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Articles from 2015 In November


Medtronic Recalls Nearly 100,000 Pacemakers

The medical device company reports that a battery problem in one of its pacemakers could interfere with normal device function.

Qmed Staff

Insync IIIA recent recall involving roughly 96,800 InSync III pacemakers has been given Class 2 status by the FDA. The recall, which covers three different models of the pacemakers, relates to a potential battery defect. In a letter addressed to doctors, Medtronic notes that 30 devices so far have been demonstrated to have a problem with unexpected high battery impedance, which could prevent the devices from supplying enough electrical current to operate normally. The recall relates to more than 9300 devices in the United States.

The battery problem could cause a variety of problems including the unexpected loss of pacing capture, erratic behavior, fluctuations in longevity estimates, and inaccurate lead impedances.

The company has received a report of one patient death where the battery problem may have been a contributing factor. The role of the problem, however, is still unconfirmed.   

In a letter to patients, Medtronic states that "if pacing capture is compromised, some patients may experience a return of heart failure symptoms due to loss of biventricular pacing. In cases involving pacemaker-dependent patients, a loss of pacing capture could result in serious injury or death."

At least 22,000 of the pacemakers remain inside patients worldwide at present.

Medtronic's cardiac-device business in Mounds View, MN is organizing the international recall of the products.

Medtronic states in the aforementioned letter to physician that "it is not possible to identify which devices might fail or when they might fail. The issue cannot be mitigated by programming changes or increasing patient follow-up frequency."

Newer generations of the company's pacemakers are not susceptible to the battery problem, thanks to a modified battery design.   

Learn more about medical technology trends at BIOMEDevice San Jose, December 2-3.

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Note: An earlier version of this article incorrectly stated that 220,000 pacemakers remained in patients worldwide.

Top 10 Biomedical Engineering Schools by Salary

Engineering is one of the most handsomely rewarded academic disciplines and, engineering continues to be the highest-paying major at the baccalaureate level. Biomedical engineers' compensation is competitive with the pay offered by many other engineering niches.

Qmed Staff

Updated December 22, 2015

According to the U.S. Bureau of Labor Statistics, biomedical engineers take home an average salary of $91,760--more than the roughly $87,000 salary range that is the average for civil and mechanical engineers and approximately the same as materials engineers' salary of $91,150. Still, biomedical engineers take home less pay on average as do electrical engineers, computer hardware engineers, and chemical engineers.

That said, the university where a biomedical engineering student chooses to attend can have a substantial influence on average compensation. Here, we round up the average starting salary for some of the top biomedical engineering programs in the United States.(Already in medtech and want to know how your salary stacks up to your peers? Check out MD+DI's 2015 Medtech Salary Survey.)

For the sake of comparison, a USA Today roundup from earlier this year reports that the average starting salary for all types of engineers is $62,998.

In the roundup below, we rank the top starting salaries for biomedical engineering grads using data from StartClass. (Note: In the case that there was a discretion between in-state vs. out-of-state tuition, in-state amounts were use.)

1. Stanford University (Stanford, CA)

Avg. starting salary for BME grads: $98,000
Undergraduate Acceptance Rate (campuswide): 5.7%
Total Enrolled Students (campuswide): 18,346
Tuition: $45,195

2. Columbia University (New York City)

Avg. starting salary for BME grads: $75,000
Undergraduate Acceptance Rate (campuswide): 7.8%
Total Enrolled Students (campuswide): 26,050
Tuition: $41,425

3. San Jose State University (San Jose, CA)

Avg. starting salary for BME grads: $73,000
Undergraduate Acceptance Rate (campuswide): 64.1%
Total Enrolled Students (campuswide): 30,236
Tuition: $7,323

4. Duke University (Durham, NC)

Avg. starting salary for BME grads: $70,000
Undergraduate Acceptance Rate (campuswide): 14.7%
Total Enrolled Students (campuswide): 15,467
Tuition: $47,243

5. Johns Hopkins University (Baltimore, MA)

Avg. starting salary for BME grads: $70,000
Undergraduate Acceptance Rate (campuswide): 19.5%
Total Enrolled Students (campuswide): 20,918
Tuition: $47,060

6. University of Illinois at Urbana-Champaign (Champaign, IL)

Avg. starting salary for BME grads: $68,000
Undergraduate Acceptance Rate (campuswide): 60.9%
Total Enrolled Students (campuswide): 44,942
Tuition: $15,020

