Mobile Medical Apps and the FDA’s Regulations

Last month, the FDA (Food and Drug Administration) issued final guidelines regarding mobile health apps regulations. The agency stated that it would not regulate apps that don’t threaten users if they fail. The mobile apps that pose a threat are the ones that would ““transform a mobile platform into a regulated medical device by using attachments, display screens, sensors or other such methods,” said the FDA. The guidance reinforce their intentions to not regulate technologies that receive, transmit, store and display data from medical devices.

The guidelines came a few weeks after the FDA authorized the first set of mobile health apps, “including one that allows the remote monitoring of glucose levels in people with diabetes. The application allows real-time data sharing from a continuous glucose monitor via an iPhone.” The agency also approved a mobile app that aims to diagnose head injuries on the battlefield, which was developed by AnthroTronix for the US Department of Defense with funding from the US Navy Bureau of Medicine and Surgery and a Rapid Innovation Fund award by the US Army.

The FDA’s acknowledgment on this matter represents, not only an achievement for the medical app industry, but an accomplishment for the healthcare workers and patients. The two previous examples prove how an app can help the medical industry. In the United States, more than 60% of the population owns a smartphone. In Brazil, 84% of the population has a mobile phone and about 36% of which have a smartphone. In the medical profession, this number is even higher. In Brazil there are some legislative peculiarities that prevent several advances, such as telemedicine.

References: http://www.empreendersaude.com.br/como-foi-a-evolucao-da-mhealth-nos-ultimos-cinco-anos/

http://gcn.com/articles/2015/02/20/fda-app-regulation.aspx

Arab Health and Brazilian Health Devices: Numbers and Results

Arab Health happened in January 26-29, 2015. 42 Brazilian companies participated at the event supported by the project named Brazilian Health Devices, which is promoted by the Brazilian Industry Association of Medical Equipment, Dental, Hospital and Laboratory (ABIMO) and Brazilian Agency for Export and Investment Promotion (Apex-Brasil).

            According to ABIMO, Arab Health is now known to be the second biggest healthcare trade fair in the world and the biggest in the Middle East. There were more than 4 thousand exhibitors, 120 thousand guests from more than 150 countries. The bottom line is Brazilian companies were not doing business exclusively with the Middle East, since the fair has become a global networking venue. The companies are expecting a US$ 21 million in business as a result of the fair.

References: http://www.abimo.org.br/modules/news/article.php?article_id=529

According to the Industry, the FDA has remarkably improved

PricewaterhouseCoopers (PwC) released a report last month showing the healthcare industry’s perception of the Food and Drug Administration (FDA). Following what was heard and seen during the annual conference of AdvaMed last October, the report demonstrated that 78% of the life science industry executives believe that "the FDA has improved the quality and frequency of its communication in the past two years." Entitled "FDA and Industry: A recipe for collaborating in the New Health Economy," the report interviewed 100 senior executives from the healthcare industry.

The FDA improved in several ways. The great majority of the executives responded that the agency provided actionable feedbacks and offered more "applicable guidance, rules and regulations”. Another interesting point showed by the report is the direct correlation between participating in meetings with the FDA at key moments during clinical development or before submitting an application and how good the relationship is between the agency and the healthcare companies.

References: http://www.mddionline.com/blog/devicetalk/its-official-industry-finds-fda-greatly-improved-1-26-15

Reasons why 3D Printing Will Control the Medtech Industry

According to Rob Richards, business development manager for Orchid Design (Shelton, CT), which is part of Holt, MI–based orthopedic contract manufacturer Orchid, 3-D printing could soon catch on for manufacturing medical devices. Richards points out that, despite the arguments that one cannot achieve the economies of scale possible through more traditional manufacturing methods, several of devices are not manufactured in the same quantity as in traditional sectors. Besides, some of them exhibit a level of  complexity that would be much more expensive to manufacture through traditional techniques.

Several other  advantages of 3D printing were defended by Richard such as its capacity of being customized, precision and biocompatibility: “The internal geometries and structures are also enabling more biocompatible, porous materials that could allow orthopedic and other implanted devices to have enhanced properties such as promoting bone growth”.

Finally, Richards states that 3D printing is already getting more accurate, faster and cost is getting lower. “It’s only going to get faster and cheaper.”

References: http://www.qmed.com/mpmn/medtechpulse/6-reasons-3-d-printing-will-take-over-medtech?cid=sm.qmed.site.qmedsocial&hootPostID=50c7322d1c83622835b281ae1c99c51c

Rethinking 2014: Planning 2015

When rethinking about 2014, some consulting companies already have stats that show how the medtech industry performed last year.

Source: mddionline.com

            The results show a solid industry, with more than $380 billion worldwide sales, 5% sales growth rate and almost 10% of return on investment.

            As for 2015, the industry in the United States is still adjusting from the new tax on their medical device sales and the European sector is suffering from its internal pressure (see our last blog entry). So it seems like emerging markets are still an attractive type of investment: Asia represents more than one-sixth of the world’s medical device market and one should expect a double-digit growth in markets such as Mexico, Brazil and Malaysia thanks to increasing healthcare spending. “Expect more device companies to focus on these import-heavy markets, with Latin America and the Middle East as the most important growth sources for medical device manufacturers.”

References: http://www.mddionline.com/article/how-did-medtech-stack-2014-12-19-2014

http://www.mddionline.com/article/state-global-medtech-markets-12-19-2014

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

References: http://www.medtecheurope.org/key-themes/industry-strategy

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.

References: http://www.qmed.com/mpmn/medtechpulse/4-consumerization-strategies-medtech-need-learn-fast