3D Printing and the Medical Industry

3D printing has taken the manufacturing world by storm; it’s used for art, parts, design, and more. Not only are the printers innovative in their own right, but they can be used in a variety of industries and in a variety of uses-some that are lifesaving.

One of the biggest areas for 3D printing expansion is within the medical industry, where 3D printing is used to provide custom medical devices and implants for patients. Since personalization and customization is crucial when it comes to medical implants, 3D printed material is the perfect answer.

In dentistry, precision is of the utmost importance. During the drilling for and implantation of dental implants, 3D printing technology is allowing for greater precision and thus greater safety and shorter turnaround times. When installing a dental implant using 3D printing technology, dentists first scan the patient’s mouth and examine it using software, while having the ability to immediately begin the production of the implant. Another way 3D printing is ideal for dentistry is through the use of surgical drill guides, when drilling inside the mouth is necessary for securing implants. Through the use of 3D printing, these implants have the highest biocompatibility and the highest customization for quality implants.

Biocompatibility is not only very important for dentistry, but also in other medical fields. 3D printing is also being used to improve the hearing aid experience. The hearing aid industry has the highest 3D printed “installed base” of customized devices. 3D printing advances have allowed for the most customizable hearing aid available, something that is extremely important when having to get a hearing aid. Hearing aids can now be completely customized by shape, fit, and color using new 3D software and printing.

Now not only used for art, architecture, parts, and machining, 3D printing technology has made one of the biggest impacts on the medical field. It has allowed for a previously unknown level of customization that will not only benefit the industry as a whole, but more importantly individual patients. The impact of 3D printing in the medical field is likely just being realized and were excited to see how this and future technology can contribute to the advancement of medical tools and implants!

New Devices to Ease Migraines

 Migraines are a severe form of headaches, most often preceded by an array of sensory conditions that affect one’s vision, proprioceptive sense alterations varying from slight tingling in the arms to nausea to abnormal sensitivity to light and sound. Intense pain is felt by the sufferer in bouts that can last from hours to days. After the pain eases, the sufferer may also go through a period of fatigue, experiencing also a clouding of judgment.

Migraines are thus a serious condition, with more than 37 million American sufferers. Studies estimate that a total of 13% of US adults have the condition, of which 2 to 3 million might be chronic sufferers. Also, migraine attacks are experienced by 5 million U.S. citizens, while 11 million blame migraines for debilitating them moderately or severely.

However, there are developments in the medical field, especially brought about by new devices that can alleviate the symptoms of the condition.

The Cerena Transcranial Magnetic Stimulator

One such device, FDA approved, is a magnetic apparatus – the Cerena Transcranial Magnetic Stimulator, which aims to control the pain inflicted by migraines. The device discharges a magnetic pulse that has been shown to disrupt the pain caused by migraines. More than 38% of the patients enlisted in the trial for the device have experienced total relief from pain after two hours of using the stimulator. However, the Cerena Transcranial Magnetic Stimulator cannot be used by epileptics or those with a history of seizures, or anyone with a metal or other implanted medical device, such as a pacemaker.

Cefaly – the Electrode Headband

The FDA has just recently approved an electrode headband called Cefaly, which is aimed at preventing migraines from occurring. The new device runs on its own battery and administers light electrical discharges to the trigeminal nerve, known to be involved in migraines.

Neurostimulation via Implants

Another helpful technological advance was suggested by Stephanie Harville, a longtime migraine sufferer. A neurostimulation device, directly connected to nerves in her head, has kept her migraine pain under control. The device changes the sensation of pain experienced during a migraine to a pleasant one. It can be turned on or off, as well as adjusted in intensity by the patient.

Dr. William Rosenberg, the director the Center for Relief of Pain at Research Medical Center in Lenexa, Kansas, who performed the implantation, suggests that the same approach could be used in other patients too. Severe back pain is already kept under control using a similar technique, and he hopes that the technology will receive approval from the FDA.

These new medical devices give hope to millions of sufferers worldwide, especially for chronic sufferers, for whom migraines can be painful and debilitating.

