Turning Medtech Product Development into a Competitive Advantage

Turning Medtech Product Development into a Competitive Advantage

Here's an innovative recipe for shaking up the medical device product development process.

Andrew Hyncik

When it comes to new product development, medtech companies are facing ever stronger headwinds. From higher regulatory hurdles to pricing pressure, or from talent shortages to the need for greater clinical validation, the prospect of shortening development cycles looks bleak.

That is one way of looking at things. Another way is to see an industry ripe for change or even disruption. After all, innovation doesn't apply just to how medical products work, it can also be applicable to how they get developed. 

Companies that are successful in changing how their products get developed stand a greater chance of reaping the rewards through increased speed to market, faster response times, and superior designs. Obviously, there are no magic bullets, but there are healthy practices which can significantly improve the odds of success. Here are a few which stand out for me:

Focus, Focus, Focus 

Be very clear upfront about what your product is intended to do, what benefits (and claims) it will offer and for whom. Don't try to please everybody, as this is perhaps the surest way to over-complicate and delay a release. This may require focusing on the needs of just one key market/region at first instead of designing for a global product right from the start. Above all, avoid scope creep. Lastly, product managers need to be 100% clear on what they absolutely need (with detailed priority lists) so that when the time comes to cut out costs/features to save the schedule they can be better prepared. Remember the old adage: "Don't bring a knife to a gunfight."

Design to Cost

Define your target price/cost and stick to these. Only deviate if there is compelling evidence and if the steering committee approves. Runaway costs and over-engineered products are far too common in medtech.

Embrace Agile Principles

Waterfall and V-model cycle development may be well-accepted processes but they are looking tired, excessively rigid, and increasingly outdated. Embrace any development approach which fosters rapid feedback cycles, informal vs. formal structures, visual vs. written planning, frequent but brief team meetings, new communication tools & sharing platforms, and parallel vs. sequential work.

Get Key Internal Stakeholders Involved Early

From the very onset of a project, all key groups need to be represented and involved. In this day and age and in addition to the usual suspects (marketing, R&D, finance, quality assurance, manufacturing, and purchasing), this should also include: clinical (for any trials/clinical claims), regulatory (for registration strategies and intended uses), risks (for hazards, mitigation, and testing), IT (for connectivity & cyber security issues), human resources (for staffing and special hiring needs), user experience (for the user-centered design and the overall product experience) and legal (for intellectual property and compliance).

Create Dedicated Project Teams

Placing key individuals across multiple projects can be a recipe for disaster. Better to have fewer, smaller, and dedicated teams than to have many large teams where everybody is partially involved and therefore, only partially committed to the outcome. Don't forget to also have clear lines of accountability. In larger teams, this can get diffused.

Invest in Early Prototypes and Demos

It's been said--and I wholeheartedly agree--that a working prototype is worth 1000 meetings. A good demo or prototype is the best way to get good and early user feedback/validation and to rally the development teams. Agile also feeds nicely into this as it can quickly get you working on a product or limited feature sets that you can show to your customers.

Create a Panel of On-Call Experts

These are the users, key opinion leaders (KOLs), or clinical experts that you can turn to on an almost daily basis with any feature, design, or usability questions you may have. Find people who share your vision and passion and who are good communicators. They can also be your internal ambassadors and bring context (i.e. the "why") to internal development & management teams. Better yet, get one or two top KOLs to act as project sponsors and attend project milestone reviews.

Plan for "Torture" and "Monkey" Testing

To avoid unpleasant surprises--which usually come after launch--bring a steady stream of product users & non-users to attempt to "break/abuse" the product in any way imaginable. These non-scripted "testing" sessions can be remarkably revealing and can save a lot of pain down the road.

Conduct a Limited/Controlled Release First

Don't go out with guns ablazing the minute you have your 510(k). Give yourself at least 1-3 months to work out any real-world kinks and bugs with a handful of friendly customers. Plan on a couple more iteration cycles after product release to address unforeseen bugs or issues. Be mindful not to immediately reassign the entire development team to a new project once you have released. There needs to be some transition time between the development and legacy/sustaining team handoff.

Get the Entire Development Team Exposed to the Users and Their Environment

Meeting with customers/users and visiting customer sites should not be the exclusive realm of product managers. Every team member, including engineers and testers, should be exposed at least once to the users in their environments. This is essential to help them gain a deeper understanding of what the project is about and who it is ultimately for. Connecting all project members to end users and to what is at stake has an incredible effect on team morale, productivity, and energy. This sounds simple, but you would be amazed at how many engineers I have met on projects who have never even set a foot inside a hospital.

