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Video shared by on in Medical Molding

In 2015, I was honored to deliver the keynote address at the annual “Molding” conference held in Chicago that year.
 
Some of the topics covered were the growth of China and how the medical market size currently compares to the US, Obamacare, attractive contract manufacturing markets, emerging technologies used in manufacturing such as 3D printing, and other trends.

More details of the conference can be found here: http://www.ptonline.com/events/details/b7f25477-e718-4975-bd14-c80187608835.

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Med Tech and Med Device Events – Stay Informed, Stay Connected

Considering recent merger and acquisition trends in the med tech/med device space, the changing healthcare landscape, and ever-innovative and emerging industry technologies, it’s never been more important to stay current, stay informed, and stay networked. Industry tradeshows offer great opportunities to accomplish these tasks, so in this blog, I offer a list of some of the best med tech and life science events occurring throughout 2017. This year, take time to educate yourself about the latest trends in the medical technology and medical device space; network with peers, thought leaders, suppliers, and OEMs; and expand your horizons through travel. You won’t regret it!


INTERPHEX

Networking and learning opportunities abound at INTERPHEX, taking place this week in Manhattan. The show brings together over 10,000 pharmaceutical, biotech, and med device industry professionals, leaders, and vendors, from around the globe, to share knowledge, best practices, and the latest technologies for cost-effective product development and manufacturing. The event includes technical conferences, panel discussions, exhibits and demonstrations, as well as partnering and networking opportunities. “Learn It, Experience It, Procure It” at INTERPHEX.

When: March 21-23, 2017
Where: Javits Center, NYC
More info: http://www.interphex.com/


MedTec Europe

MedTec Europe takes place in April and is the leading European event showcasing medical component and service providers. With 600+ exhibitors, the event includes ample opportunitiy to network, learn (at presentations, conferences, and workshops), and experiencing the latest innovations (visit the Innovation Gallery and the Start-Up Academy on the show floor). Pre-registered attendees (7,000+ expected) can take advantage of the event’s “matchmaking service” to book meetings with key players in the med tech space.

When: April 4-6, 2017

Where: Messe Stuttgart, Germany

More info: http://www.medteceurope.com/europe/


The MedTech Strategist Innovation Summit

Also in April, the MedTech Strategist Innovation Summit, considered the premier medtech investment forum in Europe, features presentations by 40+ early-stage med device companies from around the world; interviews and discussions with thought leaders, med device executives and VCs; and an Innovator start-up competition. This spectacular event is worth traveling for.

When: April 25-27, 2017

Where: The Shelbourne Hotel, Dublin Ireland

More Info: https://www.innovationinmedtech.com/conference/the-medtech-strategist-innovation-summit-dublin-2017/


BIOMEDevice Conference (BCS will attend)

A little closer to home (mine anyway), New England’s largest annual medtech event offers ample opportunity to connect with over 4,000 engineers, executives, and suppliers in the end-to-end medtech design-to-manufacture space. Get face-time with product and service providers, find solutions for your needs, deepen your knowledge, make connections, and see you there!

When: May 3-4, 2017

Where: Boston Convention & Exhibition Center, Boston, MA

More Info: http://biomedevice.mddionline.com/


CMEF – The China International Medical Equipment Fair (BCS will be in attendance)

Visit Shanghai to participate in Asia-Pacific’s leading event showcasing and serving the entire med device value chain and market. The show features the largest gathering of medical device/equipment manufacturers, and related products and services, in the Asia-Pacific region. Nearly 4,000 med device manufacturers from 24+ countries expected to attend with a breadth and depth of products and services including medical imaging, IVD, electronics, optics, first aid, rehab nursing, medical IT and outsourcing.   Attendance usually exceeds 150,000 attendees at this twice a year event.

When: May 15-18, 2017
Where: National Exhibition & Convention Center, Shanghai, China
More info: http://www.cmef.com.cn/g1225.aspx


MD&M East (BCS will attend)

Join BCS and Immerse yourself in medical technology at the East Coast’s largest annual medtech event, MD&M East. This year’s event has a special focus on 3D printing, smart manufacturing, and design and innovation, with a key note address by Silicon Valley icon Steve Wozniak. This amazing tradeshow features a plethora of opportunities to learn from, and connect with, industry players, thought leaders, executives, engineers and professionals.

