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Articles from 2017 In June

Is This Test a Major Advancement for Blood Diseases?

FDA has granted its first-ever authorization for a test that uses flow cytometry to aid in the detection of several leukemias and lymphomas.

Staff Report

FDA has given Beckman Coulter permission to sell its ClearLLab Reagents, the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas. FDA reviewed data for the test through the de novo premarket review pathway, which is designed for low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device. 

The ClearLLab test is designed to detect cancerous cells in blood, bone marrow, and lymph nodes. It also provides laboratories and clinicians with information about what type of leukemia or lymphoma is present, FDA noted. It works by marking proteins found on the surface of cells with fluorescent dyes for further analysis on a flow cytometer.

"This represents a major step forward for the hematology-oncology community," said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health, which is part of FDA's Center for Devices and Radiological Health. "Laboratories and healthcare professionals now have access to an FDA-validated test that provides consistent results to aid in the diagnoses of these serious cancers."

The agency's authorization of the ClearLLab was supported by a study designed to demonstrate the test's performance, which was conducted on 279 samples at four, independent clinical sites. The study compared the test's results to alternative detection methods used by the clinical sites. The study showed that the results of the test aligned with the study site's final diagnosis 93.4% of the time, and correctly detected a cancer presence 84.2% of the time.

This authorization, through new special controls FDA is establishing along with it, opens a regulatory door for future developers of similar tests for leukemias and lymphomas.

[Photo courtesy of Pixabay]

Could This Bring Epilepsy Surgery into the 21st Century?

Researchers from Cleveland Clinic, Mayo Clinic, and the University of Campinas in Brazil, will use a $3.4 million NIH grant to develop a comprehensive risk calculator to determine which patients will most benefit from epilepsy surgery.

Amanda Pedersen

Researchers are working on a risk calculator, known as an epilepsy surgery nomogram, that could offer an individualized prediction of surgery outcomes for patients with drug-resistant epilepsy.

A $3.4 million grant is expected to help a multi-center research team develop a tool to predict individual outcomes in epilepsy surgery, which the researchers say would bring patient counseling into the 21st century and expand it beyond a doctor's best-educated opinion to a more scientific-based approach.

The National Institutes of Health grant, led by Cleveland Clinic's Lara Jehi, MD, will support the creation of an epilepsy surgery nomogram (ESN) using diagnostic technology and predictive modeling. The project is a five-year collaboration between the Cleveland Clinic Neurological Institute's Epilepsy Center and the Cleveland Clinic Lerner Research Institute's Quantitative Health Sciences team with Mayo Clinic and the University of Campinas. The study will incorporate robust patient data into a risk calculator known as a nomogram to better determine which patients will most benefit from the procedure.

"The typical current path to epilepsy surgery reveals the unquestionable need for process improvements that could be fostered by a tool like the ESN," said Jehi, research director of the Cleveland Clinic Epilepsy Center. "Patients now hear the 'average' chance of success with this brain surgery, but do not know what their individual chance of success is: 'How did a patient like me do with this procedure?' The nomogram will enable us to bring patient counseling into the 21s century and expand it beyond our best-educated opinion to actual science."

Jehi said the new tool will "arm physicians" with the ability to better select optimal surgical candidates and estimate the likelihood of seizure freedom after epilepsy surgery. This type of surgery is a treatment option for drug-resistant epilepsy but currently remains underused due to multiple factors, including the inability to predict individualized outcomes following surgery. The clinic noted that patients undergo sophisticated testing to determine the area of the brain triggering the seizures, but the decision to initiate this workup, and the final choice to do the procedure, are subjective and variable.

The grant will allow the multi-center research team to build on its first ESN, which used basic clinical patient characteristics, such as age, gender, and seizure frequency, to provide an objective, individualized prediction of postoperative seizure outcomes at two and five years after the surgery. The first nomogram and its initial retrospective validation were recently published in Lancet Neurology.

The researchers said the new, enhanced risk calculator will factor in additional clinical, imaging, genetic, electrophysiological, and histopathological data. The comprehensive ESN will be developed from a retrospective cohort of 450 patients from Cleveland Clinic, Mayo Clinic, and the University of Campinas. The new tool will also be prospectively validated in 250 patients from the same centers.