Continuously Seek Internal Alignment

Management regularly changes, requirements get updated, and project members come and go. Over time, people and strategies can drift apart. That is why it is imperative for project teams to regularly seek and reaffirm alignment from all key departments and stakeholders. Without internal alignment, failure is almost guaranteed.

Conduct Lessons Learned Exercises

Regularly conduct audits, surveys, and debriefs to understand the things that worked and didn't on a project or during a particular phase. Out of these, seek to find new ways to improve internal processes. Black belts are great at this sort of stuff. Develop your own internal Six Sigma ninjas or hire some outside experts to help if necessary. Also, assign change owners and create reward systems to encourage continuous improvement of development processes.

Stay Close--Very Close--to Your Customers and Patients

Yes, it sounds like a cliché, but so few companies do it well and do it consistently. Travel budgets are the first things to get cut and field research is usually more frontloaded on a typical waterfall project. Product managers should spend at least 20% of their time year round visiting customers and observing patients and users. Attending trade shows doesn't really count. You have to be in situ and in the clinical context to really gather meaningful insights. The big answers to tricky questions are seldom found in the office. You need to get out there to discover them. Any findings or trip reports also need to be promptly shared internally so that everyone can benefit.

In medtech, every day is a competitive race to the finish line. Companies that are able to adopt new work methods and to continuously readjust how their products get developed stand a significantly higher chance of winning in the market. It starts with an open mindset and the determination to find and refine best-in-class methods.

Got any best practices of your own? Share them in the comments section.

Andrew Hyncik is an International Strategic Marketing & Product Development veteran with 20 years of experience in the medtech, healthcare, and pharma industries. To read more from Andrew Hyncik, visit or subscribe to Parifornia.com: Insights in international marketing and business.

[Image courtesy of HYWARDS/FREEDIGITALPHOTOS.NET]

How Medical Device Design Is Like Ping Pong

Kablooe Design turned to table tennis to teach medical device design lessons at MD&M Minneapolis. Here's why. 

Chris Newmarker

"Playing ping pong is like competing in the marketplace. And if you don't go through the process correctly, if you skip parts of the process, you're going to be at a disadvantage in your development. You're going to be at a disadvantage when you compete as well," says Tom KraMer, CEO of Kablooe Design, located north of Minneapolis. 

That's why Kablooe Design had a ping pong table set up smack dab at Booth #1238 on the show floor of MD&M Minneapolis, September 21-22. Through a game of drawn cards, a "Wheel of Competitive Disadvantage," and some wacky looking paddles, they taught lessons about skipping steps in the design process. Here's what it looked like:

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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How Robotically Assisted Surgery Is Gaining Momentum

Since the Da Vinci surgical robot made its mark at the turn of the millennium, additional medtech companies have turned their attention to advanced-technology surgical systems and tools--with support from FDA and CMS.

Maureen Kingsley

Intuitive Surgical and da Vinci

The slow but inevitable--and now quickening--trend toward more automated and robotically assisted surgeries began in earnest in 2000, with the launch of Intuitive Surgical's Da Vinci system, the first such system approved by FDA. Da Vinci, used for soft-tissue surgeries, features robotic arms that reach inside the human body, carrying out movements a surgeon makes on external controls. It is in use in major surgical centers and hospitals in the United States, Western Europe, and elsewhere.

Newer Entries: Mako and Navio

Since Da Vinci's debut, both Stryker and Smith & Nephew have carried on the innovation begun by Intuitive Surgical, launching their own Mako and Navio systems, respectively. The former, the Mako robotic arm, has been on the market for 10 years, with about 300 units sold and used for orthopedic surgeries within the United States during that time. To Stryker's advantage, the Mako just recently earned the regulatory green light for performing total-knee replacement surgery. (It previously was approved for partial-knee-replacement surgery only.) Stryker expects sales of the system, which features a robotic arm that the physician grasps and directs to the hip or knee joint being replaced, to increase in 2017, now that total knee replacements are approved and public acceptance of robotically assisted surgery technology has increased.