When: June 13-15, 2017

Where: Jacob K. Javits Convention Center, New York, NY

More Info: http://mdmeast.mddionline.com/


MPO Summit (BCS sponsor / attendee)

MPO Summit focuses on medical device manufacturing outsourcing innovations. This year’s event takes place in beautiful downtown San Diego , closely located to the San Diego County Life Science cluster (and growing Medical Device maquiladoras of Tijuana and Mexacali). Symposia focus on critical issues impacting today’s industry stakeholders, and the Summit offers ample interactive networking and educational opportunities. Meet OEMs, contract manufacturers, suppliers, consultants, investors, and academicians, and develop tools and capabilities to compete and grow in todays’ challenging business climate.

When: October 18-19, 2017

Where: Marriott Marquis San Diego Marina, San Diego, CA

More Info: http://mposummit.com/


Medica Trade Fair (BCS will attend)

When: November 13-16, 2017
Where: DÜsseldorf, Germany
More Info: http://www.medica-tradefair.com/

One of my favorites, the Medica Trade Fair in Germany, takes place in November and is more than just a medical industry tradeshow. Nearly 5,000 exhibitors showcase products, services, and innovations from an array of areas including electromedicine, diagnostics, medical technology, information and communication systems, equipment, and commodity consumables. Forums and seminars include panel discussions; special exhibitions demonstrating the latest techniques and device innovations; and career recruiting and planning. This event is a perfect platform to exchange ideas and networking with industry players from throughout the world.


MedTech Impact Expo and Conference

December is a great time to visit Vegas, and MedTech Impact Expo and Conference is a one-of-a-kind event. The show connects thousands of healthcare professionals from around the world to share best practices and learn about emerging technologies. MedTech Impact offers educational opportunities including case studies, an exhibit hall showcasing wearables, biosensors, and 3D printing technologies. The conference focuses on how technology is redefining healthcare.

When: December 15-16, 2017

Where: Venetian/Palazzo Resort, Last Vegas, NV

More Info: https://www.medtechimpact.com/


In closing, take time to attend a few trade shows in 2017 – stay connected and informed. It’s good for you and your business!

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Potential Effect of Trade Deals on Medtech Industry

Written By: Mark Bonifacio • Founder and President, Bonifacio Consulting Services

Possible Trade Deal Spurring Uncertainty

One issue that may have significant repercussions on the MedTech M&A market is the changing landscape on free trade and the trade agreements currently in place.

The U.S. medical device industry is expected to remain highly competitive globally, partially due to national characteristics that allow companies to bring new and innovative technologies to market. The industry has increasingly embraced globalization, and an ever-growing number of multinational firms are aggressively pursuing markets around the world. These firms are focusing greater attention on international sales, joint ventures, mergers, and acquisitions. Global demand for medical devices driven by rising expenditures and healthcare-related investments in developing markets through infrastructure (new hospitals and clinics), public health insurance and an overall greater focus on health. Also, global demand is likely to grow due to lifestyle diseases, aging populations in primary markets, new and significant emerging markets, and rising global income levels in developing countries, according to a U.S. Department of Commerce report. Further, the global convergence of standards and regulatory requirements should help facilitate global market growth and further trade opportunities. The Medtech industry must not lose sight of this.

America’s chief global competition currently comes from Germany (Siemens AG and B. Braun), Japan (Hitachi Medical Corporation, Toshiba Medical Systems Corporation) and The Netherlands (Royal Philips). Notably because of its past and recent acquisitions, Philips currently produces more medical devices in the United States than in the E.U. While most projections show the United States maintaining its competitive advantage in the foreseeable future, international markets and low-cost device producers are expected to remain competitive, therefore giving America a run for her money.

With the Trump administration ending the Trans-Pacific Partnership (TPP) and threatening to restructure the North American Free Trade Agreement (NAFTA), many multinational Medtech firms and others that rely on these agreements remain on edge, since many of their strategic manufacturing models and current supply chain models depend on these agreements.