7. University of Washington (Seattle, WA)

Avg. starting salary for BME grads: $67,100
Undergraduate Acceptance Rate (campuswide): 55.5%
Total Enrolled Students (campuswide): 42,444
Tuition: $12,394

8. California Institute of Technology (Pasadena, CA)

Avg. starting salary for BME grads: $67,800
Undergraduate Acceptance Rate (campuswide): 7.9%
Total Enrolled Students (campuswide): 2231
Tuition: $43,362

9. Northwestern University (tied)

Avg. starting salary for BME grads: $65,000
Undergraduate Acceptance Rate (campuswide): 13.9%
Total Enrolled Students (campuswide): 20,959
Tuition: $47,251

9. Cornell University (tied)

Avg. starting salary for BME grads: $65,000
Undergraduate Acceptance Rate (campuswide): 15.0%
Total Enrolled Students (campuswide): 21,131
Tuition: $47,286

10. University of California, Berkeley

Avg. starting salary for BME grads: $64,800
Undergraduate Acceptance Rate (campuswide): 14.2%
Total Enrolled Students (campuswide): 36,137
Tuition: $12,972

Runners Up

University of Pennsylvania
Avg. starting salary for BME grads: $62,500

University of Wisconsin, Madison
Avg. starting salary for BME grads: $62,000

Massachusetts Institute of Technology
Avg. starting salary for BME grads: $60,800

Georgia Institute of Technology
Avg. starting salary for BME grads: $60,300

University of California, Los Angeles
Avg. starting salary for BME grads: $60,000.   

Learn more about cutting-edge medical devices at MD&M West, February 9-11 at the Anaheim Convention Center in Anaheim, CA.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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St. Jude Launches World's First Upgradeable Chronic Pain Management System in Europe

St. Jude Medical announced Monday that it is launching the world's first and only software upgradeable, nonrechargeable spinal cord stimulation system for chronic pain patients in Europe.

The Proclaim Elite Spinal Cord Stimulation System is also MR-conditional and can deliver both traditional spinal cord stimulation and burst stimulation. Burst stimulation is different from traditional or tonic stimulation in that the implantable device delivers closely spaced, high-frequency stimulation to the spinal cord and doesn’t result in the tingling sensation that patients feel during the traditional spinal cord stimulation process. Some chronic pain patients cannot tolerate traditional spinal cord stimulation because of the tingling sensation

By making the spinal cord stimulation system nonchargeable, the Minnesota device maker—the world's 14th largest by revenue—is making the device more consumer friendly. 

“We developed the Proclaim Elite SCS system to create a more patient-centric spinal cord stimulation therapy option,” said Allen Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical, in the news release. “With the launch of this device we are transforming the standard of care by packaging a series of important benefits into a single SCS device. The Proclaim Elite SCS system offers patients a combination of advanced pain therapy options and the convenience of a device that doesn’t require recharging, while removing barriers for future therapy and diagnostic options.”

Typically, St. Jude's rechargeable SCS system needs to be charged once a week, while other competing devices may need to be charged daily, according to a St. Jude Medical spokesman.

In another nod to the consumerization of healthcare, the novel device has software upgrade capability such that future enhancements will not require a surgical replacement of the implantable device. 

While the Proclain Elite SCS system with burst stimulation is available in Europe, in the U.S., burst stimulation is not yet available. Roughly two weeks ago FDA approved a version of the device that is nonrechargeable, upgradeable and MR-Conditional. St. Jude is currently studying burst stimulation through the SUNBURST U.S. clinical study, results of which will be presented at the North American Neuromodulation Society (NANS) in Las Vegas, Nevada, Dec. 10 - 13.  

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb

[Photo Credit: Freedigitalphotos.net user taesmileland]

The Guide to the Future of Medicine: Infographic

Medical Infographic

Learn more about user-centered design in a workshop dedicated to the topic at BIOMEDevice San Jose, December 2-3.

Modular Design Works for Google and IKEA, but Does It Work for Medical Devices?

Modular Design Works for Google and IKEA, but Does It Work for Medical Devices?

A recent trip to Sweden, a hub of modular design, inspired this engineer to reflect on the pros and cons of modular design for medical devices.

Nigel Syrotuck

 

A number of buildings in Sweden take advantage of modular design to reuse parts.

