|Exam Name||:||Foundation Bridge IT Service(R) Management ISO/IEC 20000|
|Questions and Answers||:||59 Q & A|
|Updated On||:||April 23, 2019|
|PDF Download Mirror||:||Pass4sure EX0-110 Dump|
|Get Full Version||:||Pass4sure EX0-110 Full Version|
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EX0-110 exam Dumps Source : Foundation Bridge IT Service(R) Management ISO/IEC 20000
Test Code : EX0-110
Test Name : Foundation Bridge IT Service(R) Management ISO/IEC 20000
Vendor Name : Exin
Q&A : 59 Real Questions
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What's occurring within the West Island and Off-Island
Mike Paterson should be a part of the Pearson academic groundwork benefit Comedy reveal on April 5 in Lachine. Tickets $25. Dario Ayala / Montreal GazetteGalleries and exhibitions
Galerie Plus, 448 leading Rd. in Hudson, items the exhibition Cityscapes via Heather Dubreuil starting April 3 with a vernissage from 5 to eight p.m. Continues unless can also 5. call 450-458-1319.
Galerie de la ville, 12001 de Salaberry Blvd. in Dollard-des-Ormeaux, items a name-for-entry exhibition exploring “the doll” and “the doll residence” as significant own or creative objects, or as important social subject matters or concepts. Continues except April 20. call 514-684-1012, native 298.
Kirkland Library, 17100 Hymus Blvd., presents the exhibition vibrant Moments through artist Doina Falcon that continues except April 17. call 514-630-2726.
Stewart corridor paintings Gallery, 176 Lakeshore Rd., Pointe-Claire, gifts the exhibition plants and Monsters — contemporary works by way of Montreal artists Ari Bayuaji and Hua Jin. Continues except April 28. call 514-630-1220, native 1778.
Dorval Museum of local historical past and Heritage, 1850 Lakeshore Dr., Dorval, gifts the exhibition Hockey Cup history which captures the genuine spirit of Quebec and it’s passion for hockey. Continues except April 21. Museum is open Thursday to Sunday from 1 to four:30 p.m. Free admission. name 514-633-4314.
Montreal Aviation Museum on McGill tuition’s MacDonald campus, 21111 Lakeshore Rd. in Ste-Anne-de-Bellevue, is open to the general public Saturday-Tuesday from 10 a.m. to 3 p.m. call 514-398-7948 or visit cahc-ccpa.com.Arts and letters
Maudie. Ciné-paintings film presentation on Thursday at 7 p.m. at the Stewart hall artwork Gallery, 176 Lakeshore Rd. Free. call 514-630-1254.
Lean on Pete. Hudson Village Theatre presentation on Thursday at 7 p.m. at Hudson Village Theatre, 28 Wharf Rd. Tickets: $20, proceeds improvement A Horse Tail Rescue. discuss with ahtrescue.org/en/film-nighttime/.
The Dollard Centre for the arts, 12001 de Salaberry Blvd. in Dollard, dangle a free drop-in paintings HIVE for adults and seniors on Friday and Saturday from 1 to 4 p.m. are attempting out artwork material, share capabilities, be taught, train and play. No event quintessential. materials supplied. call 514-684-1012, local 213.
Dawson Comedy night with headliner Bowser and Blue and opening acts Rodney Ramsey and Amanda McQueen on Saturday at 7:30 p.m. on the Dawson faculty Theatre, 2000 Atwater Ave. Tickets: $forty five consist of wine and cheese after the display. seek advice from dawsoncollege.qc.ca.
Louisana: a world aside. go back and forth lecture with Marc Laberge on April 4 at 7 p.m. on the Pointe-Claire Cultural Centre, 176 Lakeshore Rd. Free, but passes required. call 514-630-1220, local 1774.
Pearson educational basis benefit Comedy exhibit with Mike Paterson and his humorous americans on April 5 at eight p.m. at Lakeside Academy, 5050 Sherbrooke St. in Lachine. Tickets $25. talk over with //pef.lbpsb.qc.ca or call 514-forty two-3000, native 37000.
homicide secret Dinner Théâtre — A Midsummer’s Nightmare: Faeries and Foul Play written via Steve Gillan. five performances: April 6, 13, 20, 27 and can 4 at 6 p.m. at Dorval-Strathmore United Church, 310 Brookhaven Ave. Tickets: $40, $35 for seniors/students, contains a 4-direction dinner and reveal. to order, call 514-793-9879 or electronic mail firstname.lastname@example.org.
Artists’ Circle West Island. in case you get pleasure from painting or drawing and would like to meet different artists within the area, meetings are held the third Tuesday of every month at 7 p.m. on the Pierrefonds Cultural Centre. art demonstrations, refreshments and a chance to share ideas and learn new innovations. For more assistance go to the facebook web page Artists’ Circle West Island or consult with artistscirclewestisland.ca.song
Jazzing It Up! The Beatles and film track. The Marcel A Trio performs on Saturday at 7:30 p.m. on the Church of St. Columba via-the-Lake, 11 Rodney Ave. in Pointe-Claire. Donation: $15, free for toddlers. visit //stcolumba.ca/song/concert-collection/
Isabelle David and Yolanda Bruno: heart to coronary heart. Classical live performance on Sunday at three p.m. on the Pointe-Claire Cultural Centre, 176 Lakeshore Rd. Free, however passes required. call 514-630-1220, local 1774.
an evening on the Opera: an evening in Venice with internationally acclaimed tenor Manrico Tedeschi on April 12 at 7:30 p.m. at the Pointe-Claire Cultural Centre, 176 Lakeshore Rd. Free, but passes required. call 514-630-1220, native 1774.
Mark Broady – AKA 2nd thought – Charity Rap concert with proceeds to the West Island girls’s guard on April 18 at 5 p.m. at Calistoga Grill, 235 St-Jean Blvd. in Pointe-Claire. Tickets: $50. to order, call 514-630-7577.
Briarwood Presbyterian Church Choir is trying to find choir members for its 10 a.m. Sunday provider. You do not should be part of the church, all you want is a love of singing. call 514-695-1879.Self-help and help
AGI’s Carers within the Kitchen — Cooking sequence. Cooking sequence introduced by means of the Alzheimer Groupe (AGI), computer Cooking faculty and L’Appui – 6-sessions starting April 3 and carrying on with to may additionally 10 on Wednesdays and Fridays from 10:forty five a.m. to 1 p.m. at Provigo Le Marché Pierrefonds, 4849 St. John’s Blvd. charge $5 per session or $30 for the sequence. limited registration. call 514-485-7233.
West Island Palliative Care house Bereavement neighborhood classes. Afternoon grownup community (French) on Wednesdays from 1 to 3 p.m. (April 10 to may also 29); evening grownup group (English) on Thursdays from 7 to 9 p.m. (April eleven to may additionally 30); Afternoon grownup group (English) on Thursdays from 1 to three p.m. (April eleven to may 30). All are welcome. To register or for extra information, name 514-693-1718, local 231 or e-mail email@example.com.
living With Arthritis. A sequence of five interactive/informal advice periods to study the coping potential and tips for arthritis and persistent ache introduced by AWISH Montreal beginning in April at the Beaconsfield Library, 303 Beaconsfield Blvd. To register and for more information, name 514-631-3288 or e-mail firstname.lastname@example.org.
