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

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