Modulär Konstruktion

This blue box controls the crosswalk. Though it sticks out like a sore thumb, it is easy to install and replace

Modular design is a way of life in Sweden: it reflects the simplicity, commitment to quality, and expertise that is ubiquitous around the country. Modular design, which means designing a product to be reused, reapplied, and repaired easily, has huge benefits for a successful product line with long-term sales goals.

Though we can also find some examples of modularity here in North America, it is much more common to find “full package” solutions: a street post with built-in buttons, a shower installed directly into your bathroom, and unique houses are the norm. Though these look nice, they must each be designed individually and are difficult to replace.

The classic example of Swedish engineering is IKEA. Styled with square edges, a simple look, and focused usability, IKEA furniture is often easy to spot right away. Another feature that may be somewhat less obvious is modularity.

IKEA furniture is often mix-and-match.

It’s not typical North American style to have a bathroom that looks like all the fixtures were just dropped in place, but at IKEA you can buy a sink, a cabinet, and a shower and stick them all in your bathroom yourself (with a couple screws). Many products are mix and match, allowing customers to reuse modules to make a bookcase that’s tall and narrow, short and wide, or even two separate units. This also inherently comes with a degree of customizability—if you design separate products that work together, you can create a kitchen that works for you and fits your needs. Though modular design requires heavy investment in upfront planning, it has many long-term advantages

Pedigree in Medical Devices

In medical devices, we have one main reason to use a modular design: the ability to reuse approved components in multiple products. Testing is cumbersome in medicine, for obvious reasons, but reusing an approved power module in a few different devices leads to a safer product with an extensive history and saves cost and time in development.

Some might argue against module reuse by saying that the best design is always custom for each use case. How could a module designed for a blood analysis tool truly be the best option for a physiotherapy device? Are we risking our newest patients’ safety by cutting a corner and reusing a design?

In fact, modular design is a form of custom design that is safer in many ways because it comes with a pedigree of successful and fully characterized parent products.

If Google Is Doing It . . .

Google is maximizing the relationship between customizability and modular design with “Project Ara,” a modularized smartphone. Their tagline is “Designed exclusively for 6 billion people,” which speaks directly to the have-your-cake-and-eat-it-too benefits of modularity—you get a unique product with existing hardware.

Though smartphones are typically held in high regard for being sleek, small, and lightweight, Google feels the benefits of replaceable and customizable components will outweigh drawbacks in those features. Each component needs an interface, a casing, and must fit a standard profile, which adds considerably to the design effort. This size versus modularity trade-off applies to medical devices too.

Google's "Project Ara" focuses on development of a modularized smartphone

Is Modular Design Right for Your Medical Device Line?

Let’s reflect on the pros and cons of modular design to evaluate whether this approach is right for your medical device.

The Pros:

Cheaper medium-volume products—Existing modules can easily be adapted to make a single unit, or many. For high to mega volumes, a fully customized product will likely be cheaper in the long run.

Faster assembly—Once all the modules are produced, it is straightforward to hook them all together, rather than soldering or gluing an integrated unit.

Easier to maintain—The customer can simply swap out the part that is not working.

Longevity—One part failure does not doom the entire product.

Easier to upgrade and customize—The customer can upgrade the parts as they need, keeping the product up to date and spreading out purchasing costs.

Next generation is one step away—When a superior technology makes your product obsolete, simply upgrade the outdated part rather than the whole device. This also keeps your clients up to date and invested in your product.

Known problems and pedigree – Because your modules have been used before, they are characterized, reliable and predictable. It is also easier to invest time supporting and improving units that have a long life span.

Testing is easier – Once a module has been tested in one product, re-testing in another product is straightforward and will (almost) certainly be successful.

The Cons:

Higher initial design cost—More design up front is often needed to make a reusable module in the first place, which pays off later with reduced iterative costs.

Often bulky and sharp edged—The simplest things to put together are cubic and blocky, so modular products often lack a sleek, streamlined aesthetic.

Expensive connectors—Though the overall bill of materials cost is often lower with modular design (by leveraging higher volumes and investing in manufacturing improvements), connectors are an expensive key feature.

May not be exactly what you need—Sometimes it may be difficult to adapt a module for what you need, which is by definition no problem for custom design.

With the pace of the industry, it’s hard to imagine anyone taking the time to invest in modularity up front, but in reality stable components like power entries, battery packs, user interfaces, and networking adapters don’t really change that often.

