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Gaining Big Advantages in Miniaturizing Medical Devices

Gaining Big Advantages in Miniaturizing Medical Devices

For example, a digital healthcare company in California has designed an ingestible tablet embedded with a sensor the size of a grain of salt. The sensor is paired with a wearable transmitter the size of a Band-Aid to detect medication intake and physiological data. The information is then transmitted to a patient’s smartphone.

With this technology, healthcare providers and their patients can access reliable data quickly and conveniently without disrupting the daily routines of the patients. In addition, with the smartphone acting as a reminder, patients can better follow their medication instructions.

Developing such groundbreaking technologies naturally requires overcoming some unprecedented challenges for OEMs.

First and foremost is the type of knowledge required. In the case of this digital healthcare company, its researchers and engineers are specialists in medical sciences—not manufacturing. They need a strategic partner to help guide them through the complex processes to turn their prototype into a viable product for the market.

Secondly, apart from components, OEMs also need to work with unfamiliar materials. For example, miniaturized wearable devices require specialized design components to ensure the device is sweat resistant and waterproof. They also have to meet health-and-safety-related requirements. These requirements are outside the realm of the design and manufacturing of typical medical devices such as an ultrasound machine. Wearable medical devices also need to be small, easy to use, and can withstand any regular movements a person may have.

Other primary concerns include the logistics and economics of manufacturing these types of new products. Many of these miniaturized devices are promising but they are still new to the market. Initial demands likely will be small before a wide adoption can be expected. As such, OEMs need to have the ability to cost-effectively produce such complex devices in small volumes.

Having the right equipment, the processes and the ability to source new materials and components all become equally daunting as designing the devices.

The good news is that OEMs do not have to do it all. A strategic partner with broad and deep experiences in servicing different industry sectors can bring a lot of viable solutions to take these innovative devices to market efficiently and cost-effectively.

"The miniaturization of devices is a nascent but promising trend. Consumer products have already been leading the charge in this area with much success."

For example, Celestica, is currently partnering with an OEM to produce a wearable electronics monitoring system. That company is responsible for assuring the design of the device for manufacturing and testing (DFM and DFT), while Celestica selected and tested tapes and adhesives for the new product and managed the necessary processes to take the product to the current final stages of product qualification, which will be followed by high-volume production.

By relying on the global supply chain, the design and engineering knowledge and the manufacturing capabilities of its partner, this OEM kept its focus and resources on perfecting and innovating in the area of miniaturization.

For a partnership between an OEM and its strategic partner to work, it may often require an adjustment on how partnerships are formed. The traditional OEM–vendor relationship is no longer adequate because many complex issues need to be considered right at the design and prototyping phase of the product. The cost and availability of components, the durability of materials, even down to the packaging need to be considered at the early stage. To uncover compatibility of components, supply chain or logistical issues at the manufacturing stage will significantly affect the go-to market costs and/or timeline. By involving a strategic partner early in the concept and design process, time to market can be shortened, and ultimately a better, lower-cost product can be achieved.

The miniaturization of devices is a nascent but promising trend. Consumer products have already been leading the charge in this area with much success. OEMs that recognize the value of partnerships are poised to embrace a new frontier in patient care.

Simin BagheriSimin Bagheri, M.A.Sc., P.Eng. is the customer engagement lead for the engineering services division at Celestica Healthtech. 

DIY Body Hackers Do Their Own Implants

Cybernetics researcher Kevin Warwick

Did you know that by implanting a small, rare earth mineral magnet into the tip of your finger you can create a sort of sixth sense for yourself that allows you to sense electromagnetic fields with your finger? This is in addition to all the additional things you could do with a magnet in your finger. While relatively simple, this procedure (which doesn't use anesthetic for legal reasons) is only the tip of the iceberg for the latest generation of people who are creating homebrew devices and implants and installing them in the comfort of their own basement.

People like Kevin Warwick and Neil Harbisson have created devices for themselves that could have remarkable medical benefits. In Warwick's case it has been nerve implants allowing him to remotely control a robotic hand. Harbisson, a colorblind artist, has developed an implant that allows him to perceive color via sounds and vibrations.