Low imaginative and prescient Self-aid association meets on April 10 at 1:15 p.m. on the Church of St. John the Baptist, 233 Ste. Claire Ave. in Pointe-Claire. Constable Liliana Bellucci from SPVM Station 5 will speak on protection and Crime Prevention. Free. discuss with LowVisionSelfHelpAssociation.weebly.com or name 514-626-2649.
activity for Arthritis. night recreation for arthritis and persistent ache with fitness and circulation professional offered with the aid of AWISH on Mondays from 6 to 7 p.m. from April eight to June 7 at the Sarto Desnoyers group Centre, 1335 Lakeshore pressure in Dorval. To register, call 514-631-3288 or electronic mail email@example.com.
Overeaters anonymous, a 12-step restoration community for compulsive overeaters, anorexics and bulimics. No weigh-ins, dues or charges. Weekly meetings at numerous areas. call 514-488-1812.
ANEB — open aid group for americans (aged 17+) affected by an ingesting disease and their spouse and children. Open to these plagued by an consuming ailment or dwelling with an obsession of their body graphic, in addition to guide corporations for their household. The corporations are exclusive, freed from can charge and require no registration or long-time period dedication. they are offered in English, on the West Island. talk over with anebquebec.com/en/capabilities/groupe-de-soutien-ouverts.
grasp – Grief recovery After a Substance Passing. A free peer aid group for people grieving the loss of a friend to substance abuse meet each Wednesday from 7:30 to 9:30 p.m. in Beaconsfield. To register, name 514-898-1220 or e mail firstname.lastname@example.org or visit grasphelp.org.
LGBTQ2+ adult & Seniors supper open to grownup and seniors who are questioning their gender id or sexual orientation every Thursday from 4 to 8 p.m. at Beaconsfield United Church, 202 Woodside Ave. consult with http://www.lgbtq2centre.com.
Al-Anon family unit companies. Compassionate support for household and friends of alcoholics. if you're bothered via a person else’s drinking you can find aid and hope in a pleasant, supportive atmosphere with many assembly on the West Island. call 514-866-9803, electronic mail email@example.com or talk over with alanonalateenqcouest.org.
adult ADHD guide neighborhood — West Island. For adults and their family who've ADHD. They meet every 2d Thursday at 7:forty five p.m. name 514-773-9815 or email firstname.lastname@example.org.
TOPS (Take Off kilos Sensibly) is a low cost non-profit organization that helps with weight-loss assist. They meet each Wednesday at 7 p.m. at Cedar Heights Park Chalet, 20 Robinsdale Ave. in Pointe-Claire. talk over with tops.org.
West Island melanoma well being Centre. acquire compassionate help and participate in classes comparable to yoga, massage remedy, counselling, and more, for free. They work together with your health care professionals to enrich your well-being and their functions help you manipulate the emotional and physical challenges that come from a cancer diagnosis. Open Monday to Friday from 8:30 a.m. to four p.m., apart from on Wednesdays they're open unless eight p.m. at 115 Du Barry St. in Kirkland. consult with wicwc.org or call 514-695-9355.
New moms aid group, provided by using the West Island girls’s Centre, meets on the first Tuesday of each month from 1 to 3 p.m. at St. Columba-by way of-the-Lake Church, eleven Rodney Ave. in Pointe-Claire. free of cost. Free childcare available. To register, name 514-781-8529.
Gamblers anonymous offers assist to anybody suffering from a playing problem. name 514-484-6666 or consult with gamontreal.ca.
household useful resource Centre, a non-income company designed to support babies age six to 25, fogeys and gurus, offers a lot of features to assist formative years who have social, tutorial and behavioural difficulties. They offer one-on-one social and study potential programs to aid toddlers boost necessary advantage if you want to allow them to attain their full knowledge. community codecs provided each Tuesday from 4:30 to 6 p.m. in Pierrefonds. For more information, name 514-685-5912.
Literacy unlimited, a neighborhood firm committed to empowering adults via more desirable literacy, offers free, exclusive, one-on-one tutoring in studying, writing and fundamental laptop knowledge. call 514-694-0007 or visit literacyunlimited.ca.
Lou Gehrig’s ailment — SLA/ALS family Caregiver support community meets the primary Monday of each month from 6 to 8 p.m. offered via NOVA West Island. name 514-695-8335, local 209.
Compassionate pals, a world self-aid, non-income corporation, offers friendship, realizing, grief education and hope for the long run to all bereaved folks. The Montreal chapter meets the primary Tuesday of each month. discuss with TCFCanada.net or call 438-257-0881.
seem respectable, believe superior. Free beauty and hair workshops for ladies dwelling with melanoma on the primary Monday of the month at the Lakeshore everyday sanatorium. To register, call 514-630-2225, local 1451.Communicaid for listening to Impaired persons (CHIP) offers carrying on with classes, features and guide for individuals affected by hearing loss in the more advantageous Montreal enviornment and the West Island. For greater assistance name 514-488-5552, local 4500 or consult with hearhear.org. health and circle of relativesSpring Into wellbeing reasonable on Saturday from 10 a.m. to five p.m. on the break inn Pointe-Claire, 6700 TransCanada. up to 50 exhibitors to assist enhance your wellbeing. Free admission. Workshops and conferences via well being gurus offered for a small charge. seek advice from wicwc.org. activities and pursuits
The Lakeshore creative Stitchery Guild presents courses in a lot of embroidery ideas and in any respect ability ranges on Thursdays from 9:30 a.m. to 3 p.m. at the Centre Noël Legault, 245 Lakeshore Rd. in Pointe-Claire. friends and new contributors welcome. seek advice from lcsg-gtal.ca.
activities, undertaking and Volleyball. every Monday and Thursday from eight to 10 p.m. at St. Charles basic college, 4331 Ste-Anne St. in Pierrefonds. 15 minutes of jogging, 1/2 hour floor recreation adopted by means of one hour of blended volleyball. Non-income, price for condo of gymnasium is $15/month. call 514-620-9259.Seniors
Line Dancing classes provided via West Island Kirkland each Tuesday at midday (inexperienced persons) adopted by using the advanced class at 1 p.m. at 16950A Hymus Blvd. in Kirkland. charge: $5, $four for members. name 514-694-2434 or electronic mail email@example.com.
Cummings West is retaining spring registration daily from 9 a.m. to 4 p.m. at ninety four Roger Pilon Blvd. in Dollard-des-Ormeaux. lessons, classes, social businesses, particular hobbies and lectures all designed for the 50+. call 514-343-3510 or cummingscentre.org.
Senior men’s Contract Bridge each Tuesday from 1 to 4 p.m. on the Edwin-Crawford home, 35 Maywood Ave. in Pointe-Claire. can charge: $5. No companion or dedication required. call 514-697-4159.
Kirkland fifty five+ club duplicate Bridge each Wednesday at 12:30 p.m. at 16950A Hymus Blvd. in Kirkland. relaxing and enjoyable afternoon enjoying bridge. call 514-694-2435 or email firstname.lastname@example.org.
