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Drug Delivery Device Manufacturers

Last updated: March 2026

This directory lists 75 drug delivery device manufacturers across the United States, from high-volume precision injection molders to specialized developers of microfluidic systems.

Buyers engage these manufacturers to solve critical problems such as accelerating design transfer from R&D to commercial production, ensuring device-drug compatibility for new combination products, and integrating sophisticated sensors for connected health applications. These partners are instrumental in navigating the complex regulatory pathways required for market entry, ensuring traceability throughout the supply chain.

Supplier types in this space range from full-service Contract Development and Manufacturing Organizations (CDMOs) offering integrated R&D, design, and manufacturing capabilities, to more specialized manufacturers focused purely on high-volume sterile assembly, advanced molding for intricate components, or custom automation for specific device types like autoinjectors or inhalers.

To engage effectively, buyers should prepare detailed User Requirements Specifications (URS), have a clear Target Product Profile (TPP), and be ready to discuss intellectual property strategies. Manufacturers will expect comprehensive design inputs, an understanding of the desired regulatory classification, and a transparent dialogue about risk management principles.

A significant trend in this category is the accelerating integration of digital health and connectivity into drug delivery devices. Manufacturers are increasingly being asked to incorporate smart features that enable data collection, remote monitoring, and personalized dosing, pushing the boundaries of traditional device manufacturing into the realm of integrated digital solutions.

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Company Directory

75 companies nationwide

American Custom Technologies

American Custom Technologies (ACT) is a contract manufacturer specializing in the design, development, and manufacture of custom topical patches. Since 1998, they have produced unique transdermal patches for nutraceutical, pharmaceutical, and cosmetic applications, operating from an FDA-compliant facility to client specifications.

Email availablePhone available

Amsino International, Inc.

Pomona, CA

Based in Pomona, CA, Amsino International, Inc. manufactures a wide range of medical devices crucial for drug delivery and fluid management in healthcare settings. Their offerings include IV infusion and medication delivery products under AMSafe brands, as well as syringes and enteral feeding systems.

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Applied Medical

Applied Medical is a vertically integrated medical device company that designs, develops, and manufactures its products in-house. The company focuses on creating technologies that enhance clinical care while improving the accessibility and affordability of high-quality healthcare globally.

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Atomica

Santa Barbara, CA

Based in Santa Barbara, CA, Atomica provides microfabrication services for complex, precision-driven components, including biochips and biotechnology applications. They offer rapid prototyping and scalable production, leveraging advanced technology and expertise in integrating diverse materials for demanding applications like drug delivery devices.

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BD

BD manufactures and sells prefillable drug delivery systems directly to pharmaceutical and biotech companies. As a global medical technology provider, it offers comprehensive solutions designed to advance global health, integrating data and connectivity into healthcare platforms.

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ClearPoint Neuro, Inc.

Solana Beach, CA

ClearPoint Neuro, Inc. is a global medical device company providing solutions for precise navigation and delivery to the brain and spine. It develops and manufactures devices enabling cell and gene therapy and drug delivery to the central nervous system, supporting translational research and clinical trials.

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Credence MedSystems, Inc.

Menlo Park, CA

Based in Menlo Park, CA, Credence MedSystems, Inc. provides innovative injectable drug delivery solutions for pharmaceutical and biotechnology manufacturers. The company develops a broad family of drug delivery devices, collaborating to solve complex industry challenges and preserve existing processes. They offer efficient, cost-effective, and safe solutions.

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Eitan Medical

Aliso Viejo, CA

Eitan Medical develops and manufactures innovative drug delivery solutions, specializing in wearable injection devices and infusion pump platforms. They offer patient-centric drug delivery technologies and integrated contract manufacturing services, bringing next-generation pharmaceutical products to market from their facility in Aliso Viejo, CA.

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Elixir Medical

Milpitas, CA

Based in Milpitas, CA, Elixir Medical develops innovative medical technologies for vascular interventions. The company creates disruptive drug delivery devices, such as the investigational DynamX Sirolimus Eluting Coronary Bioadaptor System. Elixir Medical focuses on re-imagining and transforming solutions for cardiovascular health.