Further on the fringe are people like Shawn Sarver and Tim Cannon of Grindhouse Wetwares, who are taking body modification to other extremes, essentially performing in-home surgies to experiment with means of modifying their bodies. Among their various projects they are currently developing a device that when implanted into the skin will communicate with a smartphone via Bluetooth and detail a person's vital stats (heart rate, temperature, and blood pressure).

In a new documentary created by The Verge, Sarver, Cannon, and their ilk detail their efforts as self-proclaimed pioneers of what they see as the next wave of human evolution. By the time FDA and other regulatory bodies and large corporations catch on, they hope to have made huge advancements in body modifications for self improvement, medical uses, and even general entertainment. Only time will tell how far this trend continues (and how far researchers are willing to go on their own), but right now Sarver and Cannon say the field is wide open for anyone with enough know-how and curiosity – and a high enough pain threshold.

Watch the documentary Biohackers and read the full article on The Verge

-Chris Wiltz is the Assistant Editor of MD+DI

Anemia-Detecting Cell Phone Device Could Impact Pregnant Moms, Newborns in Developing Countries

Innovative and tech-savvy university researchers have been pioneering the development of low-cost medical devices that leverage cell phones, which are often much more accessible in developing countries than traditional medical devices or technologies. Continuing to push progress in this area, student researchers at Johns Hopkins University have created an inexpensive technology that converts a healthcare worker's cell phone into an anemia-detection device for pregnant women and newborns that is optimized for use in developing countries.

This conceptual image illustrates how the HemoGlobe screening device, slipped onto a patient's finger for an anemia test, would connect with a health worker's cell phone. (Credit: Johns Hopkins University)

Pregnant mothers in developed nations are routinely tested for anemia, which results from a deficit of healthy red blood cells and is often attributed to a lack of iron, and treated accordingly. However, anemia in mothers that may not have access to medical care in developing areas may go undetected and cause complications for both mother and baby.

Seeking to address this unmet need, the students built an anemia-detection device called the HemoGlobe. The device features a sensor that is placed on the patient's fingertip and connects to a healthcare worker's cell phone. It then measures the levels of hemoglobin, the iron-based protein that enables red blood cells to store and release oxygen, in the patient's blood by shining various wavelengths of light through the skin. When the test is complete, the cell phone display shows a color-coded test result that indicates the severity of the disease. If anemia is detected, the patient can receive proper treatment.

The HemoGlobe device has received a $250,000 seed grant to further develop the technology and can be produced for just $10 to $20 each, according to the students.

"This device has the potential to be a game-changer," says Soumyadipta Acharya, an assistant research professor in the department of biomedical engineering at Johns Hopkins University and the students' faculty adviser. "It will equip millions of healthcare workers across the globe to quickly and safely detect and report this debilitating condition in pregnant women and newborns."

For more information about cell-phone based medical devices, check out:

Crux Biomedical CEO Shares Thoughts on Unique Vena Cava Filter

Crux Biomedical CEO Shares Thoughts on Unique Vena Cava Filter

Now cleared by FDA, a retrievable inferior vena cava filter (VCF) from Crux Biomedical (Menlo Park, CA) could be a game-changing technology. VCFs, which are used to help prevent pulmonary embolisms in at-risk patients, are in high demand. An estimated 259,000 VCFs will be deployed this year. Yet the basic design of VCFs had remained largely unchanged for decades before the development of the Crux device. In 2010, FDA issued an alert outlining problems linked to the available devices, including their tendency to tilt, migrate, or fracture after placement. In addition, the available devices could be difficult for clinicians to retrieve.

To address these issues, Thomas Fogarty, MD; Frank Arko, MD; and a group of engineers got together in 2004 to design a new vena cava filter from scratch. They ended up creating a device markedly different than VCFs currently on the market and began testing the device, ultimately launching a clinical study. At the Society for Interventional Radiology Meeting held March 24-29 in San Francisco, the results of a pivotal study were released documenting a 98% success rate for the device (both placement and retrieval) along with an average retrieval time of 7 minutes.

