Tag Archives: Medical

3D printing could expand medical device regulation: Here’s how

FDA today offered a clearer picture of how it plans to regulate the 3D printing of medical devices – including in non-traditional settings such as medical facilities and academic institutions.

FDA 3D printing“In order to help ensure the safety and effectiveness of these products, we’re working to establish a regulatory framework for how we plan to apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalized devices for specific patients they are treating,” FDA Commissioner Scott Gottlieb said in a statement.

Gottlieb also highlighted new guidance that clarifies what the FDA in the U.S. would like to see in submissions for 3D-printed medical devices. The guidance includes FDA regulators’ thinking on device design, testing of products for function and durability, and quality system requirements when it comes to 3D printing. FDA is describing the document as a “leapfrog guidance” because it offers initial thoughts on technologies emerging in the industry.

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3D bio-printing: A medical revolution?

As medicine advances, technology is playing an ever-increasing role. The development of CT and MRI scanners to see inside patients, pacemakers to keep hearts beating, and prosthetic limbs that interact with the nervous system, have proved how valuable technology can be for our health. Has technology got our backs again, this time with an organ transplant crisis?

There is a severe need for new organs for transplantation around the world. In the last decade, nearly 49,000 people have had to wait for a life-saving organ transplant, in the UK alone. Of those, over 6,000 people have died whilst waiting – all possibly preventable if organs had been available. The issue is, with an ageing population and a safer environment, there are fewer organs available for transplant, and more organ failures requiring a transplant. The vast majority of the demand is for kidneys, with over 5,400 on the current UK waiting list.

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3D-bioprinted ears could be ‘five years away’

Patients could benefit from printed body parts in just five to 10 years, according to Reza Sadeghi, chief strategy officer at Biovia group of technology company Dassault Systemes.

A bioprinted ear (Credit: Wake Forest Institute for Regenerative Medicine)Bioprinting first generated media buzz several years ago, when researchers showed videos of ears grown in a lab and 3D-printed skin.

Since then, the bioprinting sector has been developing at light speed, thanks to computer models, lab experiments and animal trials. The major progress today is the successful development of biomaterials that can actually be used for bioprinting, Sadeghi told PE at the Manufacturing in the Age of Experience conference currently underway in Shanghai, China. He also predicted that human trials are now less than half a decade away.

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How far away are we from 3D printed drugs and medical devices?

pharma-3d-printed-drugs.pngDecades ago, we used to say technology was the wave of the future.  Today, with technologies such as additive manufacturing, we are living in the future.

Additive manufacturing, or 3D printing, is being used increasingly across numerous industries, from automotive to entertainment to pharmaceutical and medical device.

According to a recent report, North America is expected to account for the largest share of the global 3D printing medical device market in 2017, a global market which is projected to reach USD 1.88 billion by 2022 from USD 0.84 billion in 2017.

While 3D printing is here, the future holds many questions. As the use of 3D printing continues to expand in the pharmaceutical and medical device space, how the FDA regulatory regime and traditional products liability principles will evolve are among these questions.

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Five ways 3D Printing will change healthcare

A new study of the potential for 3D printing in the healthcare industry predicts wide-ranging advancements and disruptions as the technology is adopted by more hospitals and manufacturers.

The report, published by Dr. Jason Chuen and Dr. Jasamine Coles-Black of Austin Health in Melbourne, Australia, outlines five key areas where 3D printing will likely have the biggest impact on healthcare.

Chuen, the director of vascular surgery at Austin Health and director of the hospital’s 3D medical printing laboratory, uses 3D-printed models of aortas to practice delicate surgeries.

“By using the model I can more easily assess that the stent is the right size and bends in exactly the right way when I deploy it,” said Dr. Chuen.

The five areas discussed in the report include:

1. Bioprinting and Tissue Engineering: Scientists are already building 3D-printed organoids to mimic human organs at a small scale, and the report predicts that eventually hospitals will be able to print human tissue structures that could eliminate the need for some transplants.