"When completed, this project will generate the first objective, validated, user-friendly epilepsy surgery prediction tool," Jehi said. "We will learn from the collective experience of thousands of patients. Instead of each physician working on an island, we can synthesize data and pull it all together to make more strategic predictions using a much more scientific decision-making process."

Achieving this goal, she said, will improve patient counseling and benefit public health.

"The development of risk prediction calculators like the ESN is vital for improving medical decision-making," said Michael Kattan, PhD, chair of Quantitative Health Sciences at Cleveland Clinic. Kattan pioneered the nomogram concept, and his risk calculators have been applied to many diseases, including coronary artery disease, cancer, type 2 diabetes, and total joint replacements.

Amanda Pedersen is Qmed's news editor. Contact her at

[Image credit: Cleveland Clinic]

Is Medtronic Gearing Up to Buy Glooko?

The diabetes data management company aims to expand its sales, marketing, and development teams through new investors to deepen its expertise in data analytics.

Kristopher Sturgis

Glooko's latest funding round secures its position in the market as the company goes up against larger competitors, such as Johnson & Johnson. The new funds also raise speculation that investor Medtronic could be gearing up to eventually acquire Glooko.

Insulet Corp., Medtronic, and Mayo Clinic have joined a $35 million investment round for Glooko, a company that has developed a digital health management system for diabetes. Medtronic also invested in Glooko's previous financing round in 2015, which raises speculation that it is likely in a prime position to eventually acquire Glooko. Samsung also participated in both the recent and previous rounds. Insulet has also worked with Glooko before, and last year launched a new data system for its OmniPod device that uses Glooko's data management technology.

Glooko said the new funds will help the company accelerate growth, broaden its international presence, and expand its expertise in data analytics. Among many new efforts, the company plans to use the investment to expand and increase commercialization efforts in Europe, as well as further the development of data analytics and artificial intelligence that can provide personalized insights for patients to improve the management of diabetes.

The announcement follows a recent deal that partnered Glooko with health coaching company Fit4D, a move designed to provide better data-driven support for patients using the company's app by connecting them with a health coach. The partnership aims to provide patients with an experience that isn't solely technology-based, but rather gives them access to a network of coaches that can provide a human touch to their day-to-day diabetes management.

The company recently completed a study and found that patients who use the Glooko mobile app experience an improvement on their average blood glucose levels, which can greatly reduce the risk of complications associated with the disease. With the cost of diabetes management continuing to rise, and studies indicating that the number of patients affected by the disease may rise to as many as 700 million by 2025, there's little doubt that systemic changes are needed to help improve the lives of millions of patients -- something that Glooko's investors hope to help the company achieve through new funding.

"This additional funding will help us to further our mission to improve the lives of people with diabetes," said Glooko CEO Rick Altinger. "With this capital, we will accelerate our investments in clinical solutions that aim to increase medication adherence, provide personalized insights and prompts that drive behavior change for people with diabetes, and deliver clinical decision support to thousands of clinicians and coaches so they can better support people with diabetes in between office visits."

The new funding could also help Glooko strengthen its position in the industry, as it competes with the likes of Johnson & Johnson.

Kristopher Sturgis is a contributor to Qmed.

[Image credit: Glooko Inc.]

Supplier Stories for the Week of June 25

Here’s what was new in the world of medical device suppliers during the week of June 25.This is a compilation of the latest news from suppliers in the medical device industry. If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to with the subject line “Supplier Stories.”[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Here’s what was new in the world of medical device suppliers during the week of June 25.

This is a compilation of the latest news from suppliers in the medical device industry. If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to with the subject line “Supplier Stories.”


Philips Fulfills a Prophecy with $2.2B Spectranetics Deal

The company was previously called out by an analyst as an attractive acquisition target because of its coveted Stellarex drug-coated balloon technology, which is expected to hit the U.S. market this year.

Amanda Pedersen

The Stellarex drug-coated balloon is expected to hit the U.S. market sometime this year. The device, which is used for angioplasty procedures, has shown a lot of promise in clinical trials and in commercial experience in Europe, where it has been available since January 2015.

