December 8, 2016

Got Safe Beef? New Report Suggests the US Doesn’t

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Basically, anywhere but the United States of America.

Almost across the board, the US ranks at the bottom (“regressive”) for produce traceability programs as ranked by a new Institute of Food Technologists (IFT) report.

IFT checked out 21 countries and rated them “Progressive,” “Moderate,” or “Regressive” based on a handful of criteria.

While the landmark Food Safety Modernization Act of 2010 (FSMA) is expected to improve things here in America, “development of regulations are still in the early stages,” the study noted. Technically, the study is called “Comparison of Global Food Traceability Regulations and Requirements.” That’s quite a mouthful, pun intended. An earlier IFT powerpoint presentation also examined this important issue.

FSMA was signed into law by President Obama on January 4, 2011. FSMA was designed to give the Food and Drug Administration (FDA) new power to regulate the way foods are grown, harvested and processed. The law grants FDA a number of new tools, the most important of which is mandatory recall authority. But that’s all in the future. The IFT report tells us what’s going on right now.

Where to start when reading the report? The ranking of 21 countries (EU, China, Japan and a few elsewhere including Brazil and the land of the Kiwis) found that the US was only one of two major beef exporters without mandatory red-meat traceability systems. It also lagged behind most of the group with a weak consumer access program.

Generally, countries in the EU (France, UK, Germany, Ireland et al) led the group. That’s thanks, in part, to tough standards imposed in 2005 that include mandatory traceability programs for food, feed, food-producing animals and any other substance incorporated into food or feed.

livestockBlog

The US did achieve some distinctions — pretty much all bad. For example, it joined China as the only countries rated regressive when it comes to the breadth of products regulatory traceability regulations.

The US, China and Canada are also the only members of another not-so-attractive-club: Regressive electronic livestock traceability programs.

In its summary, the report diplomatically notes the obvious: The US “trails most other nations.”

Let’s wrap this up on something of a positive note.The US did make the top category for voluntary traceability programs. An optimist might say US meat exporters are significantly exceeding their nation’s relatively lax regulatory requirements. Pessimists might still urge you to think twice before buying that next cheeseburger, chicken sandwich, or tilapia in America — at least until the FSMA kicks in.

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FDA Works to Soothe Industry at Medical Device Cybersecurity Webinar

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The FDA will focus more on a device maker’s overall approach to ensuring cybersecurity rather than burrowing down and kicking the tires on each individual risk mitigation program, FDAs Abiy Desta said at an agency webinar Oct. 29.

That’s not to stay the agency is lightening up on its quest to make industry take device cybersecurity seriously. Rather, it appears to be the FDA’s way of reminding device makers to focus first on addressing the overall big picture with a sound rationale and then apply it to any number of potential risks down the decision tree.

In its Oct. 2 guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” the agency laid out its basic requirements, though at today’s event the agency stressed it would accept other approaches — as long as their strategy was defensible.

That “alternate” approach must have controls in place, and be able to prove to the FDA that its program contains the proper response to those controls as outlined in the premarket submission.

Cyber SecurityDesta, Office of the Center Director at the Center for Devices and Radiological Health (CDRH), also urged industry to take advantage of the FDA’s posted consensus standards contained on page 7 of the Oct. 2 guidance. It’s available online. To use it, type “security” in the title search to find the current list of IT and medical device security consensus standards recognized by the FDA. It’s a handy reference.

He also outlined some of the core functions FDA wants to see addressed in a comprehensive cybersecurity program, including:

  • Limiting access to trusted users by using layered privileges, appropriate authenticity, and strong passwords.
  • Protecting users and data by terminating sessions after a period of inactivity, setting up physical locks, and limiting access ports.
  • Detecting, responding and recovering by implementing features that tell a user if the device has been compromised, provide information on what to do when it occurs, implement features to preserve critical functions with the ability to reboot and recognize drivers, and provide methods for retention and recovery of device configuration.
  • Establishing a hazard analysis program that clearly evaluates risk potential, provides information on control put in place and the appropriateness of those controls to mitigate an identified risk, and a matrix that links cybersecurity controls to the risk being mitigated.

