Medical Device
Design and Development
From Concept to Commercialization
with Confidence
Our Development Process
User Research and Requirements
Identify your user needs and turn them into actionable design inputs.
Concept Generation and Risk Analysis
Evaluate feasibility, measure risk and assess market impact of your design options.
Design Refinement and Engineering
Refine your chosen concept and develop detailed engineering designs.
Verification
Testing
Test your designs to ensure they meet all product and regulatory requirements.
Manufacturing
Transfer
Validate and optimize your device to prepare for manufacturing.
End-to-End Design and Development
User Research and User Needs
Industrial Design
Multi-Disciplinary Engineering
Human Factors and Usability Testing
Theory of Assembly and Manufacturing Transfer
Concept Generation and Prototyping
Systems Architecture and Engineering
Design Verification and Standards Testing
Packaging and Instructional Design
Post-Market Support and Rapid Troubleshooting
Support at Every Stage
No matter where you are in the phases of medical device development, our broad expertise and specialized facilities are here to help you ensure your product’s success in the market.
Phase 0: User Needs Research and Requirements Development
During user research and requirements gathering, you’re focused on accurately identifying the needs of your intended users and translating these into clear, actionable design inputs. From the outset, we consider regulatory requirements, engage with your stakeholders, and identify possible risks associated with the product.
The Battelle Advantage:
Our team specializes in comprehensive user research and testing to ensure that your users’ needs become concrete product requirements.
Phase 1: Concept Generation and Risk Analysis
The concept generation and risk analysis phase is focused on generating innovative concepts that meet your identified user needs and product requirements. At this stage, various design options are being considered, evaluated for feasibility, and assessed for market impact. Simultaneously, risks associated with each concept are being analyzed and strategies are designed to mitigate them.
The Battelle Advantage:
Innovation is what we do, and medical devices is no exception. For over 60 years, our team has been generating inventive concepts grounded in user research and technical feasibility. Count on our rigorous risk analysis processes and testing facilities to bring potential issues to light early. We enable you to select the right concept that meets needs and requirements, and aligns with your business objectives and risk tolerance.
Phase 2: Concept Refinement and Engineering Development
In Phase 2, your focus is on refining your concept and developing detailed engineering designs. Manufacturing, cost-effectiveness, and performance must be considered at this point in the process. By the end, you should have a design that meets user needs and product requirements and can be manufactured efficiently and cost-effectively.
The Battelle Advantage:
Transform your concept into an intuitive design ready for verification and validation with our trusted human factors engineering expertise. Combine our industrial design and engineering acumen to balance both usability and requirements in your design, while making decisions that promote efficient and cost-effective manufacturing later on.
Phase 3: Design Verification Testing
In the verification phase, you’re conducting rigorous testing to verify that your design meets all of the defined product requirements. Properly executed design verification will ensure that your design is ready for manufacturing.
The Battelle Advantage:
Smoothly navigate the device verification process with our meticulous, customizable approach to testing and 75,000 ft2 of specialized facilities. We emphasize your product requirements while maintaining regulatory compliance to prepare your product for a successful transfer.
Phase 4: Design Transfer and Manufacturing
As you transition into Phase 4 of the development process, you want to transfer your design to manufacturing. Factors like process optimization, validation, and quality control are crucial for a successful design transfer. By the end of this stage, your device should be ready for scalable manufacturing while meeting quality performance requirements.
The Battelle Advantage:
Our experience with manufacturing transfers ranges from high mix, low volume to low mix, ultra-high volume products, including a path to semi-automation and automated production. Allow our diverse team of advanced materials and advanced manufacturing experts to aid your internal or external teams while scaling designs into production.
Accelerate Development with Licensable Innovation
The Right Facilities
to Scale Complex Challenges
What Clients Are Saying
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“The product concepts you created have received the most positive customer research results we have ever seen!”
”Surgical Equipment Manufacturer
Director, Advanced Development
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“I am extremely pleased with how you are conducting the (human factors) studies.
”Global Pharma
Group Head, Human Factors Engineering
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“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
Featured Experts
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Steve Huckaby
Principal Mechanical EngineerMr. Huckaby has over 28 years of experience as a mechanical engineer focused on medical device design and development. At Battelle, his work includes product definition and concept generation, requirements definition, detail mechanical design and analysis, electromechanical system layout and integration, verification and validation testing, and manufacturing transition and follow-on support.
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Jessica Sanford, Ph.D.
Senior Human Factors EngineerJessica Sanford joined Battelle 26 years ago and currently serves on the Battelle Medical Devices team as a Senior Human Factors Engineer. Jessica has been working in the field of human factors research for 33 years, and spent the last 12 years applying her knowledge to medical device research and development. Currently, she focuses on using research and design to help medical device customers tackle unique problems and challenges. Jessica holds a PhD in Quantitative Psychology from The Ohio State University. -
André LaFreniere
Vice President, Commercial Business Development and Sales Medical Device, Pharma/Drug Delivery, Data Science, HealthAndré LaFreniere leverages his 20 years of experience in healthcare technology to advance opportunities and solve challenges in healthcare. Andre’s product development and commercialization knowledge spans collaborations with commercial clients across pharmaceuticals, biotechnology, medical devices, diagnostics, and healthcare systems to solve complex problems and change healthcare for the better. -
Andrew Sweeney
Industrial Designer IIIAndrew Sweeney brings a decade of expertise in commercial product design and medical device development, with experience collaborating with multi-disciplinary teams including industrial designers, engineers, and scientists. His time in commercial product development involved research, strategy, 3-D form development, CAD, and model making, which are crucial in the initial device development stages. Andrew's skills extend to surface modeling, 3-D rendering, and rapid prototyping, essential for evaluation and proof of concept. He has also played a pivotal role in creative direction, developing key insights and numerous innovative concepts. -
Yelena Davis
Principal Electrical EngineerPrincipal Electrical Engineer Yelena Davis brings 37 years of electrical engineering experience to the Medical Devices team at Battelle. Yelena's deep electronics competence ranges from semiconductors to PCB design, and combines with sharp project management and lean manufacturing skills to bring even the most complex medical devices safely to market. -
Mike Marshall
Principal Mechanical EngineerAs Principal Mechanical Engineer, Mike Marshall leverages 3 decades of mechanical engineering experience to solve complex challenges for the Battelle Medical Devices team. Mike's deep mastery of skills like Design for Manufacturing, failure analysis, product design and injection molding as well as his expertise in FDA ISO 13485 compliance catalyzes the development of technically sound, regulatory compliant medical devices. -
Chloe Funkhouser
Systems Engineer IIIChloe Funkhouser is a Systems Engineer on the Medical Devices team, with 9 years of experience in medical device research and development and 7 years of experience in biological materials science research. She has supported product development of electromechanical medical devices and their associated disposables, including implantable devices, injector pens, infusion pumps, and hemodialysis and peritoneal dialysis systems. She has experience leading project teams through safety risk management activities, requirements development, verification planning and execution, systematic root cause investigations, and the design and validation of custom test methods and fixtures. -
Dave Giles
Senior Director, Commercial Business Development and Sales Medical Devices, Diagnostics, Neuro Analytics, PFAS Medical DevicesDave Giles' experience spans more than 20 years leveraging advanced medical technology knowledge and data analytics to create innovative solutions across medical device, biotechnology, neurotech, pharmaceutical and diagnostics. Dave has a broad perspective on how breakthrough technology can solve complex problems and advance healthcare for Battelle clients.
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