There may be other, more obvious suitors for Spectranetics Corp. than Philips, but those potential acquirers seem to have a lot on their plate right now and are unlikely to engage in a bidding war for the company, according to multiple analysts. Royal Philips, of Amsterdam, the Netherlands, said it would pay $38.50 a share for Spectranetics, which is about $2.2 billion, including cash and debt.

The fact that the Colorado Springs, CO-based company is being bought did not come as a surprise, especially because one medtech analyst previously called Spectranetics out as an attractive acquisition target.

What makes Spectranetics such a hot deal right now is that its Stellarex drug-coated balloon (DCB) is expected to hit the U.S. market later this year. The angioplasty device has already shown promising results in Europe, where it has been on the market since January 2015, and in a U.S. pivotal study.

"We view Stellarex as the coveted asset in the deal," said Jason Mills, of Canaccord Genuity. He said the Stellarex platform, which is used for angioplasty procedures, represents a "no-compromise solution," with best-in-class results in both less and more complex patient populations, according to data from a European randomized controlled trial and from a U.S. pivotal study.

Mills said late last year that he expected Spectranetics to be scooped up by a major medical device company before Halloween 2017, and sure enough, Philips fulfilled that prophecy for the analyst.

The company also has a strong pipeline behind Stellarex, Mills noted in a report, including a below-the-knee indication that the company is already in talks with FDA about for a trial that could begin later this year, an indication to treat in-stent restenosis, and an indication to use Stellarex for arteriovenous fistulas. Spectranetics also has a new laser platform in the works, as well as an advanced atherectomy catheter technology designed to address calcium, Mills said.

Three of the largest peripheral vascular companies (C.R. Bard, Boston Scientific, and Medtronic) already have DCBs, and Rick Wise of Stifel said this makes them unlikely to go after Spectranetics. Bard, in particular, would be an improbable contender because it is being acquired by Becton, Dickinson and Company. 

Wise noted that there are three major companies that lack DCBs and atherectomy (Abbott Laboratories, Cardinal Health, and Terumo), but he suspects that both Abbott and Cardinal Health are too preoccupied with other deals at the moment to pursue Spectranetics. Terumo could have an interest in the company, he said, but he is unsure of its acquisition strategy.

The acquisition price represents a 27% premium over the company's closing stock price Tuesday, before the deal was made public.

Frans van Houten, CEO of Royal Philips, said the company is ready to accelerate its strategic expansion into therapy devices, which this acquisition will do. The deal is expected to be revenue growth and profit accretive by 2018, he said, given the projected revenue and other synergies.

Spectranetics' shareholders reacted favorably to the news, sending the stock (Nasdaq: SPNC) up 26.15% ($7.95) to close at $38.35 Wednesday on substantially higher than average trading volume.

What Does Your Heartbeat Say about You?

What Does Your Heartbeat Say about You?

The PocketECG aims to reinvent arrhythmia diagnostics through enhanced physical activity monitoring data.

Kristopher Sturgis

The PocketECG mobile cardiac telemetry system from MEDICALgorithmics includes extensive data on physical activity.

When it comes to diagnosing heart arrhythmia, running a simple electrocardiogram (ECG) often only tells part of the story of a patient's heart. ECGs are often used to diagnose arrhythmias, but they can also help diagnose other serious conditions like coronary heart disease and cardiomyopathy. While the results are quick and painless, the data can still be limited when it comes to long-term monitoring of the heart.

A new cardiac company based out of Poland, known as MEDICALgorithmics, aims to fill some of these data gaps with the introduction of their flagship technology, the PocketECG. The device was designed to provide healthcare professionals with a more detailed report on heart rhythm and activity, and includes extensive data on physical activity. Marek Dziubinski, president and CEO of the company, said that the company's vision is driven by science and mathematics to design better diagnostics.

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"MEDICALgorithmics is a science-driven organization," he said. "[We are] using our knowledge of applied mathematics and medicine to create better diagnostics. What sets us apart is the way we process ECG signals and the diagnostic information we can derive from the processed data."