Smith & Nephew's Navio is a newer market entry, designed by Blue Belt Technologies and acquired by Smith & Nephew in late 2015. The Navio, like the Mako, performs total-knee-replacement procedures, but the Navio's surgical instrument is contained in a hand-held cutting tool led by precision guidance. The system automatically pauses the motion of the cutting tool if the surgeon moves it beyond the intended area. Seventy-five of the half-million-dollar systems are in use in the United States, including one at the St. Cloud (Minnesota) Surgical Center, where a patient named Vicki Woods got the state's first robotic total-knee replacement in August. The makers of both the Navio and the Mako claim better implant alignment and longer implant life over conventional open surgeries. The systems are intended to provide the least-invasive surgery available.

Additional Players

Beyond Mako and Navio, other digital, sensor-based, and robotic surgical systems and tools are joining the movement. Chicago-based Briteseed's Safesnips are one such technology. Briteseed's low-cost optical sensors integrate directly into the jaws of surgical dissectors and energy tools, providing real-time information back to surgeons. Another, the Mazor Robotics Renaissance Guidance System, is intended to improve outcomes in such spine procedures as degenerative repair, pedicle screw fixation for complex spinal deformity, and vertebral augmentation. Additionally, corporate heavy-hitters Johnson & Johnson and Google have jointly funded a company, Verb Surgical, whose goals include creating "a future unimagined even a few years ago, which will involve machine learning, robotic surgery, instrumentation, advanced visualization, and data analytics," according to the Verb Surgical website.

Better Reimbursement

Both Medicare and medical device companies have forecast that demand for total-knee surgery will grow significantly as members of the baby-boomer generation move into their retirement years. Perhaps with this prediction in mind, the outpatient advisory panel for the federal Center for Medicare and Medicaid Services recommended this summer that Medicare start covering total-knee replacement surgery in same-day surgery centers, instead of just covering the procedure with overnight hospital stays--a move that is likely to benefit marketers of robotically assisted surgery devices, which are increasingly being placed in outpatient surgery centers.

Maureen Kingsley is a contributor to Qmed

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[Image courtesy of Intuitive Surgical]

Catheter Materials Innovation Wins Top Prize at MD&M Minneapolis

Polymer extruder Zeus has created catheter polymer braiding with tensile strength comparable to metallic braiding, enabling MRI to be used during catheter based procedures. The innovation won this year's MD&M Minneapolis Innovation Prize.

Chris Newmarker

Zeus Catheter LCP

Zeus (Orangeburg, SC) on Wednesday won the MD&M Minneapolis Innovation Prize among exhibitors with the non-metallic catheters it is enabling through LCP monofilament fiber launched at the show. 

Having catheters without metallic braiding enables MRI imaging during procedures. Not only is MRI superior in some respects to the fluoroscopy presently in use, but it lowers radiation exposure risks for both patients and doctors, Irina Roof, PhD, Zeus's staff material scientist, explained to the innovation tour group that selected the contest winner. 

To achieve this, Zeus figured out how to do something that Roof says had not been achieved before, extruding and braiding liquid crystal polymer (LCP) in a way that it retains properties associated with the matierial. Roof declined to disclose how the company specifically achieved this.

The result, though, was impressive: Zeus says it LCP fiber has an average tensile strength of 1.2 Gpa, compared to 1.0 Gpa for 304 stainless steel (annealed). The fiber also provides excellent torque response, pushability, and distal end deflectability

The innovation beat out other finalists including a vacuum-based decontamination floor mat from Circuit Solutions (Minnetonka, MN), 3-D printed rapid prototyping molds from Diversified Plastics (Minneapolis), a super precise knife barrel hinge from Liquidmetal Technologies (Rancho Santa Margarita, CA), and a mobile health-based breast cancer screening solution from Pressure Profile Systems (Los Angeles). 

One major properties difference between the LCP fibers from Zeus and the steel is that average elongation at break is 1.7% for the LCP, versus 31.1% for the steel. But Roof says it is the tensile strength that is most important to catheter manufacturers. 

The LCP monofilament is braided over a catheter base liner during construction to provide mechanical strength and support, with the braiding then covered with a layer of Pebax or another nylon jacketing material reflowed under heat shrink

The reflow and bonding process causes the braiding to become fused between the nylon bonding material and underlying liner, achieving structural reinforcement. Zeus's proprietary processes are able to create a fiber with extremely low potential for fraying. 

