Deaton Engineering

Biomedical Engineering and Medical Device Design

Recent advances in technology have opened the door to many exciting new product opportunities for medical device firms. But competitive pressures and strict regulatory requirements make it tougher than ever to bring a new product to market. In addition, Medicare and insurance cutbacks on patient reimbursement are putting pressure on margins.

Total quality management: define, design, build, validate, and improve. Deaton Engineering applies a risk-based approach to medical device manufacturing. This technique can deliver substantial improvements in productivity while maintaining the highest assurance of product and human safety. We deliver cost-effective, FDA-compliant solutions by assisting you in developing a plan to meet your goals.

We employ a Total Quality Improvement methodology for design, validation, and manufacturing. We partner with you to develop and deliver innovative engineering solutions to support your project initiatives, whether it's a mechanical design, a production scale-up, a major automation project, or a plant expansion.

Medical Device Design, Validation, Manufacturing Automation, and Machine Design

Medical Device Design

Deaton Engineering is experienced with the FDA's requirements for medical devices. We incorporate good documentation practices and validation strategies into our designs. We consider the impact of the design on manufacturing techniques, cost control, cleaning, and sterilization procedures. Our engineering staff can produce your medical device prototypes and provide documentation for 510K submittals, and UL and CE certification.

Risk-Based Validation Engineering Services

Deaton Engineering manages the validation process by developing a strategy that includes requirements, risks, and test procedures to ensure compliance with good manufacturing practices. Deaton Engineering can develop Installation, Operation, and Performance Qualification protocols for any type of manufacturing process, facility or equipment.

Computational Methods to Support Regulatory Filings for Medical Devices

Utilize FEA to reduce product development costs, limit liability risk, reduce time to market, and support FDA 510k filings. Identify and analyze worst-case implantable device size for use in mechanical testing. Verify radial force, anchoring, dynamic compliance, and fatigue loading conditions.

Manufacturing Automation & Machine Design

Deaton Engineering designs fully automated manufacturing systems that incorporate industrial robots, vision systems, and QC testing. We specialize in building turnkey process and equipment solutions that are reliable, cost-effective, and GMP compliant.


Biomedical Engineering & Design Services

  • Medical device design
  • Cardiovascular device design
  • Orthopaedic design
  • Medical electronics device design
  • Orthopaedic implant design
  • Orthopaedic surgical device design
  • Surgical instrumentation design & prototyping
  • Premarket notification 510(k)
  • Premarket approval (PMA)
  • Implantable design; spinal, orthopaedic, neurological, dental, & cardiovascular
  • Human factors engineering & design
  • Device master record (DMR)
  • Concept development
  • User requirements and functional specifications
  • Solid models
  • Prototypes
  • Design for verification and validation
  • Development of Class I, Class II, &
    Class III medical devices
  • Quality system integration
  • Orthopedic device design
  • Computational testing
  • Identifying worst-case device sizes
  • In vivo loading conditions
  • Anchoring and fatigue loading conditions
  • Design verification and validation
  • Medical device engineering
  • Medical device product design list
  • Engineering services list
  • Validation engineering services list
  • FDA, regulatory and safety services list



FAQs:

What services does Deaton Engineering offer to the Medical Device industry in Texas?

Deaton Engineering provides a range of services tailored to the Medical Device sector, including:

  • Medical Device Design: Developing innovative device designs that comply with FDA requirements, cost control, and sterilization procedures.
  • Risk-Based Validation Engineering: Managing the validation process by developing strategies that include requirements, risks, and test procedures to ensure compliance with good manufacturing practices.
  • Manufacturing Automation & Machine Design: Design fully automated manufacturing systems incorporating industrial robots, vision systems, and quality control testing to enhance productivity and maintain high safety standards.
How does Deaton Engineering ensure compliance with Texas-specific medical device regulations?

Deaton Engineering stays abreast of both federal and Texas state regulations governing medical device manufacturing and distribution. They ensure that all projects comply with guidelines set forth by the Texas Department of State Health Services (DSHS), including adherence to state-specific statutes and federal laws adopted by reference.

Can Deaton Engineering assist with facility optimization and safety in Texas-based medical device manufacturing plants?

Yes, Deaton Engineering offers support services for production systems in FDA-approved facilities across Texas. Their engineers can design, improve, or support systems that run operations, including on-site construction management and start-up support, ensuring efficiency and safety standards compliance. Deaton provides engineering, design, automation, and validation services across Texas, including in Austin, Dallas, Fort Worth, Waco, Houston, and San Antonio.

How does Deaton Engineering approach process automation for Texas medical device companies?

Deaton Engineering designs and builds individual equipment or complete manufacturing lines to automate and improve processes. They utilize GAMP-compliant designs to create turnkey solutions that are reliable, cost-effective, and suitable for GMP validation, catering to the specific needs of Texas medical device manufacturers.

How can Texas medical device companies initiate a project with Deaton Engineering?

Companies can contact Deaton Engineering here, or by visiting their Georgetown, Texas headquarters, a suburb of Austin, Texas. They offer free consultations to discuss potential projects and provide estimates, facilitating collaboration with Texas-based medical device firms. Deaton provides engineering, design, automation, and validation services across Texas, including in Austin, Dallas, Fort Worth, Waco, Houston, and San Antonio.