As size is often a noncritical metric in medical devices (especially cart or table-top units), trading off for a larger unit can make sense if you have the budget for the initial design effort to make simple, reusable parts and get the most out of your labor. Simplicity is complicated, but like so many things in life it’s worth the effort.

Check out the future of medical technology at the world's largest medical design and manufacturing event—register for the MD&M West Conference, February 9-11, 2016.

Nigel Syrotuck is a mechanical engineer at StarFish Medical, a medical device design company headquartered in Victoria, British Columbia.

[Images courtesy of NIGEL SYROTUCK, IKEA, AND PROJECT ARA/THE VERGE.COM]

Does Disruptive Innovation Really Have to Be So Disruptive?

The rate that technological breakthroughs are being developed continues to increase at breakneck speed, leading to seismic shifts in how people interact with technology on a daily basis. It is thus vital to ensure that developers of new technologies consider human behavior to engage users amidst a landscape marked by unprecedented change. 

Craig Scherer

Craig Scherer
Craig Scherer is a senior partner and cofounder of Insight Product Development. 

The digital health and Internet of Things authoritative Web resource, WTVOX.com reminds us that: "The world is changing fast. Faster than any time in human history... it took fifty years for one in four Americans to adopt electricity...It took thirty years for the same number to utilize the radio... eighteen years to "accept" the color TV. Thirteen years for mobile phones and only seven for laptops. That's how fast the world is changing."

In the white paper The Guide to the Future of Medicine from medical futurist Bertalan Mesk, MD, PhD we can see a great deal of technological influence that will change medicine in the very near future. We can even see further progress in many of the areas outlined in this infographic even since it was published just two years ago.

There is so much commentary in the media highlighting both companies and technologies that got left behind by failing to think differently and holding on too long to their sacred cows. In my last article, "what is Disruptive Innovation; and Why You Can't Afford to Ignore It", I discuss several ways to be on the lookout for disruption and how to rethink your views about how your organization manages disruptive innovation and technology. The next step in embracing this rapid change and accommodating disruption is to think about how people behave.

The top 10 medical technologies for 2015, as listed by WT VOX, are all virtually transparent to the user and their core behaviors and beliefs. Sources of innovation including Big Data, the Internet of Things (IoT), nanotechnology, artificial intelligence (AI), augmented reality (AR), Micro-Electro-Mechanical Systems (MEMS), and nanotechnology are all disruptive technologies, but they all will enable products and services to support and enhance users' behaviors, not force change on them.

Creating Innovation that Sticks

Guide Small
The Guide to the Future of Medicine by Bertalan Mesko, MD, PhD (Click to see a larger version)

So how do we innovate technologies that promote adoption? And, is it really necessary to require people to change their attitudes and behaviors to use a new technology? The key to driving initial adoption and to combatting early abandonment is to attempt to understand our target users completely and develop solutions that fit within their core belief systems and expectations. Everett Rogers' "Diffusion of Innovation" calls out some key requirements for our new innovations that help drive to sustained success. It is important to use these "barometers" to evaluate new opportunities:

  • They should have clear advantages over current offerings in the space, and the improved outcomes should be obvious to virtually everyone.
  • The new offering should have a relative lack of complexity as it is hard to replace a simple solution with a more complex one; people just aren't wired that way.
  • There should be a way for users to try the new technology with little personal risk.
  • We should be able to assure that our new solutions have a high level of compatibility with existing values and behaviors.

User-centered Design: The Nemesis of Innovation?

Last year, Fast Company reported in the article, User-Led Innovation Can't Create Breakthroughs, that "...creative people will feel limited and bored, not inspired, if they have to start out a creative process with a lot of user knowledge."  Reading this, makes me feel like there is a real disconnect in what user-centered design is all about. As device designers, we are not trying to have users "design" the product for us, we are trying to understand how the result of our efforts will best fit into current cultural, behavioral, and workflow expectations in order to promote first time use and adoption.

In the past, we have witnessed organizations blindly follow a user-centered design methodology even to the point of creating a "four-step stage gate" process around it. In reality, there is a huge difference between asking a user what the next disruptive product should be and getting feedback on workflow or usability for a complex product with a great deal of constraints.

Arguably, users can only get you so far.  There are a plethora of other variables that contribute to disruption that must be considered. User-centered design on its own is a great tool for incremental innovation, but that in combination with understanding other influences such as emerging technologies, business contexts, user trends, and industry needs, is what leads to broader sweeping change. 