Email availablePhone available

Enable Injections

Cincinnati, OH

Enable Injections is a healthcare innovation company based in Cincinnati, OH, specializing in the development and manufacturing of its enFuse wearable drug delivery platform. This device delivers large volumes of medications subcutaneously, offering a hands-free and convenient patient treatment experience.

Email availablePhone available

Glaukos

San Clemente, CA

Based in San Clemente, CA, Glaukos develops and leads the global ophthalmic market with novel therapies for chronic eye diseases. The company specializes in pioneering new treatments for glaucoma, corneal disorders, and retinal diseases, including the development of sustained-release drug delivery platforms.

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Health Care Logistics

Circleville, OH

Health Care Logistics manufactures specialized drug delivery devices. They offer an easy-to-use disposable mucosal automation device, ideal for dispensing naloxone hydrochloride, featuring a compatible Luer lock connection. This company focuses on providing essential medical equipment for critical healthcare applications.

Email availablePhone available

HDA Technology

Forest, CA

Based in Forest, CA, HDA Technology provides comprehensive medical device engineering, development, and contract manufacturing services. Specializing in FDA registered and ISO 13485 certified production, they deliver high-quality, compliant devices, including various drug delivery systems, from concept through full production.

Email availablePhone available

Precision Die Cutting Company

Buena Park, CA

Based in Buena Park, CA, Precision Die Cutting Company specializes in precision die cutting for complex medical components. They manufacture transdermal, nutraceutical, and wellness patches, alongside parts for device attachment and diabetes CGM/insulin delivery systems. The company holds ISO 13485:2016 and FDA certifications.

Email availablePhone available

ICU Medical

San Clemente, CA

ICU Medical designs and builds medical devices for medication delivery, infusion therapy, and pharmacy preparation. Their product line includes infusion pumps, catheters, compounding automation, and closed system transfer devices. They focus on providing tools that simplify workflows and reduce risks for healthcare professionals.

Email availablePhone available

Kindeva Drug Delivery

Woodbury, MN

Kindeva Drug Delivery is a CDMO specializing in comprehensive drug delivery solutions, from development to commercial manufacturing. They leverage expertise in injectable, inhalation, and dermal methods, utilizing dedicated aseptic operations and fill suites in the US. The company helps accelerate pharmaceutical products, including innovative low-GWP inhaler technologies.

Email availablePhone available

LTS Lohmann

Lakewood, NJ

Based in Lakewood, NJ, LTS Lohmann develops and manufactures innovative oral, transdermal, and intradermal drug delivery systems. They provide comprehensive solutions, including Transdermal Therapeutic Systems, Oral Thin Films, and Micro Array Patches, aimed at improving patient compliance and expanding therapeutic opportunities.

Email availablePhone available

Medterials

San Carlos, CA

Based in San Carlos, CA, Medterials designs, develops, and manufactures specialized drug administration devices and sustained release formulations for combination medical products. They offer services for drug encapsulated microspheres, nanoparticles, and semi-solid formulations, specializing in ophthalmology, cardiovascular, and wound care.

Email availablePhone available

MGS

Germantown, WI

Based in Germantown, WI, MGS is an expert partner for drug delivery device contract manufacturing. They specialize in the development and customization of autoinjectors, insulin delivery disposables, and wearable injectors, offering advanced solutions for the life sciences industry.

Email availablePhone available

Micron Solutions

Micron Solutions, a contract manufacturing organization based in Fitchburg, MA, specializes in thermoplastic injection molding, precision machining, and assembly. They produce custom parts and components, including silver-plated medical sensors for disposable electrodes and drug delivery devices, serving clients of all sizes.

Email availablePhone available

Monaghan Medical Corporation

Plattsburgh, NY

Based in Plattsburgh, NY, Monaghan Medical Corporation develops and manufactures innovative, high-quality, patient-oriented aerosol drug delivery devices. They specialize in respiratory management products for conditions such as asthma and COPD, providing a range of devices including nebulizers and valved holding chambers.

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Nest Scientific USA

Woodbridge, NJ

Nest Scientific USA manufactures medical devices, including an intranasal atomization device for rapid and non-invasive medication delivery. The company specializes in providing innovative solutions for various medical and laboratory applications, serving the healthcare industry.

