1. Surgical and Laboratory Instruments and Devices

2. Ward Engineering is a provider of quality medical device design, development, and manufacturing services as well as thorough documentation. Founded in 1990, our multi-disciplinary team of experts posses a wide breadth of medical device experience with the goal of providing superior medical device development and manufacturing services to our clients. Mission Statement

3. Facilities Location: Columbus, OH Location: Columbus, OH Size: 22,000 sq. ft. facility located on 4 acres Size: 22,000 sq. ft. facility located on 4 acres 8,000 sq. ft. CNC machine shop 8,000 sq. ft. CNC machine shop 5,000 sq. ft. clean assembly area 5,000 sq. ft. clean assembly areaResources Employees: 22 Employees: 22 Engineers, machinists and assembly technicians Engineers, machinists and assembly technicians Quality assurance and documentation specialists Quality assurance and documentation specialists Expertise in design, testing and fabrication of complex Expertise in design, testing and fabrication of complex medical devices and laboratory equipment with medical devices and laboratory equipment with supporting documentation supporting documentation Facilities and Resources

4. Development process starts and always centers around the and always centers around the client client Typical clients include surgeons, Typical clients include surgeons, inventors, large and small inventors, large and small companies companies Services provided range from a Services provided range from a complete development program complete development program to a la carte assistance. to a la carte assistance. Documentation is critical Documentation is critical component component Proposal Project Plan Market Analysis Proposal Project Plan Market Analysis Intellectual Property Regulatory Strategy Manufacturing Strategy Intellectual Property Regulatory Strategy Manufacturing Strategy Development Process

5. Design Plan Design Plan Design Input Design Input Product definition Product definition Product specification Product specification Concept sketches Concept sketches Intellectual property Regulatory strategy Regulatory strategy Laboratory notebooks Laboratory notebooks Internal design review Internal design review Design Plan Product Definition Product Specification Design Plan Product Definition Product Specification Concept Sketches Laboratory Notebooks Internal Design Reviews Concept Sketches Laboratory Notebooks Internal Design Reviews Development Process Concept Phase

6. Layout Design Critical Experiments Breadboard devices Layout Design Critical Experiments Breadboard devices Laboratory notebooks Internal design review Preliminary Risk Analysis Laboratory notebooks Internal design review Preliminary Risk Analysis Development Process Development Phase Layout design Layout design Critical experiments Critical experiments Breadboard devices Breadboard devices Update definition/specification Update definition/specification Internal design review Internal design review Preliminary risk analysis Preliminary risk analysis

7. Drawing Package Bill of Materials Cost Estimate Design Review Drawing Package Bill of Materials Cost Estimate Design Review Verification Testing Change Control FMEA Validation DHF Verification Testing Change Control FMEA Validation DHF CAD engineering designs and drawings Testing Prototyping Design verification testing Design failure modes effects analysis (FMEA) Device cost estimate Packaging design Design validation Prepare for regulatory submission Lock design & issue complete drawing package Finalized manufacturing strategy Design History File Development Process Engineering Phase

8. Process Documentation Assembly Fixtures Process FMEA Process Documentation Assembly Fixtures Process FMEA Process Validation Packaging DMR Commercial Product Process Validation Packaging DMR Commercial Product Development Process Production Phase Process development Process development Design & build assembly tooling Design & build assembly tooling Process FMEA Process FMEA Design transfer to manufacturing Design transfer to manufacturing Process validation Process validation Packaging validation Packaging validation Final design review Final design review Device master record Device master record Manufacture commercial product Manufacture commercial product

9. Portfolio Automated Embedding System Auto-TEC ® –Description Automated Embedding System capable of embedding up to 120 specimens per hour using Paraform ® sectionable cassette technology. –Objective Develop completely new type of cassette and automated method of embedding –Result Product currently on the market Five years of engineering and development at Ward Engineering for development of 6- axis transfer mechanism including mechanical and electrical systems. Five years of engineering and development at Ward Engineering for development of 6- axis transfer mechanism including mechanical and electrical systems.

10. Automated Embedding System Auto-TEC ® –Result Ward Engineering also responsible for design and development of Paraform sectionable cassettes including multi-cavity production mold Embedding instrument includes over 2000 parts, of which 600 are manufactured at this facility. Ward Engineering has assembled over 15 units and is expected to assemble 15 more units before complete transfer of manufacturing methods to client is complete. Portfolio

11. Accu-Edge ® Grossing Tools –Description State of the art grossing tools including cutting board, tissue tampers, and grossing forks. –Objective Develop and manufacture instruments to insure standardized tissue processing results for more accurate diagnosis –Result Product currently on the market Ward manufactures and packages tools for client Ward manufactures and packages tools for client Portfolio

12. Teno Fix ® Tendon Repair System –Description The Teno Fix® tendon repair system is indicated for the repair of severed or lacerated digital flexor tendons –Objective Develop implant technology and a delivery instrument allowing for consistent, repeatable repairs that are strong, safe and effective –Result Product currently on the market Ward developed initial technology with supporting documentation and successfully transferred to manufacturer Ward developed initial technology with supporting documentation and successfully transferred to manufacturer Portfolio

13. Portfolio Drug Delivery Device –Description Drug delivery system for safe and effective subcutaneous or intra- muscular injections –Objective Develop automatic injector with proprietary delivery and needle protection systems –Result Ward designed and developed delivery device up through pilot production Ward designed and developed delivery device up through pilot production

14. Portfolio Drug Delivery Device –Result Developed 11 multi-cavity production grade plastic injection molding tools Developed proprietary syringe system for use in device Designed and developed six assembly stations with supporting documentation for stability batch manufacture Completed design history documentation to aid in submission of new drug application to FDA

15. Automated Immuno-Histological Stainer –Description Modular, multi-position stainer intended to perform automatic, random access stain processing using special immuno- histochemisty techniques –Objective Redesign breadboard unit for manufacturing –Result Ward significantly improved mechanical, electrical and pneumatic systems in a nine month development program Ward significantly improved mechanical, electrical and pneumatic systems in a nine month development program – Portfolio

16. Automated Immuno-Histological Stainer –Result Six pre-production units were manufactured and utilized for customer evaluation. Six pre-production units were manufactured and utilized for customer evaluation. Design and manufacturing documentation successfully transferred to client to aid in manufacture of unit Portfolio

17. Tubal Ligation System –Description Endoscopic loop ligation device to be used for tubal ligation –Objective Develop instrument specifications through prototypes to be used for pre- clinical trials –Result Ward iterated through several concepts and designed and developed several prototype devices considering challenges such as ligation, grasping and cutting Ward iterated through several concepts and designed and developed several prototype devices considering challenges such as ligation, grasping and cutting Portfolio

18. Anastomotic Clip and Delivery System –Description Anastomotic system to replace graft-to- artery suturing procedures in coronary bypass surgery –Objective Develop device and hand held delivery instrument for use in pre-clinical coronary bypass surgeries –Result Ward designed and developed several versions of the device and method for installation Ward designed and developed several versions of the device and method for installation Portfolio

19. Portfolio Other projects –Gastrointestinal Stapler Device –Methods for Implantable Bone Prosthesis –Minimally Invasive Lung Disease Implant and Delivery System –Tissue Stabilizer for Open Heart Surgery –Minimally Invasive Heart Valve Delivery System

20. Portfolio Part examples showing design and manufacturing capabilities