Maintenance & Repair in Indiana

Paragon Medical is a medical device manufacturing and component supplier specializing in end-to-end product development and precision manufacturing for medical OEMs. The company designs and manufactures precision components, surgical instrumentation, orthopedic implants, drug delivery systems, and single-use disposable devices across multiple surgical specialties including orthopaedics, cardiovascular, surgical robotics, dental, endoscopy, laparoscopy, and gastroenterology. Paragon operates FDA-registered manufacturing facilities with ISO 8 Class 100,000 certified cleanrooms for medical-grade packaging and labeling. The company provides comprehensive services spanning concept development, design control, regulatory affairs and FDA submissions, verification and validation testing, manufacturing scale-up, and commercialization support. Manufacturing capabilities include precision machining, additive manufacturing, and assembly of components from surgical materials, specialty alloys, and plastics in volumes ranging from prototype quantities to multi-million unit production runs. Paragon serves medical device manufacturers requiring contract manufacturing, OEM partnerships, and integrated new product development support. The company emphasizes vertical supply chain integration and functions as an extension of client in-house development teams.

MicroMed is a specialized endoscopy solutions provider founded in 2006, serving healthcare facilities across the Midwest and nationally. Operating as a centralized service center and authorized FUJIFILM Medical Systems service partner from Indianapolis, MicroMed delivers comprehensive endoscopy support including pre-owned flexible endoscopes (FUJIFILM, Pentax, Olympus), third-party repair services, custom procedure and cleaning kits, consumables (valves, injection needles, hemostasis clips), and advanced software solutions. The company offers ScopeCycle endoscope tracking software for electronic cleaning data capture and reporting, NewCura image management and physician report writing tools, and flexible financing partnerships. MicroMed focuses on reducing customer supply and repair costs, improving throughput, and enabling practices to concentrate on patient care rather than logistics management.

DOT America, Inc. is a medical device coating and surface treatment specialist serving the orthopedic and dental implant industries. Based in Columbia City, Indiana, the company provides comprehensive surface preparation and coating services for medical implants and surgical instruments. Core offerings include PVD (physical vapor deposition) coatings for wear resistance; titanium plasma spray (TPS) coatings to promote osseointegration and bone growth; hydroxyapatite (HA)-sprayed coatings for rapid bone tissue formation; bone on-growth surface treatments to address implant loosening; Type II anodizing (DOTIZE®) for abrasion resistance and fatigue strength; and Type III color anodizing for multi-component implant systems requiring color differentiation for ease of use. The company also provides surface preparation services including polishing, micro-blasting, passivation, electro-polishing, and laser marking/engraving for FDA Unique Device Identification compliance. DOT America holds FDA facility registration #3011461101 and maintains ISO 13485:2016 certification through Intertek. The company operates as the US subsidiary of DOT GmbH (Rostock, Germany) and commenced operations in 2015 with an investment of approximately $4.5 million in Indiana. Products serve orthopedic, dental, and general medical device manufacturers seeking outsourced coating and surface modification capabilities. The company functions as both a contract manufacturer and strategic partner, offering integrated solutions for device performance enhancement and supply-chain consolidation.

Instrumental Machine & Development (IMD) is a quality-focused manufacturer of orthopedic and medical instrumentation based in Warsaw, Indiana. The company specializes in the design, manufacturing, and assembly of orthopedic surgical instruments, sterilization trays, and operating room accessories. IMD serves the orthopedic surgical community with comprehensive capabilities spanning single machining operations to full-scale manufacturing and assembly services. The company maintains ISO 13485:2016 certification for medical device quality management systems and is ANAB-accredited, demonstrating commitment to regulatory compliance and manufacturing excellence. IMD offers robotics integration, equipment services, and custom product development to support orthopedic facilities and instrument manufacturers. The company emphasizes on-time delivery, quality assurance, and customized solutions tailored to customer specifications. IMD's manufacturing and assembly capabilities support both OEM partnerships and direct hospital/surgical center procurement.

