While working for Hewlett-Packard’s medical group, a manager said, “When the barriers to entry are high, those who overcome them have a strategic advantage.” That adage has remained important in the context of the ever-changing regulatory processes that are an integral part of bringing a new medical device to market.
There has been much debate and consternation, especially recently, about the 510(k) process, and there will undoubtedly be changes going forward. This article proposes a fundamental shift in the philosophy of how regulatory processes could interact with the product development process and paradigm to produce greater efficiency and more predictable results, regardless of how regulations evolve in the future.
As a product designer, it is often easier to criticize the process than to figure out how to make it work to your advantage. However, there are steps that can be taken during the product design phase to make the regulatory process more effective. Design for regulatory can become a strategic advantage. This article discusses what design for regulatory’ entails and what it would mean to incorporate regulatory thinking into the design process.
The Regulatory Challenge
What does design for regulatory mean? It is a process just like those currently in practice:
Each of these paradigms brings the domain expertise of what is considered a downstream product development activity into the early design process. The goal is to eliminate surprises late in the product development process that often produce negative effects such as expensive reworks, missed milestones, and ultimately delays in market introduction and sales.
So how do we start? The first thing to do is to google “design for regulatory.” You’ll find mostly bits of narrow work on EMC and wireless design, and the Web sites of several regulatory affairs consulting companies. There are very few online search hits on how to introduce regulatory concerns into product design and even less information about that process for medical product design.
Let’s start by understanding the goals of the regulatory processes. In general, they exist to ensure that safe and effective products are delivered into the market place with appropriate risk-benefit ratios. Every manufacturer, designer, regulatory professional, medical practitioner, and consumer has this as a common goal. However, if this is the case, why are there continually issues? The issues originate in the way regulatory compliance is treated during the development process. It is often seen as an afterthought or a necessary evil to be tested for and sometimes gamed at the end of the process when negative regulatory feedback is very frustrating and expensive. Even one request for additional information can be devastating to a company’s plans and financial well-being. Funding for start-ups and small companies is often tied to regulatory milestones.1
Some companies take risks, purposely or not, by trying to do the minimum required or carefully crafting claims in the hope of getting past FDA. Although these strategies may sometimes work, clearly they do not lead to predictable success, because they can lead frustrate or anger reviewers. A perceived movement toward a more risk-averse FDA make this approach less likely to produce a successful outcome.
So what can you do? With existing ‘design for …’ processes, teams consist of the stakeholders who ensure successful execution of the plans. Similarly, companies can incorporate regulatory affairs professionals (or those with extensive regulatory experience) directly into their design teams to ensure that the regulatory concerns and requirements are addressed in planning and subsequent design phases. This approach encourages the team members to use their experience and expertise to design products and test programs that will allow the creation of regulatory-ready products.
The team can also gather the data and analysis to support smooth submissions and hopefully clearance and approvals.
As with any good multistep reform process, the first step is to admit that there is a problem and agree that the organization wants to solve it. Although regulatory progress is difficult to track until a product is near the end of the development process, the resources to do so either already exist in organizations or can be identified and assigned (or contracted) responsibilities early in the project. Any costs involved are limited to the necessary regulatory resources. There are large savings to be gained from limiting redesign, additional tests, rounds of regulatory review, and delayed sales.
Intended Use and Indications for Use
The most important product features to agree upon in the beginning of the development process are intended use and indications for use. Although the exact definition of these terms (other than what is provided in 21 CFR 801.4) is currently under discussion at FDA and will evolve, they essentially refer to what the device will do and how it will be used.
Companies often get to the end of product development and have heated internal discussions with designers, marketers, and regulatory groups, discovering that the features and claims made in submissions do not support the marketing materials. The process of making changes and realigning messaging is expensive and highly disruptive to an organization. Having a clear discussion and agreement, as well as forming a written documentation up front that including intended use, indications for use, and claims, will add consistency and predictability. The claims form the starting point for submission packages, provide requirements, and drive specifications in the product design. Verification and validation testing and collateral materials, such as user documentation and marketing materials, become well aligned with claims from the beginning of the process.
Standards and Guidance Documents
Industry standards should be used and referenced wherever it is appropriate. Standards can be a touchy subject in the competitive marketplace, but they are essential for evaluating and comparing performance. Groups such as AAMI have shown that standards can be effectively developed in an open and nonthreatening forum and include all parties concerned.
Standards allow agencies to efficiently evaluate conformance and hold each device to a minimum level of performance. Standards do not stifle innovation but instead channel it towards exceeding performance and reducing costs by concentrating company efforts. They also allow direct head-to-head comparisons in the marketplace between competitive products.
When a design team uses standards and guidance documents as design input, the documents should provide the minimum requirements. Exceeding the standards can have market advantages if doing so results in demonstrable benefits. For example, IEC 60601-1-11 requires an operating temperature range of 5°–40°C for transit operable home healthcare medical equipment. However, there are many use environments use in which this specification could be exceeded—Fairbanks, AK has an average low temperature of -28°C in January and Phoenix, AZ has an average high temperature of above 41°C in July.
