FDA issues draft technical guidance for additive manufactured devices

How can quality systems evolve to realize the potential of 3D printed medical devices?

3D printer

The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), also known as 3-dimensional printing (3DP). AM is a process of joining materials to make objects from 3D model data, usually layer upon layer, as opposed to subtractive manufacturing methodologies 1. “The process begins with a 3D model of the object, usually created by computer-aided design (CAD) software or a scan of an existing product.  Specialized software slices this model into cross-sectional layers, creating a computer file that is sent to the AM machine.  The AM machine then creates the object by adding layers of material on top of each other until the physical object is created.

Companies pursuing AM capabilities choose between divergent paths (figure below):

Path I: Companies do not seek radical alterations in either supply chains or products, but they may explore AM technologies to improve value delivery for current products within existing supply chains.

Path II: Companies take advantage of scale economics offered by AM as a potential enabler of supply chain transformation for the products they offer.

Path III: Companies take advantage of the scope economics offered by AM technologies to achieve new levels of performance or innovation in the products they offer.

Path IV:Companies alter both supply chains and products in pursuit of new business models.

us-dupress-additive-manufacturing

This technology provides many new possibilities for Life Sciences companies. Parts made using the AM process can contain incredible geometric configurations in addition to being stronger and lighter with a higher level of precision.  AM is a key enabler for creating custom products (e.g., custom implants, custom pharmaceuticals, custom tools). However, it is a disruptive technology that presents unique challenges to many Life Sciences organizations pursuing adoption. These challenges can significantly impact how organizations develop and control the product including design controls, process qualification, software validation, and various others. In many cases, established quality systems are not able to accommodate some of the unique challenges that this exciting new technology can offer.

Quality Management Systems: It’s critical for life sciences companies to define the quality requirements and develop an AM/3DP quality manual addressing the following areas:

us-dcrs-qms-3dp-am

  • Design Control and Characterization requirements
    • Design Controls need to be established for verification and validation in accordance with 21 CFR 820 Subpart C with a particular focus on (1) material properties (tension, compression, torsional strength, porosity, surface finish), (2) geometry, and (3) risk analysis on sterilization needs and product biocompatibility. The draft guidance recommends understanding the manufacturing tolerances of the AM machine with respect to the feature sizes of the finished device. One should also consider that pixilation of features, where smooth edges become stepped, can lead to inaccuracies in final finished device dimensions. In addition, for devices made from medical imaging data, there may be effects on the device’s size or shape due to image resolution, image processing algorithms, rigidity of anatomic structures imaged and the clarity of anatomic landmarks used to match the device to the patient’s anatomy
  • Purchasing Control requirements
    • In accordance with 21 CFR 820 Subpart E, purchase controls are a key component to ensure supplier quality. Supplier evaluations, purchasing data, and proper documentation need to be maintained.  Particular attention should be focused on the supplier’s quality management systems not only from a compliance perspective but more importantly, their capability of producing a high quality material, component, or product
  • Identification and Traceability of Product
    • Consider how and where unique device identification (UDI) will be applied
  • Production and Process Controls
    • In accordance with 21 CFR 820 Subpart G, controls are necessary to ensure validation of software, processes, process changes, and manufacturing equipment. Procedures need to be in place for calibration, maintenance, environmental controls, material handling, and operating personnel
    • File Format (imaging, manipulation software, machine files) conversion errors may lead to dimensional and geometric inaccuracies of the device. Therefore file conversion steps should be simulated
    • Build preparation software to support preparatory processes such as build volume placement, addition of support materials, slicing, and creating build paths should be validated
    • Minimal acceptance criteria for source data such as Computer Tornography (CT), Magnetic Resonance Imaging (MRI), etc. needs to be established for key parameters, such as slice spacing, resolution, orientation, artifacts, time since scan, etc. This is especially true for patient matched device design and can be challenging, given the variability in the field and the desire to provide the desired treatment
    • Machine parameters and environmental conditions have a direct effect on the quality of the device and should be controlled. Examples of parameters are energy delivery system power, build speed, build path, energy density, and nozzle diameter. Environmental conditions such as temperature and humidity may need to be controlled depending on the material used.
    • Manufacturing material has a significant effect on the properties of the device. Therefore, parameters such as article size and size distribution, viscosity, pH, purity, molecular weight, melting point, and chemical composition should be specified. Studies on recycled material should also be considered
  • Acceptance activities
    • Nondestructive evaluation techniques such as ultrasound, computed tomography, X-ray, confocal microscopy, and hyperspectral imaging may be used for verification of geometry, microstructure, and some performance characteristics. For destructive tests, representative test samples, or coupons, may be used. The guidance recommends that coupons be used during process validation, and to identify worst-case conditions of manufacturing process
  • Product Handling, Storage, and Distribution controls and procedures
    • In accordance with 21 CFR 820 Subpart L, handling, storage, and distribution controls must be properly established to prevent product contamination (via personnel or equipment) and product deterioration
  • Throughout the product lifecycle, records management (DMR, DHR, DHF, Complaints, QS records), documents management, statistical techniques (process capabilities, sampling plans), quality systems requirements (resource capability and training), and traceability must be an area of emphasis to ensure compliance as well as servicing of the equipment, in accordance to 21 CFR 820 Subpart N

Global Regulatory Landscape:

  • European Union (EU): European medical devices law is currently being redrafted with the aim of introducing a new Medical Devices Regulation, is anticipated to be released in 2016, which may differentiate between custom made and custom made class III implantable
  • Medicines and Healthcare products Regulatory Agency (MHRA): Guidance on custom manufacturing “manufactured specifically in accordance with a written prescription of a registered medical, intended for the sole use of a particular patient practioner
  • Health Canada: Guidance for Health Care Professionals on Special Access and Custom-Made Medical Devices

For more information on the FDA draft guidance for Additive Manufacturing, please contact:

Satya Patloori
Senior Manager
Deloitte & Touche LLP
spatloori@deloitte.com
Milos Ruzic
Senior Consultant
Deloitte & Touche LLP
miruzic@deloitte.com
George Serafin
National Managing Director
Deloitte & Touche LLP
gserafin@deloitte.com
Mutahar Shamsi
Specialist Leader
Deloitte & Touche LLP
mushamsi@deloitte.com

 


1 ASTM International, Standard Terminology for Additive Manufacturing Technologies. Designation: F2792 − 12a, 2013, p. 2.

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