Medical device recalls reached record highs in the first three months of 2018 due to software complications that are likely to continue with the spread of high-tech devices. Device recalls increased 126 percent in the first quarter of 2018. At 343 recalls, it was the highest number in a single quarter since 2005, according to a report by Stericycle’s Recall Index, which tracks recall data across several industries.

Software was the biggest driver of medical device recalls in the first quarter, accounting for 23 percent of all recalls. Software issues have been the leading factor in device recalls each quarter since the beginning of 2016.

Bethany Hills, an attorney at Mintz Levin in New York who chairs the firm’s Food and Drug Administration (FDA) practice, says the rapid increase is not totally unexpected. Medical device software is becoming increasingly complex, with analytics that provide a higher level of clinical decision support.

“The more complex the software, the more likely it is that the developers did not account for all variables in the clinical environment, increasing the risk of bugs and errors,” she explained in a FierceHealthcare interview. “This risk increases further if the device manufacturer outsources software development because integration of outside software and the inability to quickly modify the code can lead to additional errors slipping through the cracks.”

All told, more than 208 million devices were recalled in the beginning of the year, more than the total number of recalled devices in all of 2017. There doesn’t appear to be one singular reason for the startling uptick, making it difficult to pinpoint an underlying trend.

Although it’s possible the first three months of 2018 were an anomaly, software challenges aren’t likely to recede. Device manufacturers are building more innovative devices with software that requires frequent updates and patches.

“[Manufacturers] don’t have this figured out yet and it’s going to continue to be a driver,” Mike Good, vice president of marketing and sales operations at Stericycle, told FierceHealthcare.

Medical Device Cybersecurity

At the same time, medical device cybersecurity has emerged as a growing concern among industry leaders and lawmakers. Legacy devices are especially susceptible to attacks. A recent report from analysts at Symantec indicated a hacker group known as Orangeworm has been launching targeted attacks on the healthcare imaging suites where devices run on outdated operating systems.

Although there have been a limited number of cybersecurity recalls, the most notable was a firmware update for Abbott-manufactured cardiac devices. According to Healthcare IT News, Abbott recently released its second and final round of planned cybersecurity updates to its pacemakers, programmers and remote monitoring systems to fix severe cybersecurity flaws in the devices.

The patch will update the battery performance alert. This allows the device to monitor for abnormal battery behavior and automatically vibrate to tell the patient when something is wrong.

The planned updates began last year, and the latest firmware update was approved by the FDA last month. The update applies to about 350,000 of Abbott’s implantable cardioverter defibrillators and implantable cardiac resynchronization therapy defibrillators.

The devices were originally manufactured by St. Jude Medical, which Abbott acquired last year. At that time, St. Jude was under fire for remaining quiet about defibrillator issues that caused rapid battery depletion. The FDA found St. Jude continued to ship these devices despite knowing about the defect.

The flaws, made public in 2016 by Muddy Waters and security firm MedSec, could allow an unauthorized user to access the defibrillators and modify the programming controls. Since acquiring St. Jude, Abbott has been working to patch those vulnerabilities.

The FDA’s recall notice said the firmware update will reduce the risk of patient harm due to premature battery depletion and potential exploitation of the flaws in the devices. The update will effectively complete the necessary patches to prevent unauthorized access.

Hills expects the medical device recall trend to continue, particularly now that the FDA is accepting devices with artificial intelligence and more complex clinical decision support algorithms. While the trend may continue, the FDA is trying to come up with possible solutions. Food and Drug Administration Commissioner Scott Gottlieb, M.D., has asked Congress for funding to create a cybersecurity “go-team” that would be housed in a new Center of Excellence on Digital Health.

Hills points out that reducing the number of devices recalled from the market requires a joint effort by manufacturers and the FDA to minimize risks prior to approval. Doing so is a delicate balance between constantly testing and validating software and the clinical benefits of using the software.

