3D Printing for Medical Devices

3D printing is a process that creates a three-dimensional object by building successive layers of raw material.

Objects are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or a Magnetic Resonance Image (MRI).  The flexibility of 3D printing allows designers to make changes easily without the need to set up additional equipment or tools. It also enables manufacturers to create devices matched to a patient’s anatomy (patient-specific devices) or devices with very complex internal structures. These capabilities have sparked huge interest in 3D printing of medical devices and other products, including food, household items, and automotive parts.

In the picture, models have been 3D-printed for (left to right, top) a brain, blood vessel, surgical guide, and (bottom) medallion printed on FDA 3D printers.

Medical devices produced by 3D printing include orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics. Due to its versatility, 3D printing has medical applications in:
• Medical devices – regulated by FDA’s Center for Devices and Radiological Health (CDRH)
• Biologics – regulated by FDA’s Center for Biologics Evaluation and Research
• Drugs – regulated by FDA’s Center for Drug Evaluation and Research

Medical device manufacturers should refer to FDA guidance documents and Quality Systems regulations for more information on specific applications.

Additional Resources (see link) are available, including:
• The 3Rs of 3D Printing: FDA’s Role
Learn how the FDA reviews and researches 3D printed medical products to protect the public health.
• How 3D Printers Work
A resource from the Department of Energy and includes descriptions of different types of printing processes
• NIH 3D Print Exchange
Offers a unique set of models, learning resources and tutorials to create and share 3D-printable models related to biomedical science. The goal of the project is to facilitate the application of 3D printing in the biosciences.
• American Society of the International Association for Testing and Materials (ASTM)
This is a collaborative, consensus organization that has published standards and test methods for additive manufacturing and 3D printing.
• America Make
A public private partnership whose members, including the FDA, are working together to innovate and accelerate 3D printing to increase our nation’s global manufacturing competitiveness.

Reprint by permission of FDA (Online Public Domain); Image courtesy of FDA Free License PubDom

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Working to Bridge Gaps in Rare Disease Product Development

There are approximately 7,000 rare diseases affecting an estimated 30 million people in the United States. Many
of these diseases are serious or life-threatening and it is estimated that half affect children. Unfortunately, most rare diseases still do not have approved therapies.  In 2018 we saw a record number of novel drugs and biologics approved for rare diseases. In particular, there were 35 novel drugs and biologics approved in 2018 with orphan drug designation. This is the highest number since the passage of the Orphan Drug Act in 1983.

These approvals included drugs and biologics utilizing programs to facilitate and expedite development and review of medical products to address unmet medical need. Among the many new orphan therapies in 2018, the FDA approved the first drug to treat patients with a rare, inherited form of rickets, and the first orally-administered drug to treat Fabry disease. The FDA also approved a new biologic for patients when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

The FDA will host a public meeting on April 29, 2019: ”Patient Perspectives of the Impact of Rare Diseases: Bridging the Commonalities.” This provides the opportunity to hear patients’ and caregivers’ perspectives on how rare diseases impact their daily lives and to assess commonalities that may help the Agency and medical product developers further understand and advance the development of treatments for rare diseases. While the differences between rare diseases are critically important, it is also important to assess commonalities to synergize product development in rare diseases.

Additionally the grant review process will be enhanced by providing grant reviewers with patient perspectives gleaned from listening sessions with patients about rare diseases. These enhancements will build on new priorities in grant review. Specifically, to address the unmet needs for rare diseases, the Office of Orphan Products has made meaningful changes to both funding focus and review process for the Clinical Trial and Natural History grants programs. They are focusing on studies of rare diseases with unmet needs that use efficient and innovative trial designs, such as adaptive and seamless trial designs, use of modeling and simulations, incorporation of real world data, and basket and umbrella trials studying multiple rare diseases/products. Applicants are asked to incorporate patient input into their research proposals.

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The Emerging Breast Imaging Standard

Many breast imaging centers have launched high risk screening clinics to augment their existing services. This has already become the new standard, as organizations look for justification to expand patient services, recommend breast MRI screening exams, and provide referrals for genetic counseling.  Offering a service dedicated to screening patients for high risk, without the proper tools, can put more stress on the breast imaging workflow.

The problem is that many systems are not set up to function on this plane. Subsequently, some sites resort to manual data entry on risk model websites to calculate each score individually. Calculated risk models, such as Tyrer-Cuzick and the Gail Model, are simply not built into the RIS mammography tracking module, mammography information system, or EMR module.

Some programs offer standalone, web-based risk platforms only, although this method adds to system fragmentation, redundancy, and increased room for error. This is especially true when the reader wants to add the risk score to their finding report, or if the site wants to include risk-related information in the patient notification letter.

Tyrer-Cuzick version 8 has 25 elements and family history factors alone, so the time required to enter this for every patient, every study, and every day adds up fast. In most cases, the facility is already required to enter this information into their existing mammography tracking solution and, in order to generate the risk score, that same information has to be re-entered into an online calculator.

MagView, however, has considered this workflow and incorporated several breast cancer risk models into their base program. They offer automated calculations for all available risk models, such as Tyrer-Cuzick, Gail, BRCAPro, and Claus. In their program, patients can enter breast cancer risk factors in advance of the appointment using a patient history portal, saving the facility staff countless hours a day. The patients can also use the patient history tablet module for electronic submission to the breast center and MagView system.