Designing and testing to a larger range can allow marketing claims of operation in less restrictive environments and could yield customer benefits or fewer service and device failure issues. These advantages must be supported with appropriate evidence as required by the regulatory process.
When there are multiple standards, such as foreign agency requirements, the regulatory and design functions need to work together to select the superset for the product specifications to allow smooth introduction into additional markets.
Guidance documents from regulatory agencies are not standards in the literal sense, but should be treated as standards and their recommendations incorporated as design input. Not taking guidance documents seriously or assuming that they are not applicable to a product is a common and unfortunate mistake. If a company elects not to follow an available guidance or uses only portions that it considers applicable, it should develop and support that justification decision early in the design process. In addition, everyone on the team should be comfortable with the decision, while the results of testing to support the decision should be incorporated into the early regulatory submission drafts.
Don’t forget to review draft guidances and search for prepublication drafts that may provide insight into changing agency expectations. Although these drafts may still be open for comments or not yet finalized, they can provide valuable insight into FDA’s current thinking in a particular area. The agency has been known to enforce draft recommendations. Paying attention to these expectations early on saves time and labor later in the process since drafts early in a product development cycle often become defacto standards or are incorporated into standards by the time the product is ready for submission.
Have a Regulatory Strategy
Once the device use and standards are understood, it is time to work on the regulatory strategy. Early in the design process, discuss and include the following key items:
These are extremely important discussions and decisions, and it is necessary that they be appropriately documented. The discussions and factors evaluated that ultimately drive the decisions are just as important to helping the decisions stick and keeping the project from disruptive reanalysis procedures.
The discussions may bring up substantive issues and create an opportunity to alter the design of the product to resolve regulatory issues. Designers should not panic or try to game the system. Most often, a company will lose with a strategy that tries to get around regulatory issues or obscure them.
Consider issues rationally. They may lead to changes that can be useful for the customer or create an opportunity to raise the bar with FDA. For example, the ability to collect additional device data during use can enable additional markets if properly specified and implemented. These types of features may also be used production testing and field service.
Comparison testing and data collection cannot be overemphasized. A company can create a submission that gives it an advantage over competitors by including excellent comparative data beyond that which was provided in past submissions. These same data can then be used for marketing purposes, making it difficult and expensive for competitors to respond once the product is introduced into the market and increasing the hurdles they’ll face when submitting data for a future product.
Consider the pre-IDE meeting and present your design for regulatory compliance case to FDA. Helping the agency understand that the device is designed to be a proactive part of the regulatory process can help the company gain support from the group that will be reviewing the submission. The pre-IDE meeting is useful for identifying issues and establishing allies at FDA.
Prepare Submission Documents During Product Design
Once the input requirements and product specifications are complete, the design team will have much of the information that it needs to create regulatory submissions for all countries in the business plan. Although the test data are missing, the tables can be created proforma to be filled in with the appropriate passing verification and validation data as those tests are completed.
All too often, these documents are prepared much later in the process. It is easier and less expensive to make changes early in the process. Regulatory changes are no different, except that in the past, companies have rarely considered altering products to facilitate easier and more complete regulatory approvals. Instead, they alter product claims and limit the market potential for their device. In the long run, this approach is more expensive.
Creating these documents early allows a company to identify and fix deficiencies relatively easily and at low cost. Early creation of these documents may also alter the regulatory strategy.
Surprises in the regulatory process can often be traced back to hazard analysis. For the purposes of this article, the term hazard analysis is used as a broad category to include failure modes and effects analysis and all other appropriate risk and hazard analysis methods as appropriate to medical devices.
Issues usually arise from the omission of hazards associated with new technologies (such as replacing a cable using wireless technology) or unrealistic scoring of the hazard or its mitigation. Whether this results from a lack of appreciation for new hazards or unquestioning reuse of the analysis from the previous product generation, omitting them can result in huge issues.
This analysis gives another opportunity to design for regulatory as it provides additional input requirements. Product design changes potentially provide the strongest mitigations and are sometimes the least expensive. Design changes early in the process are much less costly and time-consuming than production tweaks. Features can be added to provide extra security or robustness to data, and additional features can aid in verification for other mitigation tasks that may not be present in the core product features and specifications.
Good guidance for hazard analysis is provided in ISO 14971, and it is often very helpful to carefully review the analysis of predicate devices.
Protecting and Patenting Features for Compliance
Pay particular attention to any features added to a product to facilitate the regulatory submission, such as those allowing for data collection during verification or validation testing, or those mitigating hazards. Review of these features and their implementation could find patentable material and once again, competitive advantages. Patents do not need to be flashy to be useful in making it difficult for a competitor to execute its regulatory strategy. Consider any feature that has been added as a result of the regulatory review or a unique design element that allows easier demonstration of safety or efficacy for protection.
Design the Test Program
Creating the regulatory plan and prototype submission early allows some creativity in combining elements to make the most efficient testing program. For example, during the setup testing phase for a new product, testing of predicate and competitive products can be performed with minimal extra work and cost. It is useful to know how the competition performs not only for the regulatory submission, but also for product marketing purposes. If a key product performance result can be identified and supported in its value to the product or for the customer, FDA might recognize it as a requirement for future products submitted by competition.
