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Contract development

Customer Focus & Flexible Collaboration

At MedRes, we employ a rigorous development process to ensure that our devices meet the highest standards for safety and efficacy.

Our contract development services are tailored to the specific requirements of each project, and include ideation, design and concept development, prototyping, testing, engineering support for regulatory and clinical development processes, transfer to pilot production and volume manufacturing.

Contract development services

1.
Ideation & design

We familiarize ourselves with your product idea, the specific clinical & market needs. We research target use cases and markets. We develop product concepts through continuous idea generation, testing & refinement cycles, until we reach a feasible solution. All this with close cooperation with you.

2.
Product development

We analyze user and patient needs and design ergonomic and intuitive interfaces. We complete the development of your product taking into consideration Design for Manufacturing principles. We pay close attention to supply chain requirements in material selection & packaging design.

3.
Clinical & regulatory compliance

We build your pilot units and support pre-clinical and clinical testing to meet applicable regulatory requirements. We compile evidence and support your regulatory submission in the EU or US.

4.
Pilot production and manufacturing ramp up

We establish your fully documented and volume-capable manufacturing line. We develop and build product-specific manufacturing tools and equipment. We integrate your product into our existing supply chain solution.

Direct Clinical Access

Fueling R&D Innovations

Our direct access to clinical facilities greatly enhances our R&D efforts. Thanks to
our partnerships with esteemed institutions globally we can complete pre-clinical
and clinical studies in an efficient and reliable way enabling timely product market
entry.

Our core technical competencies

Our core product expertise

Endoscopes

We possess extensive expertise in endoscopy, developing solutions that range from disposable to reusable and from rigid to flexible designs.

Our experience covers diverse medical fields, including gynecology, urology, and cardiology. With a deep understanding of various configurations, from diameter and length to image quality, we customize endoscopes for specific medical applications and camera setups, integrating the ideal working channel  for optimal performance to meet our clients’ specific requirements.

MedRes contract manufacturing

MedRes contract manufacturing

MedRes contract manufacturing

MedRes contract manufacturing

Resectors

We have significant expertise in resectors, ranging from disposable to reusable and from rigid to flexible designs, specifically tailored for the characteristics of specific lesions. Our comprehensive knowledge is derived from diverse projects in the urological and gynecological domains.

We have innovated handheld surgical devices with diverse cutting edge geometries, matched drive constructions to a variety of motors, ensuring performance and precise control. Our experience also encompasses the development of flexible shafts and the integration of fluid management.

Catheters

With years of experience in catheter design, we use our technical knowledge to move projects from concept to final product. Our focus is on material selection, effective prototyping, and thorough testing. We excel in areas like tip configuration, lumen structure, and material flexibility. Our catheters prioritize patient safety, meeting the strict standards of the healthcare industry with consistent reliability and efficacy.

MedRes contract manufacturing

MedRes contract manufacturing

MedRes contract manufacturing

MedRes contract manufacturing

Nitinol implants

Our capabilities include the design and testing of a wide range of nitinol implants. Nitinol, renowned for its unique shape memory and superelastic properties, has carved its niche in the medical world owing to its biocompatibility and adaptability.

These traits make nitinol particularly suited for a variety of medical implants, such as stents, guidewires, and heart valve components. With significant expertise in this field, we are committed to leveraging nitinol’s potential to create state-of-the-art implants that cater to the dynamic needs of surgeons and interventionalists.

Controllers & Generators

We have a wealth of experience in developing external controllers for surgical handheld devices. These controllers integrate control panels, peristaltic pumps, motors, and specialized PCBs.

MedRes contract manufacturing

MedRes contract manufacturing

Merging development

expertise with nitinol innovation

Merging development expertise with nitinol innovation

Our US R&D Hub functions as both a business development and customer management hub for all MedRes clients and an R&D center specializing in the design, prototyping, and functional characterization of Nitinol-enabled cardiovascular implants and instruments.

We tap into nitinol’s versatile features to develop cutting-edge medical solutions. Our overarching expertise lies in the capability of blending the transformative potential of nitinol with our profound medical device developmental knowledge. 

In Nitinol engineering, we place special emphasis on the following steps in device development:

1.
Predictive simulations

Conducting computational simulations to predict the functional performance of design candidates with the unique characteristics of Nitinol in mind.

2.
Procurement for prototyping

Sourcing appropriate Nitinol materials for prototype fabrication.

3.
Advanced prototyping

Processing prototype articles, which includes engineered variations of laser cutting, shape forming and surface finishing Nitinol.

4.
Precision metrology

Using precision metrology to comprehensively characterize prototype articles, as well as function testing, encompassing mechanical characterization and simulated clinical use of Nitinol implants.

5.
Designing delivery systems

Matching implant design with delivery system design services.

Integrated engineering team

Boasting a comprehensive spectrum of expertise, our team encompasses product designers, mechanical and electrical engineers with specializations in hardware and firmware, a software developing unit, biomedical researchers.

Thanks to this diverse composition and our collaborative approach, we are ideally positioned to support product development from its inception. The distinct areas of expertise within our team include:

Our team's diverse composition allows for a comprehensive approach right from the idea's inception, considering function, safety, ergonomics and integration with other tools and instruments right form the very beginning.

Housing product designers, mechanical, software and electrical engineers, and specialists in hardware and firmware, our multifaceted teams ensure that every detail of medical device development is covered by a colocated team, eliminating delays and reducing loss of information in team communication.

Inhouse biological researchers, biomedical engineers on our teams bridge complex engineering concepts with real-world medical needs, ensuring that products are precisely tailored to actual clinical needs and use scenarios.

Our focus on quality is uncompromised. V&V and Documentation Engineers meticulously manage technical documentation, while our hands-on technicians guarantee precision throughout the compilation of Technical documentation files and design history files.

Our guiding principles

Contract development

Flexible customer cooperation

We can support you at any stage of your product life cycle, starting together at ideation or joining the project at a later stage. We customize our product development process based on your need. We adapt each stage to your unique requirements.

Contract development

Customer first culture

From tight oversight to loose collaboration, you define the level of your involvement in project execution. Communication is key to success; therefore we always keep you up to date and proactively seek your input during the process. All your requests will be answered promptly.

Contract development

Design for excellence

We have deep knowledge in planning design verification and validation activities in a cost effective & compliant way. Our Design for Excellence guidelines ensure shorter overall development cycles coupled with lower manufacturing costs.

Contract development

Speed to market

Our engineering and manufacturing teams collaborate seamlessly for efficient design and development processes. This collaboration allows us to introduce new design iterations and commence pilot production, whether in low to mid volumes or even singular batches.

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