analyses, we check whether and how a product idea can be implemented under the given requirements. We evaluate various concepts in terms of technical feasibility, identify potential challenges and propose solutions. This includes, for example, initial test set-ups or prototypes with which we validate key technologies and functions on a small scale. Economic considerations are also taken into account: We estimate whether the required materials, production processes and development costs are within budget. These preliminary studies allow us to identify risks at an early stage - such as technological hurdles or high cost factors - and make informed decisions about the continuation of the project. Our feasibility studies provide you with clear answers as to whether your idea is practically feasible and under what conditions. In this way, we create transparency and security in the early project phase and lay the foundation for targeted development.

To ensure the functionality and reliability of a design even before production, we rely on extensive simulations. Using modern CAE (Computer Aided Engineering) tools, we can virtually simulate and test product functions. For example, we carry out finite element analyses (FEA) to calculate mechanical loads and material stresses and predict the product behavior in the respective application. For plastic parts, for example, we use a filling simulation that shows in advance how the injection molding material flows in the tool and where there is a risk of geometric distortion. These virtual tests allow us to iteratively optimize the design without having to immediately build real prototypes for every change. Overall, simulations shorten the development time and increase quality: problems are detected and rectified at an early stage, product performance becomes predictable and reliability under real conditions is already validated on the digital model.

Complete technical documentation is essential in the medtech environment. For every development project, we create a complete Design History File (DHF) - the development file in which all our product development steps are recorded - as well as the Device Master Record (DMR) - the manufacturing file with all the specifications for production. These documents ensure that every step from the first draft to series production is documented in a traceable manner. This includes, for example, development plans, drawings, parts lists, test specifications, validation reports and user information. With a clean DHF, we ensure that it is always possible to trace how the design was created and that it meets the underlying requirements. In the DMR, we record in detail how the product must be manufactured, tested, packaged and stored - these specifications ensure consistent production quality. Both files are carefully versioned and maintained so that they are always up to date. The documentation meets the criteria of ISO 13485 and not only contributes to quality assurance, but is also a prerequisite for approvals and audits. With NICOLAY as your partner, you can be sure that your project documentation meets the highest standards and that DHF/DMR includes all the content that was jointly defined at the start of the project.

As a development partner in medical technology, we ensure that your products meet all current regulatory requirements. Our processes are certified in accordance with DIN EN ISO 13485, the globally recognized quality management system for medical devices - this forms the basis for standard-compliant development and production. We take the requirements of the EU Medical Device Regulation (MDR) and relevant harmonized standards (e.g. ISO 14971 for risk management) into account as early as the development phase. We know: The MDR requires comprehensive technical documentation and strict proof of safety and performance. That is why we integrate the conformity requirements into every project right from the start. For the international market, we also observe the guidelines of the US FDA. Our development files (DHF) and quality processes are designed to meet the criteria of the FDA (21 CFR Part 820, Quality System Regulation) - including design controls, validations and complete traceability. Thanks to this compliance, our customers can market their products in both Europe and the USA without having to worry about delays caused by regulatory hurdles. NICOLAY provides flexible and compliant support for your project.