Medical Device Solutions. Battelle. Applied Research Device Development Clinical Research Sustaining Engineering

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1 Medical Device Solutions Battelle Applied Research Device Development Clinical Research Sustaining Engineering

2 0 2 Overview Applied Research Device Development Clinical Research Sustaining Engineering People drive our success. Experienced program managers work with integrated teams of engineers and life scientists to tackle our clients complex medical device development challenges. Battelle Medical Device Solutions proven experience and unparalleled resources enables our clients to turn a clinical need into a safe and effective medical device. 15 years serving the medical device industry 250+ clients 150+ dedicated medical device professionals Specialized engineering and life science facilities Thousands of engineers, scientists, and specialists across Battelle

3 experienced Overview We deliver comprehensive research, development, and product support services to medical device, biotechnology, and pharmaceutical firms representing a wide range of therapeutic and diagnostic markets.

4 Capabilities 0 4 Capabilities Engineering and Program Management Life Sciences Industrial Design and Human Factors Clinical Research Engineering and program management Our program managers and engineers bring extensive medical device experience to all projects helping to achieve program goals in a cost-effective and timely manner. Battelle Medical Device Solutions applies experts to our clients programs in these and other areas: Project Management Systems Engineering Biomedical Engineering Electrical Engineering Software Engineering Mechanical Engineering Manufacturing Engineering Polymer and Materials Science Optical Engineering Quality/Regulatory Compliance life Sciences One of our strengths lies in the collaboration of engineering and life sciences to solve complex medical device, life science, and biotechnology challenges. Based on our clients needs, we can integrate life scientists into programs from a broad array of disciplines including: Biochemistry Cell Biology Immunology Molecular Biology Oncology Pathology Pharmacology Physiology Toxicology

5 di v er s e industrial design and human factors Knowledgeable and experienced in medical device design, our Industrial Design and Human Factors staff are fully integrated into our development teams. Our clients programs benefit from the contribution of specialists in: Human Factors Engineering Task Analysis User/Use Profiling Usability Testing Cognitive Psychology Interface Design Rapid Prototyping and Simulation Product Design Visual Communications Quality/Regulatory Compliance 0 5 Capabilities clinical research* Customers have access to a wide range of clinical research services including pre-clinical studies using appropriate models, less stringent user preference studies, and sophisticated largescale medical device clinical studies. We can meet your program s clinical research needs with experts in the following areas: Biostatistics Monitoring and Medical Affairs Pharmacokinetics/Toxicokinetics Quality/Regulatory Compliance Analytical Chemistry Strategic Review and Consultation Database Design and Development * Clinical research services provided by BattelleCRO, a Battelle subsidiary.

6 Applied Research Technical Risk Assessment Subsystem Feasibility Demonstration System Feasibility Investigation 0 6 Applied Research Battelle Medical Device Solutions applied research service reduces the uncertainty of device development through a systematic understanding of the requirements and targeted feasibility experiments. By identifying and qualifying technical risk first, we help our clients make downstream device development more predictable in scope, time, and cost. Clinical Needs Concepts applied research Detailed Design Stage 1 Stage 2 Stage 3 Technology Technical Risk Assessment Subsystem Feasibility Demonstration System Feasibility Investigation

7 systematic applied research case study Cyberkinetics Neurotechnology Systems, Inc. 0 7 Applied Research Battelle developed algorithms that successfully isolated important brain activity enabling improved processing of the brain signals. In conjunction with the new algorithms, Battelle developed patient training techniques to support the study. The combination of Battelle-developed patient training and pattern recognition software delivered unprecedented results for Cyberkinetics BrainGate Neural Interface System (BrainGate System) clinical trial participants. In 2006, participants in the BrainGate pilot trials, conducted under FDA Investigational Device Exemption, utilized the BrainGate System to demonstrate improved computer cursor stability, control and novel click functionality using algorithms and techniques developed by Battelle. In another demonstration of a possible application of the BrainGate System in the future, one participant was able to remotely steer a motorized wheelchair. Battelle also developed an extraction tool and non-surgical repair that allowed Cyberkinetics to restore function of the intricate, skull-mounted electrode connection in-situ. The restored electrodes allowed the clinical study participant to continue in the trial. In 2007, Cyberkinetics BrainGate System was recognized as one of the top 100 most innovative new technologies by R&D Magazine. Images provided by Cyberkinetics Neurotechnology Systems, Inc.