Accommodating Disruption

User-centered design is less about discovering how to be disruptive and more about how to make disruption acceptable and adoptable. When minute clinics first appeared, the one thing they did not require users to change was their perceptions around the quality of care delivered. The fact that consumers could wait ten minutes in a drug store instead of three hours in an emergency department of a hospital to get a certified clinician to evaluate their health issues was very appealing. What this new service did not do, was require users to lower their expectations for level of quality that they would expect from a healthcare provider in a more traditional setting.

Another great example was the advent of the automated external defibrillator (AED). When these products came out, they did not require people to have the training level of an EMT, they instead used illustrations like ones that people were familiar with in CPR training and augmented them with voice commands. This made a very stressful situation more palatable while increasing the odds for better medical outcomes.

In the world of surgical devices, two companies are delivering disruptive innovation by perfectly accommodating current workflows. Britseed's SafeSnips technology can identify the presence, size, and location of vessels embedded in tissue and feed this information back in real time to the surgeon before a dangerous cut is made.  To a surgeon, this is like adding headlights to a car when driving at night. This breakthrough technology is virtually transparent to the surgeon, fitting perfectly into their surgical workflow. Even Intuitive Surgical's highly regarded da Vinci system is designed to mimic the surgeon's natural physical interactions with tools. For the surgeon, it is designed to feel like they actually holding and manipulating the device that is doing the procedure.

None of the consumer health or surgical devices listed in any of the examples above required their target user groups to "design" their own solutions. The developers of these products and services instead created solutions that are categorized as disruptive innovations and also had the greatest probability of adoption because they took the time to understand their user's behaviors, workflows, and expectations. In the end, user-centered design will not stifle creativity but if fact will focus efforts toward solutions that accommodate users' behaviors and attitudes in ways that encourage adoption and minimize abandonment.

Craig Scherer, co-founder and senior partner at Insight Product Development (Chicago).

Learn more about user-centered design in an Insight Product Development workshop dedicated to the topic at BIOMEDevice San Jose, December 2-3.

Your Medtech Summer Reading List: How to Get What We Pay For

How to Get What We Pay For: A Handbook for Healthcare Revolutionaries

Healthcare futurist Joe Flower posits that we can fix healthcare in How to Get What We Pay For: A Handbook for Healthcare Revolutionaries. The key, he writes, is to get all stakeholders—providers, insurers, employers, and patients—to work together. Flower will also share his insights in a keynote address in conjuction with the wireless conference at BIOMEDevice San Jose, taking place December 23, 2015. 
             

[image from AMAZON]  

Indian Government Scrutinizing Price of Medical Devices

Indian Government Scrutinizing Price of Medical Devices

After allegations arose that multinational device makers were inflating maximum retail price of products, the Indian government has asked them to submit price details.

Arundhati Parmar

As hospitals place pricing pressure domestically on device makers, those selling products in India are having to face government scrutiny abroad over the retail price of their products.

According to press reports, the Indian government has asked device makers to review pricing of their products and submit the details of maximum retail price (MRP) of the products to the Indian drug regulator National Pharmaceutical Pricing Authority, the entity that also oversees medical devices pricing.

“There have been cases where companies are selling imported stents for at least 3-to-4 times of its actual landed cost in India, so this is not justified, the companies need to review their pricing”, a senior official told the Press Trust of India.

Landed cost refers to the price at which they were imported. 

That same official added that the government has received complaints that device makers are paying huge commissions to hospitals and doctors who use their stents thereby driving up the price that consumers pay.

A representative of the Indian medical device industry charged that the practice of inflating the MRP was rampant.

"The malpractice of arbitrary MRP labelling is widely prevalent and the situation is serious enough to warrant immediate government intervention to rectify the situation," said Rajiv Nath, forum coordinator of the Association of Indian Medical Device Manufacturers.

Nath added that it is a duty of the Indian government to ensure a level playing field between imported and domestically produced medical devices. 

If the allegation is true, it will be interesting to see how the Indian government manages the situation.  But for consumers in India, the scrutiny might be well warranted given that the overwhelming majority of Indians are not covered by insurance and have high out-of-pocket healthcare expenditure. According to a 2012 McKinsey report on the Indian healthcare market, health insurance covered only 5% of Indians in 2004.