Highly accelerated life testing and highly accelerated stress screening testing are excellent methods. However, do not underestimate the value of testing the boundaries during standard performance testing.
A test program will often adhere to the internal and advertised specifications to set test limits. This information is essential for submissions, but while a test is set up, it can be very useful to continue the testing to establish design margins and potentially useful characterization information. This information can help demonstrate the robustness of a design and might allow for an increased warranty to the customer or lower accrued warranty cost expectations.
Test failures are inevitable. Fixing issues that are identified during validation or verification activities provides another opportunity to consider the big picture and include regulatory considerations.
Although EMC has received attention from the agency (including establishment of a relationship with the FCC), don’t forget that it is also an issue for the customer. EMC testing of competitive products can yield an understanding of potential interactions as well as their product weaknesses. It will allow design changes that make products more compatible and support the customer with useful installation and operation information. It could also potentially supply sales and marketing departments useful competitive data.
Design Teams and FDA Submission
The designers have unique insight into the product and its technology. It is an advantage to use this knowledge in drafting particular sections of the submission, technology descriptions, and comparisons. Since the entire team has been involved in the process, everyone will be proactive and engaged. There will likely be sections of the submission that can be reused directly from product design documents, because they contain supporting material such as drawings.
Reviewers Are Your Friends
Finally, the reviewer is your friend; the design team should believe this statement too. Make it a primary goal to educate your reviewer(s). They have a huge workload that consists of many different products and may not have the depth of knowledge and expertise to fully appreciate your product. Think about helping a friend understand this great new product and you’ll have a much better submission.
Education is even more important if this product introduces a new technology or technique. Don’t assume that once it appears on Wikipedia your reviewer will be an expert. Once this is established as an operating principle, good things can happen. People will think about how to make the reviewer’s job easier by providing excellent data and supporting material. Any new or complex concepts will be accompanied by excellent industry and peer-reviewed reference material. Reviewer-friendly submissions will help you gain allies at FDA.
Design for regulatory is a valuable concept, regardless of future changes to agency requirements or processes. Other ‘design for…’ paradigms have shown that up-front, early consideration of tasks that are usually performed at the end of the product development process reduces time to market and costs associated with redesign.
Although following the suggestions in this article is not without cost, doing so is a worthwhile investment. The development of a solid regulatory strategy and the incorporation of regulatory resources into the design process will ensure fewer surprises and allow for more efficient and potentially easier FDA submissions. This paradigm can also yield better competitive information and product positioning and potentially create a competitive advantage in the marketplace.
1. Conroy S, “Reduced VC Funds Means New Challenges for Medtech Start-Ups,” MD+DI 32, no. 10 (2010): 18; available from Internet: http://www.mddionline.com/article/reduced-vc-funds-means-new-challenges-medtech-start-ups.
Bill Saltzstein is founder of Code Blue Communications Inc. (Woodinville, WA).
Today’s consumer expects to be connected via their mobile device wherever they go – especially in their vehicles, which have become more than transportation; they are a mobile extension of the owner’s living space.
But charging a smartphone in a vehicle is antiquated and inconvenient. Connectors don’t always fit the device, necessary adapters can be lost, cables get tangled, and connecting while driving creates a safety hazard.
Wireless in-vehicle charging solutions with high quality standards can provide OEMs the flexibility to design and develop unique solutions that are both convenient and essential to consumers.
However, while wireless in-vehicle charging presents the ideal solution to many of the traditional charging problems consumers face, its development and implementation comes with significant design challenges.
Inventor and technology pioneer Nikola Tesla first demonstrated the potential of wireless charging in 1891 with wireless “inductive” transfer of energy for lighting incandescent bulbs. Inductive charging converts an input voltage into a constant output voltage, the same way a standard combinatorial circuit component functions. The key difference is the power supply unit.
In wireless charging, the wound coils used in the power supply unit are wound separately. A magnetic field is created from a precisely defined frequency (between 105 kHz and 205 kHz) via the coils in the transmitter modules. The coils in the receiver devices receive electrical power with the identical frequency and generate voltage that charges the device’s battery.
Electromagnetic compatibility (EMC) standards in automotive applications are stringent. EMC, the unintentional generation, broadcast, and reception of electromagnetic energy, can create unwanted effects on a vehicle’s electrical system such as electromagnetic interference (EMI).
For an example look at the modern automotive KeyFob system. KeyFobs now control not only vehicle door lock/open and trunk open/close functions, but also critical in-vehicle and remote engine start functions. The electromagnetic fields created by wireless charging can have a negative influence on KeyFob system performance. It’s vital that the wireless charging system does not emit EMC that interferes with the keyless go system.
That design challenge is intensified when the driver places the KeyFob on or near the wireless charging station. In this case, the vehicle operating system may not find the KeyFob signal and the car would not start; or not operate at all. The development of advanced EMC shielding techniques is essential to ensuring the seamless operation of the wireless charging system with the KeyFob and other critical in-vehicle communications.