________________________

Ryan Lahti is the managing principal of OrgLeader and author of The Finesse Factor: How to Build Exceptional Leaders in STEM Organizations being published in early 2019. Stay up to date on Ryan’s STEM organization tweets here: @ryanlahti

(Photo: Medicine Equipment, Pixabay)

GE Healthcare and Roche entered into a strategic partnership to co-develop and co-market digital clinical decision support (CDS) solutions. GE Healthcare is a worldwide leader in medical imaging equipment, while Roche Diagnostics is the global leader in in-vitro diagnostics. The partnership will initially focus on products that accelerate and improve individualized treatment options for cancer and critical care patients.

The two companies aim to develop an industry-first digital platform, using advanced analytics to provide workflow solutions and apps that support clinical decisions. This will allow the seamless integration of in-vivo and in-vitro data, patient records, medical best practice, real time monitoring and the latest research outcomes. Clinicians will then have the comprehensive decision support for providing the right treatment and quality of care for their patients.

For example, oncology care teams with multiple specialists will have a full data dashboard to help them collaborate on treatment decisions for cancer patients at each stage of their disease. In the critical care setting, data from a patient’s hospital monitoring equipment will be integrated with their biomarker, tissue pathology, genomic and sequencing data. Physicians will be able to identify, or even predict severe complications before they strike.

According to FierceBiotech, GE chief innovation officer Nadeem Ishaque cites the bringing together of diagnostic images, pathology and genomic information for a breast cancer patient as an example of the potential of the collaboration. Ishaque stated, “By leveraging this combined data set using machine learning and deep learning, it may be possible in the future to reduce the number of unnecessary biopsies that are performed due to suspicious findings in the mammograms and possibly also reduce mastectomies that are performed to combat ductal carcinoma in situ, a condition that may evolve into invasive breast cancer in some cases.”

The strategic partnership will have to navigate the new FDA guidance on CDS solutions. Some types of CDS will no longer be defined as a medical device and subsequently regulated by the FDA. Software that suggests a provider order liver function tests before starting statin medication is an example. However, the FDA will continue to enforce oversight of software programs intended to analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram. These programs use analytical functionalities to make treatment recommendations. Consequently, they remain medical devices under the Cures Act, because inaccurate information provided in the CDS has the potential for significant patient harm.

Many of the ideas driving the GE-Roche collaboration have been discussed for years, but action to date has not resulted in a noticeable reduction in healthcare inefficiencies and medical errors. With medical errors being the third leading cause of death in the U.S., an effective CDS solution by GE and Roche could have a significant impact.

“This is the first time that two major players in healthcare have combined advanced analytics with in-vivo and in-vitro diagnostics to this degree. We believe this alliance will help accelerate the delivery of data-driven precision health for customers, patients and the healthcare industry,” said GE Healthcare CEO Kieran Murphy in a recent press release.

As Murphy suggests, the potential for clinical decision support software success is there. We just need to see empirical evidence to show it.

Related posts:

Human Dx Changes the Process for Medical Diagnoses

Artificial Intelligence and Deep Learning Aid Cancer and Stroke Diagnostics

———–

Ryan Lahti is the founder and managing principal of OrgLeader. Stay up to date on Ryan’s STEM organization tweets here: @ryanlahti

(Photo: General Electric Logo, Flickr)

How close are we to cyborgs being a practical reality? Some say that Dr. Kevin Warwick became the first cyborg back in 1998. While at the University of Reading in the U.K., he decided to implant a radio-frequency identification (RFID) chip in his shoulder. He wanted to see how well sensors within his office building could pick up the chip’s presence and respond by turning lights on or off and giving him access to locked doors. In 2002, Warwick proceeded to up the ante considerably by having a surgeon implant a device called the BrainGate. With its 100 electrodes, it tapped directly into the nerves of his arm, giving him remote control of a robotic hand.

More recently, Neil Harbisson and Moon Ribas have integrated other forms of technology into their bodies. Harbisson, whose U.K. passport shows he’s the first legally recognized cyborg, was born colorblind. He designed an antenna which translates colors into one of 360 musical tones he’s memorized. At first, he connected it to headphones and a laptop. Eventually, he persuaded a surgeon to drill into his skull, implant a chip and fuse the antenna to his occipital bone. Ribas has a Bluetooth implant in her left arm designed to analyze the earth’s seismic movements. The implant vibrates at different intensities based on data from online seismographs. Harbisson and Ribas say the merging of technology with their bodies has created new senses.

