Tuesday, December 30, 2014

European Healthcare System: Changes for a Sustainable Future

Europe might need to rethink its healthcare system in order to put it back on a sustainable track. Not only the European industry is suffering from increased demand, as a result of its demographic trend (expanding elderly population), but also because government spendings are under pressure and there are ever fewer healthcare professionals.
According to MedTech Europe, the industry has developed a Contract for a Healthy Future, its five-year strategy, in which they commit themselves to adapt their “business model to deliver value-based innovations which will help steer European healthcare systems onto a sustainable path.” MedTech Europe and Boston Consulting Group have developed a report that “looks at how companies respond to the new market realities and where the industry stands in terms of making the necessary changes.” The report is called “Slow Burn – The Need to Transform the Medtech Model in Europe” Their website also features an Economist Report which shows how 5 European member states have already taken measures in order to keep their healthcare systems sustainable for the future.

More information on the MedTech Industry's 5-Year Strategy is available at www.reforminghealthcare.eu

Monday, December 15, 2014

Important Key Points to Keep in Mind about Consumerisation Strategies

During the BIOMEDevice San Jose 2014, Andrew Atwell, principal at Samsung Open Innovation Center, stated his concerns about consumerization issues in the healthcare sector. According to him, there are four key trends that medical devices companies should keep in mind.
First of all, and following other sectors: free data. Not only gathering health information, but sharing it between devices. These data, however, must provide and  convert it into relevant actionable information. Another important fact pointed out by Andrew Atwell is the importance of releasing the information in real time. According to him, in medical labs there are still many paper-based results that are manually entered by a lab tech. “The doctors should be able to see the data immediately at a patient’s bedside or on the golf course,” Atwell said. Doing so, patients would properly follow protocols after leaving hospitals and it would prevent readmissions. The last concern stated by Atwell was about usability. “The traditional form factor of many medical devices has been frustrating for many users.” Both patients and doctors are demanding medical devices and systems that engage users.

Monday, December 1, 2014

Brazilian Health Devices in MEDICA - Düsseldorf,GE

During November 12-15th, the renowned international event of the medical devices sector MEDICA took place in Düsseldorf, Germany. The Brazilian companies, under the Brazilian Health Devices - ABIMO’s project in partnership with APEX-Brasil - attended the event and the expectation for the next 12 months is US$ 16 million in business development as a result of the trade fair.
There were a total of 50 Brazilian exhibitors at MEDICA and the numbers are impressive: more than 3 thousand new contacts in more than 120 countries. As an instant result, MEDICA provided US$ 2.292 million in new business for the Brazilian companies.

Monday, November 17, 2014

Middle East and North Africa: Potential Target Markets

Consisting from Mauritania to Pakistan, from Egypt to Iran, these countries have been making huge efforts in order to increase both level and coverage of healthcare, regulate the sector, making it easier to operate and guarantee quality of products to the patients. Despite financial limitations and/or geopolitical instability, the overall trend is positive and sustainable political breakthroughs. Over the last two years, a continued effort to establish regulatory systems in additional countries is steering confidence in the sector.
The value of the medical devices market in Middle East and North Africa is estimated around US$ 4 billion and it’s growing by 5% per year. This heterogeneous market comprises approximately 650 million people with a cumulative GDP of more than US$ 5.2 trillion.
Mecomed is the Middle East and North Africa medical devices and diagnostics trade association.  Established in March 2007, they aim to build and improve the industry image and perception; help in substantially reducing non-compliant business practices; enhance access to key stakeholders; collaborate in critical projects with common interests. For more details, visit www.menamedtechforum.com.

Wednesday, November 5, 2014

Brazilian Medical Industry Grows More than Expected

As opposed to what is likely to happen with most of the sectors, the Brazilian medical industry will grow more than initially proposed. Abimed (Brazilian Association of Medical Devices, Products and Supplies) corrected the estimated growth of this year, from 8% to 10%.
“The healthcare sector growth tends always to be higher than the GDP’s, since the population is aging and technologies brings innovations”, says Carlos Goulart, Abimed’s President.
Other statistics are also optimistics. The industry sales grew by 9.3%; the production by 5.7% and jobs creation grew by 3,7% during the period January - August/2014, when compared to the same period of 2013.