Temperature extremes present another challenge. Not only do they have a negative impact on a mobile device, but on the wireless charging station as well. The typical operating temperature for a smartphone is 0O C to 35O C. The interior of a vehicle sitting in a parking lot on a sunny summer day can easily reach more than 37O C. Conversely, that same interior can quickly dip below 0O C on a winter day. If not appropriately designed and protected, such extreme temperature fluctuations can lower the performance of the wireless charging system or cause damage that leaves it inoperable.
EMC and temperature fluctuations also can affect the efficiency of the system. When transferring power from the platform to the smartphone, some energy will inherently be lost. However, many wireless charging systems can achieve efficiencies of only about 45% under perfect conditions. EMC shielding and thermal management play an important role in increasing the energy efficiency of the in-vehicle system.
Every vehicle interior is different – including unique aesthetic and ergonomic designs and electronic functionalities and interfaces. In the meantime, Qi (pronounced “chee”) is the only wireless charging standard available and every phone that has wireless charging inside will be Qi-certified. The coil area on many of these phones is different and the wireless charging system must be able to work with every version and no matter what the position of the phone is on the charging station.
Wireless charging modules’ charging times are also dependent on the distance between the transmitter and the receiver module. Currently, technology is available to bridge distances up to 4mm. Greater distances are possible, but only at a higher transmitting power level, which would negatively affect the EMC in a vehicle interior. To meet the automotive industry’s EMC standards, there is a need to reduce the electrical field below the limits.
This is where proper innovative EMC shield technology combined with protected input circuitry enables a system to exceed automotive EMC requirements.
The latest wireless charging models for the auto industry are highly efficient compared to other systems – offering efficiency up to 62% (battery of the car to battery of the smartphone) at 5W with a rand of 4mm between the TX coil (WCh) and the RX coil (smartphones).
While wireless in-vehicle charging is becoming available for connected car solutions, its development and innovation continues. Next-generation devices available in the next two to three years will be able to simultaneously charge multiple devices and have downward compatibility. Additionally, other devices are to be used inductively – those with irregular, non-planar 3D surfaces such a game consoles, cameras, toys, and wearables are all conceivable.
Particularly exciting in the automotive wireless charging market is the integration of the Near Field Communication (NFC) standards that make other applications possible that have traditionally required high data security. Through NFC integration, wireless charging technology also can be used for authentication, simple pairing, sending point of interest, or as a car key – opening more possibilities for application in future connected cars.
Frank Scholz has been involved in the pre-development of wireless charging systems at Molex Connected Vehicle Solutions becoming a product manager in 2013 in this category. Scholz has a background in radio frequencies and broadcasting technology previously working for Telefunken in Berlin. He holds an Engineering Degree in Telecommunication at the University of Applied Science of Karlsruhe.
This summer (August 27-29), Drive World Conference & Expo launches in Silicon Valley with North America's largest embedded systems event, Embedded Systems Conference (ESC). The inaugural three-day showcase brings together the brightest minds across the automotive electronics and embedded systems industries who are looking to shape the technology of tomorrow.
CHICAGO, Aug. 1, 2022 /PRNewswire/ -- EMC filtration market is projected to grow from USD 861 million in 2022 to USD 1,160 million by 2027; it is expected to grow at a CAGR of 6.1% during the forecast period, according to a new report by MarketsandMarkets™. The growth of the market is attributed to the stringent environmental and EMC regulations, increasing adoption in industrial automation applications, and increasing deployment of data centers in developing nations. During the forecast period, development of EMC and power quality filters for new application areas such as electric vehicle and renewable energy is expected to create growth opportunities for the market.
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EMC filters product type to account for larger share of EMC filtration market in 2022
EMC Filters accounted for a larger share of the EMC filtration market in 2021 and it is expected to remain dominant throughout the forecast period. Increasing focus on considering electromagnetic compatibility to calculate the quality of electromagnetic products has accelerated the market potential for EMC filters. For example, in the power systems designing process, EMC filters help enhance the overall anti-interference capacity and service life of the power systems by offering good electromagnetic compatibility. Increasing efforts by regulatory bodies toward developing stringent noise regulations to suppress noise generated from electronic devices to a reasonable level will accelerate the growth opportunities for EMC filter manufacturers. Also, EMC filters help achieve immunity, reduce emissions, and fulfill fast transient requirements to deliver a robust design for electronic devices. Therefore, government and regulatory bodies have set policies and regulations for adopting EMC/EMI filters. For instance, in the US, the Federal Communications Commission regulates EMI and the set EMI policies under Title 47 Part 15, which focus on noise immunity and noise emissions of electronic devices among various industries.