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Newcomb Spring Corp.

Newcomb Spring Corp. is a custom spring and wire form manufacturer specializing in high-quality, precise components. The company produces autoinjector springs essential for safe medication delivery, alongside a broad range of compression, extension, and torsion springs, and metal stampings for various applications.

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NOVO Engineering

Vista, CA

NOVO Engineering, based in Vista, CA, offers comprehensive product development engineering. They specialize in hardware and software design for diverse drug delivery device platforms, supporting synthesized drugs and biologics. Serving medtech and biotech sectors, their team develops complex systems, devices, and instruments from concept to launch.

Email availablePhone available

Pacific Die Cut Industries

Hayward, CA

Based in Hayward, CA, Pacific Die Cut Industries offers custom die cut solutions. Its PDCI Medical division provides converted products and services for transdermal drug delivery, nutraceutical therapy, and arthritic pain relief, serving the medical, automotive, and electronic markets.

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PassPort Technologies, Inc.

San Diego, CA

Based in San Diego, CA, PassPort Technologies, Inc. develops a novel transdermal drug delivery system. Their advanced microporation technology platform enables efficient delivery of small molecule drugs, peptides, proteins, therapeutics, and vaccines. The company also advances an internal pipeline of off-patent drugs via the PassPort® system.

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Pathway Medtech

Santee, CA

Based in Santee, CA, Pathway Medtech is a contract manufacturer and developer specializing in medical devices. The company offers medical product design, development, market clearance, and manufacturing services, including high-precision short-run assembly and high-volume manufacturing within the U.S.

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PCI

Based in Philadelphia, PA, PCI specializes in the development and manufacturing of advanced drug delivery systems and drug-device combination products. The company offers comprehensive services, including commercial packaging technology for non-sterile products, supporting clients through development and manufacturing stages.

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Pharm-Int (Pii)

Pharm-Int (Pii) is a Contract Development and Manufacturing Organization (CDMO) with over 30 years of experience. Specializing in complex drug product manufacturing, Pii offers aseptic manufacturing, oral manufacturing, and prefilled syringe services. As a Jabil Company, Pii provides customized, high-quality solutions for pharmaceutical clients.

Email availablePhone available

Pocono Pharma

Cherryville, NC

Based in Cherryville, NC, Pocono Pharma is a U.S. contract manufacturer specializing in transdermal delivery systems (TDS) and topical patches. They offer scalable, cGMP-compliant solutions for designing and manufacturing matrix-coated products, including kinesiology tapes, for pharmaceutical and cosmetic markets.

Email availablePhone available

Respiratory Delivery Systems Inc. (RDS)

Based in Chelmsford, MA, Respiratory Delivery Systems Inc. (RDS) manufactures clinically proven spacer and chamber devices for metered dose inhalers (MDIs). These U.S.-made aerosol devices, including MicroChamber® and MicroSpacer®, facilitate deeper lung penetration for patients with COPD, asthma, and other respiratory conditions.

Email availablePhone available

StarFish Medical

Irvine, CA

Based in Irvine, CA, StarFish Medical provides comprehensive medical device design and development services. Specializing in sectors including Drug Delivery, they offer in-house capabilities to transform concepts into final products, supporting clinical trials and seamless transfers to contract manufacturing organizations.

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Strouse

Based in Westminster, MD, Strouse is an FDA-registered and ISO 13485 certified custom manufacturer for drug delivery devices. They specialize in precision converting flexible materials and advanced engineering, providing solutions for products like microneedle patches. Strouse supports efficient and scalable production for medical applications.

Email availablePhone available

Tegra Medical

Rosemont, IL

Based in Rosemont, IL, Tegra Medical offers end-to-end contract manufacturing for medical devices and complex components. They specialize in precision-engineered instruments and implant solutions for orthopedics, spine, and trauma applications. The company also provides custom wire and tubing with secondary processes like grinding, cutting, and coating for prototyping.

