With the evolution of the combination products developed by medical device manufacturers and pharmaceutical companies in partnership, the need for a robust quality management system is accelerated.

In an effort to improve health and safety for the patients, the healthcare industry has introduced combination products. The objective is to create and deliver safe products that can fulfill customer needs for quality healthcare. Many new therapies are researched and tested for a range of diseases, which are further administered in many new ways.

These new ways are about combining drugs, biological product/devices, and medical devices for minimizing the adverse events while making a significant improvement in treatments and user experiences.

What are the Combination Products?

Combination products are the newly introduced therapeutics that include a combination of two or more products. The combination could be of biologics/device, drug/device, drugs/biologics, or drug/device/biologics, in a regulated manner and marketed as a single unit.

There are many examples of combination products like drug-inlayed implantable devices, drugs contained in delivery devices especially in medical kits, and drugs and devices that are packaged separately but are meant to be used together.

Need for Combination Products

Combination products are proven drug-delivery approaches for the pharmaceutical and medical device companies in an equally effective manner. In fact, both these units of the healthcare industry have found that the combination products are more effective in patients care than that of a single component working alone.

Considering the success of combination products since their inception and the potential waiting to be unleashed, it will be of no big surprise that combination products will mark an expeditious growth in the coming years. Furthermore, the next decade is going to witness many more combination product solutions that will be covering medical devices, biologics, drug-delivery systems, along with the electronics and nanotechnology.

Critical Factors to Consider While Building Supply Chain for Combination Products

The organizational success depends on its ability to control different variables required for the development of the combination products, which relies on the selection of the right manufacturing partner or device supplier. Additionally, you need to maintain a balance of the development support and manufacturing services.

It is often a common scenario to witness project delays and complications due to collaboration among different organizations. There could be a lot of factors that may result in confusions. For example – a product development starts with the design. On the basis of what, you decide on the components’ requirements from the suppliers. When you handle design and manufacturing yourself, you need to ensure knowledge transfer to your teams about the quality of components required and the quality checks they need to perform before moving ahead with the manufacturing. However, you have advanced supplier management software to help you with the critical phases from the selection of a supplier to tracking their performance on a regular basis.

It won’t be wrong to say having a good supply chain process is necessary to meet the targeted key deliverables and the product launch dates.

Roles of Quality Systems Management

When you will have the right vendor to help you with the combination product development efforts – their necessary capabilities will enhance the experience through quality systems management. And, this is important because the drug and device regulations overlap each other. For the majority of the times, the overlap of the regulations is evident.

For example, both the regulations are applicable for management, personnel, and organization. Also, both of them need electronic documentation and record-keeping.

In fact, both the regulations are considered similar by the U.S. Food and Drug Administration (FDA) since they are meant for attaining the same goals. Nevertheless, each regulation is different in terms of characteristics of the product-types they are tailored for.

The manufacturer for the combination product chooses needs to assess the possibilities where they can comply with both the sets of regulations for processing and executing the product development while being considerate about the requirements of the cGMPs (Current Good Manufacturing Practices), Quality Systems (QS), and other regulations.

9 Tips to Build an Effective Post-Market Supplier Strategy for Combination Products

It becomes difficult to manage CAPAs especially when you have multiple suppliers for distribution of combination products. The best way to manage CAPAs that includes multiple suppliers is through purchase controls. There should be proper processes for validation and verification of the CAPAs already executed. You can leverage quality metrics to track suppliers for the continuous improvement and verification of the CAPA. Here are some tips that will help you in building an effective post-market supplier strategy for combination products;

• Establish a Post-market risk assessment process for suppliers wherein they can receive, investigate and mitigate CAPAs and Complaints.
• Connect all the quality system indicators including nonconformances, audit findings, customer complaints, product failures, etc. to the CAPA system of product owner’s for appropriate risk management of the major and critical quality issues.
• Highlight all the important guidelines for suppliers in the Quality Technical Agreement and Planning Document.
• Make sure every CAPA for the combination products is verified and validated for effectiveness. You can refer to 483s combination product sites for the requirements specified by the FDA.
• Be sure to deploy the right people for the determination of the root cause since ineffective root cause analysis may result in repetitive quality issues in the market.
• Make sure you add all the potential nonconformances in a document that you identified in the development phase – be it in software, product design, or product residual as they need to be monitored for the overall improvement and productivity.
• Be specific about the identification of complaint receivers so that the right suppliers receive the complaints and process it appropriately within time. The root cause identification will help you determine the right supplier agency to notify.
• Familiarize the Complaints management team with the latest FDA Guidance on Post-market Safety Reporting for Combination Products.
• Always keep in mind that the Product Owner should notify the FDA for safety reporting, not the Supplier.

Therefore, we can say that it is very important to develop a robust post-market strategy for combination products to demonstrate the relationship between the suppliers in regard to commercial operations. However, the product owner may have different suppliers for the development phase.

Having a proper strategy for managing post-market product complaints will benefit organizations during routine inspections from FDA.

To Summarize:

If you want to manage the post-market surveillance activities for the combination products that are under multiple suppliers, you need the right supplier quality management system provided that being product owner you know exactly what is required. Also, the experienced quality professionals must be in place to ensure product maintenance throughout the product lifetime.

Go with the guidelines and tips shared above to manage your way to a successful compliance state with the support of a powerful supplier quality management system.

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