Brazil’s trend on the healthcare industry

While ABIMO (Brazilian Healthcare, Medical and Dental Equipment Industry Association) doesn’t have the final numbers of the Brazilian healthcare industry for 2015, we can analyze the sector’s trend until the previous year. The industry of medical and dental equipment grew by 9.1%, in comparison to 2013; while the job market grew by 2.3%.

Source: European Medical Device Technology

Due to Brazil’s large population and increase spending on healthcare, the country’s imports on medical devices passed the US$ 1 billion mark. The exports, however, reached US$70 million only. The United States is both the main origin of imports and destination of exports. Followed by Germany, China and Japan in the origin side and Argentina, Mexico and Belgium on the destination side. There’s a huge gap on the sector’s average revenue per unit between imports (US$ 114.99) and exports (US$33.04) - which makes the trade balance even worse.

The bottom line is that Brazil continues to be a great buyer of healthcare products due to its inability to meet its own demand. On the other hand, the country can be a great source of exports due to competitive prices, strong regulatory and intellectual property system.

WIMAS 2015: International Workshop on Additive Manufacturing for Healthcare

WIMAS (International Workshop on Additive Manufacturing for Healthcare) took place in Campina Grande, Brazil from November 18-20^th. The event gathered together representatives from several different sectors interested in applying additive manufacturing (commonly known as 3D printing) in healthcare. Among the guests, there were people from the academy like researchers from IME  (Military Institute of Engineering) from Rio de Janeiro, NUTES (Center of Strategic Technologies for Health) and the team from the Sao Paulo-based Renato Archer Institute. There were also representatives from regulatory bodies like ANVISA (Brazilian Health Surveillance Agency) and the FDA; public institutions like the Ministry of Health and the SENAI Innovation Institute. Besides people from the private sector and companies like URI Medical and Biokyra.

      During the event, it was discussed relevant strategic issues for the application of the technology in healthcare as the development of protocols throughout the model building process, from segmentation of the medical image, i.e. regulate programs that make this process, until the manufacturing process used for materialization of the implant or biomodel, besides the form of sterilization and the risk ratings for each 3D printed product.

In addition to the round discussions, Biokyra had the opportunity to present the surgical cases that have recently been done and the products that are being developed within the company.

The future of medical device startups

The panelists from a Tuesday panel of Silicon Valley–based medical device entrepreneurs at BIOMEDevice San Jose conveyed the clear message that the venture funding for medical devices has dried up, but opportunities abound in the medical device space. One of them is Kathy Stecco, the co-founder and chief medical officer of Panthera Medtech, a startup acquired by Avantec Vascular Corp. (Sunnyvale) – that had 20x return without any venture capital backing.

“I am pushing people away from the VC route. The more you can bootstrap and look for alternative funding, the better it tends to be for the long-term growth of your company,” said Stecco.

According to Kathy Stecco, many medical devices could be developed by small teams of self-financed rogue entrepreneurs working with a team of consultants. “If you have a 510(k) device, you can often self-fund your device. Go shopping at Fry’s Electronics, build your prototypes, do your testing on your own—do whatever you can on your own,” she said. “It is doable to get a 510(k) by yourself—especially if you don’t need clinical trials. You can either use your own financing or apply for grants to help with funding.”

Tom Ross, CEO of Pontis Orthopaedics, suggested that medical device startups grow their team based on how far the technology is from commercialization. More established companies might need more full-time support. The route of a startup can change, requiring more consultants than full-timers.

It is beneficial to frequently look for third-party insights from people who are not personally interested in the startup’s growth.  

Brenneman, CEO of Rox Medical, recommended that startups look for funding overseas. “There is a lot of money coming out of China right now,” he says. “It comes with big strings attached, but there’s a lot of funding there. ... There’s also some off-shore money coming from Europe into the U.S. market. If you are going long and have a PMA device, you might consider that.” When considering Chinese money, it is a great idea to get Chinese patents, says Joel Harris, senior director of intellectual property at InCube Labs (San Jose). “It used to be that people didn’t take the Chinese patent system seriously, but it is increasingly important. China is now part of the WTO. Any Chinese partners are going to want to see that patents are filed there,” he said. “Just keep in mind that when you file in various foreign jurisdictions, it can get very expensive.”

Biokyra is a medical device company based out in Brazil that started off as a startup. It develops minimally invasive medical devices, from the idea/need to the pre-series production.