To learn more about the device, MD+DI reached out to the company’s CEO, Mel Schatz, who shared his thoughts on the device and FDA’s recent clearance of it. 

 The Crux vena cava filter is the first that is bi-directionally retrievable. 

MD+DI: What is your opinion on FDA’s clearance of the device? Earlier, Thomas Fogarty, MD said he was cautiously optimistic that the FDA would approve the device relatively quickly.

Mel Schatz: It has been an interesting eight-year effort. You have a certain advantage when you design a product from scratch. We feel very confident that the design changes that we made are the most significant in probably 40 years. We are bringing something to the market that has the advantage of a bi-directionally retrievable device that can be anchored in the vena cava without worrying about perforation. In addition, it conforms to the IVC so it doesn’t tilt and is built more to suit the dynamics of the vessel. I think those are the reasons that we have been able to gain such high retrievability and such favorable data.

I know Dr. Fogarty was very optimistic of a fast review. Regarding the review process, we would have to say that the FDA was very proactive in moving the process along and very motivated. But I think everybody’s experience in the regulatory process is different and dependent on the product they are seeking approval for.

Like many other firms seeking clearances, we are seeing new standards and for most of the companies, including Crux, it seems like it just takes longer than you expected or it should. We are hopeful that the reforms, both from MDUFA and other legislative initiatives, will continue to make the process more predictable and transparent. I think that is critical to our ability to get new therapies out in a more timely manner so the United States can maintain global leadership in medical technology and so patients in the U.S. can benefit more rapidly.

In summary, we had a mostly positive experience with FDA. We would have liked to have it faster but I think that is probably true of all medical device companies right now.

MD+DI: It seems like there was a real market need for a novel vena cava filter design—especially considering the warning FDA released on VCFs in 2010. Do you think that helped accelerate the path to market for the Crux device?

Schatz: The FDA never made comments to us in that regard. I do believe that the alert that came out in 2010 was an important milestone in recognizing that some of the products had not been performing to physicians’ satisfaction. That might have had some impact on the FDA but we did not have any specific reference to that in the review process.

MD+DI: The design for this product is quite a bit different from other VCFs. What are your thoughts on its market potential?

"I am very confident about the advantages of our device, which were echoed in the excellent data that we achieved in our recent pivotal trial." 

Schatz: I am very confident about the advantages of our device, which were echoed in the excellent data that we achieved in our recent pivotal trial. The results demonstrated low complication rates and excellent retrievability and offered more choices for the physician along with a very fast learning curve.

I believe physicians will have more confidence in using the Crux device. Based on our clinical experience, I believe it will have very wide acceptance in the marketplace. Physicians who participated in the study were very complimentary and seemed anxious to use the device on a routine basis. I think the inquiries that we have seen subsequent to the Society for Interventional Radiology (SIR) presentation and the recent FDA clearance suggests that there are a lot of physicians who are ready to use it.

I would be surprised if within a couple of years, the Crux VCF is not a market leader in this category. This goes back to what I said earlier about designing the device from scratch: we were able to design the device around the dynamics of the inferior vena cava and make the product work accordingly.

MD+DI: Dr. Fogarty had mentioned that Crux was exploring another potential application of the technology related to placement of aortic valves. Would it be possible to get an update on this?

Schatz: A couple of years ago, it was pretty obvious to us that after designing a filter for a large vein such the IVC, we could modify our device design and size it appropriately for virtually any lumen or vessel in the human vasculature. We did not have the time or resources to expand our efforts until the last couple of years.

We started hearing the enthusiasm about percutaneous aortic valve repair. The Partner trial showed that percutaneous valve patients experience three times the stroke rate versus the surgical arm, emphasizing the need to minimize strokes when you are deploying that new valve. It comes down to an issue of protecting the carotid vessels.

We felt we could design a more effective approach to trap clot, plaque or pieces of calcium that may result from the valve repair procedure. We began prototyping efforts.

