Solution

Medical Devices

From concept innovation and human centric design of new products, to device commercialization, and more, Battelle forges the path for medical device development. We work with clients throughout the product development journey–fostering science and engineering to solve your complex medical device challenges.
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A Proven History of Successful Medical Device Development 


Comprehensive Medical Device Development


From the initial insight and discovery phase to post-launch, Battelle integrates a deep knowledge base and a device agnostic approach throughout the medical device development process. Our medical product research and development facilitates the creation of rapid response solutions across industries to solve problems that were previously unsolvable.

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Our Services


Every product ideation starts with an expert level of analysis and research, tailored with a scope on the industry.



Market Research and Competitive Analysis

  • Competitive Product Features and Benefits
  • Competitive Teardown and Assessment
  • Contextual Inquiries
  • Market Feedback Research

Technical and Regulatory Research

  • Initial Regulatory and Standards Reviews
  • Requirements Gathering
  • Technical Due Diligence
  • Technical Landscape Survey
  • Technology Advancement Activities
  • Technology Feasibility Research

User Research

  • Anthropometric Assessment
  • Contextual Inquiries
  • Ethnographic Research
  • Focus Groups
  • User Needs
  • Task Analysis
  • Achieve its Primary Intended Purpose


Our thought leaders guide you from concept to solution through design, development, testing, strategy, and more.



Concept

  • Concept Generation
  • Co-Created Concepts
  • Concept Development
  • Design Inputs
  • Design Validation
  • Industrial Design
  • Materials Innovation
  • Multidisciplinary SME Approach

Feasibility

  • Engineering Testing
  • Focused Works-Like Modeling
  • Intellectual Property Development and Protection
  • Material Compatibility
  • Technology Assessment

Definition

  • Key Performance Indicators
  • Looks-Like Modeling
  • Technology Strategy and Road Mapping

Additional Services

  • Platform Expansion
  • Proof of Concept
  • Rapid Prototype – 3D Modeling
  • Risk Reduction Prioritization
  • Structured Selection Process
  • Technical Risk Reduction


Battelle takes you to market entry with a well-defined, highly-organized product structure.



Verification/Validation

  • Algorithms  
  • Artificial Intelligence and Machine Learning 
  • Design for Automated Assembly 
  • Bill of Materials 
  • Clinical Builds 
  • Design for X 
  • Design for Manufacturing 
  • Design History File / Design Master File 
  • Design Verification Testing 
  • Device Function / Robustness Enhancement 
  • Drop Testing / Impact Simulation 
  • FEA (static, dynamic, impact) 
  • IFU / Labeling /Packaging
  • Molds 
  • Preclinical Testing 
  • Process Validation 
  • Prototype Build and Test
  • Safety Risk Management (FMEA, Hazards Analysis, etc.)
  • Simulation Analysis
  • Software Development
  • Tolerance Analysis / Six Sigma
  • Total Product or Component Redesign
  • Usability Studies (summative & formative)
  • Verification Testing
  • Fluidics Design & Modeling 


We help you solidify your product as an industry leading solution through continuous re-innovation.



  • Development for Mitigations
  • Failure Analysis
  • FDA Recall Resolution/Notice Letters
  • Innovation for Mitigations
  • Product Redesign
  • Root Cause Investigation
  • Threat and Risk Assessment 

Navigating the Medical Device “Valley of Death”

Avoid the top 5 critical risk retirement mistakes with this white paper and minimize cost and time, make informed decisions, quickly eliminate poor ideas and give clear data to stakeholders.
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Our Experts


Photo: Injector medical device with a medication bottle

Is Your Medical Device Designed for the Real World?


Identify best practices for human factors research and drive informed decisions about your device product development with this white paper authored by our Battelle human factors experts.

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The Right Facilities to Scale Complex Challenges

Innovative products require highly-technical equipment in structures that can fulfill exact requirements. Battelle’s specialized facilities comprise over 75,000 square feet of space, dedicated to human centered design and medical device development, including intelligent 3D printing capabilities within our state-of-the-art infrastructure.

Battelle uLab

Our uLab enables the development of safe, effective medical devices by prioritizing the user. We can execute full-service user research, from study design to data analysis and reporting, to ensure you get the best data from the most complex requirements.
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Doing Business With Us


Whether you are government agency, commercial company or supplier partner that wants to work with Battelle, we have the contract vehicles and processes in place to make working with us easy, fast and efficient.


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