Custom Packaging & Contract Manufacturing in

Indianapolis, IN

Yes. Stephen Gould Indianapolis is FDA-registered for contract manufacturing of medical devices. We provide packaging, kitting, assembly, labeling, and fulfillment services for Class I and Class II medical devices. Our ISO 9001:2015 certified quality management system includes the documentation, traceability, lot tracking, and controlled processes required for medical device handling. We can support device manufacturers with sterile and non-sterile packaging, procedure kits, surgical trays, and combination product assembly.

Stephen Gould Indianapolis operates an advanced prototyping lab with capabilities across multiple materials and processes. Our prototyping services include: 3D printing for rapid concept models and functional prototypes, thermoforming for plastic trays, blisters, and clamshells, laser etching for precision cutting and marking, foam fabrication for custom protective inserts, and traditional die-cutting for paper and corrugated samples. This range of in-house equipment allows us to produce prototypes in days rather than weeks, enabling faster design iteration and validation before production investment.

Yes. Stephen Gould Indianapolis has 3D printing capabilities in our prototyping lab. We use 3D printing for rapid concept visualization, functional prototypes, custom inserts, and design validation samples. 3D printing is particularly valuable for complex shapes, custom fitments, and projects requiring quick iteration. While 3D-printed parts are typically used for prototyping rather than production, they allow you to evaluate form, fit, and function before committing to production tooling for thermoformed or injection-molded components.

Stephen Gould Indianapolis operates a 156,000 square foot facility in Whitestown, Indiana—just north of Indianapolis near I-65. The facility includes our design center with advanced prototyping equipment, contract manufacturing areas with mixing, filling, and labeling equipment, kitting and assembly workstations, warehousing space for inventory management and fulfillment, and office space for our engineering and quality teams. Our ISO 9001:2015 certification and FDA registration apply to the entire facility, enabling regulated product handling throughout.

Stephen Gould Indianapolis is ISO 9001:2015 certified and FDA-registered. ISO 9001:2015 certification demonstrates our quality management system meets international standards for consistent processes, documentation, and continuous improvement. FDA registration covers indirect food contact, indirect OTC drug contact, and contract manufacturing of medical devices. These certifications and registrations are audited and maintained to ensure ongoing compliance with quality and regulatory requirements.

Yes. Stephen Gould Indianapolis has invested in specialized equipment for mixing, filling, and labeling operations. We can fill liquids, powders, and granular products into bottles, jars, pouches, and other containers, then apply labels and package finished goods for distribution. This contract manufacturing capability goes beyond traditional packaging services—we’ve completed projects like the Gilchrist & Soames bath salts program, where we acquired mixing, filling, and labeling equipment specifically to deliver higher-quality products than the client’s previous supplier.

Yes. Stephen Gould Indianapolis has high-volume rework capabilities for major retailers and manufacturers requiring product modifications at scale. Rework services include relabeling, repackaging, kit reconfiguration, product inspection, and quality remediation. Our 156,000 square foot facility, experienced workforce, and quality management systems allow us to handle large rework projects efficiently while maintaining documentation and traceability. We’ve supported major retailers with time-sensitive rework programs requiring rapid turnaround and seamless distribution.

Yes. Stephen Gould Indianapolis is FDA-registered for indirect food contact, meaning we can handle packaging that comes into contact with food products. We provide packaging design, contract packaging, kitting, and fulfillment services for food manufacturers. Our experience includes confectionery packaging (like our Galler chocolate project), specialty food gift sets, and food manufacturing support. Our quality management systems and facility standards meet the requirements for food-contact handling.

Stephen Gould Indianapolis has in-house thermoforming capabilities for prototyping plastic trays, blisters, clamshells, and custom inserts. Thermoforming heats plastic sheets and forms them over molds to create shaped packaging components. Our thermoforming equipment allows us to produce prototype quantities quickly for design validation and fit testing. For production volumes, we coordinate with our network of thermoforming suppliers to deliver cost-effective manufacturing at scale while maintaining the design specifications developed in our prototyping lab.

Prototyping and design engagement is scoped based on project complexity and production commitment. When Stephen Gould is awarded the production or contract manufacturing business, design and prototyping support is often included in the program. For projects requiring extensive prototyping, multiple iterations, 3D printing, thermoforming samples, or specialized development, prototyping may be scoped separately with transparent pricing. Our Indianapolis team can typically produce initial prototypes within days of receiving product samples and specifications. Contact us at +1 317 769 8282 to discuss your project requirements.

Contact our Indianapolis office by phone at +1 317 769 8282 or submit an inquiry through stephengould.com. To prepare for your consultation, gather details about your product (dimensions, materials, regulatory requirements), quantities (annual volume, batch sizes), timeline requirements, and any specific needs like FDA compliance, medical device handling, prototyping requirements, or contract manufacturing services. Our team will schedule a consultation and can arrange a facility tour to demonstrate our prototyping lab, manufacturing capabilities, and quality systems. Ask for Don Hildebrandt or reference our Indianapolis office.