Single Seniors Breakfast each Sunday from 8 to 10 a.m. at Brasserie Le Manoir (nook of Hymus and St-Jean Blvd.) Breakfast and exchange with other single seniors. You pay on your own breakfast.and so forth.
Christ Church Beaurepaire Lenten Lunches each Wednesday (unless April 17) from 11:30 a.m. to 1 p.m. at 455 Church St. in Beaconsfield. home made soup served with bun, cheese, dessert, tea/espresso. Tickets: $eight. visit christchurchbeaurepaire.com.
Animatch meet and greet on Saturday from eleven:30 a.m. to 2:30 p.m. at Animo and so forth., 204 Dorval Ave. in Dorval. consult with animatch.ca.
household spaghetti supper and quiz evening on Saturday from 6 to eight p.m. at Briarwood Presbyterian Church, 70 Beaconsfield Blvd. Freewill offering for AMCAL.
Hudson struggle Memorial Library booklet sale starts Monday at 2:30 p.m. and continues unless April 6 at 2 p.m. at 60 Elm St. in Hudson.
in the Spirit of Advocacy — West Island Citizen Advocacy Annual Wine Tasting Fundraiser on April eleven from 6:30 to 10 p.m. at the Sarto Desnoyers group Centre, 1335 Lakeshore Dr. in Dorval. Tickets: $100. visit volunteerwica.com or name 514-694-5850.
Ham supper on April 13 at 6 p.m. at Valois United Church, 70 Belmont Ave. in Pointe-Claire. Ticket: $20, $10 for children beneath 10 years. to reserve, call 514-695-5014.
Boutique 24 Thrift store presents apparel, household articles, jewellery and books every Thursday from eleven:30 a.m. to 3:30 p.m., and on the ultimate Friday of each month from 6 to 9 p.m. and Saturday from 10 a.m. to 2 p.m. at Adair corridor, 24 Maple Ave. in Ste-Anne-de-Bellevue. Donations welcome. call 514-453-2902.
Thrift shops for NOVA offer garb for the whole family unit, shoes, books, family unit gadgets, earrings, and so on. Thrift store and used book place, 43 Ste-Anne St. in Ste-Anne-de-Bellevue. name 514-457-1642. Thrift shop at 2750 St-Charles Blvd. in Kirkland. call 514-697-6692. furnishings and Used publication Thrift shop, 449 Beaconsfield Blvd. in Beaconsfield. name 514-694-8417. Boutique NOVA in Plaza Pointe-Claire. Boutique NOVA Hudson, 455 main Rd. and a 2nd new vicinity 538 leading Rd. in Hudson. call 450-202-6682. All are open from Tuesday to Sunday from 10 a.m. to four p.m. Donations welcome. talk over with thriftshopsfornova.com.Volunteers
The Teapot 50+ Centre in Lachine is at present looking for volunteers drivers and receptionists. clinical transportation is supplied to seniors residing in Lachine, if required. Receptionists requested to decide to three hours per week. name 514-637-5627 or email@example.com.
ABOVAS — a non-profit corporation that presents accompanied-transport for West Island residents going to clinical appointments on the island of Montreal. if you want suggestions and would want to use this service, or if in case you have a number of hours to offer with access to a motor vehicle and would want to volunteer, e mail firstname.lastname@example.org or name 514-694-3838, or consult with abovas.com.
Volunteer West Island fits you with volunteer alternatives that suit your pastimes in the West Island. seek advice from cabvwi.org or name 514-457-5445, ext. 226.
The Canadian melanoma Society is attempting to find volunteers to assist with their annual daffodil crusade with the intention to run April four-7 — specifically with the sale of flowers, deliveries, compilation of money and managing the elements of sale. minimum age: sixteen
The household resource Centre helps families with infants experiencing learning and/or behaviour issues by offering particular person and community aid to the little ones and their fogeys. They are seeking for volunteer board participants who are inclined to turn into actively involved within the corporation, deliver concepts to the desk, assist fundraising efforts and help carry focus.
Moisson Montréal is now the biggest meals financial institution in Canada because of its meals donation and distribution programs. They count on over eleven,000 volunteers per year to make the redistribution of over 86 million greenbacks’ value of donations possible. Volunteers are essential for the handling and sorting donated meals it truly is to be re-dispensed to affiliated non-earnings. Volunteers additionally help the head cook. at last, there are also volunteers who help with ordinary facilities renovation initiatives. minimum age: 16, or 12 & over if accompanied through an adult.
AVATIL is a company that helps consumers with light to moderate intellectual handicaps achieve independent living. Their board of administrators is hunting for a brand new member and a treasurer with finance/accounting journey to begin in April. complete of 7 conferences in Lachine, September via may additionally.
The West Montreal Readaptation Centre (WMRC) is trying to find volunteers to assist in their workplaces in Lachine and in Beaconsfield with administrative tasks. The company is additionally trying to find volunteers who would want to spend about 2 hours per week spending time with an adult who has highbrow disabilities, developmental or autism spectrum disorders.
West Island Citizen Advocacy is a Centraide/WICS community company that matches volunteers with seniors or with individuals plagued by a handicap. name 514-694-5850 or discuss with volunteerwica.com.
A ninety 12 months-historic Pointe-Claire girl would like the business of a volunteer. She enjoys analyzing and would benefit from the enterprise of a feminine volunteer for brief walks and friendly chats.
A Dorval resident in her 30s would benefit from sharing a while with a pleasant female volunteer. She is English-talking and makes use of a motorized wheelchair to assist her mobility. She needs someone to accompany her to the bank or her appointments. She would additionally like to share meaningful conversation out at the mall or simply enjoy a cup of coffee.
A French-speaking man in his 70s in Pierrefonds who these days suffered from a stroke, would recognize a male volunteer to smash his isolation and provide social assist through pleasant domestic visits and accompaniment on social outings. he is specially in a wheelchair and can stroll very short distances with the support of a walker.Dépanneur demolition approved to make way for residential mission essential remedy is still out of attain for cancer affected person
effortless dosage: Razorback Concrete enterprise, the competent-mix organisation, introduced PENETRON ADMIX to the combine for the foundation slabs and maintaining walls of the inspection pits and facility constructing.
For the Arkansas DOT and R.L. folks, the value of sophisticated product performance and challenge support made the difference in picking out Penetron.
EAST SETAUKET, N.Y. (PRWEB)March 25, 2019
accomplished in February 2019, the West Memphis/I-forty Truck Inspection Pit serves as one of the most Arkansas DOT’s leading truck inspection websites on the busy I-forty interstate highway. Penetron turned into chosen as the favored crystalline waterproofing product due to confirmed efficiency and the remarkable venture help with the aid of the local Penetron representatives.
The inspection pit facilities maintained throughout the United States through state transportation departments feature one or two narrow pits or trenches in the floor of the inspection facility, deep adequate for someone to stand upright in, where a car will also be parked over. The Arkansas department of Transportation (DOT) keeps inspection facilities on the I-forty (and different interstate highways), the state’s major east-west toll road that connects California and the Southwest with the Southeastern united states.
