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.
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
- 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 Generation
- Co-Created Concepts
- Concept Development
- Design Inputs
- Industrial Design
- Materials Innovation
- Multidisciplinary SME Approach
- Engineering Testing
- Focused Works-Like Modeling
- Intellectual Property Development and Protection
- Material Compatibility
- Technology Assessment
- Key Performance Indicators
- Looks-Like Modeling
- Technology Strategy and Road Mapping
- 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.
- 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
- 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
years of medical device design and development experience
companies assisted as their medical device research and development partner
success rate for FDA submissions with Battelle human centric design work
specialty labs dedicated to medical research and development
granted medical technology patents and 100+ patents pending.
Building Better Solutions Through Empathy and Rigor
“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!”
Global Medical Device Manufacturer
Vice President, R&D
“The product concepts you created have received the most positive customer research results we have ever seen!”
Surgical Equipment Manufacturer
Director, Advanced Development
“I am extremely pleased with how you are conducting the studies. It is refreshing to see how well organized and executed everything is compared to other design firms we have worked with.”
Group Head, Human Factors Engineering
“One of the best audits I’ve done in 15 years.”
Contracted Supplier Auditor
“I wanted to commend your team on several best practices including the very well done research summary report…I was very comfortable with your research and translation approach appreciating both the rigor and the protection of early convergence the team employed. You have built a great foundation for innovation!"
Commercial Automation Manufacturer
Director of Innovation
The Right Facilities to Scale Complex Challenges
Jennifer SimkinsUser Experience/User Interface Designer, Certified Usability AnalystJennifer is a top visual designer, working within the healthcare and consumer industries. With over a decade of experience, her background in UX/UI design experience uniquely promotes Battelle, and includes integrating user-centered analysis throughout the design process to inform design decisions, the development of wireframes, and more.
Grant LeffingwellPrincipal Research Scientist
As a Certified Usability Analysts (CUA) on Battelle’s Human Centric Design team, Grant helps manufacturers improve the safety, usability and user satisfaction of their devices. His experience spans all types of devices from mHealth apps to drug delivery, and he leads a wide variety of usability research efforts.
From concept innovation and human centric design of new products, to device commercialization, and more, Battelle forges the path for medical device development.
We transform your neurotechnology and bioelectronic medicine innovations into market-ready solutions. Our experts help you solve your problems, manage your risks and accelerate your development timelines - from concept to FDA registration.
Technology - For the first time ever, this wearable sleeve enables you to take real-time, high-resolution measurements of the nerves and muscles of the forearm. This technology is used in targeted stimulation interventions that recreate dexterous hand movements.