Cyborg Nest, a London startup, is manufacturing DIY kits to enhance senses and bring transhumanism to the mainstream. The first kit, the North Sense, is essentially a $425 wearable implant. “It does one simple thing,” says co-founder and Chief Executive Officer Liviu Babitz, who was fitted with one in December. It produces “a short vibration every time you’re facing north.” That doesn’t sound like an advantage worth body modification, but Babitz likens the experience to a second childhood. “I remember my son discovering things as his senses developed and the look in his eyes when it happened,” he says. “I feel the same.”

Stanford genetics department chairman Michael Snyder says these implants aren’t as fringe as they sound. He employs similar medical sensors to detect colds, Lyme disease and diabetes risk. He calls the North Sense “analogous to the radiation monitor that I use.” The World Economic Forum says Cyborg Nest’s type of biohacking could be commonplace by 2020. “If you’re alive today, you’re probably going to end up having at least one electronic attachment,” Babitz says.

It’s not just startups that see a human-technology integration as reality versus science fiction. Google has a vision for cyborg eyes that goes well beyond the idea of smart contact lenses. The Alphabet-owned company filed a patent on the idea of replacing the human eye’s natural lens with an electronic lens implant. Such a cyborg eye implant could replace normal eyesight functions and correct for eyesight problems. The concept’s existence also hints at future possibilities for putting the capabilities of a smart contact lens directly inside the eye.

The Google patent application envisions a laser drilling a hole in the lens capsule that protects the human eye’s natural lens, according to research provided by legal technology firm ClientSide. Ultrasonic vibrations would help shatter the eye’s natural lens so that the fragments could be suctioned out the hole. That would clear the way for the injection of the electronic lens device and a fluid capable of solidifying into silicone hydrogel. This would produce a new electronic lens that can adjust its shape to provide the appropriate focus for normal eyesight — or correct for problems such as nearsighted vision without requiring extra contact lenses or glasses.

A cyborg eye implant like this could change its shape and adjust the wearer’s vision by using technologies such as liquid crystals , micro mirrors and tiny micro-fluidic pumps. It may also include additional lenses to help fix eyesight problems such as myopia (nearsightedness) or astigmatism.

The implant could wirelessly send data to a smartphone, tablet or laptop that has an Internet connection. These devices could pass on the data to an optometrist’s office or a clinic. In response, an optometrist or another medical expert could send signals with commands to change the programming that controls the electronic lens vision. This would equate to a wireless update for corrective lens prescriptions.

Some argue that cyborgs are not just a reality–they are a necessity. At the World Government Summit, Elon Musk warned that humans must become cyborgs if they are to stay relevant in a future dominated by artificial intelligence. Musk argued that as artificial intelligence becomes more sophisticated, it will lead to mass unemployment. He stated, “There will be fewer and fewer jobs that a robot can’t do better.”

If humans want to continue to add value to the economy, they must augment their capabilities through a “merger of biological intelligence and machine intelligence”. If we fail to do this, Musk contends we’ll risk becoming “house cats” to artificial intelligence.

While you may not see the Terminator, the Borg from Star Trek or even the Six Million Dollar Man walking down the street today, you can certainly find real examples of technology integrated with the human body. We may not know enough to tell if this transhumanism could prevent us from becoming house cats. However, evidence does suggest it can provide solutions to address vision problems and other medical issues.

———–

Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti

(Photo: Cyborg, Pixabay)

Medical device cybersecurity continues to be a major concern for companies given the impact breaches can have on the health of patients. Johnson & Johnson (J&J) and St. Jude Medical are prime examples. Johnson & Johnson’s Animas unit recently disclosed cybersecurity flaws in its wirelessly controlled insulin pump that hackers could exploit and potentially deliver unauthorized doses of insulin to patients. While such an attack could result in insulin overdose and hypoglycemia, Animas says the risk of attack is low.

