Design, Research and Development

  • Conceptual Product Design / Industrial Design

    From idea to finished product, we will help you with the design process from a sketch of a basic idea to finished product. We use several product design methodologies to ensure your product meets several criteria in terms of cost, manufacturability, ease of use, lifecycle time, etc.

  • Research and Development

    We strive to create useful solutions to develop new products and solutions for your future growth. Our work is always based on a scientific method approach, our engineers work on investigative activities to develop solutions to your engineering challenges based on scientific principles. We also have the support from academics of worldwide renowned Universities in many specialized fields such as Electrical, Mechanical and Biomedical Engineering.

  • Computer Design and Engineering Drawings

    One of our core strengths is the creation of product or process designs using Computer Aided Drawings (CAD) for the purpose of visualization, dimensional validation, rendering, and specification of manufacturing processes. Our design engineers are Certified Solidworks Associates and create designs based on manufacturing and assembly principles (DFMA). Final engineering drawings for prototype or production release are generated and include manufacturing as well as tolerancing specifications.

  • Structural / Thermal / Electromagnetic / Fluid Dynamics Validation

    Early stage product design wouldn´t be complete without a virtual validation of the designs we create. We ensure those designs will perform according to the Mechanical, Thermal, Electromagnetic, Electrical or Fluid Dynamics requirements of the products based on computer numerical models. Finite Element Analyses provide us with feedback based on the material properties, shape, and boundary conditions of the design.

  • 3D Reconstruction from Imaging Technologies

    We can do anatomical 3D models out a wide array of imaging modalities to enable the use of such geometries for physical construction of in-vitro models for pre-clinical procedure planning or experimental testing. The 3D computer geometries can also be used for anatomically correct development of implants or devices as well as to use such models with computer simulations.

  • Medical Art and Illustration / 3D Animations

    Conceptual design work and medical art are not only useful but essential for a variety of purposes within the medical device development industry:
    • Product presentations and marketing
    • Clinical procedures training
    • Regulatory documentation procedure illustration
    • Patent application drawings
    • Medical case reconstruction
    • Brochures
    • Instruction manuals
    • Illustration or animation of pathological conditions or medical device usage
    • Photorealistic rendering

Prototyping and Low-Volume Manufacturing

  • 3D Printing Services

    Modern additive manufacturing capabilities allow us to 3D print your designs in different materials and technologies depending on the application needed. We can print in the most popular technologies including Fused Deposition Modeling (FDM), Polyjet, Stereolitography (SLA) for most polymer-based work. Selective Laser Sintering (SLS) for metal applications can be used for Titanium, Stainless Steel, Aluminum and other alloys. Prototypes can then post-processed and be sanded, polished, painted depending on our customer´s needs.

  • 3 and 4-axis CNC Machining

    Our facilities have CNC machining centers to manufacture custom parts with a high level of precision (0.0001”) made of almost any material including Titanium, Stainless Steel, Aluminum and other alloys. Typically this process is suitable for parts that require to be under heavy structural stress, or for components of testing fixtures and tooling or final production parts.

  • 7-axis CNC Swiss-lathe machining

    When components require turning operations we use our state-of-the-art CNC swiss lathe with 7-axis for producing highly detailed metal parts with precision levels of 0.00001”. This process is suitable for small parts in either small or high volume production.

  • Thermoplastic Injection Molding

    We can create and manufacture our own injection molds. We have a 22-ton thermoplastic injection molding machine as well as hand-injection molding machines to do small batch production.

  • Additional Manufacturing Services

    • Surface treatment of metals, plastics through micro-abrasion
    • Ultrasonic cleaning
    • Metal passivation
    • Vacuum and gas purge packaging
    • Laser cutting and marking
    • Electrical Discharge Machining
    • Heat seal packaging
    • Thermoforming
    • Quick RTV silicone molds for conceptual work
    • Custom fixture fabrication
    • Custom instrumentation

Testing and Inspection Services

  • Mechanical Testing (Static and Dynamic)

    Any material, finished product or procedure usually requires an experimental validation of its mechanical performance. We can design and develop a wide range of static or dynamic mechanical tests, including the design and manufacturing of custom or standard testing fixtures as well as custom test control sequences based on extension, load or strain. Our expertise in mechanical design and testing includes the development of ASTM or ISO standard tests. Our lab facililties are equipped with an Instron Electropuls E1000 static and dynamic tension/compression testing equipment with +/-2000 N dynamic load cell. Tests can be performed and controlled based on extension, load or strain. Strain based tests are performed using an Epsilon digital extensometer.
    Static testing up to +/- 710N
    • Tension (ASTM D638, E8, E345, D882, D1708, F2516, ISO 527, etc.)
    • Compression (ASTM D695, ISO 604, etc.)
    • Flexure (ASTM D790, D6272, ISO 178, etc.)
    • Stress relaxation (ASTM E328, D6048, D1646, D6147, ISO 3384, etc.)
    • Creep (ASTM D2990, D7337, etc.)
    • Peel (ASTM F88, F2256)
    • Tear (ASTM D1004)
    • Friction testing (ASTM D1894)
    • Solution-immersed tests at controlled temperature of 37°C+/-2°C for specific medical applications
    • Torsion tests
    • Biomedical standard tests (ASTM F2458, F2606, EN455, etc.)
    • Creation of custom test control sequences
    • Stress-strain curve generation of custom specimens
    • Custom reports
    Dynamic testing up to +/-1000 N from 0.01 Hz to a maximum frequency of 100 Hz
    • Fatigue testing of materials, components or assemblies to determine product lifecycle
    • Real-time calculations
    • Full control on cyclic waveforms
    • Dynamic Mechanical Analysis Calculations
    • Elastic Stiffness and Energy Calculations
    • Creation of custom test control sequences including ramps, waveforms, frequencies, amplitudes, etc.
    • Custom reports

