WDSrx has expanded its capabilities to produce custom kits and other special projects requested from a wide range of clients from large medical businesses to individual customers. Special projects such as kitting and assembly is handled by experienced production technicians and overseen by the WDSrx Quality Assurance Department.
Kitting and Assembly plays an integral part in our logistics services since many pharmaceutical manufacturers with medical devices typically require this additional service to be completed for them by an independent third party.
WDSrx supports client requirements to assure continued fulfillment of orders during warehouse migration and the kitting process of completed and assembled kits for future distribution. This process reduces cost for clients compared with individual medical device assembly programs that assemble each kit as each order is received “just in time”.
Type of Kitting and Special Projects
Kitting and Assembly of Prescription Medical Devices
Medical device assembly often includes multiple components that must be assembled within special packaging for shipment. These components may come from various separate sources. All components must be received in the proper quantities and at the correct time in order to begin kitting and assembly. It may be necessary to scan each item within the kit as well as additional packaging to comply with requirements of the DSCSA (Drug Supply Chain Security Act). WDSrx trained technicians are skilled at managing assembly and distribution of medical devices.
Deliveries to medical professionals are a large part of B2B Kitting and Special Projects. WDSrx provides order fulfillment with clients to ship medical devices and other therapeutic products directly to their practitioner accounts. These healthcare experts are often a source of information for companies that want to generate business with their patients for therapies and treatments. For example, a kit for patient testing placed in a practitioner’s office may be purchased by the patient for home use after receiving the treatment directly from the provider.
Separate items often generate higher revenue when they are combined in a single package. For example, individual vitamin supplements that are more effective when taken together are bundled to add convenience and to improve profit margin. WDSrx performs bundling services at multiple warehouse locations. Projects are completed as a one-time project or on an ongoing basis for continuous product availability. Bundling combinations include Buy-One-Get-One (BOGO) promotions.
Similar to test driving a new car, product sampling allows patients to determine whether a product is effective prior to purchase. Generally, the sample is provided in a limited quantity and size. Customers receiving product samples are more likely to utilize in future. Product sampling occurs with prescription and over-the-counter medications. Personal care products manufacturers also sample frequently. Distribution of samples often involves regulatory compliance to assure medications are distributed only to authorized recipients including medical practitioners. Sampling guidelines may be modified by the FDA to include fulfillment directly to patients.
Multiple items that are aggregated into a single package and assembled on a large scale are completed more efficiently with a Kit-To-Stock program. Skilled technicians are mobilized to produce bundled packages that are placed back into inventory when completed. This practice allows orders to be fulfilled for long periods of time between re-stocking, generating savings and also streamlining fulfillment.
Holiday and Special Promotions
Businesses tend to have special promotions during holiday seasons to attract new customers as well as a reward to their existing clients. Bonus product offers increase customer loyalty and improve customer satisfaction. Small promotional gifts surprise customers and stand out among competitors. WDSrx places samples, gifts and other items with each order during a certain time period or depending on order value. These innovative kitting programs customize experiences for recipients and extends company goodwill that is often reflected in future business growth.
With heightened competition for e-commerce customers, printed boxes, special packaging materials including tissue paper and ribbon, elevate the delivery experience for demanding customers. Although standard corrugate shipping boxes are available, logo-printed cartons and other identifying elements positively reinforce brand identity as desirable, unique and special. WDSrx works with clients to source, print and implement custom packaging solutions for maximum impact.
Certain products require a new label be placed over the existing label to reflect the changes requested by the client. Relabeling products can provide additional information or instructions helpful to the consumer. In some instances, countries have different regulations about printing label ingredients or other requirements. New country-specific labels must be re-applied to primary packaging in order to comply with international specifications. Relabeling projects apply to pharmaceutical products as well as personal care products. WDSrx maintains current approvals and licensing necessary for relabeling projects.
Repackaging involves removing a product from the original packaging, placing the product into new containers and managing the disposition of the original packaging materials. For example, medications may be repackaged into bottles with smaller or larger quantities according to customer demand. Repackaging of medications requires current FDA registrations for the facility where the work is performed. Personal care products are often repackaged to conform to separate requirements. Products with inadequate packaging that may be damaged during transit are often repackaged with crush-proof or reinforced materials.
Small quantities of products allow practitioners to provide preferred treatments to their patients to encourage purchase of larger quantities. Product sampling allows customers to get a better understanding of a product. Sampling involves prescription medication, over-the-counter products, dietary supplements, nutritional foods and animal health products. The FDA regulates medical product sampling and is considering rules changes that allow samples to be delivered directly to patients instead of only to authorized practitioners. WDSrx possesses all relevant licensing and monitors current compliance regulations to assure proper order fulfillment.
Informational brochures, product manuals, coupons or rebates are examples of marketing materials that may be sent separately or together with product orders to patients and consumers. Many medications must be distributed with patient information sheets. Shipments of personal care products and other items may include discount coupons, new product introductions or special promotional incentives. A campaign to distribute marketing materials increases product knowledge, improves the learning curve associated with new products and surprises and delights consumers with additional benefits and savings.
FDA Compliance for Product Sampling
Prescription Drug Marketing Act
Samples of medications and related products are governed by the Prescription Drug Marketing Act of 1987. PDMA is part of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the relevant implementing regulations regarding drug samples are in 21 CFR Part 203, Subpart D. This legislation was enacted to increase the integrity of the pharmaceutical supply chain for patients. The law regulates the distribution of sample products.
The WDSrx Quality Assurance and Regulatory Compliance team helps assure clients that distribute samples are in compliance with PDMA and other rules and guidelines. These rules are subject to change and require constant monitoring to remain compliant. For example, during the COVID-19 pandemic in 2020, the FDA relaxed rules to allow samples to be delivered directly to patients instead of only to licensed prescribers.
WDSrx conforms to international quality guidelines set out in ISO 13485 for medical devices.
The PDMA requires that licensed practitioners must first request the samples before they are shipped. As an additional protection, a verification must be performed to confirm the prescriber is currently licensed and in good standing. Finally, an AOC form (Acknowledgement of Content) must be signed confirming delivery is returned to the original shipper.
WDSrx specialists manage sampling programs for medical device, prescription and over-the-counter manufacturers. Phone scripts are developed in partnership with clients to work directly with patients and practitioners for a variety of Sampling Programs and Patient Assistance Programs (PAP), providing medications available to a wider group of patients with valid prescriptions. Documentation is collected and the entire process is monitored by WDSrx personnel to confirm accurate record-keeping.
Collection of patient information requires compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This legislation guarantees protections to individuals that their personal identifiable information remains private. WDSrx conforms to HIPAA requirements for all sampling programs and Patient Assistance Programs.