Getting a 2nd Opinion
On the west-certain lane of I-forty in Arkansas, the West Memphis DOT inspection facility lies instantly west of the Hernando de Soto Bridge, which crosses the Mississippi River from Memphis, Tennessee. The Arkansas DOT uses the inspection pit on the I-forty to examine the underside of westward-sure vehicles and heavy automobiles to behavior safeguard inspections, reminiscent of brake and suspension assessments, and also to determine for any illicit elements that can be connected to the undercarriage of the truck.
The West Memphis DOT inspection facility has now added two new inspection pits, every about 10’ x 50’, in addition to a facility building. during the planning part of construction, a competitive crystalline product turned into at first exact for this challenge. although, upon assessment of the certain concerns with the concrete combine, the local Penetron skilled become called in to deliver a “second opinion.”
attempting to find a Sulfate-Resistant mix
“R.L. humans building, the challenge contractor for the Arkansas DOT project, mentioned concerns about the excessive groundwater degree current at the development web site, as well as the fact that the concrete could be uncovered to the highway salts from the vans,” explains Christopher Chen, Director of The Penetron community. “The necessities known as for a sulfate-resistant concrete mix to counter the frustrating soil situations.”
decreasing the permeability of the concrete has an instantaneous correlation with the potential to resist the aggressive chemical substances present in the soil, the street salts from the vehicles, and the excessive water desk due to the region of the task in the area of the Mississippi River. Penetron crystalline know-how reduces concrete permeability and gives finished insurance plan towards concrete deterioration led to by chemical assault, freeze-thaw cycles and corrosion – to appreciably enhance concrete sturdiness and repair life.
Extending Concrete sturdiness
Penetron labored with the R.L. men and women crew to plan an ideal answer to offer protection to all exposed concrete on the DOT inspection facility. Razorback Concrete enterprise, the in a position-mix corporation, introduced PENETRON ADMIX to the brand new concrete used for the basis slabs and maintaining walls of the inspection pits and facility building. PENEBAR SW-45 waterstop strips were used to seal the building joints.
moreover, PENETRON crystalline fabric turned into utilized topically to very nearly three,000 square ft of existing concrete constructions – in combination with PENECRETE MORTAR to seal the cracks in the current concrete – to prolong the sturdiness of the buildings.
“For the Arkansas DOT and R.L. humans, the price of superior product efficiency and venture assist made the difference in settling on Penetron,” concludes Christopher Chen.
The Penetron neighborhood is a number one manufacturer of strong point development items for concrete waterproofing, concrete repairs and ground guidance techniques. The neighborhood operates through a global community, providing assist to the design and development community via its regional workplaces, representatives and distribution channels.
For more counsel on Penetron waterproofing solutions, please visit penetron(dot)com or fb(dot)com/ThePenetronGroup, electronic mail CRDept(at)penetron(dot)com, or contact the corporate members of the family branch at 631-941-9700.
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ITIL, a service management standard developed by UK’s OGC (Office of Government Commerce), is the most accepted and adopted standard in the world. Since the ITIL is service-oriented, it is composed of five main categories namely service strategy, service design, service transition, service operation and continuous service improvement (Rouse, 2014). By adopting ITIL for managing IT, businesses are able to use IT not simply as a back-end solution but rather as a service provision partner to the business.
Disney is one of the largest organizations to adopt ITIL, the others in the US being the IRS, NASA, HSBC, IBM, Microsoft and HP. By aligning IT-related assets, costs and tasks to business objectives, organizations are able to offer better services at lower costs and improve efficiency. Additionally, by adoption ITIL, organizations are able to match changing business objectives with IT service management and delivery.
This makes ITIL well-suited to large organizations in manufacturing, IT, retail, pharmaceuticals, finance, entertainment and finance due to its IT infrastructure-centric nature in relation to business goals. Some of the goals organizations have when adopting ITIL include increased ROI from IT, increased customer engagement and satisfaction levels, easier management of IT especially the relationship between various aspects like assets, costs and returns, improved morale and higher employee retention rates and improved service delivery and performance.
Disney’s ITIL adoption
The adoption of ITIL by Disney began in 2008 and was spearheaded by a then recent hire, Glen Taylor, hired to spearhead the organization’s monumental undertaking. The goal of the effort was to adopt an integrated and holistic approach to IT service management. Given the scale of Disney, the adoption of ITIL for IT service management was not only a good match but also crucial to business operations (ITIL Training, n.d.). This is due to ITIL origins as a way of dealing with distributed, decentralized and heterogeneous computing architectures and assets.
IT service management is critical to Disney as it accounts for around 30% of the company’s revenue and is the only part of the company that deals directly with customers each minute. The scope of IT infrastructure, operations and other IT-related factors of Disney’s TP&R is huge given it handled over 118 customers each year and has 42 resorts, two cruise ships and parks and over 36,000 rooms all over the world.
For Disney, some of its most important goals in adopting ITIL were to improve service delivery, increase customer engagement and increased ROI from the company’s IT infrastructure and assets. In particular, increased reliability, availability, maintainability and scalability of IT services were the reasons Taylor pushed for the implementation of ITIL in management of IT services. By ensuring 100% availability of IT services, Disney’s TP&R could ensure that they delivered on their promise to provide their perfect experienced visitors with the perfect experience.
There are some great results that have been achieved since the as a result of Disney adopting ITIL. For one, Disney’s IT services are now integrated and managed using the ITIL standards. This has resulted in major improvement in the performance and efficiency of IT infrastructure. Using ITIL, Disney is better able to manage the services it offers its customers using the service portfolio management process concerned with service pipeline, catalog and retirement. This provides better insight and easier management on how to identify, evaluate, implement and retire services provided.
The adoption of ITIL has enabled management to understand and affect customer demand better using models such as user profiles and business activity patterns. This enables the company to identify how a certain demographic responds to a given service and how they use the service over some given time. Combined with the financial management process which allows for more transparent understanding and easier management of IT-related costs and opportunities, it has reduced IT service costs and better ROI.
There are many challenges that large organizations like Disney face in implementing ITIL adoption. For one, the decentralized and distributed nature of IT architectures in different locations makes it hard to standardize IT services. Disparate architectures, hardware, protocols, languages and standards must be harmonized in order to offer integrated IT services management. Additionally, adoption of any standard in a relatively large organization is a big challenge in itself since not only are there technical challenges to the project but other challenges like employee indifference, cultural resistance to change and the scale problem of implementing a service management standard in such a large organization.
There are several reasons why Disney was successful in its ITIL adoption and implementation. For one, given the scale of Disney, it was not possible to adopt ITIL within a short period of time, which required phased-out and incremental implementation. Secondly, to ensure successful and widespread adoption of ITIL within the company, one of the first thing Disney did was to market ITIL to the employees. This included a top-down marketing approach which went down the executive level dubbed Lunch ’n’ Learn and a bottom-up approach using methods such as Disney’s internal social network named BackLot which enabled employees to hold discussions and share documents.
The third reason the adoption of ITIL within Disney was successful was due to an education program initiated in the company. This saw 250 people get ITIL Foundation training from the executive level of the CIO downwards. After the training, the buy-in policy used in ITIL adoption and implementation resulted in more than half of those who underwent the education programme voluntarily undergoing a certification examination. Additionally, 20 people were selected in order to increase and cement organizational commitment and buy-in to ITIL adoption, who were put on an Expert level path. Having an experienced ITIL expert spearheading the adoption of ITIL also greatly helped the success of the undertaking.