Finally, the agency expects to be able to read a document that shows a plan to provide patches and updates as needed and that assures overall device integrity.

While FDA noted that cybersecurity is also the responsibilty of others in the chain including hospitals and patients, it made it clear that the first place it will look in the event of a breach is the device maker’s office.

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Medical Device Cybersecurity Risks Are The Wrong Kind of Halloween Fright

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Well, Halloween is approaching boys and girls. And while it’s fun to don a Dracula (or Miley Cyrus) costume and get some yucks faux scaring folks, the FDA is acting like a responsible parent by setting up a medical device cybersecurity educational seminar later this month in Arlington, VA. It appears to have filled up already, but a webcast recording will be made available.

Getting a tiny adrenalin rush when a nine-year-old Frankenstein jumps out at you in the dark is one thing; finding out some nineteen-year-old hacker has infiltrated your proprietary product and customer information isn’t the right kind of fright.

Seems like someone out there in the bureaucracy has a little sense of humor, because October is National Cybersecurity Awareness Month. FDA, along with the Department of Health and Human Services and the Department of Homeland Security, hope to bring together a wide swath of stakeholders, including medical device makers, to their Oct. 20-21 “Collaborative Approaches for Medical Device and Healthcare Cybersecurity.”

Participants will be encouraged to help regulators identify barriers to promoting medical device cybersecurity; discuss innovative strategies to address challenges that may jeopardize critical infrastructure; and enable proactive development of analytical tools, processes, and best practices by the stakeholder community in order to strengthen medical device cybersecurity. It’s shaping up to be a good agenda, but it’ll probably only be as strong as the attendees who show up to share war stories and discuss best practices with regulators and others.

iStock_000020037007SmallBroadly speaking, the symposium hopes to help advance medical device cybersecurity by swapping information about the most current online threats, identifying gaps, advancing usage of the feds’ “Framework for Improving Critical Infrastructure Cybersecurity”, and developing tools and standards to build robust, comprehensive protection programs, among other areas of focus.

One of the topics will be the FDA’s new guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” released Oct. 2. That guidance provides some helpful definitions (helpful in the sense that this is how the FDA views the world), and what kind of cybersecurity protection program the agency expects from medical device makers and their kin.

Some say the threat of medical device security hacks has been hyped up a bit. I’m no expert there. But a report issued earlier this year from a cyber expert at SANS Institute (sponsored by cybersecurity vendor Norse), says some 94% of medical institutions report being victims of some type of cyberattack. This isn’t a report specifically about medical device makers, and I’m certain the vast majority of the attacks were relatively small and easy to thwart. Regardless, those numbers deserve some attention.

Hyped or not, I don’t imagine you’ll see an attendee at FDA’s event getting a jump on Halloween and showing up dressed as a sophisticated hacker, though. That’s just too scary.

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It’s Time to ‘Get’ IEC Before It ‘Gets’ You

Russ King, Managing Partner, Methodsense

Russ King, President, Methodsense

FDA medical device recalls are on the rise. An increasingly active FDA, coupled with the rise in software components for medical devices is adding up to new challenges for manufacturers. Given this reality, it’s important to understand how the FDA uses the IEC 62304, an international standard developed that, among other things, says product testing by itself is not enough to prove software is safe for patients using the medical device.

The standard provides a common framework for medical device manufacturers to develop software. Conformance with this standard provides evidence that there is a software development process in place that fulfills the requirements of the Medical Device Directive. Because it has been harmonized with the Medical Device Directive in the EU and recognized as a Consensus Standard by the FDA in the US, IEC 62304 can be used as a benchmark to comply with regulatory requirements in both markets. To date, this standard has been recognized in most countries that use compliance standards to fulfill regulatory requirements.

Complying with 62304 enhances the reliability of your device’s software by requiring attention to detail in design, testing and verification, ultimately improving the overall safety of the medical device.

Here’s the $64,000, or usually much higher, question: Does your device have to meet IEC 60601-1 requirements?

