Does the Medical Device Directive pose a threat to additive manufacturing?

  Is the Medical Device Directive a threat to additive manufacturing?

By Bryan Austin, General Manager, Renishaw, Division of Medical and Dental Products

When the new Medical Device Regulation (MDR) came first in the European Union (EU) In 2017, a three-year countdown for full application came into force set. The MDR could dramatically affect the way medical devices are manufactured in the EU, especially those manufactured using additive manufacturing (AM). This article gives an overview of how companies in the additive manufacturing industry should deal with MDR.

The new regulation suggests that any medical device mass produced by industrial processes no longer falls under the "tailor made" exception of its own clinical evidence to approve its sustainability. It also needs its own CE mark to prove that it has been tested and meets all relevant standards.

The problem is that there is no clear definition of "mass production" or "industrial manufacturing processes". Without the definition of these terms, there is a risk that the prescriptions cover additively manufactured patient-specific implants (PSI) when manufactured on an industrial scale, although they are each unique.

Additive manufacturing for healthcare

Additive manufacturing is a core technology for the rapid production of custom metal parts with complex geometry for the medical sector. Metal powder is fused layer by layer using a laser to form complex components that are not possible with subtractive production. [0005] Additive manufacturing can produce variable surface area components for various surgical procedures. It can also produce more complex grating structures more efficiently than conventional subtractive edits.

The main advantage of the technology is that implants can be developed specifically for the patient's magnetic resonance imaging (MRI) or computed tomography (CT). This means that medical devices can be manufactured as a unique, unique product that meets individual needs.

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Benefits of AM

Patient-specific additively-made implants help to improve treatment processes, reduce the number of surgery revisions, and shorten operation times. This can also reduce the cost of the NHS and provide better treatment outcomes.

Traditionally, if a patient had a specific cranial tumor, a surgeon would first have to remove the tumor and close the wound. The patient would then need additional CT scans to determine the size of the required skull plate, depending on the size of the wound from the previous surgery. The surgeon would then perform a second procedure to insert the implant. [0005] Additive manufacturing eliminates the need for a second procedure because it allows for the preplanning and fabrication of patient-specific surgical instruments that accurately define the size of the wound. As fewer procedures are needed for the same result, the process improves for both the patient and the surgeon.

Despite the benefits that AM offers so far, the new MDR may affect the future of additive manufacturing in the medical industry.

What can you do?

The MDR has already been published, but the following guides can be influenced if enough manufacturers have input. Patient-specific implants are already being used in surgical interventions around the world, with Renishaw specifically working with several hospitals in Wales and the southwest of the country to improve patient outcomes.

An interpretation of the current prescription might mean that we will not be able to help patients in the same way as soon as they are in full force. For the technology to realize its potential, industry and healthcare must work together to develop a set of evidence to demonstrate the effectiveness and utility of the technology.

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The only way to prevent MDR from having a negative impact on additive manufacturing is not just for hospitals and healthcare professionals, but for patients who have the potential to get a better result.

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