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Image by Chris Newmarker/Qmed]

New Human Neural Stem Cells Could Boost Tissue Engineering

The new technique can generate rapidly-differentiating human neural stem cells that could be used to build three-dimensional models of human tissue and other tissue engineering applications.

Kristopher Sturgis

This photo shows human induced neural stem cell lines (red) grown in co-culture with skeletal muscle (green) and cell nuclei visualized by blue DAPI staining.

A new technique for tissue engineering has been developed by researchers out of Tufts University in Massachusetts that could pave the way for the development of three dimensional models of the human brain and other organs. David Kaplan, PhD, professor in the department of biomedical engineering at Tufts University and one of the lead authors on the work, said that the technique could be used to develop models for future drug studies.

"Because these neural stem cells differentiate quite rapidly and maintain their neuronal characteristics, even when cultured with other cell types, they can be utilized for applications like drug screens and to generate complex innervated tissues," Kaplan said. "We hope to utilize this human 3-D brain model for various applications including the development of disease models, as well as future drug studies."

The technique involves converting human fibroblasts and adipose-derived stem cells into human induced neural stem cell lines that eventually acquire the features of active neurons, all in as little as four days time. While their research isn't the first to generate neural stem cell lines from fibroblasts and adipose-derived stem cells, their new technique does accomplish the feat faster and more efficiently, as all other previous methods typically take around four weeks.

"Basically you use a starting cell type that is easy to harvest from humans," Kaplan said. "In this case we used cells derived from either skin or fat tissue, and then we genetically modify them and culture them using a very specific technique. The procedure results in the generation of induced neural stem cells, which can then be utilized for multiple downstream applications."

Tissue engineering techniques continue to evolve as researchers explore new avenues that could unlock innovative and potentially game changing discoveries. Earlier this year researchers from Harvard created a mathematical model for 4-D printed objects that could have a significant impact on tissue engineering and bioprinting techniques. Elsewhere, last fall researchers from Penn State University created promising new citrate-based biomaterials that could serve as biodegradable materials for nerve and blood vessel regeneration.

Both projects represent the growing focus on new methods and materials for bioprinting and tissue engineering research. In their latest study, Kaplan and his colleagues were able to create a working three-dimensional model of the human brain and actually observed neurons firing back and forth. However, the truly novel element of the research is the ability to generate cells more quickly, which could lead to the development of larger, more sustainable three dimensional models of other organs.

"In general, 3-D models for human organs are specifically designed to mimic their in vivo counterparts," Kaplan said. "While our specific brain design may not necessarily be useful for other organ models, our group can generate other 3-D models of tissue and organs."

As the group moves forward with their research, Kaplan said they hope the research can be used as a tool to better understand the brain and its surrounding tissue, and eventually generate models of other human organs for similar research.

"Moving forward, we hope to utilize this technology as a tool to understand various disorders of both the brain and innervated peripheral tissues," he said. "We think that this technique could greatly impact future research in that it will allow for the generation of relevant human models of multiple innervated tissue types."

Kristopher Sturgis is a contributor to Qmed.

[Image courtesy of DANA CAIRNS/TUFTS UNIVERSITY]

Medtronic Recalls Temporary Pacing Lead System

The Class 2-level recall involves thousands of devices.

Chris Newmarker

FDA recently issued a Class 2 designation for a recall involving thousands of Medtronic temporary lead pacing systems because there is the potential for them to connect to a hazardous voltage. 

The recall involves 11697 of the Model 6416, with 6174 of the devices in commerce inside the United States. As of  May 23, the devices involved in the recall were made after May 1 2014, with expiration dates through April 12, 2018. (A full list of lot numbers is on FDA's website.)

The 6416 temporary transvenous pacing lead is meant for intracardiac pacing and/or EGM recording for up to seven days. The disposable system includes an active fixation, bipolar lead and a soft-tipped, lubricated guide catheter.

The recall was needed because the devices do not comply with design standards meant to prevent connecting a patient's lead to a possible hazardous voltage, according to FDA. 

"The electrical connectors on the leads do not have the proper insulation required by the standard," Medtronic spokesman Ryan Mathre said in an emailed statement.

Medtronic sent affected customers an Urgent Medical Device Recall letter in June, advising them to identify, quarantine, and return affected products. 

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Graphic of model 6416 courtesy of Medtronic]

Looking to Leave Medtech?

Looking to Leave Medtech?