Monday, October 20, 2014

Digital Health Funding is Accelerating beyond that of Traditional Healthcare

During USC's 2014 Body Computing Conference, experts agreed that digital health funding is accelerating beyond that of traditional healthcare. According to Rock Health (a company that provides startups with funding and full-service support), digital health is one of the fastest growing niches overall in venture funding today and is attracting investors from several different areas. Unexpectedly, it is surpassing medical devices in aggregate funding.
Casper de Clercq, a partner at Norwest Venture Partners, a leading investor in medical device firms, pointed to a trend in data collection. “There are other industries that are way ahead. Walmart, Target, Amazon, and Google know way more about our healthcare and our health situation than probably most of our providers do.” He mentioned the famous case of a Target store discovering that a customer was pregnant simply by monitoring her buying habits.   
Malay Gandhi, managing director of seed fund Rock Health, stated that large medical device companies are transforming their business models from a pure hardware business into a services business. “Technology enabled services in this category, where the medical device becomes a data acquisition mechanism, and you have software, analytics, and a services or patient management platform is really the future of medical devices.”

References: http://www.mddionline.com/article/venture-investment-digital-health-surpasses-medical-devices-141006

Monday, October 6, 2014

Risk and Challenges of Healthcare Systems Internationalization

Medical device manufacturers have identified “emerging markets” as their principal source of revenue growth in the coming years. However, during the last Economist’s Health Forum in Boston, major academics and industry’s players discussed the risks and challenges associated with rising demands in these countries.
The discussion explored a growing concern that the healthcare model in the United States and Europe isn’t sustainable or even necessary to meet the healthcare needs in many cultures. These nations will need to create a “more of an outpatient-oriented and prevention-oriented delivery system” that will require behavioral changes by physicians and patients.

“(...) replicating a hospital-based system in less-developed nations requires not only new infrastructure, but wholesale change in the behavior and practice of patients and physicians. (...) also demand a financial investment that even Western nations are having difficulty paying(...)” Peter Berman, a professor at Harvard University’s School of Public Health

Victor Joseph Dzau, MD, president of the Institute of Medicine brought an academic, clinical, and corporate perspective. He stated that every culture is different and needs specific solutions. “You won’t succeed unless you are really on the ground and really understand the culture”. Device companies must create local solutions to local problems in order to succeed.

Monday, September 22, 2014

Scenario of the Brazilian Medical Devices Market

MedTechWorld MD&M Brazil 2014, one of the main events of medical devices in Brazil, happened on August 26-27 at Transamérica Expo Center in Sao Paulo. This edition gathered together more than 3,000 professionals and 40 exhibitors.
One of the many interesting presentations was a study, conducted by Dr. Kleber Stelmasuk and Dr. Vitor Asseituno, both from Empreender Saúde, outlining the market scenario of research and development of medical devices in Brazil. The study revealed the strengths and weaknesses to enlarge the exports, increase the contact between university and industry for research and development, and identify what are the proposals to consolidate Brazil as a major global competitor of medical devices and nursing material. It also pointed out the concern about the deficit in the healthcare sector, since the industry doesn’t keep up with the patients’ demand.

Monday, September 8, 2014

2014: So far, a great year for the MedTech Industry in the USA

      According to the MedTech Half-Year Review, issued by EPVantage, 2014 has been telling an optimistic story for the medical device sector.
     Some points of this report have to be mentioned: merger and acquisitions stands at US$27.2 billion, compared to US$19 billion of 2013. The report also notes that the value of M&A in 2013 was close to being the lowest in a decade. More merger and acquisitions are to be announced until the end of 2014/beginning of 2015. During the first six months of 2014, medtech venture capital investments stand at US$1.9 billion, less than half of the US$3.9 billion raised in all of 2013. But second quarter of venture capital investment was up 33% from the first quarter of the year, so the expectations are still high. FDA approvals are also moving very fast. For PMAs, the average review time was 18.4 months compared to the average of 35.9 months in 2013.