Dziubinski said that the device is the most complete arrhythmia diagnostic system on the market, as it provides the quality that reporting physicians have come to expect with traditional holter systems, while still maintaining the ability for long-term and online monitoring with symptom reporting and physical activity tracking.

Marek Dziubinski

The device comes with a bevy of features that make it standout from other ECG technologies. Dziubinski said that it is the only mobile cardiac telemetry device cleared by FDA to date that can record and annotate every QRS complex and recognize its morphology. He said that combining this with the physical activity monitoring feature allows physicians to see a better correlation of data, which can provide more meaningful heart rate measurements that can better guide treatment decisions for patients.

Currently there are a range of cardiac conditions that cannot be diagnosed with a single ECG test or any other standard arrhythmia detection method. The PocketECG aims to become the first device that can make precise diagnosis possible through the complete disclosure of monitoring data, as well as the transmission of a patient's ECG for up to 30 days--allowing for the labeling and morphology-based classification of every single heartbeat.

"Many of our competitors developed products that were designed to capture the ECG at infrequent intervals and extrapolate potential arrhythmia information based on those limited signal samples," Dziubinski said. "The PocketECG transmits, discloses, and labels every heartbeat, enabling an efficient and full statistical ECG analysis with easily accessible reporting. We also provide access to the onset and offset for every arrhythmia episode. These are unique features of our technology that make precise diagnosis possible, even for the toughest arrhythmia cases."

Dziubinski said that MEDICALgorithmics has always approached the process of development and creation a little differently than other companies, maintaining a focus on finding the best real solution to existing problems. He believes this mindset sets MEDICALgorithmics apart and is the key to becoming a leader in the industry of cardiac diagnostics.

"Our latest PocketECG technology upgrade will allow physicians and nurses to distinguish between heart rate changes caused by arrhythmia, and those caused by a patient's physical activity," Dziubinski said. "We believe this is true innovation that adds value and addresses the need to objectively evaluate the ventricular rate of the heart."

It is these values that have helped MEDICALgorithmics evolve into one of the largest and fastest-growing cardiac monitoring companies in the world. The company also recently acquired a majority stake in Medi-Lynx Inc., a U.S. service provider that specializes in around-the-clock customer service and support to patients and clinicians across the country.

"I am an active scientist and what drives me and the rest of our team is finding solutions for real-life problems. We collaborate on research projects with scientists and electrophysiologists throughout the U.S. and in other parts of the world," he said. "I believe that our innovative technology, combined with the Medi-Lynx focus on tailored service, makes us a standout diagnostics partner for clinicians."

Enhanced data on heart activity and a strong emphasis on understanding the needs of physicians and patients seem like a formula for success. After all, we could all afford to listen to our hearts a bit more.

Kristopher Sturgis is a freelance contributor to MD+DI.

[Image courtesy of PR NEWSWIRE, Headshot courtesy of MEDICALGORITHMICS]

Medtech: Beware of the GOP's Double-Edged Sword

Yes, the Senate healthcare bill would effectively kill the much-loathed medical device tax, but the proposed legislation could be a double-edged sword for the industry.

By now most stakeholders in the industry have heard the stats that support a permanent repeal of the 2.3% medical device excise tax, which Congress suspended in 2015, and which is due to return at the end of this year unless permanently repealed.  

The strongest argument the industry has lodged against the device tax is that it's a jobs killer, as data from the U.S. Commerce Department showed that the medical technology industry experienced a decline of nearly 29,000 U.S. jobs while the tax was in effect. The American Action Forum, a center-right policy institute, claims that permanent repeal of the device tax could result in more than 53,000 additional industry jobs, compared to what would occur if the tax remains in effect.

So it comes as no surprise that industry advocacy groups would be quick to applaud any effort that would effectively kill the innovation-harming device tax, even if that means supporting a healthcare bill that would repeal the tax, but also leave 22 million more people without health insurance over the next decade, and cause premiums to rise over the next two years.

Earlier this week, AdvaMed shared a Journal Gazette article via Twitter, which was written by Rep. Jim Banks, a Republican congressman from Indiana, who voted for the American Health Care Act (AHCA) in May. Both the AHCA and the Senate's recently released draft legislation dubbed the Better Care Reconciliation Act include a full repeal of the device tax. AdvaMed's Tweet didn't directly support the Senate bill, but simply stated that device tax repeal is "a vital component" of the GOP's overhaul of current healthcare legislation.