3D printing helps high-risk surgery in Brazil

China and the west have been constantly showing us how 3D printing makes life-threatening and complex procedures much safer. However, this is happening elsewhere too. A team of surgeons in Blumenau, South of Brazil, has used 3D printed medical models to increase the probability of success of a surgery on a six-year-old girl suffering from orbital hypertelorism.

3ders.org

It was a complex and high-risk operation because the doctors were forced to work in an area close to lots of vital organs and blood vessels. The team therefore decided to develop a 3D printed model of the girl’s skull in order to prepare for the surgery. The replica was also at hand during procedure and definitely contributed to the six-hour surgery’s success. One of the doctors explains. ‘After spending some hours studying the 3D printed skull, we practiced the crucial bone incisions on it and also used it as reference during the actual surgical procedure. Having a model to manipulate, as an addition to the imaging exams, was very important for the success of the final result.’

The surgeons were very satisfied with the 3D printing model and have already ordered the next one for a forthcoming spine reconstruction surgery, which will give the patient a few extra centimeters in height.

“MRI images and CT scans were used to make this medical model, which took 57 hours to 3D print. Finishing work to ensure complete accuracy took another 16 hours, and all the work was outsourced to the Brazilian-based 3D printing service bk3D. According to the company’s managing partner, this is just one of the ways in which 3D printing can be used to improve medical practices. ‘There are numerous possibilities for 3D printing to aid healthcare, from surgical procedure planning to the replacement of entire bioprinted organs. We still have a long way to go, but it is already possible to enjoy the benefits that engineering offers,’ he said.”

As 3D printing is already being used to save lives, we can only hope it will become common in every hospital around the globe.

Updates of Medical Device Regulatory System in 5 Major Markets

As the world does not agree on a harmonized medical device regulatory system, manufacturers face different scenarios in terms of market entry, registration requirements and compliance issues to be able to sell their products in foreign countries. Therefore, it’s important to monitor regulatory updates in major markets.

Brazil: ANVISA (Brazilian Health Surveillance Agency) has shown intentions to make market entry less burdensome—both externally for Brazilian market registrants and internally. Early this year, the government passed a new law, which allows ANVISA to do the following:

• Expand validity timeframes for some medical devices by up to 10 years.
• Accept quality management inspection reports conducted by other regulators.
• Expand certifications of laboratories authorized to conduct inspections and postmarket surveillance activities.
• Revamp requirements for registration transfers.

ANVISA must still develop its own regulations to take advantage of the new law. However, the regulator is now fully authorized to streamline the country’s device registration process. ANVISA has also extended its deadlines for technical requirement responses: registrants now have 120 days, rather than 90, to respond to ANVISA inquiries. Brazilian clinical testing rules for medical devices have also been harmonized more closely to those of international standards.

India: Although a comprehensive regulatory system has not yet been implemented, the Indian government has adopted significant actions to launch a more substantial medical device regulation. The government has proposed the creation of a new regulatory body, the National Medical Devices Authority (NMDA), a step towards a more strong regulatory system, which would provide transparency and predictability.

China: Despite recent initiatives towards a more structured and transparency to the registration process, China’s medical device regulatory system remains complicated and expensive. China Food and Drug Administration (CFDA) has formalized and clarified clinical trial requirements for medical devices and even established a process similar to FDA's substantial equivalence that can waive clinical trial requirements for qualifying devices. However, medical device registration fees have increased substantially in 2015. In many cases, it’s more expensive to bring a device to market in China than in the United States.

Japan:  The Pharmaceutical and Medical Device Law (PMDL), which replaced the country’s longstanding Pharmaceutical Affairs Law (PAL) last year, has impacted all aspects of the registration process. PMDL allows Japanese market registrants to utilize third-party certification from Registered Certification Bodies instead of Pharmaceutical and Medical Devices Agency (PMDA) reviews. There is also a new pre consultation program for manufacturers beginning their Japanese registration efforts.

South Korea: The Ministry for Food and Drug Safety (MFDS) has already introduced a new pathway that requires Korean Good Manufacturing Practice (KGMP) certification earlier in the registration process. MFDS has also suggested other changes to be implemented over the next months. The ministry is also planning to regulate in vitro diagnostic devices as medical devices rather than pharmaceutical products, which manufactures will have to ensure compliance under the South Korean Medical Device Act instead of the Pharmaceutical Affairs Act and comply with KGMP. Low-risk device market pathways in South Korea are also scheduled for reform.

References: http://www.mddionline.com/article/global-regulatory-update-2015-07-28-15