When looking at various standards and frameworks to use for integrated IT services management, it is important to consider the appropriateness to the problem at hand. Another highly regarded and widely adopted ISO/IEC 20000, which has some key similarities and differences with ITIL (IT Governance, n.d.). For one, both ITIL and ISO/IEC 20000 are meant to make it easier for organizations to manage IT services. Secondly, they are meant to provide a framework to integrate IT services in order to improve efficiency and align business needs to IT resources and constraints.
There are some key differences between ITIL and ISO/IEC 20000. For one, although ITIL is considered a standard, it is more of a set of best practices that organizations should enforce for integrated IT services management. In contrast, the ISO/IEC 20000 is a standard that organization enforces to be certified for IT services management. This means that ISO/IEC 20000 is auditable and certifiable for organization while the ITIL is not auditable and is certifiable for individuals.
Furthermore, ITIL can be viewed as a stepping stone for organizations who later plan to enforce the ISO/IEC 20000 standard or some similar standard. Organizations first seek to address an immediate concern such as a failed or underperforming service then implement the ISO/IEC 20000 standard to see if they have implemented and comply with the ITIL standard. This means that had Disney adopted the ISO/IEC 20000 standard, it would still have achieved the results it has although it would have faced even greater challenges in implementing integrated IT service management.
IT Governance. (n.d.). ITIL® — IT Infrastructure Library® — and IT Service Management. Retrieved from https://www.itgovernanceusa.com/itil
ITIL Training. (n.d.). How and why ITIL was adopted by Disney. Retrieved from https://www.itiltraining.com/blog/2017/04/11/disney-itil-adoption/
Rouse, M. (2014, October). ITIL (Information Technology Infrastructure Library). Retrieved from http://searchdatacenter.techtarget.com/definition/ITIL
SAN JOSE, Calif.--(BUSINESS WIRE)--LDRA Certification Services (LCS), a division of LDRA, the leading provider of safety-critical software verification tools and software best practices for the past 40 years, is announcing a fully compliant IEC 62304 and ISO 14971 certification solution for medical device manufacturers. This offering brings together a team of certification industry experts fully accredited in medical standards along with certification-readiness tools tailored to meet the demands of IEC 62304 and its related ISO 14971 risk management standard.
The safety and effectiveness of software in a medical device relies on proof that the software fulfills the specifications for the software without causing unacceptable risks. The IEC 62304 standard requires compliance to ISO 14971, which details what is needed for the development and maintenance of risk and quality management systems for medical devices at a systems level. Building on the ISO 14971 foundation, IEC 62304 focuses on guidelines specific to software.
For medical device manufacturers implementing these new standards for the first time, there is considerable challenge in interpreting the guidelines of these complementary standards. Correct interpretation of the software and system objectives outlined by the standards is one of the areas where LCS adds its greatest value to the producers of medical device systems. The LCS comprehensive solution encompasses software, hardware and systems expertise.
The strength of the LCS solution is reinforced by a team of renowned industry experts with experience in hundreds of product certifications. Leading the LCS team is Todd R. White, an expert on automated quality and compliance management systems, whose expertise extends into medical electronic systems and standards, including IEC 62304. Mr. White is flanked by Dr. Holly Hildreth, a safety engineer with expertise in a wide range of international standards. Dr. Hildreth’s certification expertise in ISO 14971 and related safety and risk analysis disciplines includes complete safety analysis from system-level Preliminary Hazard List, Preliminary Hazard Analysis and Fault Tree Analysis (FTA) to software FTA/Failure Modes, Effects and Criticality Analysis (FMECA). These analyses of safety requirements, design, code and test are flowed back into system-level analysis. The LCS team’s collective expertise in all phases of software, hardware and system development, including the pending IEC 62304 TÜV® certification, assures IEC 62304 certification applicants predictable and cost-effective compliance.
“To avoid litigation or FDA crackdown, the medical industry is faced with a seemingly insurmountable challenge—to adopt and apply best-practice standards to medical applications where the amount of legacy code and third-party software is substantial,” noted Ian Hennell, LDRA’s Operations Director. “Since studies indicate added functionality is the primary cause of errors, deployed code has been insufficiently tested. Guidance from industry expert auditors helps companies streamline their compliance efforts and achieve certification readiness as efficiently as possible.”
An FDA analysis of 3140 medical device recalls from 1992 to 1998 revealed 79% of the recalls related to software failures were caused by defects introduced after software upgrades. This extreme level of incidents related to service or maintenance of medical device systems has driven regulators to stipulate a software maintenance process considered to be as important as the software development process in IEC 62304. The most effective way to bridge the gap between development and maintenance processes is through a comprehensive lifecycle traceability and verification management system such as the LDRA tool suite as prescribed by LCS.
“As medical devices have become increasingly complex and Internet-connected, the leap to certification readiness becomes exponentially more challenging,” confirmed Dr. Holly Hildreth, ISO 14971 auditor and LCS team member. “Not only do manufacturers need to validate their own software applications, but all third-party software must be rigorously tested within the medical device system to ensure that no unexpected events or failures are triggered, especially during the maintenance phase.”
The LCS team implements the certification process using the LDRA tool suite, a comprehensive software analysis and validation solution. The LDRA tool suite automates all stages of the verification process to achieve compliance readiness from requirements traceability to analysis, unit testing and validation. Using a broad range of qualifiable verification capabilities that support IEC 62304 certification objectives at all class levels, the LDRA tool suite manages and tracks lifecycle artifacts to achieve bidirectional traceability, as well as automated regression testing, through the development and maintenance phases.
The full capabilities of the LDRA IEC 62304 certifiable support package will be demonstrated at DESIGN West in San Jose, CA, March 27–29 in Booth 1337. Visit the booth to see how a software project can achieve certifiable readiness through requirements traceability from requirements creation through development and validation for the certification standard you need.
For more than 35 years, LDRA has developed and driven the market for software that automates code analysis and software testing for safety-, mission-, security- and business-critical markets. Working with clients to achieve early error identification and full compliance with industry standards, LDRA traces requirements through static and dynamic analysis to unit testing and verification for a wide variety of hardware and software platforms. Boasting a worldwide presence, LDRA is headquartered in the UK with subsidiaries in the United States and an extensive distributor network. For more information on the LDRA tool suite, please visit: www.ldra.com.
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Caption for screenshot 1:Selecting the IEC 62304 standard to import into TBmanager®
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The medical device industry is well known for its technology, a central aspect that MD&DI covers in each and every issue. Less often noted are the many outstanding people without whom that technology would not exist. In the following pages, MD&DI pays special tribute to 100 of these individuals.
Many outstanding candidates were nominated by this magazine's readers. Not surprisingly, given the nature of this industry, it was a difficult task to choose only 100 people.
Every person in this group has made significant contributions to the industry. But this is not meant to be a “top 100” list. Rather, it is intended to represent the wide diversity of individuals that make up this industry. From CEOs of large corporations to freelance engineers, from physician inventors to public health officials, from the well-known to the unfamiliar, this group reflects the face of the industry.
Practical considerations of space limit the amount of information that can be given for each of these 100 people. However, 16 of them from representative areas of the industry have also been profiled at greater length. Together with their 84 peers, they are examples of what makes this industry so special.