The U.S. Commerce Department reports that trade between the United States and its NAFTA partners has soared since the agreement was enacted: U.S. goods exports to NAFTA partners have increased by almost 300 percent from 1993 to 2014, going from $142 billion to $552 billion during that period. Moreover, U.S. trade with Canada and Mexico exceeds U.S. trade with the European Union and Japan combined. Federal statistics show that annual exports of U.S. medical devices to Canada have more than tripled since the year before NAFTA was signed into law, and exports of medical device products to Mexico have more than quadrupled.

According to the Plastics Industry Association (PIA), NAFTA is responsible for 47.2 percent of the U.S. plastics industry’s $59.1 billion in global exports. The top three plastics exports markets are Mexico, Canada, and China, generating an overall trade surplus of nearly $39 billion. Plastics plays a significant role in many medical devices and single-use products.

The TPP agreement removes tariffs on medical devices, supports increased regulatory coherence among member states, and widens stakeholder influence and transparency toward reimbursement and pricing. Ultimately, the TPP would have resulted in quicker approvals of medical devices, benefiting U.S. companies that export to signatory partner countries.

Many trade organizations are now cautious as the nascent Trump administration looks to overhaul all or some of these agreements. Although I firmly believe these pacts can all be improved, it is important for our president and Congress to consider the long-term impacts of nixing the TPP (and or NAFTA) before making any final decisions. As a former owner and operator of a medical device CM that took advantage of NAFTA to supply high-value components to other NAFTA trade partners, I join the growing chorus of business owners urging the new administration to carefully consider all implications of upending or exiting these agreements. A hasty decision and any perceived short term benefits could jeopardize American Medtech leadership and rivalry in a globalized economy.

 

Mark Bonifacio is founder and president of Bonifacio Consulting Services (BCS) LLC, a global consulting and advisory firm to medical device OEMs, contract manufacturers, private equity, and other investors in the Medtech manufacturing sector. Bonifacio has a B.S. in plastics engineering from the University of Lowell (now UMASS-Lowell), and more than 25 years of experience in medical device manufacturing across many therapeutic disciplines and market segments. After working for major medical device OEMs, Bonifacio co-founded APEC, a Baldwin Park, Calif.-based contract manufacturer, and sold it to what is now Freudenberg Medical) in 2007. He founded BCS in 2008. BCS is headquartered in Boston, Mass., and has offices in California, Florida, and China.

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Pace of Medtech M&A Activity Not Likely to Abate in 2017

Written By: Mark Bonifacio • Founder and President, Bonifacio Consulting Services

Predicting the future is a risk, fraught with difficulty, especially in the healthcare sector. A myriad of unforeseen factors can affect outcomes, ruining even the most conservative of forecasts.

Some prophecies have better odds than others. Consider, for example, the consolidation that has reshaped the medical device sector over the last few years. There are strong indicators that this industry-wide consolidation will continue this year as existing platforms, new private equity players, and sector-related strategics all vie for assets. The only uncertainty is the pace at which this activity will occur.

From Trend to Norm

The mergers and acquisitions of medtech OEMs and contract manufacturers (CMs) last year progressed at a blistering pace, and it appears that rate could continue in 2017 barring any major political upheaval or unforeseen chaos. The CM market, in particular, seems poised to continue this rapid pace of consolidation.

Medtech industry executive Bill Ellerkamp detailed much of the recent activity in the medical device outsourcing market in his article in the January/February issue of MPO. Since that time, Vention Medical closed its deal for Lithotech Medical, an Israeli-based developer of complex nitinol wire-based technologies (Real time update: Vention was itself sold by KRG as two business units, one to PE Backed Medplast (DMS business) and the Advanced Technology piece of the business to publicly traded Nordson Corp). Ampersand Capital Partners made an undisclosed investment in Corpus Medical Inc., a Silicon Valley-based contract development and manufacturing organization focused on interventional medical devices, catheter-based delivery systems, and implants. Finally, Medtronic plc is reportedly shopping around the medical supplies business it inherited with the blockbuster Covidien acquisition.

The overall backdrop for these deals continues to remain strong. Low interest rates, deal leverage multiples, cash on private equity and strategic balance sheets, continued OEM consolidation, outside U.S. suppliers and foreign investors looking for U.S. beachheads are all contributing to this high demand.

