Executive Brief

The future of medical device manufacturingMeet Baby Boomer demand while controlling costs

HighlightsImprove agility.

Foster collaboration.

Keep up with changing demands.

Lower costs and reduce lead times.

Gain a competitive advantage.

Take advantage of heighteneddemandAs people get older, history proves they will require moremedical care. That has critical implications for the medicaldevice industry, since Baby Boomers (people bornbetween 1946 and 1964) began crossing into the “65 andolder” category in 2011. According to US Census Bureauprojections, the number of Americans who are 65 andolder will double to 88.5 million between 2010 and 2050.¹

Yet despite the increasing demand incurred by agingBaby Boomers, research shows that the medical deviceindustry has been negatively affected by the recent globaleconomic crisis, as well as healthcare reform measuresaimed at cost containment.²

Not only that, medical device manufacturers, suppliers,and service contractors face a complex and changingregulatory environment affecting the development,manufacture, inspection, sale, and maintenance ofproducts. That’s because the FDA continues to changeregulations governing approval of new products,standards for good manufacturing practices, andstandards for maintenance, inspection, and repair ofmedical equipment.

Plus, medical device manufacturers are faced with amedical device tax, patent and intellectual property issues,product liability, rapid product obsolescence, andcompetition from alternative products, such as bone,organ, and tissue replacements.

In order to maintain a heightened state of readiness andresponsiveness, medical device companies such as yoursmust rely more heavily on IT solutions. Withnext-generation ERP systems that include the newestanalytics and tools for collaboration, you can meet BabyBoomer demand while controlling costs.

Gain a competitive advantageUpstart medical device competitors can overtake yourcompany before you realize what happened. But byembracing a couple of key initiatives, you can go a longway toward maintaining a strong competitive position.

Increase agility

Agility in manufacturing means more than increasing theend-to-end throughput that starts with initial programmanagement. Speed is only one factor, although it iscertainly an important component. Agility also dependsupon access to qualitative insights. The ability to adaptand respond to external requirements is a good litmus testfor process modernization. Fortunately, advanced ERPtechnologies simplify these complex processes.

Automatic monitoring and escalation alerts can help youtrack key issues and abnormal events, both internally andwithin your external supply chain. Easy-to-use, real-timereporting and analytic tools help personnel throughoutyour operations monitor their goals, key performanceindicators, and driving factors.

2 The future of medical device manufacturing

With next-generation ERP systems thatinclude the newest analytics and toolsfor collaboration, you can meet BabyBoomer demand while controlling costs.

¹US Census Bureau, The Next Four Decades: The Older Population in the United States: 2010 to 2050, May 2010, p. 1,http://www.census.gov/prod/2010pubs/p25-1138.pdf.

²Frost & Sullivan: “Setting the Stage for What’s Next in Medical Devices,” Sept. 25, 2012, press release, http://www.frost.com.

Improve collaboration

Collaboration tools are another way that ERP technologykeeps up with changing demands. Because organizationsare operating with ultra-lean workforces, “socialenterprise” is more than a buzz phrase—it’s a way toimprove production with synergy and collaborativethinking. Manufacturers and suppliers can take advantageof fully integrated solutions that allow real-timecollaboration and data sharing, including computer-aideddesign diagrams and 3D images.

With seamless connectivity throughout the manufacturingsupply chain, you can maintain tighter version controls,manage ripple-effect changes, track critical escalations,and capture relevant dialogue in context to the product.You’ll be able to track, report, and validate teamdecisions—one of the greatest benefits of an integratedcollaborative system. Because the ERP system documentsdata in terms of the shift, machine, and product, you canreference the content for future decisions, plus reportingand process improvements. This historical documentationproves invaluable when legal or compliance issues arise,such as questions about due diligence, intellectualproperty rights, and change validation or risk mitigation.Nothing is left to memory, guesswork, or chance.

With collaboration tools, you can also speed productintroductions and innovation while reducing risk due topoor cross-discipline knowledge. Greater cooperationbetween design engineers, suppliers, and productionteams helps to speed the entire product developmentcycle, from creative brainstorming all the way throughcosting, testing, and production. For example, your teamscan use collaboration tools to confirm model numbers andensure that correct versions are used on the assemblyline and on scheduled preventive maintenance. They’ll beable to get questions answered immediately, withouttime-consuming, costly delays.

Thanks to instant communication tools, you’ll be able toaccommodate last-minute change orders and shop floorscheduling shifts with minimal disruption to the overallprocess flow.

As a result, you can bring new concepts to market morequickly, responding to shifts in market demand andchanges in regulatory compliance issues.

Sustain manufacturingexcellenceWith Infor® Industrial Manufacturing for Medical Devices,you get the tools you need to meet Baby Boomer demandwhile controlling costs. With a single system, you can trackthe movement of materials and parts from receipt toshipping. You can help ensure that products meet orexceed the standards required by customers andregulatory agencies, because Industrial Manufacturing forMedical Devices includes FDA validation scripting. You’llbe able to safely use electronic signatures, because thesystem complies with Title 21 CFR (Code of FederalRegulations). You’ll also be able to bring products tomarket more quickly, as well as track and manageafter-market maintenance and service.

With Industrial Manufacturing for Medical Devices, you getthe tools you need to:

• Trace lots and serial numbers in the event of recalls.

• Record the history of devices, leading to productimprovements.

• Track customer complaints and help desk interactions,improving customer service.

• Quickly handle the return material authorization (RMA)process, increasing efficiency.

3The future of medical device manufacturing

With Infor Industrial Manufacturing forMedical Devices, you'll be able to bringproducts to market more quickly, as wellas track and manage after-marketmaintenance and service.

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You’ll be able to address the critical challenges you faceevery day, including:

• Supply chain management. Lower costs and reducelead times by integrating your system with the supplychain management systems of distributors andhospitals that need to deliver supplies the same day.Integrate your entire supply chain, from purchasing tomanufacturing to distribution.

• Quality management. Establish, track, and manageevery engineering activity and supply chainexpectation, while supporting business growth andprofitability goals. Create critical manufacturingspecifications for products, processes, equipment, andmeasuring devices, and improve enterprise teamcollaboration with vendors, customers, andemployees.

• Manufacturing control. Make many of your mostcomplex manufacturing processes faster, morereliable, and more profitable with sophisticatedmanufacturing management capabilities.

• Sales and operations planning. Make better planswith relevant, up-to-date information from many sources.

• Native integration. With sophisticated Infor ION®integration technology, you can optimize speed andquality while maintaining strong financial performancefor long-term success. No matter how complex yourmanufacturing scenarios, Infor ION technology canhelp make your sourcing, planning, and production aunified whole.

• After-market service and maintenance. If yousupport your customers with installation, warranties,ongoing maintenance, or break-fix repairs, get thespecialized functionality you need to manage yourservice operation. You’ll be able to better manageservice calls, warranties, service contracts, schedulingand dispatch of technicians, and as-servicedconfiguration tracking.