A Special Report
• An FDA process that has become “broadly more stringent over the past decade,” according to P&M Corporate Finance; and
• Pricing pressures from Group Purchasing Organiza- tions (GPOs).
Some medical manufacturers may be better equipped to deal with the challenges than others. For example, the largest 10 compa- nies in the medical device industry gen- erate the bulk of the industry’s revenues, but census data suggest that more than half of medical device companies employ less than 20 individuals. Start-up firms, who may be doing the most innova- tive work, will need capital not just to
MEDICAL 2013
MANUFACTURING Supplement to Manufacturing Engineering
research and develop, but to manage a more complex ap- proval process and initial launch phase with new taxes. The new tax, it is worth noting, is applied to top-line revenue, not profits.
Large medical manufacturers have outlined a variety of strategies to deal with the new tax and other financial hurdles, such as reducing capital expenditures, job cuts and passing the extra costs on to hospitals, a goal which may be difficult to execute depending on the negotiating environ- ment for certain devices or equipment.
Despite the challenges, investment is expected to remain fairly constant, as it has for the past 10 years, at between 7 and 9% of revenue, and there are many promising new tech- nologies and trends on the horizon.
Biomanufacturing, nanotechnology and additive pro- cesses hold special new promise in the future. Building or growing a custom device with biological—or living— features is on the horizon. Already, additive manufactur- ing is being used to customize all sorts of features for patients, from dental pieces and prosthetics, to custom- ized molds on which physicians can practice a compli- cated surgery.
The new CAMWorks 2013 Sync Manager simulates a front and rear turret simultaneously machining a part on a multitasking mill-turn machine.
Beyond that, manufacturing software firms continue to expand the reach of their products. Shops can now measure a product before it’s even built by backplotting machining in CAD/CAM, even drilling down to surface finish characteristics. Prototypes also can be tested for performance before they are even built, too, with FEA software that can predict how a material machined, molded or built a certain way will react in certain wind, water, speed or crash conditions.
April 2013 |
ManufacturingEngineeringMedia.com 9 Software
The critical linchpin holding much of this advanced manu- facturing world together is software.
In fact, the manufacturing industry owes much of its productivity gains in recent years not necessarily to new machines and tools, but rather to the software that runs them. Software has long been critical in designing parts and manufacturing them, but it is increasingly important in allowing machines to multitask, complete lights-out opera- tions, alert technicians and executives when something is wrong or is in need of attention. Indeed, without this software, the new world of additive manufacturing would be virtually impossible.
Manufacturing software today goes well beyond traditional CAD/CAM and PLM, although those areas are also growing in capabilities and prowess, with the use of faster multicore and embedded processors and the potential for cloud-based programs. In CAM, for example, developers are perennially adding new toolpath creation capabilities as well as the ability to program machines to do ever-more operations simultane- ously or in one setup.
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