FDA’s initial thoughts on 3D printed medical devices

The U.S. Food and Drug Administration (FDA) has recently released a draft guidance for the 3-D printed medical devices sector. The agency took into consideration inputs from device manufacturers, 3-D printing companies, and academics who testified at a 2014 hearing. According to QMED, the document covers device design, manufacturing, and design testing and for the purposes of the draft, FDA identified four main types of 3-D printing—powder fusion, stereolithography, fused filament fabrication, and liquid-based extrusion.

Source: QMED

3D printed medical device producers would have to “clearly identify every step in the 3-D printing process, and might need to submit a ‘high-level summary of each critical manufacturing process step,’” the guidance says. They would also have to record each step’s risk, and describe how they would lessen those risks. “The type of testing data needed would depend upon whether the device is an implant, load-bearing, and available in standard sizes or custom-made for each patient, or as FDA put it ‘patient-matched.’”

The implications for 3-D printed devices are enormous – therefore the draft guidance is the agency’s initial thoughts on the technical considerations surrounding the design, manufacture and testing of 3-D medical devices, which have few precedents. “While this draft guidance includes manufacturing considerations, it is not intended to comprehensively address all considerations or regulatory requirements to establish a quality system for the manufacturing of your device,” the agency said.

The draft guidance “provides a solid basis for medtech innovators to understand what is needed to prove safety, efficacy, and consistency to growing on-demand components for the human body,” said Derek Mathers, an adjunct professor of 3-D printing at the University of Minnesota and business development manager at Worrell Design in Minneapolis.

     “Standard-sized 3-D printed devices are offered in discrete sizes, and include features that are too complex to be manufactured with traditional processes like machining and molding,” he explained. “Patient-matched 3-D printed devices are devices that are digitally scaled (manually or by using an algorithm) to match a patient’s specific anatomical features. The FDA identifies that these bespoke devices will require significantly more validation work across every step of the ‘scan-to-fit’ design process.”

Medical Devices & Product Development: following every step

Harshal Shah, vice president of the Global Medical Technology Division at Cambridge Consultants, gave an interview for MD+DI online earlier this month on his insights on FDA approval processes and commercialization strategies for medical devices. As he works closely with medtech companies and innovators, Harshal advises that product developers must identify the category in which the product is going to fall into according to FDA’s guidelines and interact with the agency in the early stages of the development. The FDA has improved drastically and has a well-published process for requesting FDA’s feedback and meeting with some of the key people who are directly involved and relevant to the innovation. He also suggests that these startups and innovators should try to invest and plan out costs for hiring regulatory advisors, as it’s a complex process.

Regarding product development, Harshal explains that innovators should work with Quality by Design and the Design for Manufacturing principles: have specific experts who specialize in Quality by Design principles and QbD audits and Design for Manufacturing audits of design work. So, one can make changes early on and produce prototypes as well as the clinical trial devices in line with what will be able to produce for commercial scale in the future, after approval

“My deep expertise is more towards the late end of the development cycle when you’re preparing for your trials and approvals. Even before you think about producing your trial size batches for your new product, it’s really a must to get a good understanding of how you’re planning to get this product into the commercial market.”

3 Biggest Challenges to Healthcare Innovators

          Medtech companies are used to running into regulatory obstacles during their innovation processes. According to MDDI, these companies are divided into three type of business: large scale medical device innovators and manufacturers; new device innovators (ranging from the surgeon with a good idea to the existing medical device company with a product line of a few products); software technology innovators. It’s true that they all share common challenges, but their primary ones are different according to their role in this complex industry.

Source: MDDI

When talking with each segment; here are the three biggest challenges they all share:

1. Cost and complexity to improve and enhance innovation: large scale medical device innovators have a great overview of the marketplace and the regulatory system, but identifying the best R&D opportunities is not always easy. Big data analytics are expensive and complex to implement. “The more incremental the deployment of any new technology can be made, the more likely you are to achieve final success.”

2. Time and volume of follow-up and tracking data from FDA: it’s very time-consuming to go through FDA notices, recalls and regulatory changes. “Technology now allows you to both take optimal advantage of the level of effort required and increase the quality of the results for you by automating the access to the data.”  

3. “Getting blindsided by regulatory issues is probably the most common complaint from software innovators”. Having access to FDA guidance, regulations and industry best practices can help these innovators avoid this type of problem.

WIMAS 2015: International Workshop on Additive Manufacturing for Healthcare

WIMAS (International Workshop on Additive Manufacturing for Healthcare) took place in Campina Grande, Brazil from November 18-20^th. The event gathered together representatives from several different sectors interested in applying additive manufacturing (commonly known as 3D printing) in healthcare. Among the guests, there were people from the academy like researchers from IME  (Military Institute of Engineering) from Rio de Janeiro, NUTES (Center of Strategic Technologies for Health) and the team from the Sao Paulo-based Renato Archer Institute. There were also representatives from regulatory bodies like ANVISA (Brazilian Health Surveillance Agency) and the FDA; public institutions like the Ministry of Health and the SENAI Innovation Institute. Besides people from the private sector and companies like URI Medical and Biokyra.

      During the event, it was discussed relevant strategic issues for the application of the technology in healthcare as the development of protocols throughout the model building process, from segmentation of the medical image, i.e. regulate programs that make this process, until the manufacturing process used for materialization of the implant or biomodel, besides the form of sterilization and the risk ratings for each 3D printed product.

In addition to the round discussions, Biokyra had the opportunity to present the surgical cases that have recently been done and the products that are being developed within the company.

New Method for Customised 3D printed Medical Devices

A new 3D printing technology enables the creation of medical devices such as catheters for premature newborns customised to each patient. These devices will be stronger and lighter than existing models.

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"If you can print a catheter whose geometry is specific to the individual patient, you can insert it up to a certain critical spot, you can avoid puncturing veins, and you can expedite delivery of the contents," said Randall Erb, assistant professor at Northeastern University in US.

“Using magnets, Erb and Martin's 3D printing method aligns each minuscule fibre in the direction that conforms precisely to the geometry of the item being printed. The researchers "magnetise" the ceramic fibres by dusting them very lightly with iron oxide, which, Martin notes, has already been approved by US Food and Drug Administration (FDA) for drug-delivery applications.”