Industrial automation application to lead EMC filtration market in 2022
Industrial automation to hold high opportunities for EMC filtration market compared to other applications in 2022 and 2027. Motor dive application holds for the majority of the share in the industrial automation application. EMC and power quality filters in motor drives are used to minimize EMI problems, high-frequency common-mode noise, leakage current issues, and overvoltage transients. The filters used in motor drive applications are selected on various parameters such as motor drive power rating, full load current rating, operating voltage, and EMC requirements such as EN 61800-3 for the power drive system. EMC filters are integrated between the inverter output terminals and input terminals of the induction motor to limit the effect of EMI, common-mode noise, and differential noise. Moreover, the introduction of new regulations by several authorities such as the International Electrotechnical Commission and the Institute of Electrical and Electronics Engineers to guide the engineers on emission limits to protect circuits and other devices will further accelerate the growth opportunities for EMC filtration in motor drive applications.
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Market in Europe to hold significant opportunities for the market during forecast period
Rising inclination toward environmental consciousness and valiant efforts to develop processes in sync with maintaining safe ecology will drive the adoption of EMC filtration solutions in Europe. A wide range of legislations and harmonization standards have come into force and been published in the field of EMC in the past few years. For example, in the European Union, the EMC directive 89/336/EEC of the Council of the European Communities focuses on the protective aims of the EMC directive that all equipment must comply with. The manufacturer or importer must ensure conformity with the respective standard in the form of a declaration of conformity. These standards and regulations will increase the adoption of EMC filters in the region.
Major vendors in the EMC filtration market include Schaffner Holding AG (Switzerland), Delta Electronics, Inc. (Taiwan), TDK Corporation (Japan), TE Connectivity (Switzerland), Littelfuse, Inc (US), Sinexcel (China), Schurter Holding AG (Switzerland), AstrodyneTDI (US), among others.
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Hosting News – CANNES, France and FRIMLEY, UK – At VMworld Europe 2009, VMware, Inc. (NYSE: VMW), the global leader in virtualization solutions from the desktop to the datacenter, announced a number of new customers across EMEA that are using the VMware platform to significantly reduce capital and operating expenses. These customers are experiencing benefits, such as simplified management, increased business agility, and dramatic cost savings, by virtualizing their desktop environments and implementing private clouds that leverage the VMware platform.
“Over the past 18 months, the discussion has ceased to be around whether we will see virtualization on a large scale across EMEA,” said Maurizio Carli, general manager, VMware EMEA. “The discussion is now around which strategic initiatives virtualization can support most effectively. Without a doubt, cloud computing is one of those initiatives. We are seeing rapid adoption of virtualization for both internal and external clouds. At a time where many companies face intense pressure to do more with less, cloud computing and virtualization have never made more sense. Together, they offer customers massive scalability and flexibility and the opportunity to significantly cut IT costs.”
VMware announced its VMware vCloud Initiative at VMworld Las Vegas 2008 in September. Since that time, the number of service providers supporting the initiative has grown from approximately 100 to more than 400.
T-Systems, one of Europe’s largest businesses, presented their cloud computing strategy at VMworld Europe 2009, and has developed a cloud computing service – Dynamic Services – which is based on VMware Infrastructure. “For us, cloud computing today already has become a reality,” says Jörn Kellermann, vice president, application line DTAG at T-Systems.
Klaus Rubik, head of engineering and systems management at T-Systems says, “My team is building a large part of the foundation for T-Systems Dynamic Services and an important part of this platform is based on VMware technology. This gives us a significant success in the market.”
An increasing number of VMware customers are using virtualization for centralized desktop management. This is reflected in the growing market demand for VMware View™, which enables IT organizations to deliver rich, personalized virtual desktops to any device from enterprise datacenters and cloud environments.
At this year’s VMworld Europe, Simon Spence, chief information officer for CB Richard Ellis, the leading global commercial real estate services company, presented his organization’s successful virtual desktop implementation. Spence and his team are rolling out a virtual desktop infrastructure to more than 4,000 employees in 39 countries, with the aim of creating a single, standardized desktop for all CB Richard Ellis staff across Europe, the Middle East and Africa.
“We are currently creating a global desktop estate that will make all applications available to our own or contracted staff in any of our offices across Europe, the Middle East and Africa,” said Spence. “The beauty of virtual desktops is that we can also provide these capabilities securely to our staff wherever they are and on whatever machine they use without any compromise on performance, even in the event of a major outage. In addition to this, we are looking to save up to £500,000 a year in capital and operating expenses by reducing hardware procurement, power consumption, datacenter floor space, cabling, and time devoted to desktop management.”
VMware’s customers are increasingly standardizing on VMware as their virtualization and datacenter platform. Nearly half (42 percent) of surveyed VMware customers report virtualization is now the “default build” of their datacenters, nearly double what was reported in 2007 (25 percent). Over half of VMware’s surveyed EMEA customers (57 percent) use VMware exclusively for x86 virtualization.
Checkpoint Systems International, a leading manufacturer of identification, tracking, security and merchandising solutions for the retail industry and its supply chain, is running all of its mission-critical SAP systems on VMware. “Any company using SAP will tell you that reliability and manageability are two of the key points they look for from any supporting platform they choose,” said Michael Nogger, IT operations manager, Europe Checkpoint Systems International, GMBH. “VMware is certainly our platform of choice. In terms of reliability, we have a very robust infrastructure, which is currently delivering 99.7-percent uptime for our critical systems.”