The EU has been using IEC 62304 since 2008, but it has gained even more traction with its incorporation into the third edition of IEC 60601-1’s Amendment 1. The inclusion of Amendment 1 shifted the standard from a recommendation to a requirement if your device utilizes software.

For those who design or manufacture electromedical equipment, 60601-1 is one of the most important safety and performance standards to meet. The standard addresses critical safety issues, including electrical shocks and mechanical hazards, such as pinching, crushing, and breaking. Devices that must meet IEC 60601-1 requirements include those which:

  • Diagnose, treat, or monitor the patient under medical supervision
  • Make physical or electrical contact with the patient
  • Transfer energy to or from the patient; and/or
  • Detect such energy transfer to or from the patient.

60601-1 Clause 14 requires manufacturers to comply with IEC 62304 unless the device’s software has no role in providing basic safety or essential performance or risk analysis demonstrates that a failure of any Programmable Electronic Safety System (PESS) does not lead to an unacceptable risk.

insulin pumpBasic safety is the main focus of IEC 60601-1. It’s important that you conduct a risk analysis to identify your device’s level of unacceptable risk and determine the role of software in risk mitigation. This analysis will determine the applicable basic safety requirements for your device, and, for some requirements, the test parameters that need to be used by the test laboratory.

The most common mistake that medical device manufacturers make is that they do not always assess which elements of risk their software mitigates. These are the elements that must be addressed by IEC 62304. For example, what would happen if the creator of a hoist didn’t properly vet the software that signaled the hoist to lower the patient at a certain speed? If a patient were lowered to quickly–or not  at all –there would be a risk management nightmare. Since software plays a role in the Basic Safety functions of the hoist, it must comply with 62304’s requirements.

In conjunction with IEC 60601-1, 62304 is intended to minimize the occurrence of these situations. When device software is mitigating a known potential hazard, ensuring that the code is developed properly is critical for the management of patient safety, as well as liability to the manufacture.

It can be difficult to determine if a device’s software is tied to its Essential Performance (EP), especially because the definition of EP has been widely debated for years. Thankfully, the definition and requirements for Essential Performance changed with Amendment 1 of IEC 60601-1 to help provide more clarity.

Determining Essential Performance begins with a list of all functional aspects of your device, including accuracy, measurements and its capabilities. Once you identify these items, determine whether any of these are already covered by the Basic Safety requirements of IEC 60601-1 or whether any item is not part of the device’s intended use. Then, and this is key, every item remaining gets posed the question, “If this item degrades, will it create a risk for the patient?”If the answer is yes, you must identify how its functionality must be maintained so the risk is still acceptable. This is your Essential Performance.

A good example to help clarify the impact of Essential Performance on IEC 62304 is accuracy. Consider a device that claims its EP is accurate within 5%. If the device is relying on software to maintain that accuracy or provide an alert when outside of 5%, and that software fails, then the manufacturer will be unable to detect if the device’s Essential Performance is being met. This means the software is providing Essential Performance.

Once you know your device software is responsible for Essential Performance, you must comply with IEC 62304 to ensure there is no unacceptable risk to a patient.

There are several situations that manufacturers often don’t realize require compliance with IEC 62304. These product features can create major headaches and costly delays if they are not properly developed. These scenarios include:

Alarms & Alerts
Alarms are often an Essential Performance requirement because they are intended to detect abnormalities. If the alarm was removed, the device would no longer meet it’s performance requirements, making the risk unacceptable. Software is used to detect the issue, instigate the alarm and make the sound.

Speed & Position Sensors
These sensors are in place to address Basic Safety concerns. For example, a hospital bed has a position sensor to keep it from crushing the operator’s foot and mammography has sensors to gauge compression. Devices like these use software to limit range of motion, speed and force.

Algorithms
Algorithms are frequently used with physiological monitoring. If the software is removed, the device is no longer able to operate as intended, resulting in the algorithms being part of Essential Performance.

It is important to note that these situations apply to the patient, operator or service personnel.

Once you know you must comply with IEC 62304, how do you go about preparing for it? To start, know that compliance with this standard is defined as implementing all of the processes, activities and tasks identified in the standard in accordance with the software safety class. 62304 itself does not prescribe a particular organizational structure or specific format for documentation, however. Compliance is determined by a review of all required documentation, including the risk management file.