Monday, August 25, 2014

Sales Increase in the Brazilian Medical Device Market

       Brazilian medical device sector is optimistic this year and companies expect sales to increase due to a growing demand boosted by the construction of new hospitals and labs, also because of the renovation of existing infrastructure.
      Regarding foreign firms, the Swedish manufacturer Sectra plans to replace the imports by a local production until 2016, by building its own factory or through a strategic partnership with a Brazilian manufacturer. The US-based Stryker, although it has no intention to produce medical equipment in Brazil yet, has an aggressive sales increase plan by exploiting other market segments with products made in the USA and Turkey. The company’s main concern is to recover the imports, which in 2013 fell by 15% because of the unfavorable exchange rate and inflation effects.
        As for the Brazilian companies, the expectation is optimistic as well. The surgical table-manufacturer Mecsul registers a sales increase of 20% each semester. 25% of Olsen’s production, medical and dental equipment manufacturer, is meant to the foreign market. Its medical line, for example, is sold in 50 countries. Over the past few years, Olsen’s foreign sales declined due to the competition with Chinese products, but the company expects this scenario to change.

Monday, August 11, 2014

Crowdfunding: How to Raise Money Online

When it is time to raise capital, crowdfunding is not a usual way chosen by medtech companies. Especially because investors want to finance opportunities less risky which can bring faster return, like softwares, than some complex device that might take years to be approved by the FDA.
However, when a medtech company choses crowdfunding to raise money, it is important to know what can increase chances of success. GoGetFunding, a company that has helped people from all over the world to raise millions, names the best practices of raising money from online donors, for example, updating a company's Facebook status as daily marketing activity might ensure the crowdfunding. 
Some statistics are shown below:
 * Campaigns with day-to-day marketing plans raise 180% more;
 * Projects with an average word count of between 300 and 500 words raise the most money. Explain who, what and why;
 * Campaigns that have a personal video raise 105% more than those that don't. If a picture is worth a thousand words, than a video is worth a million.   
     Finally, GoGetFunding suggests 10 steps to use their statistics and raise money online:
1. Nurture relationships with your inner-circle of friends, family and extended networks,
       2. Evaluate how much you need to raise,
       3. Set a realistic deadline,
       4. Gather a small fundraising team,
       5. Have a marketing plan,
       6. Create an awesome, personal fundraising page,
       7. Launch!
       8. Reach out to your inner circle and then extended networks,
       9. Engage, update and thank,
       10. Success!


Monday, July 28, 2014

A Role Model for the Medical Device Industry

Germany has more to proud of than the World Cup championship. While the European Union is suffering from an economic crisis, Germany has maintained a growing healthcare industry, showing impressive strength in all areas ranging from R&D and medtech startups to regulation and market growth.
The medical device sector is the largest employer in Germany, according to BVmed 2011/2012 industry report. With 5.4 million employees, almost one in seven jobs in Germany can be found in the healthcare industry. Germany represents 14.6% of medical device global share (second only to the United States) and exports 65% of medical technologies made in the country. To fight against the effects of an ageing population, Germany has implemented a series of major healthcare reforms over the past 20 years.
It seems like the medical device industry has a lot to learn from Europe’s strongest country.

Monday, July 14, 2014

Brazil’s Medical Device Market: Opportunities and Challenges

As an important emerging market that has captured the attention of foreign medical device manufacturers, Brazil currently imports 60% of its medical equipment, amounting to US$1.9 billion. With 200 million inhabitants, an Unified Health System (SUS) and an estimated 36 million Brazilians ascended into the middle class within the past four years, public and private partnerships are necessary to increase the access to a better standard of care demanded by the Brazilian people.
However, this attractive market also shows some challenges. This is especially true when it comes to registration and certificates system, audits processes, administrative and import obstacles. ANVISA is Brazil’s National Health Surveillance Agency that suffers from processes delays and lack of professionals. Some initiatives have already happened in order to facilitate registration processes and market access, as  the Memorandum of Understanding that was signed by U.S., Canadian and Australian Notified Bodies with their Brazilian counterparts in 2012.