Unlike the auto, aerospace and consumer industries, the medtech industry is a highly fragmented space. Driving this consolidation is a need for some business sophistication for owner/operator, (“mom and pop type operations”) and most importantly, there is extreme macroeconomic pressure to reduce healthcare costs across the globe (especially in the USA as our overall healthcare GDP spend approaches 18%!).

All of this indicates we will see much more movement between the med device players in 2017.

 

Mark Bonifacio is founder and president of Bonifacio Consulting Services LLC, a global consulting and advisory firm to medical device OEMs, contract manufacturers, private equity, and other investors in the medtech manufacturing sector. Bonifacio has a B.S. in plastics engineering from the University of Lowell (now UMASS-Lowell), and more than 25 years of experience in medical device manufacturing across many therapeutic disciplines and market segments. After working for major medical device OEMs, Bonifacio co-founded APEC, a Baldwin Park, Calif.-based med device contract manufacturer, and sold it to what is now Freudenberg Medical) in 2007. He founded Bonifacio Consulting Services in 2008. BCS is headquartered in Boston, Mass., and has offices in California, Florida, and China.

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The Trump Administration’s Effect on the Medical Device Industry

These are exciting times we live in, especially for the med tech industry. There is a tremendous amount of scuttlebutt around Trump’s plans for the FDA and CMS and the affect those, and other proposed changes will have on the medical device community.

Medical Device Tax Elimination

Permanent elimination of the medical device tax, repealed in December of 2015, is extremely likely under the Trump administration. This tax legislation would positively impact medical device manufacturers and suppliers by reducing costs and allowing them to produce their products much cheaper and may even alter outsourcing needs and bring back jobs to the U.S.

Major Changes to ACA

During his campaign, Trump was very vocal about his plans to replace the Affordable Care Act (Obamacare) with a patient-centered healthcare solution which is to be simpler and more readily available to the general public. His plans include employing “Health Savings Accounts” which would allow patients to choose their healthcare suppliers and have more control over their care. It is very unclear yet however if these changes will result in a rise in healthcare costs or savings and how they will affect the medtech industry.

The FDA and CMS

Some of Trump’s biggest plans for change include easing regulations and a shift in leadership for the FDA. Fewer regulations imposed upon the FDA could mean quick turnarounds for approval of new products. However, there are rumors that Trump also plans to reduce the workforce of the FDA, which in turn could result in delays. What is clear, is that a Republican Congress and FDA would certainly be industry-friendly and help eliminate current obstacles and open up possible opportunities.

Outsourcing

Plans to sanction manufacturers who outsource to countries other than the U.S. may vastly impact the medical technology industry, which relies heavily on outsourcing to be to be cost-effective and competitive. However, repealing the medical device tax may offset the costs of moving operations back to the U.S.

Mark Leahey, president, and CEO of the Medical Device Manufacturers Association (MDMA) was quoted as saying: "We look forward to working with President-elect Trump, the new Congress and all policy makers to confront the obstacles standing in the way of innovation," he said in a statement. “We have had a strong tradition of broad, bipartisan support to advance issues important to the med tech community such as suspension of the device tax, reauthorization of MDUFA, protecting intellectual property rights and more, and we hope this will continue."

If Trump does indeed keep his campaign promises, his administration will result in significant changes to the industry. However, it is too soon to tell whether those changes will be positive or not. Still, a lot of questions remain; how will Medicare and Medicaid be affected, how does protection of intellectual property rights factor in and what will the future healthcare be? These are just some of the questions on the minds of medical device professionals that we will have to wait to see to have answered.

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CES 2017 – The Exciting Medical Device Highlights

The 2017 International CES (Consumer Electronic Show) takes place every January in Last Vegas, Nevada and includes over 3800 exhibits from manufacturers, suppliers and developers of exciting new consumer technologies. This event is widely attended and this year over 165,000 people visited to learn about cutting edge innovations in all areas of consumer electronics.