However, Chuen says that “Unless there is some breakthrough that enables us to keep the cells alive while we print them, then I think printing a full human organ will remain impossible. But where there is potential is in working out how to reliably build organoids or components that we could then bind together to make them function like an organ.”

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3D Printing improves healthcare in drug creation and surgery planning

A popular research firm has forecasted a 10.0% of the people living in the developed world to have 3D-printed items in or on their bodies by 2019. Furthermore, over a third of surgical procedures incorporating the use of implanted devices and prosthetics could involve 3D printing as a central tool. Another research company has estimated the 3D printing market to grow from a US$0.66 bn in 2016 to a US$1.21 bn by 2020. 3D printing in healthcare has been prognosticated to bear a transformative impact of the cloud or the World Wide Web. Besides organ models, 3D printers could be engaged in healthcare to produce human skin, drugs, prosthetics, hearing aids, and medical and dental implants.

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3D Printing fills in the gaps in Gaza’s medical supplies

In al-Shifa, the largest hospital in Gaza, there are only two stethoscopes in each department. Most doctors diagnose patients by putting an ear to a chest and listening the old-fashioned way.

“That would be the best-case scenario,” said Dr. Tarek Loubani, a Canadian doctor working in Gaza. “If someone’s full of blood, most doctors aren’t going to put their ears to the chest. So, doctors are making decisions without that piece of information.”

That’s a scary prospect, but stethoscopes and other pieces of medical equipment are scarce in Gaza. Thanks to a decade-long Israeli-Egyptian blockade, many medical devices are banned from entering Gaza without special consideration because of Israel’s dual-use concerns, meaning that there are concerns such items could be used for military purposes. There’s also the issue of cost. A stethoscope can cost as much as $300, which is about what a doctor in Gaza makes in a month.

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3D printed blood vessels offer new possibilities for testing drugs

Bioprinting enthusiasts envision a future where we’ll be able to print functional human organs on demand, putting an end to transplant waiting lists and health problems and deaths related to organ failure.

3D-bioprinting-vascularized-tissue-blood-vesselsThat future isn’t unrealistic nor out of reach, but it’s going to arrive slowly—artificially re-creating an organ is a massively complicated task involving dozens of small pieces that must fit together perfectly in order to work as intended.

One of those pieces fell into place just last week, when a multi-national team published a study in the journal Biomicrofluidics detailing its efforts to develop 3D printed vascularized liver tissue. They used the artificial tissue for drug toxicity testing, mimicking a living environment to analyze the effect certain drugs would have on patients.

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3D Printing our way to better healthcare

In the late 1990s, a young patient required a bladder replacement, something for which a transplant wasn’t possible.  The doctors treating that patient came up with an alternative solution: make one.  They called on the expertise of the Wake Forest Institute for Regenerative Medicine to build a scaffolding in the shape of the required organ, and on that framework, they grew a bladder using the patient’s cells.  This was one of the first uses of 3D printing in the healthcare sector. Since then, 3D printing has become a significant tool in healthcare.

At the start of the 21st Century, the hearing aid industry worldwide used injection moulding and traditional handcrafts to form inner ear implants.  In that first decade, though, 3D printing began to be used, making the case into which the delicate electronics was sat such that each fitting was shaped to the ear canal of each individual patient, something that would have been prohibitively expensive, with long lead times to deliver if done using traditional techniques.  In the USA, the entire hearing aid industry shifted to 3D printed implants within 12 months, and today over 90% of the industry uses 3D printing.

That same shift is now happening in dentistry, where crowns and implants are scanned or moulds taken by a dentist, who send the required shapes to a 3D printing laboratory that then makes the necessary items to the exact specification for that patient, all in a fraction of the time that it traditionally takes.

So what is 3D printing?  Have we invented Star Trek-like replicators that can make anything in any shape, in any material?