New Hope in Treating Antibiotic-Resistant Infections

Treating Antibiotic Resistant MRSA

Every day it seems there’s a new report related to antibiotic resistant superbugs wreaking havoc in hospitals across the country. Just recently, a drug-resistant Gram-negative bacteria was found to be infecting young children between the ages of 1 and 5 years old. While the infection rate is still considered low, it is on the rise, and is concerning for parents of small children. And according to a report from the CDC, of the 2 million people who become infected by drug resistant bacteria per year, 23,000 die as a result.

In an effort to control the threat of antibiotic resistant bacteria, researchers at Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed) are hoping to “tame” drug resistant MRSA rather than unsuccessfully trying to kill it. LA BioMed researcher Michael Yeaman has received a $1.6 million Innovation Award from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH) for this purpose.

In the past, and even now, when a person becomes ill the course of action is typically a hospital stay with a round of antibiotics. As bacteria and other microorganisms adapt to develop coping strategies against the antibiotics, drug resistant strains are created. Therefore, the very treatment of infection has ultimately led to the spread of untreatable illness.

It is this reality that has inspired the concept of “taming” infection, rather than going after it with even more antibiotics that it can gain resistance to. The researchers will be working to disable MRSA’s adaption mechanism to reduce the likelihood of it building resistance to treatments.

We look forward to reading more about the progress of this work as it becomes available. Of course, the best way to combat infection is to prevent it in the first place, which is why it’s so important to ensure a sterile hospital environment. Nutek Corporation is an FDA-registered sterilization facility that provides sterilization services for medical devices and tools. Learn more about our offerings online or by calling 866-WE-EBEAM (933-2326).

Heading Into Spring with More Biomedical Device Tradeshows – Will We See You There?

While much of the country has been gripped by the winter that would not end, here at Nutek we’ve been actively going out and promoting our new offerings. This past February, we networked among thousands of event exhibitors at MD&M West in Anaheim, CA. The event was a huge success, and we look forward to next year’s show from February 10-12, 2015.

Until then, we’ll be keeping ourselves busy with a host of other activities and events. This month, for example, we have two exciting shows taking place the same day! BIOMEDevice Boston is another MD&M event that will bring us over to the East Coast, at the Boston Convention & Exhibition Center. It will take place March 26-27, 2014 and will bring together hundreds of exhibitors in the medical device industry. We’ll be showing off our medical product sterilization services at Booth #738. There will also be a variety of 2-hour Learning Labs for participants to take part in, in addition to a speed networking event, and free admission to three other events collocated with BIOMEDevice Boston.

Also taking place on March 26, 2014 will be the Fifth Annual Bay Area Biomedical Device Conference taking place at San Jose State University. We are proudly sponsoring this educational event, which will include numerous distinguished speakers and industry panels.

Rounding out the list of upcoming events, MD&M Texas is taking place May 7-8, 2014 at the Fort Worth Convention Center. Speakers include C-level executives at premier health and medical industry organizations, and Learning Labs include Rapid Ideation & Prototyping: Driving Speed to Market, 3D Printing Strategies, and more.

If you’ll be attending any of these events and would like to meet us there, let us know on Twitter! We look forward to seeing you!

Decontaminating Lab Supplies, Disposables and Consumables

In both the medical and general scientific research communities, the importance of having contaminant-free lab equipment, instruments and products can’t be overstated. If any part of the testing chain is contaminated – pipette tips, vials, Petri dishes, assay plates, etc. – it can throw off all the data and make it unusable. Rather than take this risk, it’s important to ensure that all materials are made contaminant-free.

In particular, ensuring that materials are RNase free and DNase free is vitally important. These substances can degrade the very RNA and DNA samples being tested if they are present in or on any of the testing materials. For example, if a researcher is running a Polymerase Chain Reaction (PCR) to amplify their genetic sample for more accurate testing, they’ll need to provide RNase free PCR tubes, among other items. RNase contamination can come from innumerable sources, so all testing equipment and products must be properly sterilized and RNase free.