Most medtech professionals say they are happy with their careers. But a minority of employees say they are disenchanted with medical devices and diagnostics. What's behind their dissatisfaction and what industries are they targeting for their next job?

The medtech industry has a lot of devotees. In response to MD+DI's 2016 Medtech Salary Survey, many medtech professionals told us that they love the industry for its job security, innovation, and its meaningful impact on patients.

But, as with any industry, not every person surveyed was head over heels for their job in medical devices and diagnostics. In our survey, we asked whether the professionals plan to keep working in the industry or are hoping to switch to another industry. The overwhelming majority, 93% said they plan to stay in the space, but the remaining 7% voiced interest in other areas.

What industries are drawing these professionals' attention away from medtech? A few of the respondents pointed to biotech and pharma as their top interest. A couple other people mentioned a potential switch to consumer products and wearables.

Hear experts discuss a case study of "An FDA-Approved Device: Was It Worth It?" at BIOMEDevice San Jose, December 7-8.

A perception of too much regulation seems to be the main culprit behind these professionals' frustration with medtech. A number of respondents cited the red tape of regulation and paperwork as a problem for the industry. Here are their thoughts in their own words:

  • "The regulatory hurdles have become far too difficult to deal with."
  • "Tired of regulations (our products are PMA) and difficulty in making design/process improvements as they require a PMA supplement."
  • "Regulations are serious barriers to entry & new product development. I'd prefer to be in a less regulated field."
  • "I'm tired of all the regulations and all the paperwork."
  • "There are probably more interesting and stable industries for people at the top of their profession. Due to FDA regulations the investment requirements are high and products take a long time to reach the market."

It's not just the high level of regulation that is leading these employees to look elsewhere. There's also a feeling that a career in devices and diagnostics doesn't pay as well as some other high tech jobs--or perhaps doesn't pay enough to offset the higher regulatory requirements.

As one person put it, "[the] medical industry is more strict than other industries but does not necessarily pay more." Another professional wrote, "Managed care and poor reimbursement limits profitability and innovation. Relative to other high tech industries, little chance your stock options are going to be worth anything."

A few others noted that the startup environment can be tough for medtech companies. One respondent wrote that there's "not enough capital or exit opportunities to go around," while another noted a "scarcity of funding for start ups."

One professional said of medtech--"While still a noble profession, since the passage of the ACA and the associated cost pressures within healthcare, I would not recommend a health care career to a new college graduate."

Sobering advice? It depends on who you ask. These young innovators are not shying away from the challenge.

[Image courtesy of MASTER ISOLATED IMAGES/FREEDIGITALPHOTOS.NET]

Should We Trust Robots in Medical Emergencies?

A recent study has shown that humans place too much trust in robotic technologies during emergency situations, even after they have proven to be unreliable.

Kristopher Sturgis

Emergency Robot Georgia TechWhen it comes to robotic technologies, is it possible we're placing a little too much faith in their abilities? That was the question asked by researchers at the Georgia Tech Research Institute (GTRI) when they decided to conduct the first study on human-robot trust levels in emergency situations. Paul Robinette, a research engineer from GTRI and one of the lead authors on the work, says that may be the case, despite how difficult it can be to observe genuine human-robot trust levels.

"Currently robots are used mainly for bomb disposal or for search in emergency scenarios," he said. "They are typically tightly controlled by trained human operators and do not have many features, so there are many difficulties in human-robot experiments. It can be challenging to create an experiment where participants will act naturally, and it's also challenging to determine the level of trust a person has in a robot. In the past, we have used a forced choice scenario, where a person has to act in a way that indicates he or she trusted the robot, supplemented by a survey of questions in an attempt to understand their choice."

In their latest study, researchers gathered a group of volunteers and asked them to follow a brightly colored robot that was labeled "emergency guided robot." In the study, the robot would lead the subjects to a conference room where they were asked to complete a survey about robots and read an unrelated magazine article. Other subjects were led into the wrong room where the robot would travel around in a circle twice before breaking down.

Once both groups were moved into the conference room, the hallway that the subjects had just walked through was filled with artificial smoke, setting off a smoke alarm. When the subjects were re-introduced to the robot, the robot would attempt to guide the subjects to safety. However, the group that was introduced to the broken down robot still decided to follow the robot toward an exit at the back of the building, rather than use the doorway marked with exit signs that they had used to enter the building. Robinette says this shows humans willingness to trust a piece of technology to do what it's supposed to do in a crisis situation.

