Research & Development
Prototyping for medical devices.
From concept to robust product design. We support medtech development teams in the structured planning and execution of prototyping iterations within the design controls process—resulting in significantly shorter development times.
What prototyping challenges arise in medtech development?
Structured prototyping is a critical success factor in highly regulated environments:
- Prototypes are often built without first defining clear evaluation goals and test criteria.
- Prototyping results are not formally documented and are therefore not included in the Design History File (DHF).
- Too few prototype iterations in the early stages almost inevitably lead to extremely costly design changes later on.
- Prototypes used for usability testing are often not representative enough of the final product design, which leads to invalid test results.
Are your prototyping findings fully documented and audit-ready in the Design History File (DHF)?
Our prototyping services.
We are transforming prototyping from a "hobby" into a highly structured, documented development tool.
Prototyping Strategy & Planning
Precise definition of the prototyping phases within the framework of design controls: What is prototyped and when? Determination of prototype types (conceptual, functional, form factor) appropriate to the respective project phase.
Evaluation Planning & Documentation
Planning prototype evaluations with crystal-clear acceptance criteria. We ensure that all test results, versions, and resulting design decisions are consistently documented in the DHF.
Rapid Prototyping & Technology Selection
Strategic consulting on technology selection (e.g., 3D printing, CNC, in-house vs. outsourced). We help accelerate iteration cycles and select the right technology for each specific evaluation purpose.
Integration into Design Controls
Close integration of all prototyping activities with formal design reviews, usability engineering, and risk analysis (ISO 14971) to ensure true regulatory compliance.
Frequently Asked Questions About Prototyping.
How many iterations are typical in medtech development?
Typically, we see 3 to 7 iterations between the very first concept prototype and the final design freeze. Fewer iterations almost always mean a drastically increased risk of "late-stage" design changes, which are extremely costly due to documentation requirements.
Does a prototype have to be manufactured in strict accordance with GMP?
Prototypes used solely for internal design evaluations are not necessarily subject to strict GMP regulations. However, prototypes used in clinical trials or formative/summative usability studies with human subjects must comply with defined safety standards.
How should prototyping results be properly documented in the DHF?
In the form of formal design change notices, evaluation reports, and review minutes. Prototype versions must be clearly identifiable, evaluation objectives must be defined in advance, and the rationale for resulting design decisions must be transparently documented.
How are prototypes and usability tests related?
Validated usability tests require representative prototypes—that is, ones that replicate the final user interface and interaction design as closely as possible. Formative tests in earlier phases can also use low-fidelity prototypes to gather quick user feedback.
Related engineering topics.
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