For RNase and DNase free products, disposables and consumables that are labelled as sterilized or sterilized processed, the sterilization processing must be validated to a Sterility Assurance Level (SAL) of 10 to the negative 6, meaning that contamination must statistically not exceed 1 per million devices or lower. To achieve this validation standard for medical devices, electron beam (E-beam) irradiation and Gamma sterilization are often used.

Companies that do not label their lab products as sterilized or sterilized processed will still need assurance and be able to provide their customers assurance that their lab consumables and disposables are contaminant free. In this case, processing their product to achieve a SAL of 10 to the negative 3 or one per thousand devices is acceptable with data and monitoring of manufacturing process is in place to assure this SAL is achieved on an ongoing basis.

And as important as it is to sterilize lab products, disposable and consumables, it is just as important to perform sterility testing and verification dose calculations to verify the effectiveness of the sterilization procedure.

For more information and to request a quote for lab product decontamination or medical device sterilization, please contact NUTEK online.

Nutek Looks Back on the Big Trade Shows of 2013

As 2013 ends, we thought it would be a great time to look back on some of the shows and conferences we attended this past year. As always, we’ve worked hard to stay ahead of the technological curve, by attending and showing at as many industry gatherings as possible. These events are also a fantastic way to keep in touch with our clients and industry peers. Out of all the shows from 2013, three stand out in particular.

• MD&M Minneapolis 2013

Hosted by the amazing folks at MedTechWorld (http://ubmmedtechworld.com/), MD&M Minneapolis is one of the most important industry shows we attend.  Held each year at the Minneapolis Convention Center, this year’s show, which ran from October 29-30, included 600+ MedTech suppliers, 85+ presentations, and 5,000 attendees (http://www.canontradeshows.com/expo/minn13/). For Nutek, it was a perfect opportunity to share our unique sterilization services with a wide array of peers and customers. We plan on attending and exhibiting at the 2014 edition of MD&M Minneapolis, which will be held October 29-30.

• Marcus Evans Medical Device Manufacturing  and R&D Summit 2013

This unique event, which was held at the Four Seasons Resort Palm Beach November 18-19, was the perfect mix of formal and informal networking and educational sessions. All of the top names in the medical device industry attended, and the summit gave us a chance to meet one-on-one with potential customers. We will be attending the 2014 edition, which will run June 26-27 at the Red Rock Resort & Spa in Las Vegas.

• BIOMEDevice San Jose

Put on by the same organization behind MD&M Minneapolis, MedTechWorld, BIOMEDevice is both an exhibition and educational show. This year’s show, which just ended December 5, included 350+ MedTech suppliers, 2,000 attendees, and 60 presenters. One of the unique parts of BIOMEDevice is the 2-day Wireless Medical Device West Conference. This show within a show allowed us to learn all the latest info about this burgeoning part of the biomedical device market. The 2014 edition will be held the same time next year, December 3-4.

In the end, despite having slightly different formats and focuses, all three of these shows allowed Nutek to learn and share new technologies and connect with new and current customers. If you want to learn more about our experiences at these show, or how you can join us at any one of them in 2014, please contact us today!

Sterilizing Sensitive Materials Using E-Beam Technique

For the medical device, pharmaceutical, and other related industries, Electron Beam (E-beam) has long been a reliable form of sterilization for various products. However, sterilization options have been very limited for more sensitive materials, including biologic agents. For this reason, Nutek has unveiled a new sterilization technique to address these challenges.

SmartDose™ opens the door to sterilizing sensitive materials and complex devices using the well established E-beam method. The new system allows one product to receive different irradiation doses in different locations at the same time. In addition, products can be maintained at very low temperatures during the process, keeping temperature-sensitive materials stable.

This new sterilization process has proven more effective than other options, increasing sterilization success by up to 67%, and has created the ability to sterilize products that until now could not be sterilized by EO, Gamma or E-beam. Customers have also reported reduction of waste by up to 40% compared to previous methods and modalities used in previous routine sterilization of their products and devices.

For some sensitive materials, this is the first sterilization option that can actually be applied without compromising the product. SmartDose™ sterilization technology is truly going to change the medical technology and research field. It is ideal for implantable devices and combination drug/biologic devices, hydrogels, bioabsorbables, allograft tissue, advanced polymers, biomaterials and more.