The Indian government has committed to boosting the Indian medical device sector to $50 billion from the current $5 billion, and is also looking at ways to create a separate regulator to oversee the medical devices sector, but within the pharma division, which so far has regulated the device industry as well as the drugmakers.

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb

[Photo Credit: Wikimedia Commons]

Learn about U.S. device industry trends at BIOMEDevice San Jose, at the San Jose Convention Center, Dec. 2-3.

Data Breaches are a Costly Threat to Healthcare

Data Breaches are a Costly Threat to Healthcare

888 data breaches in the first six months of the year alone are straining the healthcare industry and putting a huge financial burden on it.

Arundhati Parmar

2015 has had quite a few data breaches and it's something that needs to be taken more seriously as we connect more devices and interoperability becomes the order of the day.

The infographic below created by Royal Jay, a software company, is based on the  Fifth Annual Benchmark Study on Privacy and Security of Healthcare Data by Ponemon Institute and shows that as a result of the breaches 34% of all health records in the U.S. now stand exposed. And data breaches cost the healthcare industry $6 billion annually. 

The infographic also suggests some technical and operational steps that healthcare organizations can take to minimize the risk of bad actors hacking into health records. The technical efforts include installing anti-malware software, data loss prevention software and two-factor authentication software. And the operational efforts include having a security and compliance oversight committee, formal security assessment process and ongoing user awareness and training among others. 

Breached: A costly threat to healthcare

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb

[Photo Credit: iStockphoto.com user crispy_fish_images]

Invitae Grows Its Genetic Testing Menu

Invitae Grows Its Genetic Testing Menu

Marie Thibault

Invitae offers testing for hundreds of genes, covering hereditary cancers, epilepsy, arrhythmias, and more.

Invitae Corporation, a genetic testing company based in San Francisco, has a lofty goal—to offer a single service with hundreds of genetic tests to help patients with unknown diseases or conditions find a diagnosis.

In recent months, the company has multiplied the breadth of its genetic testing menu, now enabling testing for more than 600 genes. These genes cover a large span of diseases, from hereditary cancers and cardiovascular conditions to neuromuscular and rare diseases, enabling patients to be tested for a specific indication or multi-gene panel using that assay.

Scott

Randy Scott, PhD, Invitae’s CEO and cofounder, says the first step in finding a cure or treatment is understanding the disease a patient has. “I’m quite passionate about this. It’s very hard to cure a disease until you understand the disease at the molecular level," he says. 

Offering a single assay with hundreds of genes allows Invitae to offer more testing options for the same price. It's a price that the company displays prominently on its Web site—a $1500 list price, a $950 price for the institutions, distributors, and payers who contract with the company, and a $475 upfront patient price. While that isn't exactly pocket change, it is a far cry from the days when one- or two-gene tests cost several hundreds or even thousands of dollars.

Scott explains that Invitae is able to offer the same test price because of economies of scale—running a high volume of the same assay limited to interpretation of a specific indication versus a specific assay run much more infrequently. The company takes a different tack than its competitors, some of whom can offer testing on thousands of genes, but run these as individual assays, creating more expense and complexity, Scott says.

In mid-November, Invitae rolled out more genetic tests to cover all major hereditary cancers as well as more epilepsy testing options. This follows another spurt of expansion in early October, which increased the company's offering to more than 600 genes. 

The company's management team recently increased its guidance on billable tests for the year from 16,000-18,000 to 17,000-19,000 billable tests. According to a Seeking Alpha transcript of the company's November 5 earnings call, Scott pointed to decreasing cost as the "first domino" that will eventually lead to more testing content, then more testing volume, and finally wider discussions with payers and more revenue.

"We're seeing early signs that the days of high-price single-gene tests are phasing out and the era of more affordable and accessible genetic testing is just beginning," Scott said on the earnings call.

What's next for Invitae? Expect another assay, potentially by mid-2016, as the company strives to reach more than 1000 genes for a price of less than $1000. "We've probably reached the limit, as we go from the 600 genes we have now to 1000, we'll actually release what will be a second assay, but it'll be focused on predominantly pediatric conditions. We now have a very comprehensive platform for oncology and cardiology and the next 500 genes will focus on areas of the central nervous system, neurological disorders, and pediatric genetic conditions, where there's not as much crossover," Scott says.

Check out the future of medical technology at the world's largest medical design and manufacturing event—register for the MD&M West Conference, February 9-11, 2016.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Images courtesy of INVITAE CORP.]