Contract manufacturing
the contract manufacturers treat their operations,” says Gourabathini. This involves aspects like how they validate their production lines as well as how they treat their at-risk devices and components. With niche devices, often a limited market release precedes production at scale, necessitating a change control process based on what the company learned in the limited release. “How quickly they’re able to perform their change controls, work with us and transfer to a scale-up production is another place where we’ve seen a lot of roadblocks,” says Gourabathini.
Implantable sensors often require specialised contract manufacturers capable of producing complex devices in small, validated batches.
Contract manufacturers follow a series of qualification and validation steps, such as installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), to demonstrate that manufacturing processes meet ISO 13485 and, where applicable, FDA 21 CFR Part 820 (QSR) requirements. These steps validate whether the manufacturing equipment is installed as specified, operates as required and performs consistently over time, respectively. Compared with large medical device companies, contract manufacturers’ specialisation in good manufacturing practices helps ensure that they can remain ISO 13485-certified across diverse product categories. When performing usability or clinical validation, companies must work with clinicians to identify the different ways patients or end users might use those devices, including foreseeable misuse scenarios, how they could fail and how they could potentially harm users. For niche specialised devices, Gourabathini says that identifying these unknowns is part of risk management. “You want to design to such robustness as to reduce risk as far as possible and provide safe, effective products to your customers.”
thorough about truly evaluating suppliers.” Jonathan Treiber
Product validation also involves close
communication between the medical device company and the contract manufacturer. This ensures that the product complies with the design specifications defined by the medical device company. “We go through an iteration process until they’re able to mimic the product and can make it at a much greater volume,” says Treiber.
For contract manufacturers, it is not enough simply to validate their lines regularly to ensure they are always up to the highest standards. They must be able to demonstrate that compliance through comprehensive documentation and audit readiness. “Medical device companies should be able to see how
36
New technologies and design features pose additional validation challenges, such as introducing dependencies on external networks or data flows. For instance, many new medical devices are network-connected and interface with hospital information or electronic health record (EHR) systems. “A lot of them are software-enabled or relevant from a cybersecurity perspective,” says Gourabathini, adding that companies need to make sure that the contract manufacturer supports all of the technologies designed in the device.
Picking the right partners
Medical device companies should apply structured supplier evaluation criteria when selecting contract manufacturing partners. Their track record with similar companies and technologies can be a good predictor of a fruitful collaboration. Contract manufacturers should also communicate effectively throughout the partnership and be flexible in responding to the changing needs of the medical device company. Depending on the particular medical device, they should have expertise in specific geographical areas or be able to produce it globally. In the latter case, companies can often benefit by working with different contract manufacturers at different locations.
Contract manufacturing firms should also be able to meet the raw material quality standards required by the medical device company’s designs and processes. “If you have some supplier requirements or you have some quality agreements in place, they should be able to work around that,” says Gourabathini.
The most important requisite, however, is trust. Medical device companies need to be able to rely on their contract manufacturing partners to meet the highest standards of safety and quality consistently. But developing trust takes time, more so when suppliers aren’t in the same geographical location as the medical device manufacturer.
“It takes a long time to be thoughtful and thorough about truly evaluating suppliers,” says Treiber. Even though contract manufacturers can produce validation-ready batches in weeks or months, he adds, the risk in picking a partner late is too high. “The vetting process cannot be rushed.” ●
www.medicaldevice-developments.com
Firn/
Shutterstock.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100