For researchers in the biotech industry, this technology will allow products to be safely delivered to the public at a lower cost and much quicker turnaround time. To learn more about the technique and Nutek’s capabilities, please contact us online. You can also follow us on Twitter for additional company updates and industry trends. We look forward to hearing from you!

California Becomes the Hub for MedTech Innovation

While most industries have suffered from decreased investment over the last year, digital health startups are defying the odds. New companies in this field have seen funding up 12% over 2012. In the first half of 2013 alone, $849 million in investments were poured into 94 digital health initiatives within 90 companies.

Remote patient monitoring represented the bulk of funding, with $102 million all together. And regionally, California came out on top with 31% of all deals.

This isn’t the only medtech news coming from the state. A number of programs and initiatives are underway to promote healthcare technology research and growth.

For example, California is home to an incubator program at the Fogarty Institute in Mountain Valley that mentors medical innovators. Five companies were selected to join the two-and-a-half year program recently. The companies selected receive support from lawyers, business people, and clinical mentors.

Since 2007, three companies that went through the Fogarty Institute’s program ended up receiving first-round funding. The combination of guidance and resources is a huge help to budding startups with radical ideas to change the face of medicine, but need some direction to get there.

The largest EMS company based in California is also making strides into the future by incorporating software to provide electronic medical records instead of the old-fashioned paper based model. The company behind this software, Beyond Lucid Technologies, is also based in Northern California. A major strength of the system is that it can work without a network connection, which is essential in the case of a natural disaster that would otherwise cripple infrastructure.

The above examples represent just a snapshot of the work going on in California’s medical technology sector. It’s clear that this state is the epicenter of medtech advancement, and we’re excited to take part in the process.

Ebeam VS EtO – Which Sterilization Process is Right for Your Product?

Before delving into the benefits of each sterilization procedure, it’s important to understand how each one works. Ethylene Oxide (EtO) functions by replacing hydrogen atoms on molecules including proteins and DNA. This disruption proves lethal to unwanted organisms (in this case, bacteria and other microbes). Electron beam (E-beam) begins with high energy electrons that collide with local electrons to break the DNA of target microbes, thus eliminating them.

Since both procedures produce the same result, how can one decide which to use? The main consideration lies in the product being sterilized, rather than the technique itself. For example, EtO is ideally suited to semiconductor sterilization. It is also very effective for complex structures, getting into every possible space.

E-beam can be used for a wide range of products as well, and is often applied to medical equipment and pharmaceuticals. It is a very quick process, taking mere minutes to sterilize a small batch of material. It also doesn’t require a quarantine period after treatment, since the process is over once the beam is turned off. For this reason, E-beam is an ideal option for products that require a fast turn-around time.

Both methods require product validation before use (both of which take a number of weeks to complete), and both are followed by a quality assurance certification. E-beam is typically a much faster process from start to finish, but both methods have their place in the sterilization industry.

How Small Scale Innovation Reaps Big Rewards

In the May issue of the journal Medical Care, a study was published that found physician entrepreneurs responsible for numerous patents in the medical device space. Having extensive experience in medicine, these entrepreneurs produce startups that are familiar with current challenges and limitations, and have the know-how needed to solve them.

Startups foster innovation for a number of reasons. Not the least of which is that they are often founded in response to a specific problem. The entrepreneurs behind them are driven to answer the tough questions that have plagued their careers. They are motivated, focused, and creative. So it’s no surprise that these startups are often attractive not only to the patent office, but to investors and larger companies, as well.

Working with medical device startups carries myriad benefits. First, you get to contribute to major breakthroughs by providing complementary services. Second, if the startup succeeds, they’ll likely continue using your offering (probably at a greater scale as their business grows). Third, successful startups often find the attention of much larger companies, resulting in occasional acquisitions. This in itself can very quickly expand your network. It also validates that your business is a trusted provider in the industry, since you now work with such high-profile companies.

By contributing to the success of small companies, you provide an avenue for them to contribute to the success of your own company. Consider it an investment of your resources, for an eventual payout of increased business and credibility.