Monday, June 30, 2014

MedTech at the 2014 World Cup

        On June 12, Brazil and Croatia match launched the beginning of the 2014 World Cup. At the opening ceremony, however, the healthcare industry was cheering for something else besides football. The first kick was given by a paralysed teenager. This remarkable feat was possible thanks to an exo-skeleton controlled by the teenager’s brain.
  "The Walk Again Project is headed by Duke University's Center for Neuroengineering in collaboration with the Technical University of Munich and a number of other universities and research groups worldwide. Together they are designing the exo-skeleton and a 3D printed helmet that contains a series of electrodes capable of capturing brain waves. This brain activity will then initiate the suit's movements.”
   During this year of 2014, medtech breakthroughs have been more connected to sport events. Aired at the 2014 Super Bowl, Microsoft commercial shows how technology in general, and medical technology specifically, has improved the lives of countless people around the world. Another amazing video of Duracell, an American football player tells the story of how, despite being deaf, he managed to become a professional NFL player.

References: http://medtechviews.eu/article/value-medtech-world-cup-and-super-bowl

Monday, June 16, 2014

Reconsider Outsourcing Strategies in China

In the last couple of decades, China has attracted manufacturers from all over the world because of low labor costs and excellent export infrastructure. By outsourcing their production, China was a way to cut costs when producing big quantities. The medical device sector was no different than that.
However, this trend may be about to change. Chinese wages and the value of Chinese currency are rising. The government mandate to raise the minimum wage, so it could bring labor cost increases of 15–20% per year in Chinese factories. Meanwhile, freight and other costs associated with offshore manufacturing are continuing to rise. There are other risks when outsourcing in China, such as intellectual property protection and quality control.
So manufacturers are rethinking their strategies of outsourcing in China. Some US-based are returning their production back to the United States. This is particularly good when the product is meant for the American market. This reduces shipping costs and challenges, gives OEMs a higher quality control and allows them to take advantages of improving efficiencies in U.S.-based manufacturing.

Monday, June 2, 2014

Hospitalar 2014: Brazilian Healthcare Fair

This year edition of Hospitalar, International Fair of Products, Equipment, Services and Technology for Hospitals, Laboratories, Pharmacies and Clinics, took place in Sao Paulo between May 20-23.
As an effort to reverse the healthcare sector trade deficit, Brazilian Health Devices (ABIMO’s project, developed in partnership with Apex-Brasil) organized an international business round at Hospitalar 2014. It reached US$ 1 million in sales and it is expected US$ 13 million for the next 12 months. The business round aimed to promote Brazilian exports, connecting Brazilian and foreign companies.
During the fair, there were purchasers from 18 countries, including interesting markets for the Brazilian industry: South Africa, Bolivia, Chile, Colombia, Costa Rica, Iran, Jordan, Kuwait, Lebanon, Mexico, Morocco, Nigeria, Panama, Peru, Kenya, Russia, Turkey and Tunisia.


Monday, May 19, 2014

New EU Medical Device Regulations

In September 2012, the European Commission released a proposal for new European Medical Device Regulations (EMDR) intended to prevent public health scandal, such as the Poly Implant Prothèse breast implant in France. The final version of the EMDR is expected to be approved in late 2014 or early 2015. However, a more likely estimate is October 2015. The original proposal indicated that there would be a three-year transition period (from 2014 to 2017/2015 to 2018) for implementation of the new regulations.
The new regulation may increase costs and eliminate early access to device innovations that patients in Europe are used to experience. A survey made by the trade group Eucomed estimated the cost of the proposed regulations at €17.5 billion (US$24.3 million). European Union's current financial situation could force the European Council and Parliament to make major revisions to the proposed regulations reducing the cost of implementation.
The original proposal has suffered several modifications, but most significant changes include:
  • The European Commission’s ability to create common technical specifications (CTS) will be expanded to all devices.
  • Formatting of declarations of conformity and technical files will be revised.
  • Manufacturers will be subject to unannounced audits by Notified Bodies.
  • Spinal implants, devices that control and monitor active implants, nanomaterial, apheresis machines, and combination products will be reclassified as Class III devices requiring technical documentation known as a design dossier.
  • Most in vitro diagnostics (IVDs) will require Notified Body involvement.
  • A Unique Device Identification (UDI) system will be required for labeling, and the European Databank on Medical Devices (Eudamed) will be expanded.

