Medtronic investing in the Endovascular Business

It seems like Medtronic is interested to continue investing in aortic and peripheral vascular business, since it has been among its fastest-growing divisions for the past five years. The company has already disclosed an investment in Arsenal AAA, a subsidiary of Arsenal Medical - which develops technology to avoid complications linked to endovascular aneurysm repair (EVAR) procedures.

A few days after the announcement of this investment, Medtronic revealed its acquisition of Aptus Endosystems – maker of two FDA-cleared fastening devices and a steerable catheter for delivery of peripheral vascular products, which Medtronic will distribute. This statement was made during the Society for Vascular Surgery’s annual meeting.

    In a press release, the company said that these two investments were “demonstrations of Medtronic’s’ commitment to leadership in the Aortic space.” According to ReportsnReports.com, the market for aortic stent grafts is expected to increase at a compound annual growth rate of 6.7% until 2020, when it is expected to reach $1.9 billion. The market research company still states  “Despite the high product price, physicians still see a significant benefit in providing endovascular options ahead of performing open surgery”.

References:

http://www.mddionline.com/article/medtronic-moves-advance-aortic-business-06-19-15

Medical Devices: From Concept to Launch

Integrated Technologies Ltd (ITL) - a global medical device product development, product design and contract manufacturing service company - has recently published an infographic that displays the entire product development cycle, from concept to commercialization and product launch.

Source: qmed.com - Infographic: The Journey from Idea to Commercialization

The infographic intends to show the development steps of a product, within a contract manufacturing company. But the process can also be replicated at large medical device companies that manufacture their products by themselves. At the bottom, one can see the early stages: idea, market research, business plan, funding round. Then comes the fun part for medical engineers: product development, product design, clinical trials. When the product is ready to be launched, marketing and sales have to do their part: commercialization.

As for post-market, Integrated Technologies Ltd listed steps such as after-sales support, obsolescence mitigation, further product development and manage regulatory change (especially true for medical devices!). The infographic also shows stages of the development of a product range, entering new markets/countries, IPO or technology transfer.

As a Brazilian-based biomedical engineering company that provides services from the idea to the pre-series production, Biokyra works to support all the stages of the project and minimize the risks of it. Our goal is to make your idea become an innovative and successful product.

References: http://www.qmed.com/mpmn/medtechpulse/infographic-journey-idea-commercialization

Foreign Capital Investment in Healthcare: China, India and Brazil

A report by the World Health Organization (WHO) on healthcare financing systems for universal coverage of 2010 suggests discussing innovative ways to increase health investment funds at a global level.

As an example of change in the entire healthcare management system is China, which has pledged by 2020 to provide health services "safe, effective, convenient and affordable" to all urban and rural residents with "a medical clinic and a hospital in each region of the country". In addition to the US $ 124 billion initially invested to restructure out-dated services, the government authorized foreign capital investment across the Chinese healthcare market, including tax incentives in some cities.

India’s situation is similar to Brazilian’s reality: lack of healthcare professionals and poor infrastructure. In 2007, the strategy to raise more money, and restructure healthcare, has allowed foreign capital investment in hospitals, which brought benefits to the country, according to a report by Rupa Chanda, published by the World Health Organization.

Brazil has recently changed the law nº 8.080/1990 and now authorizes foreign capital investment in hospitals.

References: http://saudebusiness.com/noticias/investimento-de-capital-estrangeiro-ja-muda-a-realidade-de-china-e-india/

http://saudebusiness.com/noticias/capital-estrangeiro-em-hospitais-como-alternativa-para-as-instituicoes/

The next Big Trend in Medtech: Contract Development

The medtech industry is going through some fundamental transformation. This is especially true when it comes to pricing pressure and the companies’ dilemma on how best to use R&D capital. Paul LaViolette, managing partner and chief operating officer of SV Life Sciences Advisers explained "I used to spend 9% of sales on R&D. I can’t do that anymore because I am investing in growth drivers that are not technology related, so I am reducing my R&D as a percentage of sales". He also realized that companies are using some of the R&D budget on maintaining market leadership in areas they already excel in.

And the next big medtech trend is related to it: "If you look at the big outsourcing trends over the last 10 years, it was contract manufacturing. I think the big trend in the next 10 years is going to be contract development”. Now, contract development companies developed engineering talent that is as good as what large companies have. LaViolette added that going the contract development route is also cost effective for medtech companies.

"Why should I hire 20 FTEs (full-time equivalents), put them on my benefits program, my retirement program, everything else when I can contract that out if I have faith that the contracted strategy can deliver the same benefit?” he asked rhetorically. "If it works out well, it can be part of my long term franchise strategy. Then I'll hire internal resources to support it."

However, LaViolette made it clear that “contract development allows companies to share the risk of developing new programs where they don't have the engineering skill sets internally.” Medtech companies are not going to do that if they are already the market leader.

References: http://www.mddionline.com/blog/devicetalk/The-next-big-trend-medtech-05-21-15

Best Applications of 3-D Printing in Medical Devices

The medical device industry is adopting 3-D printing for several applications. But what are the best uses for this type of technology today? The best 3-D printing medical device applications include external wearable devices, clinical study devices, and orthopedic implants.

External wearable devices are suited for 3-D printing because they are usually customized to fit each individual. This devices are attached to the outside of the patient and can be made much larger or thicker than surgical devices or implants. Biocompatibility requirements can be evaluated by ISO 10993-1. These devices fall within the “surface device” category with skin contact limited to unbreached skin. The amount of experimental testing needed depends on the biocompatibility information available for the materials used and the ones used in the fabrication processes. Initiatives like the Biocompatibility Consortium for Additive Manufacturing are underway to help create standards for assessing and validating 3-D printing processes.

Clinical study devices are suited for 3-D printing as well, where build quantities are low and design changes after evaluation are likely. “For a device with multiple components, 3-D printing offers a cost effective way to create clinically usable parts without the cost ($10,000–$30,000+) and development time (4–8+ weeks) of injection mold tools.”

Orthopedics and dental are another type of area where 3-D printing found excellent adoption.  A key performance aspect of orthopedic implants is fixation in the bone. The benefits with additive manufacturing are that the effective porosity and the thickness of the ingrowth area can be controlled throughout the build and the manufacturing completed all in one process.

References: http://www.mddionline.com/blog/devicetalk/top-3-medical-device-applications-3d-printing-05-01-15

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