We have currently developed a very unique catheter based device that can be used to protect the carotids during percutaneous valve procedures. As we talk to more cardiac and vascular surgeons, there is quite a large interest in a protection device if it is both easy to use and cost effective in a number of complex cardiovascular procedures where strokes are of concern. We are very confident that the platform we have developed for the IVC will be of value in many other areas of the human vasculature.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Bioactive Coating Improves Efficacy, Longevity of Implants for Deep Brain Stimulation

Deep brain stimulation has emerged as an exciting and promising field for treating both neurological and psychological disorders ranging from Parkinson's disease to depression. But the long-term viability of implants designed for DBS remains uncertain as current electrodes tend to induce an immune response in the patient's body that reduces the treatment's efficacy over time. Looking to overcome this challenge, researchers at Tel Aviv University (TAU) have developed a bioactive coating for electrodes that suppresses the brain's immune response, thereby increasing the longevity and efficacy of the implant.

For optimal results, the brain-computer interface must function seamlessly, according to the researchers. Once implanted under the skin, the medical device emits high-frequency currents that are then transferred to the brain via electrodes. However, the electrodes are often identified by the body as foreign bodies. Consequently, the body attacks the electrodes and forms a barrier to the brain tissue receiving treatment. In turn, the efficacy of the DBS treatment decreases because the signals are not properly communicated to the brain.

Addressing this barrier for DBS implants, the Tel Aviv University researchers have applied a protein-based bioactive coating to the electrodes that serves to camouflage them while also suppressing the brain's immune response. Although other researchers have explored the use of protein-based coatings for such applications, the TAU team sought to employ a protein that is actually active within the brain itself to suppress the immune response to the electrodes. Dubbed interleukin (IL)-1 receptor antagonist, the protein, in its natural setting, serves to maintain physical stability by localizing brain damage, essentially preventing the immune system from overreacting to trauma, according to the researchers.

Touted by the team as the first bioactive coating made from this particular protein, it safely and effectively integrates the electrodes into the desired brain tissue without interrupting normal brain function. In fact, the researchers report that their coated electrodes outperformed both noncoated and other protein-based coatings in preclinical studies conducted with animal models. As a result, the coating could lead to a more-stable, long-term DBS implant design, the researchers note.

Looking to the future, TAU's Aryeh Taub anticipates that the electrode coating could someday even contribute to the development of an interface capable of restoring lost behavioral or motor function resulting from tissue damage. "We duplicate the function of brain tissue onto a silicon chip and transfer it back to the brain," Taub says, explaining that the electrodes will pick up brain waves and transfer them directly to the chip. "The chip then does the computation that would have been done in the damaged tissue and feeds the information back into the brain, prompting functions that would have otherwise gotten lost."

Weekly Vitals: Chick-fil-A and the Medical Device Industry, Medtech M&A, and More

Former Vante CFO Adam Smith brought some unexpected controversy to the doorstep of his employer, a supplier to the medical device industry, this past week. Smith gained national attention when he posted a video on YouTube that went viral showing him berate an employee of the fast-food chain Chick-fil-A for working for the company, whose president, Dan Cathy, has openly opposed same-sex marriage. Smith was fired and issued an apology following the uproar. In other news, MPMN explores the driving factors behind M&A activity in the sector. Read about these and more top stories of the past week in our roundup below.

Outsourcing Gets Political

If you’re located in one of the battleground states for November’s election, you’ve probably seen at least one advertisement accusing presidential hopeful Mitt Romney of outsourcing American jobs overseas. Recently, the war of words between President Obama and his Republican rival escalated into an attack on offshoring itself.

In July, Senate Democrats tried to advance a bill intended to curb overseas outsourcing and bring jobs back to the United States. The Bring Jobs Home Act would give companies that return jobs to the United States from overseas a tax break to cover 20% of their insourcing expenses. To pay for that tax cut, it would end deductions for outsourcing expenses currently available to companies that move jobs overseas.