So far, that's about as close as any industry group has come to voicing an opinion on either bill publicly, although a blog Scott Whitaker, president and CEO of AdvaMed, wrote for RealClear Health suggests that it might have made more sense for lawmakers to deal with the device tax separately, instead of including it in a broader piece of healthcare legislation.

"The tax is different from other ACA-related taxes, and deserves separate consideration," Whitaker wrote. "It's not grounded in any healthcare policy, it's not linked to coverage, and it's not in the best interest of patients."

Many would argue that the GOP's most recent attempt at healthcare reform is not in the best interest of patients either, yet the industry has been largely silent on that issue.

Senate Republicans were initially expected to vote on legislation repealing the Affordable Care Act this week, but on Tuesday decided to delay the vote until after the July 4 recess. That decision came after a Congressional Budget Office score on the measure found the bill would leave 22 million more people without insurance compared to present law over the next decade. The analysis also found that the Senate bill would cause premiums to rise over the next two years, although premiums would decrease starting in 2020.

In a June 26 letter to Senate leaders, James Madara, MD, executive vice president and CEO of the American Medical Association (AMA), explained why the AMO is opposed to the draft legislation. "Medicine has long operated under the precept of Primum non nocere, or 'first, do no harm," Madara stated. "The draft legislation violates that standard on many levels."

Nadim Yared, AdvaMed's chairman, has said that the organization's top priority is to ensure the device tax is repealed, "no matter what form."

While there are many solid arguments for why device tax repeal is at the top of the agenda for AdvaMed and other industry trade groups, surely medtech leaders will, at some point, look beyond the "job-killer" tax and consider what the GOP's proposed legislation could mean for millions of patients.

If these patients do not have health insurance, won't that eventually harm medical innovation just as much as the device tax has?

Amanda Pedersen is Qmed's news editor. Contact her at

[Image courtesy of Pixabay]

A Medical Device’s True Colors

A Medical Device’s True Colors

When you're asked to visualize a medical device, what color is the product? You probably answered gray, blue, or beige.

But, RTP Company, a supplier of custom-engineered thermoplastic compounds, is hoping to shake up the medical device color palette. The company's Colour Development Team has created the Hueforia offering to help device makers and designers choose colors that emphasize branding, appeal to users, and stay on top of trends.

"Hueforia was developed by RTP Company to fit a market need for color expertise as it pertains to plastic," said Alex Davis, RTP Company's Global Business Manager for Color. "This requires experts who understand both color design principles and the nature of thermoplastic compounds, and fortunately we have a whole team of experts at RTP Company." 

The Hueforia color collections tap into the idea that color can be a meaningful part of medical device design. Brian Lynch, sales engineer for RTP, explained that Hueforia gives device designers, marketers, and brand managers a chance to create and imagine new looks while still matching colors across materials.

The collections draw inspiration from everything, including automotive, social media, fashion, furniture, and global cultures. The 2018 Hueforia collection includes themes like "Ageless Wonders," based on awe-inspiring destinations around the world like the Grand Canyon and Stonehenge, and "Heavy Metal," including pigments with names like "Deep Purple" and "Midas Touch." The collections are years in the making. The 2017 collection, launched last year, was created in 2014 and 2015.

"The colors in our 2018 'Ageless Wonders' collection have generated the most interest across a wide array of customers due to their relatable, earthy hues that exhibit confidence and empowerment," Davis explained. "Our Hueforia Team is uniquely positioned to offer color recommendations, provide guidance on thermoplastic material selection, and manufacture these compounds globally."

Color is important for branding, user appeal, aesthetics, and trends, but ensuring that the color can stand up to the demands of the product is essential in the medical device industry. Many of the thermoplastic colors in the Hueforia collections have been extensively tested for biocompatibility. RTP representatives can also discuss other characteristics of a colored thermoplastic compound that matter in the daily use of device, like how the color holds up when exposed to heat, sterilization, and UV.