References: http://www.mddionline.com/article/what-expect-new-eu-medical-device-regulations

Monday, May 5, 2014

Brazilian Health Surveillance Agency simplifies Import processes

Anvisa (Brazilian Health Surveillance Agency) is adopting actions in order to improve the import processes of healthcare products. RDC 15/2014 introduces significant changes to the Certificate of Good Manufacturing Practices and aims to help the new technologies’ registration in Brazil.
First significant change is to validate auditing reports made by third parties  (other regulatory agencies). Also, Anvisa will no longer emit certificates for lower risk products, as gloves, syringes and some surgical devices. Although this measure removes the need for inspection,  it does not change the criteria of effectiveness and security required. Finally, Brazilian Health Surveillance Agency will allow that the protocol of the certificate request is accepted to submit registration applications, maintenance and amendments of highest risk products. This means that a manufacturer will no longer need to wait  for grant of certificate to have an analysis of his products started. With the two processes happening concurrently, the time of arrival of new equipment in the market should be reduced.

References: http://saudeweb.com.br/42867/anvisa-simplifica-processo-de-importacao-de-produtos-de-saude/

Monday, April 21, 2014

Brazilian Health Devices keeps Impressing

Healthcare companies supported by Brazilian Health Devices, and ABIMO’s (Brazilian Association of Medical Devices and Equipment Industry) project, perform better than the national industry as a whole when it comes to exports. In collaboration with APEX-Brasil (Brazilian Trade and Investment Promotion Agency), the 160 medtech companies that participate in the project exported together US$ 190 million in 2012 and their main exports partners were USA, Mexico, Peru, Germany, Venezuela. While the Brazilian industry has reduced imports by 14.8% between 2011 and 2013, the healthcare companies that integrate ABIMO’s project increased their exports by 7.1%.
ABIMO and APEX-Brasil renewed their agreement to keep boosting Brazilian medical and dental devices exports. However, the Brazilian Health Devices’ Manager explained that besides boosting the exports, the Brazilian Trade and Investment Promotion Agency seeks an effective process of internationalization for Brazilian healthcare companies, focusing not only on trade expansion, but also in developing the competitiveness of Brazil.

Monday, April 7, 2014

Increasing Healthcare Costs

According to L.E.K. Consulting, medical device companies are suffering from unprecedented pricing pressures. Recently, the consulting company published the results of a survey with American hospitals’ CEOs reporting that reducing costs is among their top five most pressing needs. Also, the purchasing process has become more complicated and all supplies and new technologies have to go through a value/cost analysis.
Despite cost pressure, most of the hospitals’ CEOs answered that they are interested in buying additional services from medtech companies, especially in clinical IT and analytics, operations management and efficiency, and education, training, and compliance. They want to see medtech firms prove that their solutions can improve the quality of patient care, lower hospitals’ overall costs, or increase the efficiency of their clinical staffs.

References: http://www.mddionline.com/blog/devicetalk/6-threats-and-opportunities-medtech-new-healthcare-paradigm

Monday, March 24, 2014

Supply Chain Strategies for Medtech Companies

Before the senior director of the global supply chain at Edwards Lifesciences’ presentation at MD&M West 2014 Conference in Anaheim, CA, he talked about the theme of his session which was the best practices for medical device companies on supply chain strategies in the face of regulatory, technology, and margin-pressure challenges, as well as legislative changes.
     The senior director explained that innovation is and will always boost medical device companies. However, one shall notice that there is another key factor in the healthcare industry: operational and supply chain efficiencies, which is requiring transformational strategies for managing the supply chain. In addition, regulatory requirements are becoming more detailed and more constraining. At the same time, there are increasing margin pressures and legislative changes. All of these different factors are forcing companies to reevaluate their operations and supply chain strategies.
The senior director advises that innovation is not enough in the face of regulatory forces, legislative changes and margin pressures. In order to remain leaders in the medical device industry, companies should improve quality, lean manufacturing operations, distribution efficiencies, and inventory optimizations. Some areas to be focus on: global sales and operations planning platform, solid manufacturing improvement program (that includes lean manufacturing principles), determining how to introduce new products to the market and supplier risk management.