The IT services company of huge German-based insurance ERGO Group is standardizing its datacenters on virtualization from VMware. As part of its AREAL project, which is being driven by growing regulatory, technical and physical resource demands, the Group has started to move over 1,000 servers to a virtualized platform.
Italian motorcycle manufacturer Ducati has virtualized around 75 percent of its systems since June 2007, cutting hardware costs by approximately 30 percent. On its new virtualized infrastructure, Ducati has been able to implement new applications very quickly, which is vital in an industry that is literally ‘fast moving’ and has enabled the company to bring new products to market in less time than in the past.
Finally, VMware has seen significant EMEA momentum for VMware Fusion 2, which was launched in September 2008. Last year VMware Fusion became the #1 selling Mac virtualization product in North America, according to NPD and it is regularly amongst the best software sellers on Apple’s online store and Amazon.com. Virtual machines created with VMware Fusion are used by the physicists at CERN — the European Organization for Nuclear Research and the world’s leading laboratory for particle physics — who are working on experiments that run on the world’s largest particle accelerator, Large Hadron Collider (LHC).
Across the EMEA region, VMware now has more than 50,000 customers, including 91 percent of the UK’s FTSE 100; 95 percent of the Germany’s DAX 100; 100 percent of France’s CAC 40; 91 percent of Spain’s IBEX 35; and 87 percent of Italy’s MIB 30.
VMware continues to expand its presence in EMEA, as evidenced by VMworld Europe 2009 in Cannes, France, which was attended by more than 4300 customers, partners and industry analysts. The show focused heavily on the momentum around both internal and external cloud computing, desktop and application virtualization and the continued development of VMware’s partner ecosystem that supports virtualization with innovative storage, business continuity, security, management and automation solutions.
VMware (NYSE: VMW) is the global leader in virtualization solutions from the desktop to the datacenter. Customers of all sizes rely on VMware to reduce capital and operating expenses, ensure business continuity, strengthen security and go green. With 2008 revenues of $1.9 billion, more than 130,000 customers and more than 22,000 partners, VMware is one of the fastest growing public software companies. Headquartered in Palo Alto, California, VMware is majority-owned by EMC Corporation (NYSE: EMC). For more information, visit www.vmware.com.
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The driving needs are clear enough. Government workloads aren’t shrinking – they’re growing. Resources are finite. A modern infrastructure isn’t just a nice-to-have. It’s an essential part of any agency’s strategy to cope with an expanding demand for data and services with limited resources.
“You can’t hire your way out of these problems. But you can leverage the power of modern computing,” Harris says.
Whether implemented in the cloud or in on-site data centers, high-end processors can now perform complex tasks faster and more accurately than people.
But this isn’t about replacing people – it’s about the force-multiplier effect and freeing staff resources for higher-level work, Harris says.
Today’s denser data storage and high-speed computing solutions, built on highly parallel processor arrays – using the same NVIDIA graphics processor technology that powers everything from streaming video games to familiar AI solutions from Google, Facebook and Amazon – can change the nature of much of what government does.
"All those consumer applications – Amazon, Facebook – they are, at their most basic level, decision aids," says Harris. “Government needs decision aids, too.”
The internet giants leverage their global reach and the massive volumes of data their users generate not only to capture those users’ imaginations and hold their interest, but to accelerate decisions like which movie to watch or which coffee shop is closest. By recognizing patterns in what users search and select, they learn what information their customers want and can more readily anticipate those needs in the future.
This same ability to intuit what users want is no less helpful in government and business, Harris says. Once again, by layering data and context, machines can learn to identify patterns and trends faster and more accurately than humans – in the process freeing people from rote work to focus on creativity and innovation.
Image analysis is an ideal example. Computers can easily be trained to seek and recognize patterns in traffic videos, surveillance tapes, or sonograms. People are fallible. They get tired or distracted or simply bored. Unlike human beings, computers never tire. Additionally, machine learning algorithms aren’t just more effective than people at such tasks, but also continue to get better over time.
Or, consider cybersecurity, which Harris sees as uniquely suited to AI because monitoring network traffic and activity is literally beyond human capacity: it’s virtually impossible to defend enterprise networks without relying on some level of AI.
Harris sees this as an incredible opportunity for federal agencies.
“The government is the world’s biggest collector and provider of data,” Harris says. “With AI, we can help our customers do a better job detecting and reacting to what’s inside the data. ”
Although we tend to think of 3D printers as high-tech toys, most of them are not especially powerful in the brain department. There are some exceptions, but most 3D printers run on either an 8-bit Arduino or some Arduino variant with a lot of I/O. There are a few 32-bit boards, but if you grab a random 3D printer, its brain is going to be an 8-bit AVR running something like Marlin or Repetier. It isn’t uncommon to see a Raspberry Pi connected to a printer, too, but — again, in general — it is a network interface that handles sending G-code to the 8-bit controller that runs the stepper motors. Would it make more sense to do things like parse G-code, map out curves, and set accelerations in the relatively powerful Raspberry Pi and relegate the 8-bit AVR to just commanding motors and heaters? [KevinOConnor] thinks so, and he wrote Klipper to prove it.