Editor’s Note: In Part Two, we’ll take a look at the best way to approach risk management.

About the author:

Russ King is President of MethodSense, a life science consulting firm with offices in the US and Europe. They guide medical device, biotech and pharmaceutical companies with quality, regulatory and technology solutions. Their services enable clients to operate more effectively during the commercialization process and beyond. As it relates to IEC 60601-1 and 62304, MethodSense provides expert guidance and interpretation, helping you with:

  • Reviewing the standard you must comply with
  • Conducting a gap analysis of your Risk Management Program against ISO 14971
  • Updating your Risk Management Documentation
  • Completing the IEC 60601-1 and other relevant tables
  • Submitting your documentation for review

MethodSense offers special thanks for the input of Medical Equipment Compliance Associates, LLC for information that significantly contributed to the content of this article. 

For questions and information, contact Russ King, rking@methodense.com

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FDA IDE Guidance Offers Industry Important Clarity

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

In its August 19 guidance for Investigation Device Exemption (IDE) Clinical Investigators, the FDA attempts to better outline its thought process for reviewing, accepting, accepting with conditions, or denying an IDE. It can literally be a matter of life and death for patients and trial subjects. Thus, the agency and industry continue to take it seriously.

FDA approval of an IDE allows the initiation of subject enrollment in a clinical investigation of a medical device that has potentially significant risks — widely defined as a device that could pose a serious health risk or death to the user, is used to support to prolong life, or is part of a diagnosis tool also being used to support or sustain life.

The guidance covers a number of important areas, some with new wrinkles, including:

IDE Decisions

FDAlogoFDA must inform sponsors or sponsor-investigator of its decision, or must notify the sponsor that the investigation may not begin, within 30 days from the date of receipt of the IDE application, or the IDE application will be deemed approved. If an IDE application is approved or approved with conditions, the sponsor may begin subject enrollment, up to the number of subjects and investigational sites specified in FDA’s decision letter, upon receipt of Institutional Review Board (IRB) approval, which may occur prior to FDA approval.

IDE Approval

An IDE application is approved if FDA has determined that: the sponsor has provided sufficient data to support initiation of a human clinical study; no subject protection concerns preclude initiation of the investigation; and no additional conditions must be met. 

IDE Approval with Conditions

FDA has clarified matters here somewhat, and appears to have given industry a touch more leeway if used wisely and safely.

If FDA approves an IDE application with conditions, the sponsor may begin subject enrollment upon receipt of IRB approval and in accordance with the limits described in FDA’s decision letter, including the maximum numbers of U.S. subjects and investigational sites, and must submit information addressing the issues identified as conditions of approval in FDA’s letter within 45 days.

An IDE application is approved with conditions if FDA has determined that: the sponsor has provided sufficient data to support initiation of subject enrollment in a human clinical study; no subject protection concerns preclude initiation of subject enrollment; but additional conditions must be met to address certain outstanding issues.

Previously known as “conditional approval,” the phrase “approval with conditions” is now used to convey that the outstanding issues do not raise concerns that preclude FDA from granting approval for initiation of subject enrollment in the clinical investigation. FDA now says resolution of those issues isn’t required prior to initiation of subject enrollment in the study, except for certain issues related to the informed consent document.

The guidance reiterates how seriously FDA takes clear, simply informed consent forms for trial participants, noting it “closely reviews” those as part of an IDE determination.

Staged Approval, Staged Approval with Conditions

In the guidance, FDA says it may grant IDE approval or approval with conditions for a portion of the intended study cohort, enabling certain outstanding questions to be answered concurrently with enrollment in this cohort. Staged approval permits the clinical investigation to begin in a timely manner while maintaining appropriate subject protections. In some cases, the sponsor proposes a staged enrollment in the IDE application. In other cases, the sponsor requests approval for the full subject cohort but the agency may decide to grant staged approval for a limited number of subjects as an alternative to outright disapproving the IDE.