The OneTouch Ping Glucose Management System comprises an insulin pump worn by the patient and a remote that uses a radio frequency communication system to wirelessly tell the pump to deliver insulin. Cybersecurity firm Rapid7 first identified the security issues earlier this year and communicated them to Animas in April.

In an interview with FierceMedicalDevices, Jay Radcliffe, a senior security researcher at Rapid7, explained that the major vulnerability is that the device lacks protection against a replay attack. If a person is in range of the device and can pick up its communications, they could “replay” those signals to cause the pump to do things that the user doesn’t command it to do. Such an attack is possible because the transmissions between the remote and pump are not encrypted. They don’t use sequence numbers either, which are unique numbers for each communication that allow the device components to talk to each other, but would ensure a hacker couldn’t carry out a replay attack.

Animas disclosed the security issues in a letter to customers. “We also want to assure you that the probability of unauthorized access to the One Touch Ping System is extremely low,” the company wrote. Animas told Reuters that it considered the device to be “safe and reliable.”

“We urge patients to stay on the product,” said Brian Levy, chief medical officer with J&J’s diabetes unit, as quoted by Reuters. Rapid7’s Radcliffe worked with Animas on the security issues and underscored the importance of understanding risk. He shared in a blog post that “removing an insulin pump from a diabetic over this risk is similar to never taking an airplane because it might crash.”

Besides Johnson & Johnson, St. Jude Medical has been dealing with medical device cybersecurity issues. A report on cybersecurity vulnerabilities in St. Jude Medical’s implantable heart devices was jointly released in August by cybersecurity research firm MedSec Holdings and investment firm Muddy Waters, which primarily focuses on short selling, or betting that the stock prices of companies it picks will decline. The report claimed that pacemakers and implantable defibrillators sold by St. Jude could be hacked in ways that could jeopardize a user’s safety. The implanted devices have wireless radios to connect to a home monitoring station that can then back up data to St. Jude.

In a Fortune article, University of Michigan researchers stated that the report by MedSec and Muddy Waters didn’t prove the flaws existed. “We’re not saying the report is false,” Kevin Fu, associate professor of computer science and engineering and director of the Archimedes Center for Medical Device Security at University of Michigan, said in a statement. “We’re saying it’s inconclusive because the evidence does not support their conclusions. We were able to generate the reported conditions without there being a security issue.”

St. Jude said the MedSec/Muddy Waters report analyzed outdated software and demonstrated a “fundamental lack of understanding of medical device technology.” Security expert Robert Graham also challenged some of the MedSec findings by stating in his blog, “The report is clearly designed to scare other investors to drop St. Jude stock price in the short term so that Muddy Waters can profit. It’s not designed to withstand long term scrutiny. It’s full of misleading details and outright lies.” To be transparent, MedSec and Muddy Waters did disclose that they had a joint financial arrangement to profit from a fall in St. Jude’s stock price.

Whether it is J&J’s Animas unit, St. Jude or another medical device company, cybersecurity remains a high priority. The FDA further underscored the importance with the release of recommendations for managing cybersecurity vulnerabilities for medical devices. The ultimate test is how well medical device companies can protect patient health by preventing cyber breaches or quickly recovering when breaches happen.

———–

Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti

(Photo: Johnson & Johnson, Flickr)

It might not be that surprising to hear that a tech company is trying to develop a wearable device that helps visually impaired people get around by foot, but an automotive company doing so might make you do a double take. Double take aside, Toyota is working to develop a wearable device for the visually impaired that will help them do more with greater freedom, independence and confidence. Called Project BLAID, it reflects the company’s commitment to enrich lives by advancing the freedom of mobility for all.

The Project BLAID device will help fill the gaps left by canes, dogs, and basic GPS devices by providing users with more information about their surroundings. Worn around their shoulders, it will help users better navigate indoor spaces, such as office buildings and shopping malls. More specifically, it will enable users to recognize elements in the physical environment including restrooms, escalators, stairs, and doors.

