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Nine Ways To Make Sure You Are Selecting The Right Device Constituent Supplier

Applying cGMPs for Combination Products to Ophthalmic Devices

Congratulations! You have found a device that fits requirements for delivery of your new drug or biologic. But is this the right device constituent for you? That, dear industry colleague, will depend on the vendor.

The device constituent is an essential part of the product that will deliver your drug or biologic substance to a patient in need. Selecting a dependable and high-quality supplier for device constituents or their components is crucial for ensuring the safety, efficacy, and quality of the final product, not to mention the timeliness of deliverables and reliability of your product launch and its post market management.

So, once you have found the device vendor options that fit (or can be customized to fit) your combination product requirements, take the time to check off the below nine considerations we advise our clients to take into account before making any final decisions:

1. Quality Management System:

Does the vendor/supplier have a robust and well-established quality management system (QMS)? This is essential to ensure that the device constituents or components meet the required quality standards for regulatory approval. The vendor/supplier should have a documented QMS that outlines the processes and procedures for ensuring the quality of their products, including quality controls for their own vendors and suppliers to ensure a consistent supply of high-quality device constituents or components. Their QMS should ensure that each batch of device constituents or components meets the required quality standards via inspection, testing, and release procedures. And, all key points regarding their responsibilities and commitments should be documented into a Quality Agreement or Quality section of your Purchasing Agreement. 

2. Regulatory Compliance:

Does the vendor/supplier comply with all relevant regulatory requirements, including FDA regulations, ISO standards, and other applicable regulations? The vendor/supplier should be able to provide documentation and evidence of their regulatory compliance.

3. Manufacturing Processes:

Does the vendor/supplier have well-defined and validated manufacturing processes for their device constituents or components? The manufacturing processes of an “off the shelf” device should be designed to ensure consistency and quality of the product. For custom devices, a robust and functioning QMS should be in place.

4. Product Testing:

Does the vendor/supplier perform rigorous product testing to ensure that the device constituent or component meets the required specifications and performance standards? The testing should include both in-process testing and final product testing.

5. Traceability:

Does the vendor/supplier have a system in place to ensure traceability of their device constituents or components? The system should enable the tracking of the product from the raw materials to the final product.

6. Technical Support:

Does the vendor/supplier have a competent technical support team that provides timely and effective support for any technical issues related to the device constituents or components, including standardized communication and problem escalation/resolution systems? Their commitment to support should go beyond development into commercialization and post market lifecycle management.

7. Continuous Improvement:

Does the vendor/supplier have a culture of continuous improvement? They should continuously review and improve their processes to ensure the quality and reliability of their device constituents or components. Do their continuous improvement processes take into account regulatory prior approval and reporting requirements?

8. Design History File:

Does the vendor/supplier provide adequate documentation for the completion of your Design History File? There are generally trade secret concerns that may complicate issues. Be sure to map out upfront what documents will be supplied directly to you versus what may be submitted in a Master File for FDA review.

9. Price for Goods and Services:

Does the vendor have one price for the goods and all of the services you need or is there a la carte pricing? Double-check that the quoted price includes not just the device, but the support services you will require or are expecting.

A thorough evaluation of these considerations can help ensure the selection of a vendor/supplier that not only can deliver high-quality device constituents or components that meet the required quality standards but will also meet your business needs.


Carolyn Dorgan, Director, Technical Services, Suttons Creek, Inc. –Carolyn Dorgan has 10+ years of experience in the Medical Device and Combination Product industries, including 6 years at the FDA leading the Infusion Devices team. Carolyn is active in the international regulatory community through speaking engagements and has participated in over a dozen international standards ranging from infusion devices, to needle-based injection systems, on-body delivery systems, and infant incubators. In addition, her unique approach to product development and risk management has been instrumental in working with products for which there are no established performance or regulatory standards which include pediatric medical devices, novel on-body drug delivery systems, and rare disease combination products. Carolyn has a demonstrated ability for working through complex problems at a system level to implement practical solutions using her multi-disciplinary background which includes engineering, software, cybersecurity, human factors, and business.