Pamela G. Bailey
President AdvaMedHeads the world's largest medical technology association, representing more than 1100 firms... involved in health policy issues for more than 30 years... has served on the domestic policy staffs of two presidents.
Donald Barcan President Donbar Industries
Leading consultant in sterile package design... coauthor of ISO 11607... has written many technical articles and lectured around the world... has served for several years as a juror for the Medical Design Excellence Awards.
Arthur A. Bertolero CEO, Founder Estech Inc.
Developed products in a small, privately held company... focused on tools for less-invasive surgical approaches for heart-related diseases and defects, including endoscopic coronary artery bypass surgery on a beating heart.
George Blank President, The MedTech Group
Involved in the engineering and manufacturing of disposable products for 41 years... member of the National Association of Manufacturers President's Council... sponsor of the Memorial Sloan-Kettering Cancer Center.
Trabue BryansExecutive VP and General Manager, Atlanta, AppTec
Cochair of AAMI Microbiological Committee and ISO delegate... authored many sterilization and validation articles for industry journals... runs business and technical operations at AppTec's Atlanta facility.
Mary BurtonPresident Specialized Medical Devices
Founded Swiss-screw parts manufacturer HDJ Company Inc. in 1962... founder of Specialized Medical Devices Inc. ... is a trustee for the Precision Machines Products Association. Tracie CapozzioQuality Systems Manager STERIS Corp.
Recipient of the 1997 Innovation Research Award... author of two publications, one for the IEEE Engineering in Medicine and Biology Conference, and the other for the University of Akron in Ohio.Peter B. CarstensenSenior Systems EngineerCDRH, FDA
Represents CDRH on human factors, anesthesia products, and respiratory devices... human factors engineering team leader at CDRH... convener of two IEC working groups.Joseph Chang Consultant
Former employee of Johnson & Johnson for more than 23 years... winner of a gold award in the Medical Design Excellence Awards for a catheter safety system... a member of an ISO TC84 committee from 1990 to 2001.Larry ClarkManager, Clinical Affairs, Vysis Inc., an Abbott Laboratories Co.
Developed IVD products... presented eight round-tables on outcomes and conduct of industry point-of-care and home-use testing product evaluations... helped develop IVD standards.Lester M. CrawfordActing FDA Commissioner
Took over top post at FDA in March 2004 when Mark B. McClellan left to head CMS... was also acting commissioner from February to November 2002... has served FDA in various capacities.J. Michael CudeCOO and VP of EngineeringCoeur Inc.
Chairman of the Medical Plastics Division of the Society of Plastics Engineers…holds patents for cardiology and surgery devices… helped four separate facilities achieve ISO certifications.Len CzubaPresidentCzuba Enterprises
Thirty-year industry veteran has specialized in design and development of disposables... participant in Society of Plastics Engineers and current president-elect... regularly leads materials seminars at MD&M conferences.Gene DickhudtFreelance Designerof Instruments and Implants
Holds more than 35 U.S. patents for medical devices, neurosurgery, and orthopedic surgery fields... first recipient of the “Patent of Distinction” award given by Medtronic for cardiovascular tined lead patent.
Joel S. DouglasChief Technical OfficerMysticMD Inc.
Developed the first alternate-site glucose meter and the first FDA-cleared mimimally invasive insulin infusion set... holds 59 U.S. patents and has had 25 products approved by FDA.Ronald B. EarleGroup Senior VP B. Braun OEM/ Industrial Div.
Oversees OEM and international divisions of $3 billion device maker... longtime global industry presence in both medical devices and pharmaceuticals... board member for MDMA and Biomet Ltd.Rich EffressChairman, CEOMedSource Technologies Inc.
Cofounder of MedSource Technologies Inc., a manufacturing and engineering services and supply chain managment group... founding partner of Kidd & Co. venture management firm.Stuart M. EssigPresident, CEOIntegra LifeSciences Holdings Corp.
Responsible for building distribution channels, acquiring complementary products, and investing in product development... serves on board of directors for St. Jude Medical Corp.
Bill EvansPresidentBridge Design Inc.
Design engineer from the UK founded a consultancy in 1992... the prolific author has won multiple design awards... projects include a Smiths Medical insulin pump... aficionado of Latin and jazz percussion and guitar.Douglas G. EvansCOO, Kensey Nash Corp.
Key in development of Angio-Seal vascular closure system and other resorbable products... leading commercialization of Triactiv Embolic Protection System... holder of 32 patents, he is also a dedicated triathlete.
David W. Feigal Jr.Head of Devices and Biologics Practice AreasNDA Partners LLC
Headed CDRH for five years until leaving in April 2004... implemented user fees and third-party reviews and inspections reforms... held positions at CBER and CDER from 1992 to 1999.John P. FrielPresident and CEOMedrad Inc.
His company received the Malcolm Baldrige National Quality Award in 2003… began company's total quality management system 15 years ago… focuses on automation rather than manual processes.
Thomas GundersonManaging Director, Senior Research AnalystPiper Jaffray
Follows cardiology and medical companies…spent 25 years covering medical devices, 13 in industry and 12 on Wall Street…focuses on marketing and project management.Frederick C. HaerFounder and Owner, FHC Inc.
Singularly responsible for the development of microelectrode needles…developed specialized devices essential to nervous system research…founded FHC 34 years ago and developed it into a 60-employee business.
Karl HemmerichManager, Plant OperationsSTERIS Isomedix
Oversees major gamma irradiation facility…holds three medical disposables patents…developed standards for radiation materials selection, testing techniques, and processing methods.David HerridgeVice President, EngineeringIncisive Surgical
Led the engineering effort to develop and launch a new bioabsorbable mechanical closure…developed a complex aortic stent…turned an early concept into a viable commercial product.
Stuart HerskovitzFounder and PresidentQosina Corp.
Founded Qosina in 1980…global insight into the industry enabled him to introduce many new product concepts from one continent to another…built a team of more than 80 people.Said HilalPresident and CEOApplied Medical Resources Corp.
Testified on bundling and other anticompetitive practices before FTC and the U.S. Senate…committed to finding healthcare solutions at affordable costs…company has 400 patents or patents pending. Linda Howe GarrizManager, Quality Assurance, Alcon Manufacturing Ltd.Chair of the Biomedical Division's Southern California Discussion Group…dedicated to providing quality education and training for Southern Californian professionals.Randy HuebnerExecutive Vice PresidentAcumed LLC
Started company that designs and manufactures implants…addresses difficult surgical problems with easy-to-use products…vice president of Surgical Implant Generation Network and ARC Surgical.Lynn IhlenfeldtVP, Product DevelopmentMinnetronix Inc.Oversees all product development efforts…20 years experience in developing medical products… helped establish and improve Minnetronix's medical device design controls system.
Mae C. JemisonFounder and PresidentBioSentient Corp.
Former astronaut and physician designs and develops NASA-patented ambulatory equipment… Directed Dartmouth's Jemison Institute for Advanced Technology in Developing Countries.Karen Jersey-WilluhnSubQIVIEW Inc.