This year, medtech took the spotlight and there were some really exciting new products that may revolutionize the area of medicine and medical device technology in the near future. Some of the medical technology product highlights are:

Neofect’s Rapael Smart Glove - was introduced to help stroke patients rehabilitate the use of their hands and fingers while recovering at home. The glove and accompanying software help improve mobility in the patient’s hands by promoting common hand movements, which increase in difficulty as the patient improves. The glove is to be worn for 30-minute sessions at a time and data is transmitted via bluetooth from sensors in the glove, back to the monitoring station. The device and monitor can be rented for $99/month.

NeuroMetrix: Quell System - is an amazing drug-free, wearable medical device, which uses stimulation of the nerve system to block pain in patients suffering with chronic pain conditions. The device is worn around the calf, like an armband. Since June of 2015, over 50,000 copies of Quell have been sold and used to control pain. Patients adjust the levels of relief through the mobile app that also monitors therapy levels, quality of sleep, body position and other physical stats.

Resound High Tech Hearing Aids - are the hearing aids of the future; connected wirelessly to your phone you can monitor settings, access WIFI and use them much like you would a headset along with the benefits of a hearing aid. They are also proven to provide relief to those patients suffering with tinnitus.

Thinfilm: YpsoMate Smart Auto Injector Pen - was designed for patients who require chronic pain medication. The injectable pen is outfitted with electronics that communicate with their mobile app, allowing the users to scan the pen and view video instructions on how to administer the pain medication. The mobile app also tracks administration, reminders, refills and usage history.

TempTraq’s Temperature Monitoring Wearable Patch - can be worn for up to 48-hours and track via Bluetooth, back to its accompanying mobile app, the patient’s body temperature and fluctuations. The app can also be set for alerts if a person’s body temperature reaches a specific number. The patch is worn under the arm and allows the patient to rest without interruption for two days. TempTraq’s thermometer patch will be available for $24.99 in early 2017.

Omron Blood Pressure Watch - is the latest in the array of blood pressure monitoring devices and is housed in a sleek, smart watch design with the ability to track blood pressure and heart health. It too connects via Bluetooth to the mobile app allowing the user not only to track their heart health data, but also see information on body index, fat percentage and weight.

These were just a few of the many high-tech, e-health medical devices exhibited at the show. The rapid pace of innovations in medical technology make this an exciting time to be a part of the medtech, and biotech industries. We believe that we are still in the age of infancy of what the future will bring to patients around the globe.

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Posted by on in Medtech
3D-Printed Organs - How Close is This Future?

Picture the scene: a well-lit operating room; the patient is anesthetized and prepped for surgery, his chest open awaiting a new heart. The surgeon stands ready as the nurse hands him a brand new 3D-printed heart, made of the patient’s own DNA to avoid rejection and ensure a perfect genetic match. Sound like science fiction? This is quickly becoming our not-so-distant future.

3D-printing is all the rage these days; offering the ability to create complex objects such as toys, trophies, plastic or metal parts and even food, using computer-generated models and a 3D-printer. The buzz in the medical technology community however is how close are we to using this regularly for live human organs. The mechanics of it are fairly simple; the challenge of printing live organs is the viability of the tissue and keeping it healthy and alive during the process.

Researchers at Wake Forest Baptist Medical Centre, devised an interesting solution by printing 3D tissue samples onto a “sponge” made of plastic combined with organic matter and nutrients to keep the cells healthy and alive. Once implanted, this inorganic matter breaks down and is replaced by cells that grow into the gaps. They call this process “biodegradable scaffolding.”

Medical researchers have been able to grow live tissue in a lab for many years, now with the advent of 3D-printing, they will be able to easily solve the issue of duplicating the complex cell structure of a specific patient with a perfect DNA match and grow larger, more substantial organs.

According to BBC News, there has already been some limited success in creating 3D-printed body parts that have been implanted into animals, without tissue rejection. This technology will soon be used in limited human testing.

In October of 2016, Harvard University researchers made significant headway by developing the first 3D-printed heart-on-a-chip with built in sensors. This revolutionary breakthrough will allow medical researchers to simulate disease conditions or a patient’s specific body makeup and use this technology to devise solutions based on the data collected by the sensors.

It is exciting to see how quickly this technology is progressing. It will not be very long before the scene set above will be a daily reality and this amazing process will revolutionize modern medicine and possibly even prolong life for decades.