The bill, which was sponsored by Debbie Stabenow (D-MI), never came to a vote. Democrats were four votes shy of the 60 votes needed to break a Republican filibuster. Four Republicans, including medtech-friendly senator Scott Brown (R-MA), broke ranks with their party to join Democrats’ attempt to force a vote on the measure.

Republicans filibustered the measure because senate majority leader Harry Reid (D-NV) refused to consider Republican-proposed amendments to the bill, including a repeal of the Affordable Care Act and an extension of tax cuts passed during the term of former president George W. Bush.

The bill is in line with President Obama’s goal of rewarding American jobs instead of outsourcing, which was among the five to-do list items he presented to Congress back in May. After the measure failed to come to a vote, White House press secretary Jay Carney criticized Republicans for blocking it.

“Rather than encouraging companies to bring jobs back to our shores, they chose to play politics and block measures that will create jobs and strengthen the middle class,” Carney said in a statement. “We will continue to push Congress to act on proposals like this one and the other remaining portions of the President’s American Jobs Act that independent economists say would create a million new American Jobs.”

Two similar bills exist in the House, as well as another in the Senate.
 

Jamie Hartford is the associate editor of MD+DI. Follow her on Twitter @readMED.

Coming to Terms with Outsourcing

According to Carey, there is a “do I or don’t I point at every company.” But device firms are usually asking this question when they are under pressure and challenged—either when a project is about to start, or even worse, when they are behind. The key is to know what, when, and how to outsource and whom to outsource to. Further, Carey said organizations must make peace with outsourcing.

John Carey, FoliageHe outlined the six steps that a company must perform to ensure that the outcome of outsourcing is successful.

Step 1: Perform a Core Competency Analysis
This is an essential step to selecting outsource partners. Such analysis determines what should remain in-house and what is best suited for outsourcing. Keep in mind that this step can affect the culture of your organization and should be approached with caution, Carey advised. He said management and a wide range of stakeholder buy in is key.

Step 2: Perform Knowledge Gap Assessments
As part of the core competency analysis, Carey said that a knowledge gap analysis can inform the evaluation. Companies may decide that a knowledge area that displays considerable gaps may still be a candidate for designation as a core competency. They might also decide to invest in closing a knowledge gap in order to develop a core competency. Conversely, the knowledge gap could lead a company to designate the knowledge area as noncore and a good candidate for outsourcing. “Identifying noncore areas should be accomplished as early in the process as possible,” he explained. 

Step 3: Protect IP
Carey advised that firms should identify true intellectual property (IP) but avoid the tendency to expand the definition. For example, “software plays a role in a lot of medical products, but there is a difference between the core algorithm development at the foundation of a product and the application software that gets developed around it,” Carey said. “It’s not unusual for companies to decide that the algorithm is the IP, and the rest of the development is noncore.” Understanding where a company’s true IP is helps them discover and avoid overspending in noncore areas.

Step 4: Decide How Much to Outsource
Once core competencies are settled, decisions can be made on how much to outsource. Guidance should come from the outcomes of the assessments. In general, core competencies stay in house and noncore competencies will be outsourced. Carey said this plan can be controversial because employees associated with non-core areas develop concerns about their future role in the company. Firms should anticipate this outcome, identify which employees are likely to develop concerns, and take measures to proactively address the issue.

Step 5: Decide When to Outsource
There are specific times in a company’s life when it will decide to outsource. And often by the time a firm decides to outsource, it is because they are under pressure, Carey said. “That is not a good time to start the process,” he says. Examples include when the firm is making a technology shift or when it is facing a short time to market for a product. A company might also decide to look into outsourcing when the bandwidth of the company begins to influence product development. Increased regulatory pressures might also help a company think that outsourcing might make sense. Expanding to a new market, where price points might come into play. “And they are, generally, just trying to remain competitive,” Carey said. However, the key to successful outsourcing is to look at these needs before they become a problem. 