IDE Disapproval

Broadly speaking, little has changed here in regards to what the FDA deems most important in an IDE request. If the agency raises patient risk issues the device company cannot adequately address, and/or if the device maker is unable to persuade the FDA that the product is important enough (e.g. life-saving) to quality for IDE designation, it will get the thumbs down.

FDA Communications

The agency says it will send a letter discussing any rejection or question about an IDE request. The letter should include the agency’s thoughts on how the study design assessment, considerations, and other suggested improvements the device maker should consider if it plans to try again.

 

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Cyber Security and Reliability Assurance Initiatives Top Priority at NERC Board Meetings

 

Trey Kirkpatrick, Vice President, Energy & Utilities Compliance, AssurX Inc.

Vice President, Energy & Utilities Compliance, AssurX Inc.

NERC held their Board of Trustees (BOT) and Member Representatives Committee (MRC) meetings in Vancouver, BC on August 13 – 14, 2014. The meeting included lively discussions on all the initiatives underway at NERC and impacting all the Registered Entities. Two of the most talked about topics were the CIP Version 5 transition and the Reliability Assurance Initiative (RAI). NERC is dealing with some very tight timelines on both of these initiatives.

The CIP Version 5 transition involves a continuous outreach program that includes conferences, workshops and training. NERC is working with the CIP auditors to ensure consistent application of audits and enforcement. A CIP Auditor Workshop is scheduled for September 2014. These will address areas of industry concern and enable input into guidance documents. There is also an effort for the coordination with CIP version 5 revisions and the Reliability Assurance Initiative. Project 2014-02 continues to be a priority for NERC and the industry as well as the new CIP Reliability Standard Audit Worksheets (RSAWs) documents. NERC and the industry are still moving forward to ensure they meet the FERC deadline of February 2015 with the required revisions to the CIP Version 5 standards.

ElectricitySunsetBlue150The Reliability Assurance Initiative (RAI) Progress report was discussed at the NERC BOT Compliance Committee meeting. The RAI has gone through various joint pilot programs with NERC, Regional Entities and Registered Entities that volunteered for the pilot programs. The RAI is focused on risks to reliability; enforcement resources are focused on noncompliance that poses a serious and substantial risk to reliability. There are many aspects to this initiative including Compliance Exception Program and Aggregation/Logging Program. The release of the RAI documentation for industry comment is coming out soon. There were questions regarding the quick turnaround for comments. NERC said that would evaluate this to ensure that the industry has enough time to comment. The RAI program will be a work in progress as it is implemented. The timeline of January 2015 is quickly approaching with lots of activities that still need to take place.

The presentation given at the NERC BOTCC meeting was very detailed and included some important slides from various regions and registered entities from the pilot programs.

Other important discussions that took place involved:

NERC and the industry are going through some major implementation challenges in 2014 and 2015. The meetings in Vancouver included some very important discussions and what impact it is having on resources, strategic direction of the ERO, and the impact all this has on reliability to the grid.

Click here to request to view the AssurX CIP Solution Webinar.

 

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FDA Guidance Advises Device Makers to Think About Home-Use

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Medical device manufacturers would be well-advised to address any potential home-use products risk at the design state, says an August guidance from the FDA.

As the agency notes, “Failure to adequately consider potentially hazardous situations during the design of home use devices may result in inappropriate use, use error, or incompatibilities between the use environment, the user, and the device. This could cause the device to malfunction, possibly contributing to death or serious injury.”

It could also make the FDA really angry.

The guidance offers advice designed to address then entire manufacturing process — and beyond. It covers environmental issues, user issues, design issues, human factors, labeling challenges, postmarket considerations, and the always fun human factor

Digging a little deeper into the guidance, FDA covers many layers of these topics, including:

  • Environmental considers such as location, contaminants, water supply, temperature, dampness and humidity, atmospheric pressure changes, air flow, travel and international use, fluid exposure and storage.
  • User considerations such as physical location, sensor/perception requirements, plus cognitive and emotional product demand.
  • Design issues, including lock-out mechanisms, maintenance and calibration, mechanical issues and special emphasis of electrical issues. As noted earlier, this is probably the section deserving the closest examination by medical device makers.
  • Human factors ranging from user training to certifications.
  • Labeling issues including describing the basic handling of the device, how to dispose of it in an emergency, disposal, and hygienic maintenance.
  • Post-market considerations such as robust customer service and medical device reporting.