These factors are saved from year to year, so the patient only needs to modify any changes in the previous history on subsequent visits. The calculators are built into the program, so no external websites or third-party programs are needed. The data is then used in the automatic risk calculation, and the radiologists can see the score in real-time, affecting their decision on follow-up recommendation. Scores can automatically be included in the finding reports, saving the readers additional time, and patients can be notified with automated text inserted into the letter based on their score.

Evidence has shown that including risk information in both the finding reports and patient letters has increased awareness along all fronts, especially when qualifying patients for additional imaging, like breast MRIs. One site reported a 100% increase in breast MRI referrals from their previous workflow using their RIS mammography tracking module as a reporting tool.

The bottom line is, increased high risk screening has improved the detection of cancers by ensuring patients who are at a high risk receive the care and additional imaging they need. In a recent study of BRCA mutation carriers and women of 20% or higher lifetime risk for breast cancer, sensitivity for breast cancer detection was 90.0% using MRI versus 37.5% for mammography and 37.5% for ultrasound (Source: Journal of Clinical Oncology. 2015;33(10):1128-35).

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New Study Shows Spinal Cord Stimulation Reduces Opioid Use For Chronic Pain

ONE YEAR AFTER IMPLANT, 93 PERCENT OF PATIENTS WHO CONTINUED SCS THERAPY HAD LOWER AVERAGE DAILY MORPHINE-EQUIVALENT DOSES THAN PATIENTS WHO HAD THEIR SCS SYSTEM REMOVED

spine-25870_1280-geralt-free-use-cc0-pixabay
Image courtesy of geralt CC0 PIXABAY

New research has found spinal cord stimulation (SCS) therapy can be key to reducing or stabilizing the use of opioids in patients battling chronic pain. In a new study, researchers examined opioid usage data from more than 5,400 patients both prior to and after receiving an SCS system implant. In an SCS system, an implanted device similar to a pacemaker delivers low levels of electrical energy to nerve fibers, interrupting pain signals as they travel to the brain to reduce the sensation of pain. Researchers have found that average daily opioid use declined or stabilized for patients receiving a successful SCS system compared to patient use of opioids prior to an implant.

In addition, while opioid usage was not different for the two groups at time of implant, patients who underwent a successful SCS implant had significantly lower opioid use one year after their implant. Patients who had their SCS system removed saw their opioid use increase again over time.

In 5,400-patient study, average daily opioid use declined or stabilized in patients receiving SCS system, while patients who had SCS system removed had higher opioid use over time.? The study, which the researchers believe makes a compelling case for considering SCS therapy earlier in the chronic pain care continuum, were presented at the 2017 North American Neuromodulation Society (NANS) annual meeting by Ashwini Sharan, M.D., director of Functional and Epilepsy Surgery at Vickie and Jack Farber Institute for Neuroscience at Jefferson and president of NANS.? The study was sponsored by Abbott (NYSE: ABT), a global leader in the development and manufacture of SCS systems and therapy options, such as the company’s proprietary BurstDR? stimulation.

Currently, more than 2.1 million people in the U.S. suffer from substance abuse related to opioid pain relievers, while worldwide an estimated 15.5 million people are now classified as opioid dependent. Chronic pain is often a driver of opioid use as patients seek relief and improvements to their quality of life. Fortunately for patients, SCS therapy has been clinically proven to offer meaningful relief to patients suffering from chronic pain.? There is potential to improve outcomes by implanting SCS systems earlier, before chronic opioid use, according to authors.

“Given the epidemic of opioid addiction and abuse, these findings are important and confirm that spinal cord stimulation therapy can offer strong benefits for patients struggling with chronic pain,” said Sharan. “Based on these results, we concluded it may be possible to improve outcomes by offering our patients spinal cord stimulation earlier, before opioid dependence and addiction can occur.”

ABOUT THE STUDY:
For their analysis, the research team assessed private and Medicare insurance claims data from 5,476 patients who received an SCS system to treat chronic pain associated with a host of conditions (excluding pain related to cancer). The data were collected between January 2010 and December 2014. The data confirmed that many patients are often prescribed increasing dosages of opioids prior to receiving an SCS system. The researchers also found:
? SCS therapy is effective for patients at any level of opioid usage prior to implantation.
? Opioid use declined or stabilized in 70 percent of patients who received an SCS system.
? Among patients who had their SCS system explanted, opioid use was higher at one year compared to those who continued with SCS therapy.

The researchers further suggested patient outcomes could be improved if SCS were implanted earlier in recognition of the clinical practice to provide increasing dosages of opioids over time. These conclusions help build upon prior research, such as results of a large multicenter randomized controlled trial in patients with failed back surgery syndrome (FBSS) that showed trends in opioid reduction or cessation among SCS patients. In addition, new technologies released in the U.S. in 2015 and 2016 hold promise to improve outcomes further and may reduce common complications resulting in explant such as the undesired changes in paresthesia, issues with charging, pain at the implantable pulse generator (IPG) site, and loss of pain relief.

SOURCE: Displayed with permission from?PRNewswire for Journalists