RTP also provides Laser-Markable Compounds, another offering that is well-suited to the medical device industry. Laser marking gives device manufacturers the ability to apply branding or unique device identifiers (UDIs) to the product without the need for inks and dyes. The Laser-Markable Compounds come in clear, white, black, and customized colors.

"These compounds can be made in a variety of polymer systems, and have great resistance to abrasion and environmental exposure," said Tim Duncan, RTP Company's Global Color Technology Manager. "Having the ability to use laser marking for sequential numbering is particularly important for compliance with the FDA's Unique Device Identification (UDI) System."

Marie Thibault is the managing editor at MD+DI. Reach her at and on Twitter @MedTechMarie.

[Top image courtesy of PUBLICDOMAINPICTURES/PIXABAY, Second image courtesy of RTP COMPANY]

Diagnostics Makers Encouraged to Help Fight Antimicrobial Resistance

Education and additional rapid diagnostics are needed to help save lives, say advocates.

Daphne Allen 

Deaths from antimicrobial resistance (AMR) could reach 10 million annually by 2050, fears a new industry alliance. Diagnostics manufacturers (along with those developing pharmaceutical and biotechnology products) have an important role to play in combating AMR, and these industries have formed an alliance to support such work.

Antibiotics may be losing their effectiveness faster than newer ones are being introduced, reported the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) last year as these industries came together at the World Economic Forum in Davos in 2016 to begin formulating an action plan.

The AMR Industry Alliance officially kicked off this May, when IFPMA Director-General Thomas Cueni announced its launch at the B20 Health Conference in Berlin. "It is estimated that, unless action is taken, the burden of deaths from antimicrobial resistance could be as high as 10 million lives each year by 2050 - more than cancer," claimed the alliance in a May 17 news statement marking the launch. 

AdvaMedDx joined the alliance as a board member to raise awareness about diagnostics along with bioMerieux and Labcorp. "Diagnostics play a critical role in any strategy to fight AMR," Tharini Sathiamoorthy, the Vice President of AdvaMedDx, told Qmed. "Diagnostics can help distinguish between infections that require antibiotic treatment and those that do not."

The challenge is that diagnostics are often overlooked, she said. "Rapid diagnostic tests are available," she said, but "one issue we have is that healthcare providers don't always know about them."

In addition, "a number of tests are being underutilized primarily because of reimbursement issues," she added. "There are few incentives to use them under private insurance or CMS. The economic piece on why they should be reimbursed should be improved."

AdvaMedDx encourages diagnostics manufacturers to raise awareness of these issues and to focus on education. "Speak up and go to events and conferences with other stakeholders," she advised. "Make sure discussions include diagnostics, particularly at the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria and the World Health Organization."

There is also more work to be done in diagnostics development. "One test that is needed is a rapid diagnostic test to determine whether an infection is bacterial or viral," Sathiamoorthy said.

AdvaMedDx is also embarking on its own separate initiative to fight AMR, a global commitment it announced in January 2017 to drive adoption of diagnostics tests, she added.

In the meantime, the AMR Alliance is developing a set of metrics to gauge progress since more than 100 companies and trade associations came together in Davos in 2016. A progress report is expected to be available in January 2018. The pharma industry also established its own roadmap for a common set of principles for global action that focus on reducing the development of antimicrobial resistance, investing in R&D to meet public health needs, and improving access to antibiotics, vaccines, and diagnostics.

[Image source: Evgeny Atamanenko/Shutterstock]

Daphne Allen is executive editor of Pharmaceutical & Medical Packaging News and a contributor to Qmed. Reach her at and on Twitter at @daphneallen

Connect and Compete Through Open Innovation

Connect and Compete Through Open Innovation

Medtech manufacturers can achieve a host of benefits--from speeding development to forming new partnerships--by looking outside their existing networks for technology solutions.

Bronwyn Monroe

Open innovation has become a mainstream practice for most technology-driven companies looking to accelerate time to market and stay ahead of the competition. The open innovation concept is based on the premise that a technology solution may exist in a more mature form outside of your own network and that connecting to an external solution provider will speed up development of new or existing products.