Email availablePhone available

The Tape Lab Inc

Dana Point, CA

Based in Dana Point, CA, The Tape Lab Inc. specializes in providing high-end, low-cost custom transdermal patch solutions. They offer a wide range of adhesive and skin-friendly options, catering to diverse customer needs for drug delivery devices. Their expertise ensures quality and effective solutions.

Email availablePhone available

TPP Tech LLC

San Diego, CA

TPP Tech LLC provides end-to-end product development and manufacturing services for pharmaceutical and biotechnology companies from its San Diego, CA facility. The company offers onshore clinical and commercial manufacturing, formulation development, quality assurance, and analytical support. TPP Tech focuses on delivering high-quality, cost-effective medicines.

Email availablePhone available

Vantage Medtech

Lyndhurst, NJ

Vantage Medtech is an FDA registered and ISO13485 certified contract manufacturer specializing in high-quality medical devices. With US facilities in Lyndhurst, NJ, and Olathe, KS, they provide MedTech solutions and manufacturing expertise, ensuring devices are produced to the highest industry standards.

Email availablePhone available

Weiss-Aug

East Hanover, NJ

Weiss-Aug MedPharma specializes in the precision manufacturing of advanced drug-delivery devices. Based in East Hanover, NJ, the company leverages its expertise to produce high-quality components and complete devices designed to improve patient outcomes within the medical and pharmaceutical sectors.

Email availablePhone available

West Pharma

West Pharma develops and manufactures innovative injectable solutions, components, and drug delivery devices. They partner with drug developers to ensure safe and effective containment and delivery of life-saving and life-enhancing medicines for patients. Their portfolio includes advanced on-body delivery system platforms like SmartDose 3.5.

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Biora Therapeutics

Biora Therapeutics develops smart-pill technologies for needle-free oral therapeutic delivery. Their BioJet™ platform utilizes ingestible smart capsules for liquid jet delivery of large molecules to the small intestine, aiming to replace injections. They also offer the NaviCap™ targeted delivery platform to enhance chronic disease management.

Email available

Evonik

Evonik is a global development partner and solutions provider for oral drug delivery within the pharmaceutical industry. The company manufactures advanced materials such as lipid nanoparticles, which are crucial for safely delivering active pharmaceutical ingredients in mRNA-based therapies and other drug delivery systems.

Email available

Gerresheimer

Denver, CO

Gerresheimer manufactures drug delivery systems, including inhalers for inhalation therapy, and pharmaceutical primary packaging solutions. They provide integrated services from concept development to finished combination products, adhering to strict hygiene and safety standards. The company operates globally with over 40 production sites.

Email available

Nano PharmaSolutions, Inc.

San Diego, CA

Based in San Diego, CA, Nano PharmaSolutions, Inc. specializes in innovative drug delivery device manufacturing. The company develops the Nano-CNS™ platform technology for delivering neurotherapeutics. This proprietary system utilizes a powder nasal spray device to facilitate efficient and targeted drug administration.

Email available

Owen Mumford

Marietta, GA

Based in Marietta, GA, Owen Mumford designs and manufactures injectable drug delivery systems. The company develops pioneering medical devices under its own brands and provides custom device solutions for leading pharmaceutical and diagnostic companies. They serve various therapy areas, focusing on life-enhancing products for patients worldwide.

Email available

Rocket Science Health

Rocket Science Health develops precision intranasal drug delivery devices. Their needle-free technology targets brain-specific therapeutics and vaccines, enabling non-clinical self-administration for at-home use. These devices precisely deliver consistent doses to nasal subregions, aiming to minimize side effects and improve patient access.

Email available

Rx Bandz, Inc.

Locust Valley, NY

Based in Locust Valley, NY, Rx Bandz, Inc. develops patient-centric auto-injectors for delivering a wide range of injectable medications. The company offers next-generation devices such as MiniJect, MultiJect, and OmniJect, providing innovative drug delivery solutions to meet consumer demand.

Email available

Adare Pharma Solutions

Adare Pharma Solutions, headquartered in Philadelphia, PA, is a global CDMO for the pharmaceutical industry. They specialize in developing and manufacturing oral dosage forms, utilizing advanced technologies for customized release, taste masking, and solubility enhancement. The company provides sophisticated patient-centric drug delivery solutions.