"In a scenario where there is limited time to make a decision, people tend to trust that a piece of technology will do what it says it can do," he says. "Our robots said that they were designed to operate in emergencies, so our participants assumed that was true. There are many possibilities for why they made that assumption, for example, it's possible they chose the first 'good enough' option they saw. It's also possible that they simply focused on the brightly lit robot making arm gestures in front of them, and it's possible they saw the robot as an authority figure with special information about the situation. We're still working on determining which of these options, or others, is actually the case."

Robinette says that they had expected that once the robot proved itself untrustworthy by unsuccessfully guiding the subjects to the conference room, that the subjects wouldn't follow it during the simulated emergency. Instead, they found that the subjects were basically willing to follow the robot regardless of how it had previously performed. It wasn't until the robot began making more obvious errors during the emergency part of the experiment, that subjects began to question its abilities.

With robotic technologies making their way into healthcare, the level of trust between them and their human counterparts will be an essential element to their success. From surgical robot technologies, to altered AI robots that can provide scheduling information to nurses, establishing a level of trust in robotic technologies will be crucial to their impact on patient care. A fact that Rubinette and his colleagues are trying to explore so that they can better understand the trust relationship between humans and robots and hopefully avoid as many issues as possible.

"So far, it seems like the best bet is to make the robot's decision process as transparent as possible," he says. "If a person can easily see that the robot is making its decision based on bad information, he or she should be less likely to follow it. We are planning future studies that examine how to make a robot's thought process obvious to nearby people, and studies that test how obviously bad a robot has to be before people stop following it." 

Kristopher Sturgis is a contributor to Qmed.

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[Image courtesy of Georgia Tech]

Senate Holds Hearing on Lab-Developed Tests

Would FDA regulation of laboratory-developed tests add cost and delays or prevent potential danger to patients? A Senate committee took on the topic this week.

Nancy Crotti

Who should be regulating laboratory-developed tests (LDTs)? Currently, that's the purview of CMS via the Clinical Laboratory Improvement Amendments (CLIA), through which the agency inspects and licenses commercial and clinical laboratories. In 2014, FDA developed draft guidance for regulating LDTs as medical devices.

Two years later, the debate rages on, as technology speeds ahead and the demand for precision medicine heats up. The U.S. Senate Health, Education, Labor and Pensions Committee took on the topic this week.

Learn how FDA regulations are impacting connected health and IoT technologies at the BIOMEDevice San Jose conference, December 7-8, 2016.

President Obama is on board. His Precision Medicine Initiative is intended to help boost research on new cancer treatments and genomic-based treatments. Last February's Precision Medicine Summit highlighted the efforts of testing firm Color Genomics to make free breast and ovarian cancer tests available to at-risk patients who cannot otherwise afford them.

Laboratory scientists say FDA needn't duplicate CLIA's efforts and that an additional level of regulation would not only be costly, but could harm patient health by delaying useful tests. Manufacturers of test kits sold to laboratories, hospitals, and clinics go through the expensive and often prolonged FDA regulation process, and generally speaking, would like laboratories that develop tests for their own use to do the same.

The question also remains whether stronger regulation of tests developed by now disgraced blood testing company Theranos would have prevented possible danger to patients and the company's downfall.

More than 60,000 LDTs are available to Americans today, regulated by CMS through CLIA, noted committee chair Senator Lamar Alexander (R-TN). Memorial Sloan Kettering Cancer Center's molecular diagnostics laboratories perform approximately 350 LDTs, including genomic sequencing tests that characterize each patient's cancer, testified David Klimstra, MD, chairman of the the pathology department at the New York City hospital.

The laboratory's MSK-IMPACT assay analyzes 468 cancer-related genes and has been used to sequence nearly 12,000 cancers, Klimstra added. CLIA and the state of New York both regulate those LDTs. Adding FDA regulation would be "duplicative and unnecessary," and so costly that it would force the center's laboratory to close, Klimstra said.

An industry representative testified that regulatory requirements that differ depending upon the type of entity that develops the test yield different standards for accuracy and reliability, and other discrepancies between the types of oversight. The level of oversight should depend on the risk level to patients, said Brad Spring, vice president of regulatory affairs and compliance for Becton Dickinson.

Spring also called for clear jurisdiction between FDA, CMS, and individual states, along with expedited regulatory pathways for tests that serve unmet needs.