Develops and commercializes physiological imaging platforms… uses her experience in clinical nursing, clinical trials, regulatory, and sales and marketing to design and develop medical products.Jonathan KahanPartnerHogan & Hartson
Thirty-year veteran in medical device law is author of two authoritative books and numerous articles... has represented hundreds of device companies before FDA... his activities have had a major impact on FDA policies.
Stuart KartenFounder and PresidentStuart Karten Design
Award-winning designer with 20 years experience... a recipient of a Medical Design Excellence Award... advisor for USC degree program for medical device engineering.J. Randall KeenePresident, CEOAvail Medical Products Inc.
Cofounder of a major outsourcing provider... 17 years in financial and operations management in the device industry... formerly CFO of a medical products company... director of several privately held companies.
Brian S. KelleherPresidentParagon Medsystems LLC
Founder of Paragon Medsystems and founder and CEO of EndoMorphix... has 25 years of industry service... recipient of the Von Helmholtz award for outstanding contributions to biomedical engineering.Mark Keller Medical Product Development Chemist Adhesives Research Inc.
Worked on blood glucose devices, wound care, and blood coagulation projects…developed a medical adhesive tape system for noninvasive skin-harvesting applications.Joe KianiChairman and CEOMasimo Corp.
A named inventor on more than 30 patents for signal processing, sensors, and patient monitoring…helped start-up company grow to have 300 employees, a global technology-license, and product-distribution agreements.Mark KramerDirector, Office of Combination Products, FDA
Develops policies and procedures for premarket and postmarket regulation of combination products…had two stints at CDRH before taking his current position in 2002... involved in combination product review.
Philip KwokManager of Research and Technology, Patient Interface Div., ResMed Ltd.
Invented more than 20 interface mask systems for treating sleep apnea…developed expertise in interface technology to improve patient compliance.Ernest LaneChief Technical OfficerArbor Surgical Technologies
Designed a porcine heart valve and a bovine pericardial heart valve…addressed disadvantages of tissue valves, including limited durability…developed various other cardiac-related products.
Robert S. LangerProfessor of Chemical and Biomedical Engineering, MIT
Has more than 500 issued or pending patents worldwide…received the Charles Stark Draper Prize in 2002…the only engineer to ever receive the Gairdner Foundation International Award.Curtis L. LarsenPackaging ConsultantDuPont Medical PackagingCochairs IoPP's Medical Device Technical Committee... led packaging-related technical committees for ASTM, AAMI, and AdvaMed... worked in packaging for more than 30 years.
Mark LeaheyExecutive DirectorMDMA
This lawyer runs day-to-day operations of a 200-member industry trade association... an advocate for the concerns of small, innovative device companies on user-fee, reimbursement, and hospital purchasing issues.Daniel LemaitreManaging DirectorMerrill Lynch
Managing director in fundamental equity research... specializes in medical technology… was a member of Emerson Hospital for 10 years and continues to serve as corporator of that organization.Szu-Min LinResearch FellowAdvanced Sterilization Products
Received Philip B. Hofmann Research Scientists Award for excellence in research in 1987…researches and evaluates new sterilization ideas and technologies…helped develop the Sterrad sterilization process.David LinkFounding PartnerEXPERTech Div., Boston Healthcare Associates
Set the tone for medical device regulation while at FDA from 1969 to 1980…first director of what eventually became CDRH…provides guidance in the areas of quality control and validation.Ben LippsCEO, Fresenius Medical Care AG
Helped develop first hollow fiber artificial kidney… led research team that developed the first hollow fiber dialyzer…led R&D into reverse osmosis, medical membranes, blood oxygenation, and artificial kidneys.Gerald LoebDirector, Medical Device Development Facility, USC
One inventor of the cochlear implant… original inventor of award-winning Bion neuromuscular stimulator… author of 38 issued patents... wrote more than 200 articles on neurophysiology and neural prosthetics.
Alfred E. MannChairman and CEOAdvanced Bionics
Created a foundation to conduct scientific and medical research for medical disabilities by developing innovative bionic solutions…founder of a manufacturer of microinfusion and continuous glucose monitoring systems.
Ted MannenManaging DirectorAventor
Former general counsel and senior VP at HIMA… helped shape HCFA's negotiated rulemaking process on diagnostic tests coverage…developed the industry's reimbursement agenda for the 106th Congress. Gerald E. McGinnisFounder and ChairmanRespironics
Named entrepreneur of the year by the Washington and Jefferson College for a benchmark innovation... also received the Entrepreneur award from the Carnegie Science Center.David McNallyChairman and CEOZevex InternationalCofounded Zevex and built it into a company with more than $25 million in annual revenues and 170 employees… provides medical product design and manufacturing services.
Hal MillerPresidentPACE Solutions
Coauthor of ISO 11607... chair of ASTM F02.60 subcommittee on medical packaging... served as longtime director of packaging technology at Johnson & Johnson before retiring and starting a consultancy in 2003.S. Fazal MohammadVP, Utah Artificial Heart Institute
Expert in the field of device hemocompatibility…played leading role in improving the hemocompatibility of many blood-contacting devices… professor of pathology at the University of Utah School of Medicine.
Conducts safety and performance testing for the device industry…performs FDA-accredited third-party 510(k) reviews…spent 21 years at ECRI, investigating many device problems and hazards.Walter Mosher Jr.FounderPrecision Dynamics Corp.
Invented first ID bands…pioneered RFID to create ID devices and systems that reduce the risk of medical error…currently developing organic semiconductors and polymer-based RFID devices.
Ted MoslerVP of Product DevelopmentGilero LLC
Medical Design Excellence gold award and Product Design & Development's engineering award winner... cofounder of Gilero... local high school science and biomedical engineering volunteer.Tom MotsenbockerVP of R&D and EngineeringMachine Solutions
A founding partner of Machine Solutions Inc. ... patent holder for core technology and inventor of segmental stent crimping, marker band swaging, and balloon processing applications.
Jerry NelsonLaboratory DirectorNelson Laboratories Inc.
Drafted or contributed to the improvement of many industry standards…provides seminar training in sterilization and cleanroom management…founded company in 1969.Henry NordhoffChairman, President, and CEOGen-Probe Inc.
Heads a company that specializes in nucleic acid diagnostics…formerly president of a company focused on treating inherited diseases…was with Pfizer Inc. for 16 years in the United States and overseas.Julio PalmazCofounder Advanced Bio Prosthetic Surfaces Ltd.Inventor of first commercially successful stent… developed the stent graft…he holds 20 patents... his company uses nanotechnology to develop interventional cardiology products.Mark PaulsenProduct Director, Healthcare MaterialsNuSil Technology
Helps both large and small companies navigate product qualification and regulatory processes for silicone materials... holds three patents for improving elastomer for electrical pacing leads.Susie PerlmanManager of Customer ServiceTitan Scan Technologies
Assists customers through product validation process…handles processing agreements, special handling requirements, shipping details, and other processes.Larry PilotPartner, McKenna, Long & Aldridge
Recognized authority on legal issues relating to medical devices…more than 30 years representing device clients… general counsel to MDMA…a key developer of FDA's regulatory program for medical devices.
Victor L. PoirierChief Technology AdvisorThoratec Corp.