Phone available

Amorphex Therapeutics Holdings Inc

Based in Acton, MA, Amorphex Therapeutics develops the TODDD™ device, a patented ocular drug delivery system. This soft device delivers drugs continuously to the eye for months, worn comfortably under the eyelid, and targets ophthalmic conditions like glaucoma and retinal diseases.

Phone available

Argonaut Manufacturing Services

Carlsbad, CA

Based in Carlsbad, CA, Argonaut Manufacturing Services is a contract development and manufacturing organization (CDMO). They specialize in aseptic drug fill-finish, including microelectronic dispensers and oral/topical delivery systems. Argonaut also offers drug-device combination product manufacturing, lyophilization, and comprehensive analytical and quality control support.

Phone available

Boston Scientific

Boston Scientific develops and manufactures innovative medical devices, advancing science for life to improve patient outcomes. The company offers a broad portfolio of solutions, including drug-eluting stents (DES) designed for sustained drug release. These devices are crucial in treating various conditions.

Phone available

Catalent, Inc.

Catalent, Inc. is a global Contract Development and Manufacturing Organization (CDMO) for pharma, biotech, and self-care companies. They accelerate the development, manufacturing, and delivery of drug products, specializing in oral delivery technologies and biologics. Catalent leverages advanced technologies and expertise to bring innovative therapies and solutions to market.

Phone available

Evolve Manufacturing

Fremont, CA

Evolve Manufacturing is a US-based contract manufacturer specializing in complex medical and life science devices, instruments, and consumables. With a 75,000 sq ft facility in Fremont, CA, the company provides full-service manufacturing for medical devices, life sciences instruments, and drug delivery systems.

Phone available

Fagron Sterile Services US

Wichita, KS

Fagron Sterile Services US is an FDA-registered manufacturer of compounded sterile preparations, including pre-filled O.R. Anesthesia syringes. With three state-of-the-art US facilities, they provide high-quality sterile medications and repackaging. The company supports hospitals and surgery centers in critical care, ophthalmics, and pain management.

Phone available

Foamtec Medical

Waco, TX

Foamtec Medical is a vertically integrated contract manufacturer specializing in high-quality open-cell medical-grade polyurethane foam solutions for the medical device industry. They offer turn-key custom manufacturing, R&D, and fabrication for precise, safe, and compliant medical devices. Foamtec serves diverse sectors, including diagnostics, respiratory, orthopedics, and drug delivery.

Phone available

GID Company

Yorba Linda, CA

Based in Yorba Linda, CA, GID Company provides all-round product design and development services. Specializing in innovative medical device design, they guide products from concept to launch for businesses across the US, prioritizing innovation and patient safety.

Phone available

Gilero

Durham, NC

Based in Durham, NC, Gilero partners with global healthcare companies to develop innovative medical devices and drug delivery systems. As a CDMO, they offer comprehensive solutions from concept to global-scale production, specializing in product development and manufacturing for the medtech industry.

Phone available

Kimball Electronics

Jasper, IN

Based in Jasper, IN, Kimball Electronics operates as a Contract Manufacturing Organization (CMO) and Electronics Manufacturing Services (EMS) provider. The company specializes in medical solutions, manufacturing various types of drug delivery devices. They offer comprehensive engineering and design services for complex electronic products.

Phone available

Medbio, LLC

Grand Rapids, MI

Based in Grand Rapids, MI, Medbio, LLC specializes in precision injection molding of medical-grade plastics. The company utilizes its team of medical industry experts to produce critical components and devices for the medical sector, including those used in drug delivery applications.

Phone available

Moog

East Aurora, NY

Moog is a global leader in motion control, manufacturing advanced hardware and software solutions. The company produces CURLIN Ambulatory Infusion Pumps, directly serving the medical sector with precise drug delivery devices. Moog aims to contribute to a healthier and safer world.

Phone available

Mott Corporation

Farmington, CT

Based in Farmington, CT, Mott Corporation specializes in advanced medical device solutions, including drug delivery implantables, diffusion testing, and surgical tools. They leverage filtration and flow control engineering, serving the healthcare industry. The company also provides additive manufacturing solutions for various technical brands.

