Product development of microfluidic consumables
Innovate with Hahn-Schickard: From Concept to Market
Hahn-Schickard supports you as a development and manufacturing service provider for medical and diagnostic products throughout the entire product development process in accordance with DIN EN ISO 13485. We assist you in planning approval studies according to IVDR specifications (EU Regulation 2017/746) and guide you through the launch of the CE-IVD product and the transition to mass production. Our expertise spans from conception to realization, and we emphasize clear communication and precise execution. Let’s transform your ideas into innovative products together!
Navigating from Vision to Reality: Our Process
I Project definition
Idea Exploration: Let’s sit down and discuss your vision. We’ll explore the possibilities, aligning your vision with our expertise. Together, we’ll lay the groundwork for what’s to come.
- System Requirements: We define the essential elements your project needs to thrive.
- Interfaces: Connecting the dots—ensuring seamless interactions.
- Critical Steps: Identifying the pivotal moments that make or break success.
- CTQ Flowdown: Quality matters. We cascade critical-to-quality factors throughout the process.
- Measurement Criteria: Metrics matter. We set the bar high and measure progress.
- Risk Assessment: Anticipating challenges and mitigating risks.
- Conceptualization: Breathing life into your vision.
- Preliminary Project Plan: Work packages, timelines, and budgets — all mapped out.
II Feasibility & conception
Feasibility check: We scrutinize the essential requirements of your system. It’s our reality check, ensuring your vision can thrive
- Proof of Concept Studies: We explore, experiment, and validate. It’s where innovation takes its first breath.
- Prototyping: From sketches to tangible prototypes, we bridge imagination and functionality.
- Low-Volume Production: Up to 50 parts—small batches, big impact.
- Functional Model Design: We sculpt the blueprint, ensuring form follows function.
- Iterative Refinement: Like a symphony, we fine-tune each note until harmony emerges.
III Product Development
At Hahn-Schickard, we don’t just create prototypes—we engineer possibilities. Here’s our roadmap to success:
- Prototype Design: We sculpt your vision into a tangible prototype, ensuring form meets function.
- ISO 13485-Compliant Development: Quality is our compass. We navigate the development process with precision.
- Iterative Refinement: Like artists perfecting their masterpiece, we fine-tune until excellence is achieved.
- Batch Production: Whether 50 or 1000 parts, we scale up without compromising quality.
- Clean Room Excellence: Our controlled environment (Class 8) ensures purity and precision.
- GMP Standards (Class B): Compliance is our foundation—meeting the highest industry benchmarks.
- Tailored Hygiene Measures: Your needs drive our protocols. Safety and efficacy are non-negotiable.
IV Prototype & Scale-up
We guarantee a smooth transition from product development to scale up:
- ISO 13485-Compliant Journey: Our development process adheres meticulously to ISO 13485 standards. From initial concept to final documentation, we ensure precision every step of the way.
- Injection Molding Transition: From concept to reality, we transform prototypes into production-ready designs.
- Scalable Production: Whether you need 1000 or 200,000 parts, we’ve got you covered. Our manufacturing prowess ensures seamless scalability without compromising quality.
- Clean Room Excellence (Class 7): Our controlled environment maintains the highest standards of cleanliness.
- GMP Class C Standards: Compliance is our compass. We follow Good Manufacturing Practices rigorously, meeting the industry’s highest benchmarks.
- Tailored Hygiene Measures: Your needs drive our protocols. Safety and efficacy are non-negotiable, customized to match your unique requirements.
- Validation Assurance: Our process validation ensures reliability, while product validation guarantees excellence. We don’t just create; we validate.
V Manufacturing
Precision Manufacturing: Bringing your vision to life - Here’s how we turn blueprints into reality:
- Seamless Handover: Your design seamlessly transitions to our in-house manufacturing department. It’s where precision meets production.
- Volume Commitment: Whether it’s 100,000 or 200,000 parts, we’re committed to delivering the agreed-upon volumes. Quality remains our compass.
- Tailored Hygiene: Your needs drive our protocols. Safety and efficacy are non-negotiable, customized to match your unique requirements
IP Protection
Whether you’re embarking on a prototype journey or a full-blown product development process with Hahn-Schickard, the question of intellectual property (IP) protection is paramount. Here’s what you can expect from us:
- Comprehensive Nondisclosure Agreements: We take confidentiality seriously. Our robust agreements shield your IP, ensuring your ideas remain yours.
- Long-Term Validity: Our commitment extends beyond project completion. Your IP remains safeguarded long after our collaboration ends.
- Holistic Idea and Design Protection: From inception to realization, we guard every facet of your concepts and designs.
- Secure In-House Cleanroom Work: Our controlled environment ensures that your IP is handled with utmost care and security.
- Knowledge Exchange with Discretion: Our team operates like a vault—professional knowledge exchange happens, but secrecy is our foundation from day one.
Combining IVD excellence: Our IVD partner network
At Hahn-Schickard, we’re not just about development—we’re about forging partnerships that propel innovation. Here’s how we shape the IVD value chain:
- Design to Production Prowess: Seamlessly transitioning from design to production is our forte. Your vision becomes reality without a hitch.
- Reliable Experience: With years of experience in microfluidics and production, we’re the steadfast partner you can trust.
- ISO 13485 Certification: Quality is our compass. We adhere to the highest standards, ensuring precision and compliance.
- Extensive Partner Network: Our connections run deep. When challenges arise, we call upon a reliable network of experts.
- Swift Communication: No red tape. We orchestrate seamless communication, ensuring clarity and efficiency.
- Cost-Effective Knowhow: Our broad expertise minimizes development costs while maximizing impact.
- Accelerated Time to Market: Your success waits for no one. We fast-track your journey from concept to market.
- Risk Mitigation: We minimize investment risks, ensuring your venture yields fruitful returns.
Ready to revolutionize IVD? Let’s create brilliance together!
