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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We Make It Happen


Battelle turns ideas into reality. With nearly 4,000 patents and 400+ R&D 100 Awards, we know how to help organizations traverse the concept and feasibility stage, eliminate disruptive product development hurdles and reach new markets. Battelle provides quick, agile, and reliable services during the commercialization process, with a 100% FDA submission success rate for human centric design work.

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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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

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
  • Industrial Design
  • Materials Innovation
  • Multidisciplinary SME Approach

Feasibility

  • Engineering Testing
  • Feasibility
  • 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 

A Proven History of Successful Medical Device Development 

Building Better Solutions Through Empathy and Rigor

Battelle’s development processes are founded in human centric design. We are focused on how people perform tasks, instead of expecting shifted behaviors to use products. With an empathetic understanding of how people interact with products, supported by rigorous testing and engineering, we find the perfect balance between user requirements and business objectives.
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Medical Devices - Vice President, R&D, Global Medical Device manufacturer

Nov 3, 2021, 06:46 AM
Title : Medical Devices - Vice President, R&D, Global Medical Device manufacturer
Name : Global Medical Device Manufacturer
Position : Vice President, R&D

“It is incredible how you were able to take so much complex information and boil it down to a simple, elegant solution. This is why we keep coming back!”

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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 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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