Orthopaedic device manufacturers, suppliers and industry experts met in Chicago at OMTEC® 2013, the 9th Annual Orthopaedic Manufacturing & Technology Exhibition and Conference, to discuss how to mitigate regulatory, manufacturing and supply chain challenges. Here are a few of the conversations you may have missed.
In the Panels:
A panel discussion on procurement and sourcing touched on how OEMs are handling supplier consolidation, outsourcing and new regulations. Steve Maguire, General Manager, Orchid Design, moderated the conversation. Here’s what they said about lead times.
In the Sessions:
Orthopaedics leads the medical device industry in number of recalls, with 578 total recalls identified between 2007 and 2011. Matthew Krueger, Chief, Orthopedic and Physical Medicine Devices Branch, Office of Compliance, Center for Devices and Radiological Health at FDA, presented data compiled by the agency.
FDA sorted the data into four categories (mislabeled, specification, sterilization, fracture), which were created based on prevalence and areas in which it foresees being able to address concerns. The percentage of each recall issued from 2007- 2011 includes: mislabeled, 24%; specification, 19%; sterilization, 7%; fracture, 9%; other, 41%. (Download the presentation here.)
With the final ruling on UDI expected for release this summer, orthopaedic manufacturers are beginning to focus on compliance. Karen Conway, executive director of industry relations for GHX, told manufacturers they need to view the regulations as a strategy and not just a project. Conway provided the following questions for audience members to ask as they prepare for UDI: (Download the presentation here.)
- Where are covered products produced? Into which markets are they sold?
- Do you need to add printing capabilities to accommodate dynamic (production) data? If so, how will that impact space and layout on the production floor?
- Do you perform late-stage labeling in warehouses or with third party logistics providers? How will their operations be affected?
- How will you handle validation of new IT equipment and processes?
- Do you have kits or combo products? If so, you do label each of them late-stage and then combine?
On the Floor:
OMTEC speaker Rob Packard walked the hall with notebook in hand, jotting down questions he received from attendees. Here are three. (Download Mr. Packard’s presentations here.)
Question: Where will FDA be in five years?
Question: If the same part is made on two different machines, and we have only validated the first machine, do we need to revalidate when we move it to the second machine?
Answer: There are three types of equipment validations: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). If you want to learn more about process validation, I recommend the following GHTF free guidance document: SG3/N99-10:2004 (http://bit.ly/StudyGroup3). The IQ is required for all of the equipment—even when you move it five feet. This is the quickest and least expensive of the validations. It typically involves connecting utilities and calibration. The OQ is the most important for process consistency. An OQ defines the outer limits for each of the process variables that you might adjust. A well-designed OQ will push the boundaries and actually make some defective product. The actual process specifications are then established inside of those boundaries. Finally, the PQ is typically a formality, because this is done at nominal conditions and repeated. Typically companies will use the first several production lots as the PQ material and the lots will be statistically sampled. There is no reason to repeat the OQ when you switch to an identical machine, and switching to a similar machine should allow you to abbreviate your OQ that you already did. Companies will also usually reduce from the typical three-lot sample to a single-lot sample for the PQ on a second machine, but this decision should be based upon historical process capability for the first machine.
Question: Is there a way to analyze the cost of doing things and weigh the benefits of cost avoidance against the costs of compliance?
Answer: This question is pointing to the concept of the Cost of Quality. If you search for this phrase, you will quickly find what is referred to as the iceberg model. The direct costs of scrap for nonconforming product are the small costs above the waterline for an iceberg, but two-thirds of the mass of an iceberg is below the waterline (i.e. hidden costs). Therefore, when you really start measuring all the hidden costs, you see that the indirect costs you are avoiding are far greater than the cost of compliance. In the worst case scenario, a single recall has put companies out of business. I don’t know if there is any published average cost for a medical device recall, but I’m sure it’s more than $250,000, and I think it’s less than $2 million. The problem is that the hidden cost of your FDA inspection frequency increasing and the hidden cost of the impact to your company’s reputation can be very large. In general, I always try to emphasize the need to implement more preventive actions than corrective actions. If you wait until something goes wrong, then you are reacting to problems, and fixing those problems is costing you more than it needs to.