How can medical device makers assess the FDA implications of 3D printing?

Adhering to FDA regulations on the manufacture of medical devices might be simpler when it’s more complicated.

That is to say: When manufacturers work in the traditional mode of large-scale, industrial production, they know the rules and are prepared to work under them. But what about when the manufacturing process becomes simpler – as in the case of 3D printing? How do the rules apply to that new frontier?

3D printing, or additive manufacturing (AM), offers device makers a range of potential advantages. They can be more innovative in design, address needs in a more customized way, and deliver products directly at the point of use. AM opens the door to offerings that would previously have been cost-inefficient because of scale.

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21st Century Cures Act (H.R. 6)

The 21st Century Cures Act (“the Act”) is intended to address a significant number of current challenges within the industry including reduction of barriers to research collaboration, incorporation of the patient perspective into the drug development and regulatory review process, earlier identification of diseases through personalized medicine, modernization of clinical trials, and the elimination of regulatory uncertainty for the development of new medical applications. It also includes provisions to incentivize the development of drugs for rare diseases, invest in science and the next generation of investigators, and support the biomedical ecosystem to accelerate discovery of new cures.

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Major health care regulatory activity still to come under the Obama Administration

As many in the US prepare to shift their attention to the upcoming presidential debates and the final weeks of the campaign, the Obama Administration is poised to release some far-reaching regulations, which will have a significant effect on the health care marketplace, including a final rule on the new Medicare payment law and some changes intended to help shore up the health insurance Exchanges established under President Obama’s signature health care law.

Highlights of some of the most significant regulatory actions still to come in the final months of the Obama Administration are provided below.

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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):

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Top regulatory trends for 2016 in Life Sciences and Health Care

Almost every element of the life sciences and health care world is in the midst of change, and it’s natural that the authorities charged with regulating those industries are working to keep up. As companies adjust to new market and statutory realities and attempt to master the “cost, access, quality” nexus, they are remodeling their business structures, alliances, innovation practices, and channels of communication. Regulators watching over all those changes are focusing on elements like the Affordable Care Act, excise taxes on high-cost employer plans, Medicare payment reform, and the 340B Drug Pricing Program. Meanwhile, the unique safety and ethics dimensions of the drug and device world bring regulatory challenges for life sciences.

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New budget agreement includes health care policy changes, but generally shifts attention to regulatory activity through 2016 elections

Posted by Anne Phelps, on November 2, 2015.

President Obama on Monday, November 2, 2015 signed into law a two-year budget deal that sets federal spending levels through September 2017 and suspends the federal debt limit until March 2017. The House and Senate passed the bill last week. The legislation generally clears the decks of any must-pass legislation until after the 2016 elections, shifting the life sciences and health care sectors’ focus in Washington largely to regulatory activity on issues such as the 340B drug discount program, the new Medicare payment law (MACRA), and the so-called Cadillac tax on high-cost employer-sponsored health coverage.

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Long-awaited release of drug discount rule mega-guidance means hospitals need to act quickly—but think long-term

Long-awaited release of drug discount rule mega-guidance means hospitals need to act quickly—but think long-term

On August 27, the Health Resources and Services Administration (HRSA), one of the federal public health agencies within the Department of Health and Human Services, released a long-awaited draft guidance intended to clarify eligibility requirements for the 340B Drug Pricing Program. The publication of this guidance marks the beginning of a 60-day public comment period before the agency releases a final rule.

The “340B Drug Discount Program”, named for the authorizing section of the Public Health Service Act, is a US federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices. Pharmaceutical companies must adhere to the program’s price discount rules as a condition of their participation in Medicaid. Over the past several years, Congress, the Administration, and health care stakeholders have been attempting to balance the program’s goals of providing drug discounts to entities that serve lower income populations, while maintaining some parameters about the definitions of qualified drugs, patients, and eligible entities to limit the expansion of the program.

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Quality System Maturity Model for Medical Devices

Assessing quality system maturity models that could help medical device companies drive quality beyond compliance

US Supreme Court building

Posted by George Serafin, National Managing Director, Life Sciences & Healthcare on July 28, 2015.

Deloitte Advisory recently collaborated with the Medical Device Innovation Consortium (MDIC) to conduct research sponsored by the Food and Drug Administration (FDA) into quality system maturity models that other industries are using. MDIC is a public-private partnership collaborating on regulatory science to make patient access to new medical device technologies faster, safer, and more cost-efficient.

While there are already explicit regulations globally for medical devices and diagnostics, the industry does not yet have a widely recognized maturity model for quality management systems (QMS). The objective of this project was to recommend specific maturity model options that could be adopted by MDIC stakeholders, including medical device industry members and the FDA.1

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Hot Off the Press: FDA Strategic Priorities

Hot Off the Press: FDA Strategic PrioritiesPosted by Seth Whitelaw, Director, Deloitte & Touche LLP

Just before the July 4,2014, the U.S. Food and Drug Administration (FDA) released a draft of its strategic priorities for the next four years. In case you were busy celebrating the holiday and didn’t have a chance to read through all forty pages of the report, here is a quick recap of some of the goals the FDA will be focusing on between now and 2018. The FDA’s updated goals align closely with the trends we highlighted in our recent mid-year overview of the regulatory environment in life sciences, which looks at these issues in more detail.

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Preparing for FDA Social Media Guideline Implementation

Preparing for FDA Social Media Guideline Implementation

The FDA has released new guidance regarding utilization of social media for advertising and promotion of pharmaceuticals and medical devices. This long-awaited guidance is the start of numerous specific guidance documents addressing defined issues in social media.

As companies search for new and effective ways to reach healthcare professionals through non-personal channels, the emergence of short-form media options is increasingly becoming a meaningful marketing and information dissemination platform. However, the legal, regulatory and safety professionals need to begin conversations with the commercial and marketing teams to take full advantage of the new communication channels, while remaining compliant. Effective processes and controls will need to be put into place to enable companies to leverage these platforms; and, in order to use these platforms, companies will need to have modified review and approval pathways to facilitate expedited approvals to keep pace with the speed of social media posting.

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