The device will be equipped with cameras that detect the user’s surroundings and communicate information to him or her through speakers and vibration motors. Users, in turn, will be able to interact with the device through voice recognition and buttons. Toyota plans to eventually integrate mapping, object identification, and facial recognition technologies.

“Project BLAID is one example of how Toyota is leading the way to the future of mobility, when getting around will be about more than just cars,” said Simon Nagata, Executive Vice President and Chief Administrative Officer, Toyota Motor North America. “We want to extend the freedom of mobility for all, no matter their circumstance, location or ability.”

While Toyota is working on a device that goes around the shoulders, Microsoft has been testing a bone conducting headset to assist visually impaired individuals. Bone conduction delivers sound to the inner ear by using your skull as a delivery method. Incidentally, bone conduction transmission works with people with regular or impaired hearing.

Microsoft’s headset is aimed at guiding visually impaired people around busy cities. Microsoft has teamed up with the charity Guide Dogs to conduct test trials in the United Kingdom between Reading and London. The trials incorporate walking directions and public transportation.

For the original trials, the headset used a prototype of Microsoft’s 3D soundscape technology along with a Windows Phone for GPS data. These worked with Wi-Fi and Bluetooth beacons that had been strategically placed in the trial location.

If headset wearers are straying from their path, they are directed with a ping to the ear on the relevant side and voice directions for turn-by-turn instructions. Points of interest are also utilized. During this time, the wearers are able to hear the real world sounds around them.

In the last few months, the headset has been given a useful update that allows the user to ask for information via voice controls. The new features are named Orientate and Look Ahead which give the user information on what is coming up in terms of distance. There’s also a physical remote, with three buttons, which allows wearers of the headset – who may be using a cane or have a guide dog on a leash – to use this instead of a smartphone.

“Cities need to be built for absolutely everyone, but no one’s going to knock them down and make them accessible,” explained Chris Yates, customer experience lead for Guide Dogs. “What we’re doing is using existing infrastructure and working around it with technology.”

While the devices from Microsoft and Toyota are still in the developmental phase, they do show some promise. Additionally, it is good to hear how companies of this caliber continue to think outside the box for ways to assist consumers.

———–

Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti

(Photo: Landmark Plaza, Flickr)

Life science collaborations continue to evolve and so does Google. According to Reuters, Novartis plans the first human tests of a smart contact lens next year. Novartis is developing this lens with Google to help restore the eye’s natural autofocus. More specifically, the lens is intended for people with age-related farsightedness, who can no longer read without glasses.

In an interview with Swiss newspaper Le Temps, Novartis chief executive Joe Jimenez shared, “This project is progressing well. I had said it would take about five years to see a product on the market.” He continued, “The calendar is on track and we are already developing a technological lens prototype (that) should be tested on humans in 2016.” In addition to addressing farsightedness, Novartis is working with Google to create smart contact lenses to help diabetics track their blood glucose levels.

Take a further look into the blood glucose monitoring arena, and you will find Dexcom is teaming up with Google to develop bandage-thin continuous glucose monitoring devices. “If you look at kids with diabetes and the size of the components, it’s pretty big and takes up a lot of real estate,” says Kevin Sayer, president and chief executive officer of Dexcom. The goal of the partnership is to combine Google’s advancements in miniaturized electronics to create a small, flexible and disposable device that could be thrown away weekly when the sensor needs to be changed. “Inside that [glucose monitor] transmitter, there’s a battery, there’s a radio, a processor, an antenna,” says Sayer. “Google has spent a lot of time miniaturizing electronics.” Today, one of Dexcom’s sensors alone costs about $70 to $75 and lasts a week. With the Google partnership, the costs are expected to decrease in a substantial way.

Incidentally, the Google we are talking about in this case is one of the new companies that Google created under its restructured and newly named company, Alphabet. This life sciences company under Alphabet goes by the fitting name of Google Life Sciences. Google Life Sciences seems to be focusing a lot on blood glucose monitoring. In a communication to Endocrineweb.com, a Google Life Sciences spokesperson shared, that the collaboration with Dexcom “is an example of how the life sciences team at Google is continuing exploring ways that making sensors and electronics small and convenient for everyday life could help people manage disease.”

