Medical devices include a wide range of products designed to improve patient condition without producing a chemical change.
The wearable medical devices market, valued at USD $27.91 billion in 2019, is expected to reach USD $74.03 billion by 2025 according to a report by Mordor Intelligence.
The evolution of medical devices is speeding their integration into the daily lives of healthy consumers in addition to patients requiring treatment. Developments in wearable technology, telemedicine and telehealth, robotics and artificial intelligence are expanding markets for medical devices and increasing opportunity for WDSrx and other third party logistics providers helping assure safe and timely distribution of these products within the supply chain.
WDSrx utilizes extensive resources and experience to manage storage, handling, fulfillment and return of medical devices for small and large manufacturers and distributors. Medical Device distribution must comply with strict guidelines and standards. Additional services including medical device assembly are required to prepare for use prior to order fulfillment. There are special processes for reverse logistics of medical devices as well.
MEDICAL DEVICE CLASSES
There are three general classes of medical devices established by the U.S. Food and Drug Administration. Each group requires specialized logistics services for storage and fulfillment.
Medical devices can range from simple tongue depressors to complex pacemakers and surgical implantations. Class I devices according to the FDA are low-risk and make up 47% of all medical devices. Class I can include bandages, handheld surgical instruments and more. Most medical devices are stored in Controlled Room Temperature (CRT) or Ambient conditions between 20 and 25 degrees Celsius.
Class II medical devices are considered intermediate-risk devices and can include pregnancy test kits, computed tomography (CT) scanners, infusion pumps for intravenous medications and more. This second category makes up 43% of all medical devices. Class II devices are also more likely to require special storage solutions like segregation or a locked cage.
Class III medical devices are considered the most high-risk because they can be very important to patient health or sustaining life. This final category makes up the remaining 10% of all medical devices regulated by the FDA. Examples of class III medical devices can include pacemakers and deep-brain stimulators. The majority of devices in this category require expedited fulfillment because they are needed immediately for something crucial like a surgery.
Physicians now more than ever are prescribing medical devices directly to patients through online channels. This brings another opportunity to logistics service providers to complete Direct-To-Patient (DTP) orders. These orders are fulfilled for individual patients.
The Telehealth Market is estimated to reach USD 70.19 billion by 2026 with an expected annual growth rate of approximately 17 percent over the period. The spike in telehealth services is directly proportional to proliferation and expansion of medical devices. Due in part to reticence or inability to travel to doctors’ offices during the pandemic, telehealth systems and physician participation increased dramatically as virtual check-ups and appointments went mainstream.
WDSrx works with medical practitioners and medical device manufacturers at the center of the very real transaction originating with virtual visits between physician orders for medical devices and their delivery to patients. The conventional medical device distribution model involves large quantities of devices shipped to wholesale and retail accounts. This model is still popular. However, new platforms for doctor/patient interaction create a new personalized distribution model in which specific devices are shipped to individual patients. WDSrx responds to the needs of business trading partners and also to the requirements for direct-to-patient medical device logistics services.
MEDICAL DEVICE KITTING
Medical device manufacturers considering outsourcing of component assembly and kitting must carefully select a partner based on their ability to perform according to rigorous Quality requirements.
A reputable warehouse kitting partner conforms to international standards set out in ISO 13485 for medical devices. An important element of a comprehensive Quality Management System, ISO 13485 guides the production team in approved methods for medical device project design, production and assembly.
Manufacturers select WDSrx for medical device assembly and kitting in order to avoid potential mix-ups, damage, deterioration and contamination that are directly related to level of experience. All projects are performed by skilled WDSrx personnel in production suites purpose-built for medical devices.
Complex regulations governing product serialization affect certain medical devices. Devices comprised of multiple parts may require a 2D barcode for each separate component to comply with DSCSA statutes. With experience managing medical device serialization and other special services, WDSrx works with manufacturers to streamline the kitting process while maintaining industry-leading Quality standards resulting in greater patient satisfaction.
A significant portion of medical devices are returned. Unlike most pharmaceutical medications, that are typically returned for destruction due to expiration or product recalls, medical devices are often returned for service repair or repackaging. Many manufacturers are now taking the extra step to design medical devices with recyclable components and materials to decrease waste in the Reverse Logistics process.
Proper DSCSA-compliant serialization is important for medical devices because they are often returned in pieces as opposed to a whole kit. For this reason, medical devices are serialized down to the unit even if they are packaged with the same item. This can specifically come into play when a Class III surgical medical device is returned. Many times, surgical implantations are packaged with multiple sizes in one kit, the correct size is used for the surgery and the remaining unused medical devices enter the returns process.
Regulatory guidelines for handling, storage and distribution of medical devices are detailed in the Code of Federal Regulations 21 CFR 820 administered by the U.S. Food and Drug Administration.
Proper application of the Code requires planning and oversight by an on-site Quality Assurance department familiar with cGDP procedures. A range of Standard Operating Procedures must be implemented with concerns for personnel, product identification, sanitary standards, production flow, labeling and packaging. WDSrx facilities conform to cGMP guidelines, are DSCSA and CTPAT compliant, and accredited by the National Association of Boards of Pharmacy.
As a pharmaceutical logistics services provider with on-site medical device fulfillment and kitting services, WDSrx provides end-to-end solutions for manufacturers with a single Quality System governing product receipt, storage, kitting and fulfillment utilizing traditional distribution models and Direct-to-Patient alternatives.
Patient privacy is maintained with full HIPAA compliance for product fulfillment and also during the reverse logistics process.
WDSrx maintains best practices with an experienced team to assure confidence for medical device manufacturers with their logistics requirements.