Contract manufacturing
Edwards Lifesciences specialises in heart valves, where patient sterile manufacturing is vital to offset infection risk.
carried out its own audits of each supplier at an incremental cost to the business. This is no longer the case with MedAccred’s ‘one-time audit hit’, which gives all companies under the MedAccred umbrella the quality and patient safety assurances they need.
Crooms says Edwards would still carry out an audit when a new supplier is chosen, but that may be a virtual audit to simplify the “onboarding” process. This approach means less cost and an eased audit burden for all partners in the supply chain. Didier Hayem, supplier quality chapter lead for diagnostics operations quality at Roche, another MedAccred subscriber, says the programme ensures “a robust manufacturing process for key processes at the supplier,” and that the scheme “supports manufacturers in choosing the best partners.”
“The more suppliers that join, the more the benefits [will grow]. All the right principles are in place, and it will drive increased standards for product quality through the supply chain. It all comes down to patient safety.”
Dannette Crooms
The commercial benefits of MedAccred don’t end with its member companies however, with suppliers that demonstrate a strong commitment to quality and safety able to build demand for their products from programme subscribers.
“MedAccred provides a differentiation based on process control and capabilities. By showing that they are experts in their field and having the corresponding accreditation, contract manufacturers can have an edge over their competitors in the attribution process,” Hayem adds.
Many accredited suppliers attest to this fact on their own websites. Bob Reeves, operations director for US injection moulding specialist Kaysun, speaks of MedAccred placing the company “in an elite
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group of custom injection moulders” on Kaysun’s blog. Other organisations in the US recognise the survival imperative behind MedAccred. On its own website, Michigan Manufacturing Technology Center writes: “With OEMs preferring or requiring a supplier to hold MedAccred accreditation for new business, it is imperative that US manufacturers with critical processes gain accreditation, or risk being shut out by global competitors.” That narrative seems especially poignant given that MedAccred won’t be going anywhere fast. Crooms describes the programme as having past its infancy stage and grown into “a teenager”. “There is lots of upside to go. We can see where the benefits are, with increased oversight of the supply chain and improved quality,” she adds.
Further development
Edwards plays an active role in the development of MedAccred, with Crooms leading a recent working group on contract manufacturers. The group spent a year looking at the role of contract manufacturing and producing a programme within MedAccred devoted to it. The new programme covers contractors and sub-contract partners and was developed with help from Bausch Health, Baxter, BD, Boston Scientific, Johnson & Johnson, Medtronic, Philips Healthcare, Roche Diagnostics and Stryker. Feedback from contract companies was a key part of the process as well. There are also MedAccred working groups examining each of the MedAccred specialities, such as injection moulding and packaging suppliers. A working group on labelling, printing and Unique Device Identifier, also led by Edwards, was set up in May. Expensive product recalls are one aspect being looked at by the group.
“The working groups determine the audit criteria, select auditors and approve audit reports. As we learn more, we update the criteria and the broader membership always gets to approve it,” Crooms explains. The future is bright for MedAccred, she says: “The more suppliers that join, the more the benefits [will grow]. All the right principles are in place, and it will drive increased standards for product quality through the supply chain. It all comes down to patient safety.” Without MedAccred approval it may be increasingly difficult to operate in a market that sees it as so important. The ‘teenager’ is growing up, and when it is even more established it will be a must for supplier firms, if it isn’t already. With patient safety, quality and commercial edge among MedAccred’s list of features, it’s a winning recipe that surely makes good sense for an industry always striving to be more efficient. ●
Medical Device Developments /
www.nsmedicaldevices.com
Edwards Lifesciences
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