Since the medical device and drug industries have transitioned into global market players, the concept of “virtual manufacturing” has grown in popularity and necessity.
What exactly is a virtual manufacturer?
In the eyes of the FDA, virtual manufacturing applies to any medical device or drug company that outsources any of its manufacturing functions. This includes, design, packaging, sterilization & regulatory functions.
Let’s look at a typical “virtual manufacturing scenario.”
A medical device company has developed a new surgical product which required the expertise of an outside design firm and an FDA regulatory consulting firm. Once the designs were developed and approved for safety & efficacy, registered & cleared by the FDA, the company then outsourced its manufacturing to a plant in Ohio. Since the product was rather expensive to produce, some of the non-technical/non-critical components were sourced from China. Additionally, the product required sterilization & specialized packaging. Therefore, the development and training surrounding and FDA quality system manual were required and outsourced to a regulatory consulting team.
You can see the complexity involved with managing the various suppliers. As a specification developer (the “virtual manufacturer” and reseller) you are not only responsible for product quality, legal and financial interactions with your suppliers, you are completely responsible for the FDA compliance status of your suppliers and all finished products and services received.
Three critical areas of corporate liability related to your suppliers revolve around (1) regulatory failures (i.e. suppliers not registered with the FDA); (2) past regulatory failures of your current suppliers, and (3) these past failures can lead to delayed or unaccepted marketing submissions by the FDA. It’s critical that any supplier listed in your FDA marketing submission not be under any form of regulatory investigation.
How do you choose the right suppliers, service providers and sub-tier suppliers to ensure FDA compliance?
1. Set up a due diligence checklist to vet your suppliers.
Common criteria include:
Be Aware: If you are using off shore suppliers for parts or finished devices, it is critical to ensure those suppliers have not been placed on the FDA import “Red-List.” Upon delivery at port, if the supplier is marked on this Red List, your products can be placed on detention without inspection and held for up to 30 calendar days. “Red List” companies can kill the productivity and profitability of your company because of the prevention of sales and fees to hold the products in detention.
The FDA’s PREDICT program (Predictive Risk Based Evaluation for Dynamic Import Compliance Technology) is an electronic system that grants import admission of FDA regulated products. Based on the data provided by this program, the FDA estimates that medical devices “may proceed” through customs (smoothly, without holding or delays) 15.2% of the time. The lesson here: know your foreign and domestic suppliers WELL.
2. Set up an evaluation system for your suppliers
3. Develop supplier acceptance criteria for your finished products.
4. Develop a process for controlling suppliers for the long-term.
Good measurements include items like:
Effectiveness (how well is the process satisfying you, the customer)
Efficiency (how well the process is using resources and materials)
Cycle time metrics (how well does the process convert inputs into outputs)
Supplier Audit programs should also be incorporated into your control process*
Using suppliers is a necessary process for most medical device manufacturing. To ensure the safety, efficacy and compliance of all facets of your end product, close management and auditing of your suppliers is as necessary as managing other product functions like design, sales or marketing.
Remember, it’s your responsibility to make sure your products meet exact product safety and regulatory requirements. This includes ensuring your suppliers have up to date certificates and registrations. Due diligence should be performed not only in the supplier selection process but also throughout the life of your supplier relationship.
Michelle Bonn’s expertise is centered on international business management, manufacturing quality control, medical device regulatory affairs and international trade. Her company, Expedient Trade, offers global, medical device regulatory services and medical device sourcing services from Asia. She has serviced customers in the medical, industrial and consumer products sectors. Her company has helped both food and medical device companies manage FDA regulation, quality management processes, set up off-shore manufacturing and streamline FDA compliance documentation. She has worked with companies in China, Cambodia, Singapore, Mexico, Italy, Scotland, England and Iceland.Michelle is a certified Six Sigma Black Belt (manufacturing quality control) and holds an MBA with a focus on international business. She has also completed RAPS medical-device regulatory certificate programs.
Contact Michelle at Expedient Trade if your company needs help managing FDA regulations, FDA manufacturing compliance or supplier management processes. She can be reached at 716 276 1255 or email@example.com(3:00)
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