Phone available

Re:Build Optimation

Re:Build Optimation specializes in advanced materials science, offering patented technology for coating plastic containers with a microscopic, pure glass layer. This capability is vital for manufacturing drug delivery devices requiring superior barrier properties and material inertness, also utilizing solvent coating systems.

Phone available

Paragon Medical

Pierceton, IN

Paragon Medical is an end-to-end solution provider specializing in drug delivery system manufacturing. The company offers complete product design and development services, guiding projects from concept through to final production. With multiple US manufacturing facilities, they serve the medical industry.

Phone available

ProSolus, Inc.

Miami, FL

ProSolus, Inc. based in Miami, FL, manufactures transdermal drug delivery systems and topical patches. They formulate and develop high-barrier-to-entry products for pharmaceutical clients, offering services from formulation through coating for ANDA, NDA, and 505(b)(2) applications with substantial manufacturing capacity.

Phone available

R&D Medical Products

Lake Forest, CA

Based in Lake Forest, CA, R&D Medical Products specializes in manufacturing sophisticated custom medical patches and transdermal patches. They provide innovative skin adhesive wearables and hydrogel solutions for diverse applications, including pharmaceutical delivery, cardiology, and wound care, from their state-of-the-art US facilities.

Phone available

Spectrum Plastics Group

Spectrum Plastics Group offers medical device manufacturing expertise for drug delivery devices. They develop and produce critical components such as extruded tubing, catheter technologies, and medical balloons, supporting healthcare innovation from concept to final product. They adhere to stringent regulatory requirements for advanced solutions.

Phone available

SpyGlass Pharma, Inc.

Aliso Viejo, CA

Based in Aliso Viejo, CA, SpyGlass Pharma, Inc. specializes in pioneering sustained drug delivery solutions for chronic eye diseases. The company develops the BIM-IOL System, an innovative device designed to integrate long-acting glaucoma therapy directly into cataract surgery, aiming to improve patient outcomes and treatment adherence.

Phone available

Teikoku Pharma USA

San Jose, CA

Based in San Jose, CA, Teikoku Pharma USA is a global pharmaceutical company developing and manufacturing life-changing therapies. They specialize in advanced topical transdermal systems, including non-opioid pain management patches, utilizing proprietary Hydrohesive® Matrix technology. Their focus is on innovative drug delivery devices for various therapeutic areas.

Phone available

Agnopharma

Agnopharma is a US-headquartered pharmaceutical CDMO specializing in contract development and manufacturing for various dosage forms, including drug implants, injectables, parenterals, and ophthalmic products. The company assists clients with product development and market entry, offering solutions for complex drug delivery systems.

No contact on file

Altaviz

Irvine, CA

Based in Irvine, CA, Altaviz develops innovative drug delivery device frameworks. The company specializes in gas-powered auto-injectors designed for high viscosity and high-volume biologics, offering solutions for complex pharmaceutical applications. They focus on advanced technologies to enhance drug administration capabilities.

No contact on file

Lupagen

Lupagen manufactures bedside cell and gene therapy delivery systems, primarily the Xynvivo™ System, for the biopharma industry. This medical device company provides extracorporeal delivery technologies, simplifying the delivery of innovative therapies through a patient-connected closed loop procedure performed at the bedside.

No contact on file

PDI Contract Manufacturing

Woodcliff Lake, NJ

Based in Woodcliff Lake, NJ, PDI Contract Manufacturing specializes in developing and manufacturing topical drug delivery systems, primarily wet wipes, for pharmaceutical and over-the-counter markets. They partner with pharma companies and consumer brands to create alternate delivery solutions.

No contact on file

Phillips Medisize

Phillips Medisize is a contract development and manufacturing organization (CDMO) that designs and manufactures products for pharmaceutical and medtech companies. They offer tailored design services from expert inhalation device engineers and develop advanced medical technologies, including cardiac catheters, serving customers globally.

No contact on file

Philips

Arlington, VA

Philips develops advanced respiratory drug delivery devices, focusing on enhancing medication efficacy and patient compliance. These innovative solutions are engineered for use in both home and hospital settings, supporting improved patient outcomes through advanced healthcare technology.