Cancer policy organization Friends of Cancer Research agreed with industry representatives that all diagnostic tests should be subject to the same regulatory requirements. FDA should work with the diagnostic industry to characterize the variability between LDTs and manufacturers' test kits, added Friends' president and CEO Jeff Allen.

Allen suggested that advanced genomic screening have its own regulatory pathway.  "The future of precision medicine and the health and lives of patients depends on the accuracy of these tests," he said.

"An inadvertent outcome of the FDA review process is to delay or make necessary testing unavailable to patients, as well as to increase cost, neither of which are good for patient care," argued Karen Kaul, MD, chair of the Department Of Pathology and Laboratory Medicine at the University of Chicago's  North Shore University Health System.

Tests that go through the FDA regulatory process "do not keep up with the standard of care as dictated by nationally accepted (National Comprehensive Cancer Network) guidelines, and are essentially frozen in time at the time of FDA approval," Kaul added.

Adding a level of premarket evaluation to the current CLIA process would be most useful and least onerous for laboratories, she said.

Nancy Crotti is a contributor to Qmed.

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[Image courtesy of Martin Falbisoner - Own work, CC BY-SA 3.0,]

Philips Teams with Qualcomm to Create Healthcare 'Ecosystem'

The move will enable providers to remotely monitor and communicate with patients managing health conditions in their own homes.

Maureen Kingsley

Qualcomm Life's 2net Platform will serve as the
connectivity system for Philips Healthsuite

Philips is continuing its deep push into connected, personalized healthcare solutions via a collaboration with Qualcomm Life, the healthcare division of semiconductor maker and telecom giant Qualcomm.

Qualcomm Life's 2net Platform, which comprises 2net Hub, 2net Mobile, and Smartlinx, will serve as the medical device connectivity system for Philips HealthSuite, a cloud-enabled network of healthcare-related devices, apps, and digital tools. By joining the Qualcomm Life 2net network, Philips can provide its HealthSuite users seamless access to a number of connected medical devices, including medication dispensers, medical-grade biosensors, ventilators, blood-pressure monitors, point-of-care self-tests, and blood-glucose meters.

Learn more about creating connected health solutions by attending the Connected Health: Device and Ecosystem Integration conference track at BIOMEDevice San Jose, December 7-8, 2016.

The goal is to "advance connected health across the health continuum--from healthy living and prevention to chronic-care management and home care," according to a Philips press release.

The collaboration enables the companies to leverage each other's respective capabilities: Philips' connected health informatics and regulated-healthcare cloud-data management and analytics will join forces with Qualcomm Life's capabilities in secure, medical-grade device connectivity and integration. The collective goal is to enable both companies to offer care providers "enhanced, scalable, connected care solutions and services within a secure global ecosystem," according to the press release. A sizeable part of this ecosystem involves providers' remote monitoring of and communication with patients managing health conditions in their own homes.

An example of an implementation of this collaboration will soon launch, according to Philips, with the company's Trilogy family of ventilators and the Care Orchestrator care-management application for patients with chronic obstructive pulmonary disease and other respiratory conditions and their care providers.

"As the home is fast becoming a viable care setting, care providers, home health agencies, and other institutions are increasingly using connected care to reduce emergency care [and] readmissions of patients with chronic diseases," Jeroen Tas, CEO, Connected Care and Health Informatics at Philips, is quoted as saying in a press release. "By collaborating with Qualcomm Life and leveraging its connectivity and wireless expertise, we aim to help care providers to engage better with their patients and contribute to the goal of improving outcomes. Patient self-management combined with 24/7 connectivity to a care network is an emerging model that enables scalable chronic disease management for patients and providers."

Philips's other recent announcements of its steady march into advanced digital healthcare technologies include the European launch of OncoSuite for visualizing and treating cancer tumors, a device in R&D for measuring blood oxygenation with a camera, and medical-grade health-monitoring devices--including a health watch, body-analysis scale, and blood-pressure analyzer--that hit the market this summer.

As for Qualcomm, this latest collaboration comes on the heels of other partnerships with big-name healthcare players forged in the past 12 months, including one with Boehringer Ingelheim Pharmaceuticals, one with Medtronic, and one with Novartis.

Maureen Kingsley is a contributor to Qmed. 

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[image courtesy of QUALCOMM LIFE]