Inventor of the implantable Heartmate Left Ventricular Assist System for cardiac transplant and destinations therapy... founder of Thoratec Corp... member of the National Academy of Engineering.Joseph A. PopperPresidentPopper & Sons
Third generation to hold the position of president of family-owned business…manufactures hypodermic needles and supplies reusable medical and laboratory products…manufactures custom specialty components.
Robert R. ReichPresident Pharmaceutical Systems Inc.
Helped draft guidelines on issues for packaging integrity…has authored more than 70 articles on subjects including bacterial sporulation, biological indicators, package integrity, and medical devices.Harvey RudolphGlobal Program Manager, Medical DevicesUnderwriters Laboratories Inc.
First FDA staffer to involve industry in development of guidance documents…member of the ISO/IEC Joint Working Group on Risk Management since its inception in 1996.
Mark A. SaabCo-owner and PresidentAdvanced Polymers Inc.
Holds more than 30 medical device patents and has developed 1000 different medical balloons... inventor of widely used heat-shrinkable tubing that is thin, strong, and small.Raymond SanderLead ModelerBattelle Product Development Solutions
Fiercely dedicated to the art and science of rapid prototyping…multiple device development projects…proponent of involving the prototyper early in a medical device project.Richard SatavaProfessor of SurgeryUniversity of Washington Medical Center
President of the Society of Laparoendoscopic Surgeons... program manager at DARPA... surgical consultant at the U.S. Army Medical Research and Materiel Command.Sam L. SayFounder and CEOSSCOR Inc.
Designed and manufactured battery-powered aspirators... helped make disposable collection components, sealed lead-acid batteries, and regulated vacuum standard in EMS field aspirators and hospital-suction devices.Michael SchollaSenior ConsultantDuPont Medical Fabrics and Packaging
Cochair of ISO working group on medical packaging... chairs AdvaMed task group on sterilization and packaging... holds six patents... expert on antimicrobial activity in polymers. Daniel G. SchultzActing DirectorCDRH, FDA
Headed CDRH's Office of Device Evaluation... at forefront of implementing user-fee system and other CDRH reforms... had distinguished surgical career before joining CDRH in 1994... became acting director in April 2004.Frederick F. SchweitzerDirector, Continuing EngineeringWelch Allyn Inc.
Industry member for more than 27 years... worked closely with FDA as an industry representative for design controls... recipient of former Vice President Al Gore's “Hammer Award” in 2000.Javad SeyedzadehSr. VP, Diagnostics Div., Bayer HealthCare
Created a worldwide quality management system…was key in obtaining approval of the first PMA for an MRI…serves on AdvaMed's committee for technology and regulations.Thomas J. ShawPresident and CEORetractable Technologies Inc.
Inventor of automated retraction safety needle devices and blood collection devices to eliminate accidental needlestick injuries…developing other medical safety products using friction ring technology.Sanjay ShrivastavaPrincipal Engineer Stent Systems Development, Abbott Vascular Devices
Developed materials for implantable devices…chair of Medical Device Task Force of ASM International…chair of the first Materials and Processes for Medical Devices Conference.
Thomas J. SommerPresidentMassMEDIC
In eight years has raised this regional device organization to national prominence... plays key role in luring device companies to Massachusetts... has worked with senior public officials to help shape device law.Bill SouthManager EtO TechTeamSTERIS Isomedix Services
Serves on AAMI committees, formulating guidelines for industry…validates process for safe and efficient sterilization for many different types of medical devices.Ron SparksPresident, CEO, and DirectorUTI Corp.
Orchestrated acquisition of MedSource Technologies... joined UTI in 2003... had a 20-year career at Smith & Nephew plc, ending as president of its endoscopy division.John SpitzleyTechnical Fellow of PackagingMedtronic Inc.
Coauthor of ISO 11607... cochairs IoPP's Medical Device Technical Committee... served on AAMI, ASTM, and AdvaMed packaging technical committees... has worked at Medtronic for 30 years.Nancy J. StarkPresidentClinical Device Group Inc.
Dedicated service to clinical device research…speaker, teacher, and author of clinical device educational materials…conducts an annual survey of clinical studies in the United States and Europe.Roger SternPresidentStellartech Research Corp.
Founded company to design, develop, and manufacture medical devices under contract to device companies…designs and manufactures ablation and thermal therapy devices and systems.John F. StigiDirector, Division of Small ManufacturersCDRH, FDA
Has educated the global medical community on FDA policies, procedures, and regulations for more than 25 years... developed accreditation processes for FDA's third-party programs.Bradley ThompsonPartnerBaker & Daniels
Chairs the drug and medical device law practice… counsels medical device companies on a wide range of reimbursement issues…counsel to AdvaMed… invented method for assessing compliance with FDA requirements.
Kimberly A. TrautmanOffice of Compliance, CDRH, FDA
Wrote the final quality system regulation and preamble published in 1996... chairs Global Harmonization Task Force Study Group 3... gives presentations on GMP and quality systems.Paul J. UpmanDirector of Scientific AffairsNAMSA
Worked in the industry for nearly 30 years…developed models and protocols for biocompatibility… adapted numerous methods of evaluating the blood compatibility status of biomaterials and devices.
Peter von DyckPresident and CEOZassi Medical Evolutions Inc.
Recent winner of Medical Design Excellence award for the Zassi bowel management system… named the Ernst & Young Entrepreneur of the Year for healthcare and life sciences in Florida.Robert WardFounder and CEOPolymer Technology GroupDeveloped many biomaterials… developed BioSpan to be used in Ethicon's heart-assist devices… introduced a polyetherurethane for applications that require implant times greater than 90 days.Matthew B. WeingerDirector San Diego Center for Patient Safety
Led the development of AAMI's medical device design process guide and guidelines on applied human factors design… researches human factors–related issues pertaining to anesthesia.Les WeinsteinOmbudsmanCDRH, FDA
Independently investigates complaints from industry about CDRH... resolves CDRH disputes with device sponsors, applicants, and manufacturers... has held a number of counsel positions with FDA and HCFA (now CMS).Larry WesserVP, Sales and MarketingIntegrated BioSciences Inc.
Has more than 40 years experience in research and development of medical devices... innovator of transfer devices... one of the first advertisers in MD&DI magazine. Michael WiklundVP, American Institutes for Research
Makes devices like heart monitors user-friendly…helped write national and international standards for designing safe devices…chairs Medical Section of Industrial Designers Society of America.Stephen B. WilcoxFounderDesign Science
Pioneer in use of observational user research, human factors, and interaction design… serves as VP for IDSA, chairing the human factors division…serves on AAMI/ANSI committee for human factors in medical devices.W. Robert WorrellPresidentWorrell Inc.
An industrial design and product development consultant to the device industry for 28 years... serves on AAMI committees on design and human factors… collaborated on several Medical Design Excellence Award winners.Jiahao ZhouFounder and PresidentBME Tech Ltd. Formulated an adhesive for ultrasound transmission and improved on ultrasound technology... created outer-control built-in pacemaker and other medical design solutions... 20 years industry experience.Zhangwu ZhuTechnical Research DirectorSterigenics
Developed and designed a microwave spectrometer to measure EtO concentration and water vapor in the sterilization process…spectrometer has been key to successful parametric release processing.
Copyright ©2004 Medical Device & Diagnostic Industry
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