  • ASTM and ISO Standards Testing Services

    Our capabilities to manufacture our own tooling and fixtures in combination with our mechanical testing equipment allow us to perform a very wide range of ASTM and ISO standard based tests such as:
    • Tension (ASTM D638, E8, E345, D882, D1708, F2516, ISO 527, etc.)
    • Compression (ASTM D695, ISO 604, etc.)
    • Flexure (ASTM D790, D6272, ISO 178, etc.)
    • Stress relaxation (ASTM E328, D6048, D1646, D6147, ISO 3384, etc.)
    • Creep (ASTM D2990, D7337, etc.)
    • Peel (ASTM F88, F2256)
    • Tear (ASTM D1004)
    • Friction testing (ASTM D1894)
    Some additional tests we can perform include:
    • ISO25539 – Cardiovascular implants — Endovascular devices
    • ASTM F1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
    • ASTM F2193 – Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
    • ASTM F1798 – Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
    • ASTM F2077 – Test Methods For Intervertebral Body Fusion Devices
    • ASTM F2267 – Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
    • ASTM F2624 – Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants
    • ASTM F2706 – Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
    • ASTM F2346 – Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
    • ASTM F382 – Standard Specification and Test Method for Metallic Bone Plates
    • ASTM F384 – Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
    • ASTM F897 – Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
    • ASTM F1264 – Standard Specification and Test Methods for Intramedullary Fixation Devices
    • ASTM F1541 – Standard Specification and Test Methods for External Skeletal Fixation Devices
    • ASTM F564 – Standard Specification and Test Methods for Metallic Bone Staples
    • ASTM F543 – Standard Specification and Test Methods for Metallic Medical Bone Screws
    • ASTM F2502 – Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
    • ASTM F1635 – Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
    • ASTM F746 – Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
    • ASTM F1089 – Standard Test Method for Corrosion of Surgical Instruments
    • ASTM F1801 – Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
    • ASTM F2118 – Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials Custom based tests and other ASTM / ISO standards are also available

  • Contact Pressure Mapping

    Thin film sensor arrays along with state of the art software allow to do an experimental pressure distribution map of the contact forces associated with a medical device, implant, surgical procedure or pathological conditions. This map is helpful in determining pressure distribution and magnitude, areas of high friction and wear, high stress concentration areas, and overall effectiveness of contact forces of a medical device or implant.

  • Biomechanical Analysis and Tissue Testing Services

    • Custom experimental joint analysis
    • Computer analysis of biomechanical interactions
    • Medical device interaction with human body
    • Implant-tissue interactions
    • Tissue characterization,
    • Dynamic analysis of tissue
    • Fatigue testing of devices or biological tissue
    • Custom Testing projects

  • Digital Microscopy and Metrology

    Our state of the art equipment allows us to perform dimensional validation of prototypes as accurate as 1 micron. We can measure optically angles, distances, areas, radii, and perform 3D reconstructions for surface height mapping and profile measurement. We can compare dimensions and measure according to standard ASME Y14.5-2009 Geometric Dimensioning and Toleancing (GD&T).

  • Thermal Imaging

    For many tests that require temperature distribution analysis (e.g. physiological liquids at 37°C), we can validate them using thermal imaging technologies. Other tests that require a temperature distribution analysis are heat transfer problems, cooling of electronic designs, creep tests, environmental chamber tests and any other particular test that requires non-contact temperature analysis. We can also validate these analyses against computer numerical models of heat distribution in either steady-state or transient modes.

Intellectual Property / Clinical Trials / Regulatory / Tech Transfer / Funding

  • Design of Clinical Trials for Specific Product Categories

    Since the nature of each medical device is different, we can conduct a research on a full list of requirements for any given particular project in terms of designing a clinical trial useful for the regulatory and approval process. We have worked in the past in designing clinical trials as well as documenting all protocols for bioethics committee approvals.

  • Follow and submission of regulatory protocols

    As part of any medical device design and development process we document and validate all design iterations and test results as part of a Design History File required by most regulatory agencies in the world in order to approve medical device submissions. We can help in documenting submission files for FDA, COFEPRIS (Mexico) and other regulatory agencies.

  • Technology Transfer Services

    Once a project is finished it can be ready for release into production. We can help providing services of transferring skills, knowledge, technologies, and methods of manufacturing to enable our clients to further develop and exploit the technology into new products, processes, applications, materials or services.

  • Funding through grant applications

    We have helped and partnered with some of our customers in order to obtain grant funds to develop their projects. Over the last years we have successfully applied for 11 grant applications for different projects medical device based projects.

  • Intellectual property

    We have extensive experience in patent submission in many countries and we work with patent attorneys that have a lot of experience in the field. Our firm can help you write your patent application for protecting your intellectual property rights.