Sunday, May 31, 2015

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.

Sunday, May 17, 2015

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.

Sunday, May 3, 2015

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.