Step 6: Select Whom to Work With
The most important qualifier for a potential partner is domain experience, Carey said. Partners must come with an understanding of the processes, tools and technologies of their domain. Among qualifications, Carey advised companies to ask about an outsourcer’s  certifications (e.g., ISO 9001, 13485, and 62304) and adherence to common industry standards (e.g., HL7, DICOM, IHE). It is valuable to look for a service provider that develops products in the same class as a firm’s FDA-regulated devices. Evaluating a contractor’s past performance and current competencies can help avoid expensive and possibly disastrous training curves

Partners should meet the OEMs’ minimum standards and ideally be willing to contribute to continuous improvement. “A good partner can give critical insight into your own development process,” he said.

Selecting the right partner, and understanding the best methods can be tricky, Carey acknowledged. “Don’t forget to communicate,” he said.
 

As Regulators Step Up Enforcement, Importance of Risk Management Grows in Medtech

The ISO 14971 standard on risk management for medical devices specifies a process to identify hazards linked to the production of medical devices. In addition, the IEC 60601 standard for medical devices have incorporated a direct reference to the ISO 14971 standard, observes Mark Leimbeck, quality and training program manager at Underwriters Laboratories (UL), who will speak on the subject in the Medtech Supplier Partnerships Conference held August 22–23 in Boston. 

Another factor is that regulators are stepping up their enforcement of regulations that are already on the books — including those pertaining to supplier controls. Leimbeck recommends that device manufacturers become well versed on the IEC 60601-1 Third Edition standard, which went into effect in Europe in June and will be recognized by FDA next year. 

 Mark Leimbeck

In light of this, Leimbeck recommends medical device companies look for synergies in complying with standards such as IEC 60601, ISO 13485, and ISO 14971. For instance, there is a Global Harmonization Task Force document that discusses integrating the ISO 13485–quality management system with the ISO 14971 risk management system, Leimbeck says. “The manufacturer’s activities that would demonstrate compliance with those standards can be integrated into kind of a common overall system that can actually improve the quality of their device and also demonstrate enhanced risk management,” he explains.

In the end, accomplishing these goals requires that device companies and their contract manufacturers work together as partners with shared goals. “If you can establish that kind of relationship, when your products are introduced to the marketplace, you will have less risk and less exposure both for the end product manufacturer as well as the component manufacturer,” Leimbeck says. “There are a lot of good things that can happen. In fact, that is what the standard writers as well as the regulators have really intended with writing those standards and regulations. With shared goals, the path to regulatory approval is simplified, and results in better and safer products in the marketplace for everyone.” 

The MD+DI MedTech Supplier Partnerships conference will gather medical device experts to share practical guidance on how to collaborate effectively with suppliers and CMOs and achieve the transition from procurement to partnership in the highly regulated and competitive medical device industry. Limited complimentary passes available. Call 310-996-9435 for more information or visit www.medtechsupplier.com.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz. 

Update: Vante's CFO Fired Over Chick-fil-A Fiasco; Former CFO Issues Apology

For those of you not familiar, Chick-fil-A's president and COO, Dan Cathy, recently pledged his public support of the "biblical definition of the family unit." It has been a firestorm ever since. On August 1, former Arkansas governor Mike Huckabee declared Chick-fil-A Appreciation Day, which was then countered by a Same-Sex Kiss Day.

On August 1, Vante's Smith recorded the following video, which included a confrontation with a Chick-fil-A window employee:
 

Following the video's release, Vante let Smith go, saying, "The actions of Mr. Smith do not reflect our corporate values in any manner. Vante is an equal opportunity company with a diverse workforce, which holds diverse opinions. We respect the right of our employees and all Americans to hold and express their personal opinions, however, we also expect our company officers to behave in a manner commensurate with their position and in a respectful fashion that conveys these values of civility with others."

Will the actions of Smith or Vante set off any further recriminations? Vante certainly hopes not. "We hope that the general population does not hold Mr. Smith's actions against Vante and its employees," said the company's press release about the incident.

If you were reading to the end to get my take on this story, I'm sorry to disappoint. Not touching this with a 10-foot pole. If you have any comments, please remember to be respectful to all sides.

Heather Thompson

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UPDATE: 

Adam Smith issued an apology over the weekend.