electronic document managementFDA’s Medical Device Reporting (MDR) regulation requires manufacturers to submit reports to the FDA whenever it becomes aware of information that reasonably suggests that a device it sells may have caused or contributed to a reportable death or serious injury, or has malfunctioned and the malfunction would be likely to cause or contribute to a reportable death or serious injury should it recur.

For the FDA Form 3500A, instructions for completing specific items on the form, and the coding manual see MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

For additional guidance on the MDR regulation and the reporting requirements refer to FDA’s guidance Medical Device Reporting for Manufacturers (March, 1997). FDA advises medical device manufacturers to also take a look at its draft guidance Medical Device Reporting for Manufacturers (July 9, 2013).

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FDA Spreads Regulatory Love Nationwide

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Detroit may be struggling with bankruptcy, but in a flurry of activity that would make industrialist Henry Ford proud, the local FDA office has been active in our latest warning letter round-up.

Indiana-based Med-Mizer, manufacturer of AC powered, adjustable and bariatric hospital beds, was hit by FDA’s Detroit office with a 12-point letter dated July 21.

Among FDA’s accusations, Med-Miser failed to:

  • Establish procedures for reviewing and evaluating incoming complaints
  • Develop, conduct and control and monitor its production process
  • Establish and maintain design controls
  • Validate a manufacturing process
  • Ensure its products meet acceptance criteria

Ventilab LLC, a manufacturer of manual resuscitation bags based in Grand Rapids, was also dinged by the Detroit office for CAPA shortcomings, inadequate complaint management, and failing to establish an acceptable risk management plan.

warning640Moving east to the City of Brotherly Love, FDA’s Philadelphia District office sent a warning letter to the maker of a sleep apnea monitor citing it for failure to ensure its device conformed to specifications and requirements. That June 30 letter was the result of a series of April 2014 inspections.

A June 27 letter called out Zynex Medical, manufacturer of the NexWave multiple mode electrical stimulator and the IF8000 electrical stimulator for perceived CAPA and design control and verification shortcomings. Zynex, baed in Lone Tree, Colorado, was also hit for failure to have adequate device master records and internal audit procedures.

Out in Napa, California where the weather is lovely and the wine flows, June 25 was probably not a day to celebrate for Dexta Corporation, manufacturer of medical chairs used for Lasik surgery and other procedures. FDA hit them for, among other things, failure to adequately train personnel, inability to verify test results, CAPA issues, and process controls problems.

Henry Ford, a man who tried to build his own utopian city in the jungles of the Amazon and modestly name it Fordlandia, would be proud of the FDA’s devotion to hard work these past few months. Perhaps there is an FDAlandia on some city planners drawing board just waiting for the green light. You never know.

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Unprecedented Energy Demand on Aging Grid: Important Discussions at NYISO Energy Conference

Trey Kirkpatrick, Vice President, Energy & Utilities Compliance, AssurX Inc.

Vice President, Energy & Utilities Compliance, AssurX Inc.

New York Independent System Operator (NYISO) had their 2014 Energy Conference in New York City at the end of June. The topics this year included; addressing the aging infrastructure, grid modernization, distributed resources, and fuel diversity. The panelists were a mix of industry experts from utility executives, a university professor, and government experts.

Steve Whitley, President and Chief Executive Officer of the NYISO, talked about the ongoing energy trends taking place in the northeast and the rest of North America. There are historic patterns of electricity demand that are being influenced by extreme weather patterns, the sluggish economy, and the adoption of more efficient energy technologies. Mr. Whitley discussed that within a span of six months, New York State set two seasonal records for peak electrical loads. Those two involved the summer heat wave in June 2013 and the Polar Vortex in January 2014. New York State successfully met these two extreme challenges by maintaining reliability and not resorting to emergency measures.