While blood glucose monitoring is a current focus, Google Life Sciences appears to be targeting a range of illnesses down the road, because National Institute of Mental Health (NIMH) director Dr. Tom Insel said he will step down in November and join Google Life Sciences. Insel, who has been with NIMH for 13 years, said he would work on Google Life Sciences projects that explore mental illnesses. For more information on Insel’s transition, see NIMH.

———–

Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti

(Photo: Contact Lens Case, Flickr)

Although the U.S. Supreme Court’s recent decision supporting the Affordable Care Act has made many people happy, there are still some who are working to repeal at least part of it. The Wall Street Journal reported that efforts to repeal the 2.3 percent medical device tax are continuing to gain momentum.

In April, the U.S. Senate Committee on Finance held a hearing in which the chairman of the subcommittee on healthcare, Rep. Patrick J. Toomey (R-PA), explained the tax is poorly designed. He said that it is a tax on sales instead of a tax on profits. The companies that spent large amounts of money making the products and bringing them to market were losing money even when they started to have sales. Imposing a tax on these sales prior to there being a profit increases the debt load that the companies have to carry, and there is only so much debt that can be financed.

In June, the House of Representatives passed a repeal of the medical device tax by a margin of 280-140 which sends the bill to the Senate. The repeal is likely to encounter a filibuster in the Senate unless 60 senators come out in favor of bringing the bill to the floor for debate.

The tax is supposed to bring in approximately $30 billion in the next 10 years. Manufacturers have opposed the tax, because they state they could produce and sell devices at much cheaper prices without the tax. Preliminary data shows that the tax has not performed well as a fundraiser for the Affordable Care Act. It raised $913 million in the first half of 2013 which was approximately 75 percent of what was anticipated. Up to 15,000 tax filers were expected, but only 5,107 medical device tax forms were actually filed.

President Obama is expected to veto any sort of repeal, because the tax funds the Affordable Care Act. An actual repeal of the tax would require another source of revenue to replace money from the tax. So, don’t be surprised if the repeal of the tax becomes a bargaining chip in the process of approving spending bills later this year.

For more information, see The Wall Street Journal.

———–

Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti

(Photo: DSC_3892, Flickr)

If you thought smartphones, tablets and wearables being used as legitimate medical devices for more than monitoring your heart rate and storing basic medical history is a few years away, you might want to adjust your time horizon. LifeMap Solutions, a growing digital therapeutics provider, just launched a pilot program for its COPD Navigator app. According to LifeMaps CEO Corey Bridges, “Chronic Obstructive Pulmonary Disease—COPD—is the third leading cause of death in the US, and it affects an estimated 24 million Americans. But patients can slow the progression of the disease and improve quality of life through effective self-management.”

Developed in partnership with researchers from the Icahn School of Medicine at Mount Sinai and with COPD experts from the Mount Sinai – National Jewish Health Respiratory Institute, COPD Navigator is an Apple iOS health app that enables patients to better manage COPD with an iPhone or iPad. The app tracks patient data including symptoms, medication and treatment adherence as well as overall quality of life. This information is seen in a user-friendly graph that allows patients to recognize patterns in their own health history and share this data with their doctors. Additionally, the app helps patients avoid environmental risk factors via real-time alerts about local air quality and extreme weather, and it offers educational content from leading respiratory hospital, National Jewish Health.

COPD is not the only medical issue that mobile health technology (mHealth) is breaking ground on to help patients. The Neutun is a new app developed by Neutun Labs to help epileptic patients. As MedGadget points out in recent article, the tracking of epileptic seizures is a crucial component in customizing therapies for epileptic patients. Traditionally, this has been done by patients keeping journals of seizures. Because this manual approach is often inaccurate due to low patient compliance and patient difficulty gauging epileptic episodes, the Neutun app was created to increase the ease and precision of seizure tracking.