Monday, March 10, 2014

Outsourcing and Innovation: Medtech OEMs

Outsourcing seems to be an increasing trend in the medical device industry and it’s expected to grow by 40%, reaching US$ 12 billion by 2018. Due to the pressure companies are under to develop devices that offer real value and not just incremental benefit, OEMs are focusing on innovation and core capabilities.
As a result, medical devices companies are asking more of their contract partners, responsibilities from front-end design to back-end services including warehousing, distribution, and regulatory assistance. According to the Millennium Research Group report, “overall trends in the medical device outsourcing space indicate that [contract manufacturers] are broadening their range of services, growing organically or through acquisition to become one-stop-shop manufacturers.”
     Another trend of OEM strategy is no longer to manufacture devices in China or Mexico for distribution in the United States and Europe. Instead, these companies are making products in emerging countries for regional and local distribution.

“To line up with our global customers, who are manufacturing in Asia for Asia, Europe for Europe, and the Americas for the Americas, we need to have capabilities in each of those geographies.”
Phillips-Medisize president and CEO Matt Jennings

References: http://www.mddionline.com/article/medtech-oems-focus-innovation-suppliers-step-their-services

Monday, February 24, 2014

How Medical Device Industry is Failing

In the recent PricewaterhouseCoopers (PwC) report, “Top Health Industry Issues of 2014”, the company declared that the medical device industry is getting back on track, boosted by the Affordable Care Act, technology advances and changing consumer attitudes. However, the medical device companies are still failing in some areas of this new landscape.
According to PwC report, due to the resistance of the medical device companies to show their consumers what they are getting for their money, more than 50% of them don’t think they have enough information on prices when buying medical devices.
Another indicator of PwC report is that less than 15% of the medical technology executives admit their company formally manages innovation. This demonstrates that the medical technology companies should be more concerned in managing their resources and investing in innovation.
The last indicator of “Top Health Industry Issues of 2014” which shows how medical device companies are failing is the waste of patient data. Few companies integrate patient data captured via apps into clinician workflows, electronic health reports and their R&D systems to drive innovation.


Monday, February 10, 2014

Regulations, 3D Printing and IT in Medtech Sector: trends for 2014

      Since the year is just beginning, it is time to make some predictions of hot trends for 2014. One of the most important fact that the medical device sector should pay attention to is the regulatory system in Europe. Some changes proposed by the current EU-Council could impact the industry severely. The next step is to find a compromise that works for all the member states and that should probably happen before European elections in May.
   3D Printing will continue to impress in 2014. Some patents of the technology will expire in February, leading to more competition and lower prices. For the next five years, it is expected to drop 60% of 3D metal printing costs.
     Finally, one cannot forget the influence of information technology in the medical device sector. After the announcement of Calico by Google and researches that are currently taking place by IBM in cooperation with National Cancer Institute of Milan or the Sloan Kettering Cancer Center in New York, digital healthcare is a key trend for this year. With sensors becoming cheaper and more powerful, one will be able to obtain more precise health related data.

Monday, January 27, 2014

2014: A Good Year for the Medtech Sector

JPMorgan Chase Analyst Michael Weinstein believes that 2014 will be good to the medtech sector. This week, the JPMorgan analyst published a research where he says to expect the medtech sector to grow 4.2% this year, up 0.8% from 2013.

“We see growth broadly accelerating in 2014-2015 as an industry that bottomed in 2011-2012 sees the benefits of new products, new markets, and small to mid- sized M&A. This is particularly true in cardiovascular devices, where we see growth accelerating at all three large cap names and ample room for innovation in small-cap, emerging growth companies – both public and private.”

Michael Weinstein

Monday, January 13, 2014

Apple gets a Patent for a Seamlessly Embedded Heart Rate Monitor

Apple was awarded a patent for a seamlessly embedded heart rate monitor within in an electronic device (an iPhone, maybe?). The patent was granted on December 24, although the the application was made in January 2009. The patent describes an electronic device with an embedded sensor to detect cardiac activity and cardiac electrical signals.
However, Apple is not interested in becoming a FDA-regulated entity, so the company’s purpose is to use the heart rate as a way to authenticate a user’s identity or to determine the user’s mood from the cardiac signals and provide data related to the user’s mood. Anyway, it is not inconceivable that there could be medical applications of this heart rate monitor by third parties, already there are companies using the iPhone to build cardiac monitors.