No contact on file

Viant Medical

Viant Medical offers integrated design and manufacturing capabilities for a full spectrum of drug delivery systems and medical devices. The company provides solutions for OEMs, specializing in interventional and inhalation devices within the MedTech industry, aimed at streamlining development and reducing risk.

No contact on file

Zeteo Biomedical LLC

Austin, TX

Based in Austin, TX, Zeteo Biomedical LLC develops patient-centric drug and biologic delivery device technology. They provide novel technology and technical services for liquid, powder, or reconstituted powder delivery applications, including primary container packaging, for pharmaceutical, biotech, and personal care companies.

No contact on file

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How to Choose a Company

  • Insist on a manufacturer with a robust Quality Management System (QMS) compliant with both ISO 13485:2016 and 21 CFR Part 820, especially for combination products targeting US and EU markets, and request evidence of their latest audit findings.
  • Evaluate their proven track record in design transfer, demonstrating clear, documented processes for moving from R&D prototypes and design freeze to scalable, manufacturable designs without compromising device performance or regulatory compliance.
  • Assess their in-house or partner capabilities for Human Factors Engineering (HFE), crucial for ensuring intuitive patient use, minimizing use errors, and securing regulatory approval for user-facing devices like autoinjectors or pen injectors.
  • Verify their cleanroom classifications (e.g., ISO 7, ISO 8) and expertise in relevant sterilization methods (e.g., EtO, gamma, e-beam) if your device requires sterile manufacturing or terminal sterilization processes.
  • Be wary of manufacturers who lack robust control or transparency over their sub-tier suppliers for critical components, especially for custom-molded parts or embedded electronics, as this can introduce significant quality, traceability, and regulatory risks. Demand a detailed supplier qualification program.
  • Scrutinize their Intellectual Property (IP) protection protocols, including comprehensive non-disclosure agreements (NDAs) and manufacturing agreements, to safeguard your proprietary device designs and drug formulations throughout development and production.

Frequently Asked Questions

What's the key difference between a drug delivery device manufacturer and a CDMO in this space?

A pure drug delivery device manufacturer typically focuses on building devices to your existing design specifications, often specializing in high-volume production or specific component fabrication. A Contract Development and Manufacturing Organization (CDMO), however, offers a broader integrated service, encompassing early-stage design, engineering, human factors studies, regulatory support, and then manufacturing, acting as a more comprehensive partner from concept to commercialization for combination products.

How early should I engage a drug delivery device manufacturer in my product development cycle?

Engaging a manufacturer as early as the concept or early development phase is highly recommended, especially for complex devices or combination products. This allows them to provide critical Design for Manufacturability (DFM) and Design for Assembly (DFA) input, identify potential material challenges, optimize processes, and contribute to the Design History File (DHF) from the outset, significantly reducing costly redesigns and delays later on.

What specific certifications and quality systems are non-negotiable for a drug delivery device manufacturer?

For global market access, absolutely require ISO 13485:2016 (Quality Management System for Medical Devices) and adherence to 21 CFR Part 820 (FDA Quality System Regulation). If targeting the European market, EU MDR compliance is paramount. Additionally, look for appropriate cleanroom classifications (e.g., ISO 7 or 8) if sterile manufacturing or assembly is required for your device.

What is a Design History File (DHF) and why is its quality so critical from a manufacturer?

The Design History File (DHF) is a comprehensive compilation of records that describes the design history of a finished medical device. It's a living document that provides objective evidence that the device was designed and developed in accordance with an approved design plan and regulatory requirements. A well-maintained DHF from your manufacturer is absolutely critical for demonstrating compliance to regulatory bodies (like the FDA or EMA) during audits, ensuring traceability, and serving as proof for design verification and validation activities.

How do I evaluate a manufacturer's expertise in Human Factors Engineering (HFE) for my device?

To evaluate HFE expertise, ask about their specific HFE process, including their methods for user research, task analysis, risk-based HFE testing, and how they incorporate user feedback into design iterations. Request case studies or examples of how they've successfully integrated HFE into previous drug delivery device projects, especially for devices with critical patient interaction points like autoinjectors or inhalers where use error can have severe consequences.

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