8 Device Development 0 8 Device Development Detailed Design Verification Validation Manufacturing Transition Our disciplined approach to systems engineering, programmatic risk management, and detailed design reduces development risk and minimizes cost and time to market. Detailed Design Industrial Design Human Factors Analysis Systems Architecture Engineering Prototyping Device Development DHF Documentation Verification + Validation Test Planning and Script Creation Assembly of Verification and Clinical Trial Units V+V Execution Preparation of V+V Results Reports Manufacturing Transition Manufacturing Partner Selection and Support Engineering/Pilot Builds Production Validation and Qualification Production Equipment Design and Fabrication

9 predictable device development case study Eli Lilly & Company Battelle Medical Device Solutions has provided research and development services for Eli Lilly and Company on more than 30 medical device projects over the past 10 years. As part of a multi-entity team, Battelle Medical Device Solutions led the development effort for Lilly s HumaPen MEMOIR, a reusable insulin delivery device featuring the ability to catalogue and retrieve the time and dose of 16 previous insulin injections including the priming doses. 0 9 Device Development device development case study MEDRAD, Inc Extravasation is the leakage of fluids, drugs, or solutions from a vein into the surrounding tissue during IV administration. While extravasations are rare, they can be detrimental to the patient. MEDRAD, a market leader in medical devices that enable or enhance CT procedures, approached Battelle to help it solve the significant challenge of reliably detecting extravasations before they become severe. Working closely with Battelle from applied research through device development, the team invented the electrical permittivity technology that enables XDS and developed the commercial product. XDS provides the first practical, reliable, and economical alternative to the current method of visual observation or physical palpitation of an injection site for the detection of fluids in the surrounding tissue.

10 Clinical Research Clinical Studies Pre-clinical Research User Preference Studies Clinical Device Builds 10 Clinical Research At Battelle, clinical research needs are considered early, reducing programmatic risk by providing appropriate clinical context in the device s development phase. By integrating device developers and clinical researchers throughout the development process, our clients better manage their programmatic risk and increase their chances of a successful clinical trial. Our specialized knowledge in medical device clinical research provides our clients with higher quality, more efficient clinical programs, whether part of a larger device development program or a stand alone service. Clinical Needs Applied Research Device Development Sustaining Engineering Concepts Technology CLINICAL RESEARCH SERVICES Clinical Strategy Planning Clinical Studies Post Marketing Surveillance Clinical Program Consulting Clinical Device Builds Regulatory Submissions Long-term Clinical Studies

11 relevant 11 clinical research case study* Obstetric Device Clinical Research Battelle managed a clinical study in support of a device designed to reduce the rate of instrumental deliveries in women receiving epidural analgesia. Battelle provided full service clinical research including: Preliminary data review and summary Protocol development and creation for the pivotal study Assistance with developing the sham device for the control group FDA communications and interactions Site selection and training Clinical site device support Data management and statistical analyses Preparation of the clinical study report After identifying and qualifying six study sites in the U.S. and Europe, on-site monitoring services were provided during the successful enrollment of 900 subjects. Following this study, the FDA requested a special presentation by Battelle as an example of the design and execution of a high quality medical device clinical study. * Clinical research services provided by BattelleCRO, a Battelle subsidiary.

12 Sustaining Engineering Cost Reduction Device Enhancement CAPA Management 12 Sustaining Engineering Battelle Medical Device Solutions helps its capacity constrained clients free up valuable research and development resources needed for new product development. We can reduce cost, incorporate new functionality, or address CAPA related issues rapidly and effectively for post-market medical devices. Cost reduction Manufacturing Process Review Materials Review and Alternatives Search DFMA Analysis Device enhancement Independent Design Reviews New Technology Insertion Verification & Validation Testing Preference Trials Replacement Part Identification Sustaining Engineering case study CAPA Response CAPA management Root Cause Analysis Design of Experiments (DOE) & Testing Design Improvement Verification & Validation Battelle Medical Device Solutions delivered sustaining engineering support to a global medical device company in response to serious CAPA related product issues. Under intense pressure to address these issues, the company sought Battelle s assistance in performing root cause analyses, experimental design, and testing. In addition, Battelle identified design changes and improvements to address the underlying performance of the device.

13 Battelle provides solutions to some of the world s most important challenges through its three global businesses: National Security, Energy Science and Technology, and Health and Life Sciences. Battelle is the world s largest independent research and development organization with technology contributions that find their way into hundreds of commercial products each year. Conducting $3.8 billion in global R&D annually, Battelle oversees 20,000 employees in more than 120 locations worldwide, including five national laboratories Battelle manages or co-manages for the U.S. Department of Energy. Headquartered in Columbus, Ohio, Battelle focuses on societal and economic impact and actively supports and promotes science and math education. Battelle Medical Device Solutions, 505 King Avenue, Columbus, Ohio tel fax [email protected]