Image result for 3d printing medicalAll 3D printing, or additive manufacture as it is traditionally known, involves making things by building them layer upon layer.  The techniques may involve laying plastic or powders on a base in the desired shape then heating or treating them to form a layer, then repeatedly doing so, building an item from the bottom up.  More recent technologies use lasers to melt metal powers and electrostatics to solidify liquid resins.

It surprises many to find that the technology is over 30 years old, and it was used primarily in designing and prototyping for much of the first 20 years, particularly in the automotive and architectural sectors.  The last 10 year has seen a significant change, though.

Today, 3D printing is a widely used, fast growing technique that is already transforming medicine.  Everyday sees news stories about an amazing application of the technology.  These range from helping surgeons to plan complicated procedures by using a 3D printed exact model of a patient’s internal organs or bones, to producing implants for joints or replace shattered bones.  Why the sudden interest and acceleration?  That comes from advances in the technology, allowing for faster manufacture and new materials to be made with higher strengths and tolerances.  It comes from the flexibility of 3D printed parts to have complex structures, and for the economic viability of producing single items with a unique shape just as cheaply as making thousands of a standard form.

Image result for 3d printing pharmaIn one example of how it is changing medicine, Joel Gibbard, CEO of Open Bionics, was recently quoted in the engineering magazine E&T describing how “the capability to produce bionic prosthetic arms for children as young as eight years old is only possible through the use of 3D printing”.  The technology reduces the time to make a prosthetic ready to wear from measurement from 3 months – when considering visiting a specialist consultant for fitting, the time taken to order and receive parts and the manufacturing process – to one day.  Moreover, the finished arm can be made lighter as the density of components can be reduced by using complex lattices rather than solid structures, something that isn’t possible with injection moulding or traditional manufacture.  This has also reduced the cost of making more sophisticated prosthetics by up to a factor of ten.

3D printing is now entering into new areas and the developments are exciting.  In the pharmaceutical space, companies are using 3D printers to make tablets with the precise dosage a patient needs, rather than treating everyone with a one-size-fits-all approach.  Some are using 3D printers to make tablets in shapes that make them more acceptable to children, easing the burden of getting them to take their medicine.

ORelated imagene company, Organvo, is producing 3D printed liver tissues that allows for the faster development of pharmaceutical treatments.  Other companies are developing 3D printed organs, such as hearts, out of materials that the body doesn’t reject as strongly as a transplanted organ would.  Others are developing 3D printed skin for the treatment of burns.  The success of early trials of these has been very positive, and promises to revolutionise healthcare.

As the technology evolves, the cost of a 3D printed item is dropping, opening up the range of patients who can benefit from it.  What does this mean to all of us?  It means that medicine is moving towards treating us more and more as individuals, with medicines, implants, and prosthetics tuned to our exact needs, and available to us faster than has historically been the case.

3D printing is one technology that is improving healthcare.  To read about others, click here.

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Why drug testing may be the most important application of 3D Bioprinting

3D bioprinting is, needless to say, great cause for excitement. Usually, most people’s minds go immediately to one idea: the idea that in the future, we may be able to 3D print working human organs that can actually be transplanted into patients, saving their lives without requiring a donated organ from another person. It’s understandable that people are excited about that prospect; 3D bioprinted organs potentially carry tremendous advantages. People could receive lifesaving organ transplants right away, without having to wait for a donor match, eliminating the years-long wait lists as well as the guilt that comes from benefiting from the death of another person. In addition, the idea is that 3D printed organs are formed from the patient’s own stem cells, eliminating the risk of rejection and the need for immunosuppressive drugs.

In reality, we probably won’t see 3D printed, transplantable human organs for several years yet. 3D printing an organ is more than just 3D printing layers of cells into the shape of a kidney or liver; those organs must be able to carry out all of the distinct functions of their natural counterparts, and they have to be capable of integrating with the body’s existing systems, which involves the development of nerves and blood vessels. Progress is being made in the development of 3D printed blood vessel networks, and the advancement that scientists have made over the last couple of years towards 3D printed organs really is remarkable, with working thyroid glands and ovariesbeing transplanted into mice, for example.

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