The Neuton app operates with the Pebble smartwatch via Apple and Android platforms. The app uses motion sensors inside the smartwatch to identify seizures and immediately start to record the intensity and lengths of the events. Furthermore, the app can send a text message to family members on a pre-set list to notify them that a seizure is occurring. While it is only available for the Pebble watch at the present time, the Neuton app is in the process of being made compatible with other devices.

COPD Navigator and Neuton apps are examples of how mHealth continues to advance beyond the basics. Given the need for more efficient ways to manage personal health and the possibilities technology offers, we are likely to see more forms of mHealth in less time.

———–

Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti

(Photo: NEC Corporation of America, Flickr)

Albert Chi, a Johns Hopkins trauma surgeon, used a 3D printer, sheets of colored plastic and information discovered online to create a prosthetic hand for approximately $20 according to The Baltimore Sun. Upon fitting a two-year-old child with a 3D printed hand, the youngster was able to pick up an object in just a few minutes. This success has created a network of volunteer medical professionals, designers, parents and 3D printing supporters who are hoping to provide hands at no cost to any child in need of one. Such 3D printed hands are especially useful for children, because they frequently outgrow prostheses creating a challenge for parents who cannot afford to replace them every year at costs up to $40,000.

In addition to prosthetic hands, Forbes recently reported that a 3D printed vertebra has been successfully implanted in a 12-year-old boy by doctors at Peking University. Because the boy had a malignant tumor in his spinal cord, the doctors needed to replace a cancerous vertebra in his neck. So, they used titanium powder (a common orthopedic implant material) in a 3D printer to create a new vertebra to take the place of the old one.

Besides lower costs, 3D printing provides the benefit of flexibility so that prostheses and implants can be printed in any shape. 3D printing involves placing layer upon layer of material such as plastic or metal in a unique pattern to produce a 3D object from a digital model. Instead of trying to make a traditional implant or prosthesis work, a medical device can be created via 3D printing that better matches the needs of a patient. In the case of the 12-year-old boy, doctors created a custom implant with tiny pores in it to allow the bones to grow into the implant and secure it without cement and screws.

Prostheses and orthopedic implants are expected to represent some of the fastest growing segments in the coming years. In the U.S. alone, demand for implantable medical devices is projected to increase 7.7% annually to $52 billion in 2015 according to Freedonia. In addition to the needs of children, this trend will be driven by the Silver Economy in which older populations seek more products and services to help them age well. Consequently, the results from the initial use of 3D printing are likely to pale in comparison to what the next few years will produce.

———–

Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti

At this point, the health data is expected to include heart rate, steps taken, and blood sugar level. In order to collect this data, consumers would need to utilize wearable devices with sensors that would detect needed biometric information. Examples of these devices range from smartwatches like Apple’s iWatch or Samsung’s Galaxy Gear smartwatch to Google’s smart contact lens recently discussed in a Wall Street Journal article. According to Reuters, blood glucose monitoring is at the top of the list for wearable devices, because this would make it easier for diabetics to monitor their blood sugar levels multiple times per day.

To make wearables more viable, Google and Apple have already established relationships with some of the largest sports equipment companies. Nike’s FuelBand will share the health and fitness data it gathers with the Google Fit platform. Nike has also been working closely with Apple on integration with the HealthKit platform. Furthermore, Adidas is developing a line of sensor-based health wearables that will integrate with the Google Fit platform.

These devices and the proposed data they will gather may take some time to come to full fruition. First, Google, Apple and Samsung will need approval from regulatory organizations such as the FDA. Then Google, Apple and Samsung will need consumers to feel comfortable wearing the devices and allowing their health data to be analyzed and potentially commercialized by these companies and their partners. It’s one thing for a smartwatch to share your heart rate, steps and temperature with other apps through the use of sophisticated biometric sensors. It is something entirely different for that data to be provided to marketers. While Google pointed out several times during its introduction of Google Fit that users would control what health and fitness data they allow the platform to access, consumer concern about “big brother” could make a longer runway necessary to get the widespread use of such platforms off the ground.

———–

Ryan Lahti is the founder and managing principal of OrgLeader, LLC. Stay up to date on Ryan’s STEM-based organization tweets here: @ryanlahti