When it came to the panel discussions, there was plenty of dialogue for the need of fuel diversity. With coal being phased out in most of the northeast and no nuclear expansion planned, natural gas is the primary fuel source for electricity generation. With one of the coldest winters in years, natural gas price spikes and operational challenges demonstrated the need for coordination between the electrical and gas industries. Many of the panelists called for stronger regulatory policies because of the growing dependence on natural gas in North America for electric generation.

electricityTowersOrangeDistributed energy resources were also discussed along with the aging infrastructure. More than 80 percent of New York’s high-voltage transmission lines went into service before 1980. New York State studies estimate that this will require replacements over the next 30 years costing an estimated $25 billion. On the other hand, photovoltaic systems in New York State increased by over 40 percent from 2012 to 2013. Wind generation in the state continues to grow requiring utilities to complete transmission upgrades to move the power from upstate New York to southeastern New York like the Lower Hudson Valley, New York City, and Long Island.

These are all good examples of what many utilities, independent power producers, and government entities are dealing with across North America. As day-to-day energy use and peak demand diverge, this impacts wholesale electric markets, grid operations and planning, as well as, demand-side management programs.

We are all concerned with electric reliability. There are new standards for physical security and cyber security. More stringent requirements are being implemented for system protection maintenance for the bulk electric system. The utilities and independent power producers are assessing and revising their internal controls and programs so that issues are being identified earlier, mitigated and tracked to completion. They are also implementing new risk management programs so that the high and medium risks are receiving the required attention from their executives.

The electric industry has many changes ahead of them in the coming years. There will always be new competition, extreme weather and new technologies, but the companies that are addressing these issues and taking the proper actions will end up being stronger and more resilient. These initiatives benefit all of us, as customers, with a resource that we cannot live without.

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Partnership of Productivity Tools Will Allow You to Focus More on Creating Quality Products

Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc.

Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc.

In 1908, the first Model T was created and more than 15 million were sold through mid-1927, proving that a focus on your core product can create a tidal wave of success. The plan and processes Henry Ford put in place to create the Model T, revolutionized the automotive industry. Having a streamlined set of processes is still important for manufacturing a quality product today. The Model T not only tells the story of efficiency and mass production, it also depicts the story of quality proving that they are not mutually exclusive.

The medical device industry is no doubt tough to do business in, whether it’s the constant threat from multiple competitors or the constant scrutiny from the FDA with 21 CFR Part 820 and Part 11, it’s an eat or get eaten world. Non-compliance with the FDA can result in a number of costly consequences including audits, recalls, production stoppage, substantial fines and potential lawsuits.

With the advancements of technology we are now able to efficiently control and monitor the process with tools such as an Enterprise Resource Planning (ERP) system combined with a Quality Management System (QMS). Having the right partnership between your ERP and QMS vendors allows you to create a reliable support system.

erp/qmsimage

With such a support system in place your company can in turn focus more on your initial quality system, developing a sound and innovative product. The theory being that creating a quality product begins with the inception of the product. A house built on sand, no matter how nice it looks, is not going to work, and the same goes for a medical device, a quality product should be the goal from the very beginning. With today’s tools Henry Ford could create the ultimate formula: efficiency + variety + quality = success

A more detailed paper, Effective Compliance Programs Demand Sound Strategy, Strong Partners written by Michael Causey, outlines some of the key advantages your company stands to gain by selecting and ERP system that is integrated with your QMS. The never-ending challenge of creating and monitoring a quality system can contribute to your company’s increased regulatory compliance and customer satisfaction.

Get the full detailed White Paper here

About the Authors

Dennis Payton is Vice President of product marketing and development with Expandable Software Inc. He has 23 years of engineering, product management and executive management experience. He holds a BS in electrical engineering from California Polytechnic State University, San Louis Obispo, and post studies at Stanford University, University of California, Santa Cruz, and UC Berkley Haas School of Business.

Ryan Hussey is a marketing professional with Expandable Software, Inc. Mr. Hussey holds a BS of Business Marketing from San Jose State University and contributes personal time to coaching youth swimming classes and teams at local South Bay Area swim clubs.

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