These external solution providers could be inventors, entrepreneurs, research labs, academics, or even Fortune 500 companies working on their own innovation for a particular application. Through open innovation, companies seeking solutions are able to expand their options and cut their development time while solution providers are able to identify new ways to utilize and monetize their solutions. If you are a medical technology manufacturer considering open innovation as a strategy within your innovation program, here are three advantages to consider.

Learn how companies including Integer Holdings and Smiths Medical are using cross-pollination to drive medtech innovation at the MD&M Minneapolis Conference on November 8, 2017.

Access to a New Network of Potential Partners

Expanding their network is one of the top reasons organizations use open innovation to address their technology needs. Medtech manufacturers, like GSK and Pfizer, use open innovation to make their needs known to solution providers through--among other approaches--online galleries. For example, GSK recently posted a need on an online open innovation marketplace where they were looking for rapid analytical tests for gene therapy products that can go from sample to result in one week. The company asked solution providers that have these tests to submit a proposal describing the solution and how the success criteria will be met with the proposed solution. Pfizer utilizes a similar approach to broadcast its needs ranging from neuro-inflammation to monoclonal antibodies for cancer treatment to partnering with an organization that has a specific type of clinical genomic database for the purpose of better understanding diseases and their correlation to certain ethnic groups.

Companies benefit from the initial connections to solution providers, but they also build a lasting network through this process and identify partners they may want to collaborate with in the future. A good open innovation intermediary can connect a healthcare company to a range of potential partners, including those well outside their own industry. In the case of the rapid analytical tests GSK was seeking, potential technologies under consideration were biosensors being used in applications including aerospace, electronic components, manufacturing, and fabrication. 

New Options to Solve Your Problem

Solution searches can be ongoing, as in the case of the open innovation galleries, or can be finite project "events" that have a specific timeline and communications plan to support the project milestones. When Essilor, the global giant in ophthalmic optics, wanted to find low-cost, easy-to-use, and scalable solutions that could be employed by vision care workers to accurately measure eye refractive errors within underserved populations, the company launched a grand challenge, a very public form of open innovation that combines technology outreach with marketing amplification.

Essilor's See Change Challenge offered monetary prizes of 25,000 Euros to up to five winning solution providers. Solution providers in 15 countries submitted proposals that included apps that run on smartphones, separate devices that work in conjunction with smartphones, and devices that do not require computing power. The innovators who submitted solutions had varied backgrounds in fields such as optical engineering, software development, public health, and design. Finalists in the See Change Challenge are currently building out their solutions to provide Essilor with a proof of concept or prototype in Phase 2 of the challenge.

Grand challenges are a way for organizations to create awareness while accessing new technology approaches. For Essilor, the grand challenge helped raise awareness for poor vision, a major global issue affecting over 2.5 billion individuals. The grand challenge was also a key component in supporting Essilor's corporate mission of improving access to healthy vision for underserved communities worldwide.

Reduced Development Time

Open innovation can increase your options for solutions faster than more traditional R&D approaches, thus decreasing total development time. Take GE's Industrial Solutions Challenge. This open innovation challenge focused on design to create a new ergonomic rotary handle to be incorporated into a soon-to-be-released portfolio of molded-case circuit breakers. By using a crowd-sourced approach to the design process, GE was able to leverage and invest in solutions from engineers, designers, and architects with extensive experience and diverse industry backgrounds. The company announced five winners of its design challenge and indicated that factors from the five winning ergonomic designs would be incorporated into the molded-case circuit breakers. As a result of using this approach, GE stated that it would be able to introduce the state-of-the-art circuit breaker platform in half the time of its previous product launches.

Open innovation is a versatile strategy for manufacturers looking to accelerate their innovation programs by leveraging external connections. Our rapid-paced global economy demands that companies do more with less and get to market before the competition. Open innovation provides multiple paths to finding new solutions, whether it be for a discrete technology or component or an entirely new way of utilizing technology to address a major global issue. Open innovation is a win-win proposition for solution seekers and solution providers alike and is an important element in any successful innovation program.     

Bronwyn Monroe is vice president at NineSigma Inc., a global innovation services firm headquartered in Cleveland, OH. Reach her at

[image courtesy of COLIN00B/PIXABAY.COM]