Klipper is mostly written in Python and it does most of the functions of traditional 3D printing firmware. It communicates with the onboard microprocessor by providing a schedule of when to do what tasks. The microprocessor then handles the timing and things like motion control for the axes and extruder. Klipper can control multiple microprocessors with no trouble and keeps them in synchronization, so you could have a processor for your extruder and one for each stepper, for example. You can use Klipper with a Cartesian machine, a delta, or a Core XY-style printer.
The host computer doesn’t even have to be a Raspberry Pi. The BeagleBone will work and — in theory, at least — so will any Linux computer. There’s a small bit of firmware you program on the microcontroller that speaks a lightweight protocol to the host computer. As for user interface, that’s easy. The host can talk to Octoprint and you can run that on the same Raspberry Pi that runs Klipper.
The microcontroller firmware only has a handful of commands. Most of those are related to something to do at a given time: operating a stepper motor or setting a PWM output. Because it is simple, you could have a small CPU and you could possibly get much faster rates. Of course, that assumes your hardware can handle a faster rate.
Klipper touts several “compelling features”:
Each stepper event is scheduled with a precision of 25 microseconds or better. The software does not use kinematic estimations (such as the Bresenham algorithm). It calculates precise step times based on the physics of acceleration and the physics of the machine kinematics. More precise stepper movement translates to quieter and more stable printer operation.
Since the microcontroller firmware is very simple, it is easy to reconfigure things in Klipper just by changing a file on the host computer. The firmware is simple and in C so it can support many microprocessors including common 8-bit and 32-bit CPUs found in 3D printers.
Klipper is able to achieve precise high stepping rates. An older AVR can apparently achieve rates of over 175,000 steps per second and rates up to 500,000 per second are possible. Higher stepper rates enable higher print velocities.
At high print speeds, oozing can be a problem. Klipper implements a “pressure advance” algorithm for extruders. When properly tuned, pressure advance reduces extruder ooze, possibly allowing faster printing. You can see a video, below, of [Bradley Muller] printing at 100 mm/s using Klipper.
If that’s not fast enough, check out this cube at 150 mm/s (wait for the first layer to finish) from [lenne 0815]:
There’s also a novel “stepper phase endstop” algorithm that can Boost the accuracy of typical endstop switches. This is especially important for the Z endstop since that can lead to a more precise first layer height and Boost print quality and adhesion.
Some of these features do require tuning. The pressure advance algorithm, for example, requires a machine-specific constant. Here’s some text from the document describing the software’s kinematics:
The “pressure advance” system attempts to account for this by using a different model for the extruder. Instead of naively believing that each cubic mm of filament fed into the extruder will result in that amount of cubic mm immediately exiting the extruder, it uses a model based on pressure. Pressure increases when filament is pushed into the extruder (as in Hooke’s law) and the pressure necessary to extrude is dominated by the flow rate through the nozzle orifice (as in Poiseuille’s law). The key idea is that the relationship between filament, pressure, and flow rate can be modeled using a linear coefficient.
You can find that value experimentally by printing a test square and finding the lowest number that gives a good-looking corner. For example, below is a mistuned corner on the left and a correctly tuned one on the right.
The endstop feature utilizes the phases of the stepper motor driver. For example, a stepper driver with 16 microsteps has 64 distinct phases. Instead of homing with one step resolution, you can home to the resolution of the stepper motor.
What’s stopping you from trying Klipper? You probably have a Raspberry Pi hanging around. Klipper’s firmware probably works with your current printer’s CPU (just be sure you know how to flash code on it and have a copy of your current firmware).
We couldn’t help but think that if you could field this on a Linux laptop, you could just have a kind of super control panel for your printer. Of course, you could do that anyway, but you’d be leaving even more computing horsepower on the table if you used a laptop to just hook into Octoprint.
From a hacking point of view, being able to make changes in the 3D printing algorithms over ssh using Python without having to flash a microcontroller ought to open up a lot of experimenting possibilities. If you have an interesting fork, be sure to send us a tip and we’ll cover it here.
2018 U.S.-Booked Air Volume: $110 million
2018: Global Air Volume: $214 million
2018 U.S. T&E: $397.7 million
2018: Global T&E: $672 million
Primary U.S. Air Suppliers: American, United, Delta
Primary U.S. Hotel Suppliers: Marriott, Hilton, Hyatt
Primary U.S. Car Rental Suppliers: National, Enterprise
Primary Global Online Booking Tool: Concur
Primary U.S. Payment Supplier: American Express
Card Program: individual bill/central pay
Primary Global Expense Supplier: Concur
Primary U.S. Travel Risk Management Supplier: International SOS
Consolidated Global TMC: Amex GBT
Dell and EMC Corp. Merged in 2016 to become dellemc. The company is now known as Dell Technologies, and the travel programs consolidated in 2018, including the full implementation of American Express Global Business Travel and the SAP Concur booking tool. U.S.-booked air tickets made through approved online tools rose from 90 percent in 2017 to 91 percent in 2018, 93 percent of those getting done without agent assistance. Dell Technologies consolidated its U.S. global distribution system to Sabre last year, as well. EMC had been on Apollo.