Genesis Plastics Welding is an ISO 13485-certified contract manufacturer specializing in RF (radio frequency) welding and heat sealing of single-use medical devices and thermoplastic components. Operating from Fortville, Indiana, the company has over 30 years of expertise in custom RF welded product design, development, and manufacturing. Primary capabilities include RF welding of single-use medical devices, clean room manufacturing, medical fluid bag production, heat sealing, plastic assembly, kitting, packaging, material selection (including PVC-free alternatives), and full device development from concept through commercialization. The company serves medical device OEMs requiring precision thermoplastic welding, contract manufacturing services, and engineering support. Genesis Plastics Welding offers collaborative design and development services, validation and verification testing, quality management system (QMS) solutions for startups, and rapid prototyping. The company is compliant with ISO 13485 medical device manufacturing standards and provides complete process transparency to customers. In addition to medical applications, Genesis has served sports protective equipment, consumer products, and industrial markets. The company emphasizes material expertise, precision manufacturing, robust quality systems, and tailored service delivery for breakthrough single-use medical device development and production.

Revelation Medical Devices (RMD) is an ISO 13485:2016 certified contract manufacturer specializing in precision medical device design, prototyping, and production for the orthopedic and spinal markets. With over 45 years of manufacturing heritage (formerly Stamets Tool & Engineering), RMD operates a 14,000 sq ft facility in Auburn, Indiana—strategically located 45 minutes from Warsaw, the orthopedic capital. The company serves medical device OEMs, startups, and established innovators with full-cycle capabilities including 3/4/5-axis CNC milling, live-tool turning, laser/TIG welding, laser etching, passivation, polishing, poly manufacturing, and non-sterile packaging/labeling. FDA-registered (No. 1836116) and committed to quality, on-time delivery, and partnership-driven development.

SpiTrex Orthopedics is a contract manufacturing partner specializing in orthopedic implants and surgical instruments. Operating as a fully integrated global manufacturing platform with facilities in Plymouth, IN (SpiTrex CTE); Lancaster, PA (SpiTrex MDI); Carlsbad, CA (SpiTrex 3D); and Le Locle, Switzerland (SpiTrex SWI), the company offers end-to-end manufacturing solutions from prototype development through validated production and finishing. Core capabilities encompass both additive manufacturing (3D printing) and subtractive manufacturing technologies tailored to high-performance implant and instrument production. All facilities are ISO 13485–certified and FDA-registered, meeting regulatory requirements for medical device manufacturing. The company provides design support, process validation, quality assurance, and scalable manufacturing aligned with medical device commercialization timelines. SpiTrex Orthopedics serves orthopedic device manufacturers requiring precision contract manufacturing with demonstrated compliance and manufacturing agility.

LifeScience Logistics (LSL) is a third-party logistics (3PL) and warehousing provider specializing in healthcare supply chain solutions. The company operates 19 strategically located distribution centers across 11 US states, totaling over 7 million square feet of cGMP-compliant warehouse space. LSL serves pharmaceutical manufacturers, medical device companies, biotech firms, biologics producers, government agencies, and hospital health systems. Core service lines include: Trade Distribution Logistics (warehousing, order processing, pick-pack-ship, order-to-cash); Manufacturing Logistics (WMS administration, compliance support, inventory staging for APIs and raw materials); and Emergency Management Solutions (disaster response, stockpile management, biomedical device maintenance, stockpile rotation programs). The company supports multiple temperature-controlled environments including ambient (20–25°C), refrigerated (2–8°C), frozen (−30°C), and ultra-low frozen (−70°C) storage for specialty pharmaceuticals and biologics. LSL maintains 300+ state and federal licenses, certifications, and registrations. Key credentials include FDA registration, NABP accreditation, cGMP compliance, AICPA SOC 1 Type II, and ISO 13485 certification. The company emphasizes serialization support, security, proactive quality assurance, and 24/7 customer service. Headquarters is in Dallas, TX, with a focus on supporting Fortune 500 manufacturers through start-ups requiring compliant, secure, temperature-controlled distribution and inventory management.