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Medical Device Cybersecurity - How Safe Are Your Devices?

With the threat of Russian Hackers, WikiLeaks, and large companies being cyber-attacked almost weekly, cybersecurity is certainly a hot topic these days, and the medical device industry adds even more complexity to this challenging issue.

Medical device cybersecurity is an ongoing and major concern for manufacturers of medical devices, healthcare providers, the FDA and patients. There are extraordinary benefits for healthcare facilities to use mobile and networked technology to offer enhanced, real-time patient care; however, with any remote or Internet-connected device, the possibility of hacking, unauthorized access, viruses and even terrorism is a real and present threat and one the medical community is extremely focused on right now.

A major issue with medical technology is that the infrastructure of the devices themselves as well as the networked systems they are connected to, are immature and more vulnerable to attacks. Historically, medical device hardware and software has been less sophisticated without any built-in security or monitoring features. This is an area ripe for immediate improvement.

Deloitte recently interviewed healthcare leaders from nine organizations and compiled a report of their findings regarding privacy, patient safety and cybersecurity and what these organizations are doing to address these concerns.

There is tremendous pressure on the medical community to develop and strategize new approaches to protecting the privacy and safety of patient data. Symantec published an interesting white paper discussing this issue, which offers a viable strategy for enhanced security and risk management.

With so much attention being focused on cybersecurity for the medical industry, in late December, the FDA published their cybersecurity guidelines. They stress that the significant threat of cyber attack on medical devices demands that cybersecurity be addressed as a lifecycle approach, beginning with device design and ongoing security monitoring throughout the life span of the device. One key point made by Suzanne B. Schwartz, M.D., M.B.A., FDA’s Associate Director for Science and Strategic Partnerships, was that it may be impossible to prevent intrusion therefore more focus should be on monitoring device access as well as risk and disaster management.

Complicating the compliance issue is that cybersecurity is an ever-evolving problem due to rapidly changing technology, more sophisticated hackers becoming proficient at accessing secure systems, and more and more healthcare data being connected to networks.

The benefits of using networked medical technology are significant, however the risks, including patient exposure, health quality and even death are just as real. Hopefully in the near future we will see improved security measures implemented to not only keep up with that threat, but to surpass it with readiness, protection and monitoring.

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Posted by on in Medtech
2016 – A Medical Technology Year in Review

Those engaged in the medtech industry will cross 2016 off as a largely uneventful, but a forward-moving year. The year was not completely devoid of any significant milestones or newsworthy items and it will not be categorized as a bad year but for the most part surely one of business as usual.

Here are the highlights of 2016 as reported by Medical Product Outsourcing magazine.

 

Theranos Disaster

Amidst allegations of unacceptable facilities test conditions, lying about test results and unproven medical device launches, along with facing federal and criminal investigations, Elizabeth Holmes company Theranos, plummeted from a net worth of 9 billion dollars to a shocking zero in the course of a few months, additionally having to lay off hundreds of employees.

Homes, has rebounded slightly working on new product, a tabletop laboratory for blood testing on the go.   Time will tell whether this new medical device is able to save the struggling company.

 

Medical Device Tax

Monday, February 1st was a big day in medtech; it was the final deadline for the medical device excise tax perhaps forever, if new legislation holds beyond the agreed-upon compromise of 2017. This largely depends on the recent presidential election. The medtech community hopes that this suspension will become permanent and alleviate many of the complications, which arose from it, since its inception in 2010.

 

Mylan’s EpiPen Price Hike

Mylan purchased EpiPen brand from Merck & Co. in 2007 and for 40 years the product has been readily available and affordable to schools and consumers. However, this past summer, Mylan increased the price from $100 up to $609 making it completely out of reach for many distressed areas. The media and public outcry was substantial. Mylan blames insurance rates for the increased price, but naysayers claim monopoly mentality and the result is that the consumer ends up paying a premium for something they desperately need.

 

Medical Device M&A News

The year started off rosy with the impending merger of Abbott Laboratories and Alere, Inc. As the months wore on however, amidst annual report deadline default, and federal investigations into Alere’s sales and practices, the two entities began publicly disparaging each other and have parted ways; both seeking out new partnerships with other entities.