Globally, the online adoption rate rose from 85 percent to 87 percent. The company also brought Japan, Chile, Colombia and Peru onto Concur’s online booking tool and expanded Tripbam and Yapta to additional markets. This year, the company plans to bring India, the United Arab Emirates, Israel and New Zealand into the booking tool and bring Sri Lanka and Bangladesh into the travel program in general. The company has a single global travel policy, and 58 percent of its 2018 U.S.-booked air spend was domestic travel. Also in 2018, Dell Technologies plans to implement Tripism, which presents booking options based on a client’s preferred suppliers, specialized provider offers and peer reviews. It also will implement meetings sourcing platform Groupize, as well as Clear, which helps travelers navigate on-site security checkpoints, and Passport Plus, which expedites U.S. passports and other travel documents. And it plans to switch to dynamic hotel pricing.
The company also intends to automate rebookings via the Tripbam and Yapta reshopping tools: Tripbam will reshop the rates on completed bookings not just at the same hotel but across a cluster of similar properties, and it will rebook automatically when it finds a cheaper rate for a like-for-like room and property. Dell Technologies will configure Yapta to rebook airfares automatically when the rate drops within the original booking’s no-penalty-cancellation window. Dell Technologies’ U.S.-booked air spend dropped $6 million from 2017’s $116 million, and the company expects it to stay at $110 million this year. Its global air volume dropped from $225 million to $214 million. The company’s U.S. T&E dropped 29 percent while its global T&E dropped 4 percent. The company’s 2018 revenue was $78.7 billion.
New Jersey, N.J., Aug 03, 2022 Fraud Analytics software automatically monitors transactions and events in real time to detect and prevent fraudulent activities taking place in the company, on the Internet or in the store. It prevents inappropriate access to sensitive company and customer data.
Despite technological advances that facilitate payment options or access to data, growing concerns about digital fraud require the implementation of fraud detection solutions. The advancement of digital fraud, financial crime and cyber attacks is challenging the growth of several companies worldwide. The growing number of fraudulent activities combined with the increasing number of online transactions are driving the development of the market. The ever-increasing use of next-generation digital channels to interact, transact and market products and services is one of the main drivers of the growth of fraudulent activity.
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The Fraud Analytics Software Market research report provides all the information related to the industry. It gives the outlook of the market by giving authentic data to its client which helps to make essential decisions. It gives an overview of the market which includes its definition, applications and developments, and manufacturing technology. This Fraud Analytics Software market research report tracks all the accurate developments and innovations in the market. It gives the data regarding the obstacles while establishing the business and guides to overcome the upcoming challenges and obstacles.
This Fraud Analytics Software research report throws light on the major market players thriving in the market; it tracks their business strategies, financial status, and upcoming products.
Some of the Top companies Influencing this Market include:IBM, FICO, Oracle, SAS Institute, Dell EMC, Fair Issac, BAE Systems, DXC Technology, SAP, ACI Worldwide, Fiserv, ThreatMetrix, NICE Systems, Experian, LexisNexis
Firstly, this Fraud Analytics Software research report introduces the market by providing an overview which includes definition, applications, product launches, developments, challenges, and regions. The market is forecasted to reveal strong development by driven consumption in various markets. An analysis of the current market designs and other basic characteristics is provided in the Fraud Analytics Software report.
The region-wise coverage of the market is mentioned in the report, mainly focusing on the regions:
Segmentation Analysis of the market
The market is segmented on the basis of the type, product, end users, raw materials, etc. the segmentation helps to deliver a precise explanation of the market
Market Segmentation: By Type
Predictive Analytics Software
Customer Analytics Software
Social Media Analytics Software
Big Data Analytics Software
Behavioral Analytics Software
Market Segmentation: By Application
Energy and Power
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An assessment of the market attractiveness with regard to the competition that new players and products are likely to present to older ones has been provided in the publication. The research report also mentions the innovations, new developments, marketing strategies, branding techniques, and products of the key participants present in the global Fraud Analytics Software market. To present a clear vision of the market the competitive landscape has been thoroughly analyzed utilizing the value chain analysis. The opportunities and threats present in the future for the key market players have also been emphasized in the publication.
This report aims to provide:
Table of Contents
Global Fraud Analytics Software Market Research Report 2022 – 2029
Chapter 1 Fraud Analytics Software Market Overview
Chapter 2 Global Economic Impact on Industry
Chapter 3 Global Market Competition by Manufacturers
Chapter 4 Global Production, Revenue (Value) by Region
Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions
Chapter 6 Global Production, Revenue (Value), Price Trend by Type
Chapter 7 Global Market Analysis by Application
Chapter 8 Manufacturing Cost Analysis
Chapter 9 Industrial Chain, Sourcing Strategy and Downstream Buyers
Chapter 10 Marketing Strategy Analysis, Distributors/Traders
Chapter 11 Market Effect Factors Analysis
Chapter 12 Global Fraud Analytics Software Market Forecast
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