First Industry Trade Group in Asia formed by Big Medical Device Makers

GE Healthcare, Abbott, Johnson & Johnson and Boston Scientific are examples of some of the biggest medical device manufacturers that decided to work together and form the first industry trade group in Asia. The group is called APACMed: Asia Pacific Medical Technology Association and expects that the Asian governments and regulators will take their interests more seriously, since now they are united - which makes their voice stronger.

The region is known for their fragmented market and APACMed CEO Fredrik Nyberg explains that it was important to start working together and form an industry group to more effectively affect change in regulations, treatment guidelines, laws and ethics. APACMed hopes the group will include local companies, since all of the founding APACMed members are western companies. However, their leadership is already speaking with a number of companies in Japan, Korea, China and Singapore, as well as an Indian industry association.

“In some markets, the challenge is in establishing better medical infrastructure like hospital beds and an adequate number of doctors. But in others, the issue is how to train medical professionals on the latest technologies or to get reimbursed for innovative products”, according to APACMed chairman Vladimir Makatsaria.

References: http://blogs.wsj.com/pharmalot/2015/04/23/big-medical-device-makers-form-their-first-industry-trade-group-in-asia/?KEYWORDS=medical+device

3-D Printing Challenges and Opportunities in the Medical Device Industry

Although the medical device industry is already finding growing use for 3-D printing - prototyping and production of finished parts - there are still opportunities for improvement. In a Q&A with Ron Belknap, the president and CEO of ProtoCAM explained the most common 3-D printing mistakes, biggest opportunities and how the medical device industry can take the most out of the technology.

Ron Belknap advises that the most common similarity when things go poorly is lack of preparation: “When clients lack sufficient time, and insist on skipping right to part build, they increase the potential for failure and chance they’ll have to repeat the whole process. Ultimately, taking a very little extra bit of time up front can help guard against adding significant total time to project completion.”  When it comes to challenges, ProtoCAM’s CEO stated that the biggest ones are when companies wait too long before asking for help with their 3-D printed parts.

Regarding opportunities, Ron Belknap said that the biggest leverage is the ability to create parts that would be otherwise impossible with conventional manufacturing processes. “For example, with additive manufacturing, internal passages can be built directly into parts without regard for tool paths, parting lines, assembly, and so forth. This can significantly reduce number of parts, potential points of failure, and manual processes required to create parts.” The president and CEO of ProtoCAM also stated that going over the budget is not something they see very often: 3-D printing “generally has a very high ROI once risk avoidance, duplication of effort, and expedited time to market are factored in.”

Ron Belknap is clearly an enthusiast when it comes to 3-D printing: “A high-precision 3-D printed model will quickly prove a design, or uncover needed design corrections. This allows engineers to spend time on fine-tuning a validated design and avoid potentially wasting time on fine details only to have to replicate the effort after remedying core structural issues. Prototyping early helps guard against such project setbacks, expedites turning the designs over to production, and ultimately increases profitability by speeding time to market.”

References: http://www.qmed.com/mpmn/medtechpulse/how-get-most-out-3-d-printing%E2%80%94and-avoid-rotten-miracles

2014 Statistics of the Brazilian Healthcare Industry

Brazilian Alliance of Innovative Health Industry (ABIIS) - that brings together three entities of the healthcare industry: Brazilian Chamber of Laboratory Diagnosis (CBDL), Brazilian Association of High Technology Equipment, Products and Medical Supplies  (Abimed) and the Brazilian Association of Implant Importers and Distributors (ABRAIDI) - released some 2014 industry statistics.

In regards to international trade, the exports increased by 7.5% in 2014 (reaching US$ 1.1 billion). Meanwhile, imports decreased by 2.23% (reaching US$ 6.9 billion). The Brazilian national production of medical equipment also grew by 8.95% in 2014, according to the Brazilian Institute of Geography and Statistics (IBGE). The Institute also recorded a 9.04% increase of sales of medical, pharmaceutical and orthopedic products. The Ministry of Labor and Employment revealed that the sector created more than 3,000 new jobs (an increase of 6.4% when comparing to the same information of 2013.

According to Carlos Gouvêa, ABIIS’ President, the sector’s performance is better than most other markets. Even though 2015 seems to be a year of economic austerity in Brazil, Carlos is optimistic saying that the demand for medical products is rising because of “the concern of people with healthy habits and early diagnosis, with search to new technologies”.

References: http://www.dm.com.br/economia/2015/03/tres-mil-novas-vagas-foram-criadas-pelo-setor.html

Simple Solutions developed to fight Global Healthcare Problems

Unfortunately, we still face a world full of challenges in regards to healthcare. There are several countries where huge populations suffer from little-to-no infrastructure leading to tortured access to care and poor delivery. However, one can see many technology endeavours attempting to narrow the inequality between developed and developing countries.

According to the Smithsonian Magazine, researchers at Columbia University have developed a chip that can analyze a drop of blood from a finger prick and when plugged into a smartphone test for HIV and syphilis in 15 minutes. The research team believe that this technology could be manufactured for at least $34. The smartphone accessory is small enough to fit in one’s hand and easily powered. This is especially suitable for places like Rwanda, where they already conducted a trial to test for HIV.

Jana Care, based in Newton - MA, in partnership with Continuum, an innovation and design consultancy company, developed another great example of technology trying to narrow the existing healthcare difference around the globe. It’s called Aina: a glucometer, that plugs into the headphone jack of a smartphone and checks blood glucose levels. It was initially developed for a certain socioeconomic lifestyle in India. However, since diabetes is a growing epidemic in emerging countries, the technology could be used in other parts of the world. Diabetes is an expensive and difficult disease to manage. So Jana Care “has created a program by which it offers disease management skills to patients through an interactive reality TV show, mobile app for diet and exercise tracking and support from diabetes educators.”

It’s exciting to see simple solutions tackling big global healthcare problems.

References:

http://www.mddionline.com/blog/devicetalk/Heres-why-global-health-so-exciting-03-04-15

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