 

UnitedHealthcare Controversial Policy Change

UnitedHealthcare gained a lot of negative press over burying a major policy change regarding patient choice, deep within the body of a member bulletin. The item was discovered and uncovered by a rival company executive and exposed to the media, which resulted in patient outcry.

This new change affects diabetics and how their care is managed and they are outraged at the limitation now imposed upon them.

 

Medtech’s Future

Michael Barbella, Managing Editor of Medical Product Outsourcing interviewed three experts in the medtech industry on summing up 2016 and what the future holds in medtech for 2017.

Mark Bonifacio of Bonifacio Consulting Services was quoted in response to his predictions for 2017, as saying: “In addition to continued M&A and the discussion around pharmaceutical pricing, I think the ACA will have to get some tweaks if it is to continue in any form going forward; while some components seem to working there are still many facets of this law that will need to be modified (there are many details too lengthy to discuss here). Connected and what I’m calling growing consumer health globally will also be at the forefront for 2017 and beyond as I believe we are on the cusp of some of the biggest changes we have seen in decades in our industry and the general healthcare space. Medical devices and technology-driven therapies will push the envelope further than we even dreamed was possible only 10 or 20 years ago. These are indeed challenging times, but exciting times as well. ”

Read the entire interview here.

 

That wraps up the highlights for medtech for 2016. Hopefully 2017 will produce more memorable and notable news worth of front-page status.

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Massachusetts is one of the top five medtech hubs in the world in terms of manufacturing and innovation, according to Mark Bonifacio. As the owner of Bonifacio Consulting Services (BCS; Natick MA), a consultancy dedicated to medical manufacturing and outsourcing, and co-founder of Apec, a medtech contract manufacturer that was sold to Helix Medical, Bonifacio knows a bit about the industry. He may be slightly biased given his geographical base, but he's not alone in touting the state's medical device manufacturing credentials. In its recent countdown of medtech innovation hubs , sister publication MPMN placed the Boston/Cambridge area at the top, calling it "one of the most important areas on the planet for medical research."

A confluence of factors have established and solidified the state's standing as a medtech Mecca, but what is perhaps most instructive is the way in which the present and the future are an extension of the past. Here are five reasons why Massachusetts continues to set the mold for medical manufacturing.

regional focus logo

1. Manufacturing clusters are in the state's DNA

"Throughout its economic history, Massachusetts has experienced the emergence, growth to national leadership, and decline of regional concentrations of related firms and organizations known as clusters, wrote Michael Best in an article published in MassBenchmarks back in 2006. He cites textiles, shipbuilding, footwear, and microcomputers among the state's historical industrial hubs to frame a conversation about the "emergence of a new cluster right before our eyes: the medical device sector." Best is professor emeritus at the University of Massachusetts Lowell.

The medtech cluster in Massachusetts is second in the nation only to California, with more than 400 medical device firms calling the state home. These companies range from well-known multinationals such as Boston Scientific and Johnson & Johnson's DePuy to a multitude of startups.

Massachusetts employed more than 24,000 people in the medtech sector in 2008, according to a study published by Deloitte in 2011. Taking into account a 3.4 multiplier effect, Deloitte estimates that industry has directly and indirectly created approximately 82,500 jobs. In fact, that number is probably greater, according to Thomas Sommer, President of MassMEDIC, an organization representing medical device manufacturers, suppliers and associated groups in Massachusetts and the surrounding region. "Battelle published a report in 2012, and it pegged the multiplier effect in Massachusetts at four jobs for every person employed in the medical device sector. That would put the total number at more than 100,000."

As plastics play an increasingly central role in the development of medical technology, it helps that the plastics processing industry has a profound presence in the region. "The plastics manufacturing tradition started here in the Leominster/Wilmington area," says John Witkowski, General Manager, Clinton Operations, Drug Delivery and Diagnostics, Nypro (Clinton, MA). "We have a manufacturing infrastructure that has evolved over more than a century, with a long tradition of moldmaking and molding expertise." That combined with a legacy of precision engineering and instrument making applied to various sectors, has served the medtech cluster well. One example is the defense industry, which was "very important to the state economy

Tagged in: Medical Molding
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