February 22, 2012

Can the U.S. Maintain its Leadership Position in Medical Devices?

According to a recent PwC study, the U.S. medical device industry is facing stiffer competition by rival countries – mainly Brazil, China and India. However, the U.S. innovation edge may face more threats from an inefficient American regulatory system, according to AdvaMed.

Unveiling its “Competitiveness Agenda” at device maker Stryker in Kalamazoo, MI, today, AdvaMed detailed six policy initiatives that would allow medical device companies to thrive.

AdvaMed’s Competitiveness Agenda proposes specific recommendations under six broad policy imperatives:

  1. Innovation in the life sciences must be a government priority, including requiring an innovation impact statement for significant new regulations that affect the health sector;
  2. The FDA review process must be reformed to reduce total review times. American patients should have as prompt access to new treatments as European patients do;
  3. Payment policies of Medicare, Medicaid and private insurers must support medical innovation and not penalize early adopters of new treatments and cures;
  4. A vigorous trade policy must support export growth and provide a level playing field for U.S.-based manufacturing;
  5. Strategic tax policies to level the playing field must be implemented, including improvements to the R&D tax credit to keep it competitive with other countries;
  6. The American research and development infrastructure must be sustained and improved. Special emphasis should be placed on creating research structures that support commercialization of the R&D.

“America is the acknowledged world leader in medical technology, but that leadership is being challenged,” said Stephen J. Ubl, president and CEO of AdvaMed. “We know medical technology has a bright future. The question is: will that future be made in America—or somewhere else? Without the right public policies in place to provide a level playing field between the U.S. and foreign competitors, America’s leadership will be lost.”

In addition to protecting jobs and helping patients, Stryker Chairman, President and CEO Stephen P. MacMillan stressed that device manufacturing is an important driver of current and future economic growth.

“Our industry plays such a great role in improving patients’ lives around the world, and we are a great source of producing good manufacturing jobs. As the markets for our products grow around the world, we want U.S. policies to be encouraging job creation here,” said MacMillan.

Read the entire release here.

Related post: ‘Crescendo of Complaint’ Calls for FDA to Improve Medical Device Regulation

 

 

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Introducing AssurX One: A complete, affordable, single source compliance solution for small- to medium-sized utility companies

The AssurX One program provides small- to medium-sized utility companies a single source solution to implement a world-class compliance management system. Included are best practice pre-configured workflows, dashboards with real time metrics, automatic regulatory updates, a secure (SAS 70 Type II certified) OnDemand system, Web-based implementation and training, along with industry focused Webinars and workshops.

Built-in metrics, robust help files and an easy dashboard-centric user interface require minimal training to get up and running quickly.

AssurX One system consistently tracks, measures and demonstrates compliance for an array of NERC and regional standards and requirements, including annual policy reviews, to asset and cyber security management, and document control.

Included in the AssurX One program:

  1. Best practices, pre-configured workflows (NERC gap analysis, self-certification schedules/calendars, document control, cyber security management), dashboards and metrics.
  2. Hosted on a secure, OnDemand system with preloaded NERC and regional standards and automatic regulatory updates.
  3. Web-based implementation and training. Tutorials provided for each workflow.
  4. Exclusive industry focused compliance Webinars and workshops.

For more information, download the detailed brochure (PDF):

 

 

 

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Trey Kirkpatrick joins AssurX as Vice President, Energy and Utilities Compliance

Trey Kirkpatrick, Vice President, Energy and Utilities Compliance, AssurX

AssurX is pleased to announce the appointment of Trey Kirkpatrick as Vice President, Energy and Utilities Compliance.  Prior to joining AssurX, Trey served as Manager, Compliance Implementation and Registration for the Northeast Power Coordinating Council (NPCC) where he was responsible for registering all entities that met the requirements of the NERC Statement of Registry Criteria. NPCC has over 305 companies registered that are responsible for over 600 functional responsibilities as owners, operators and users of the bulk-power system.

While at NPCC, Trey was chairman of the NPCC Compliance Committee (CC) reporting directly to the NPCC Board of Directors.  As chairman, he worked closely with NPCC staff and stakeholders to continuously improve the compliance monitoring and enforcement process at NPCC.  He was also chairman of the NERC and Regional Entities – Registration and Certification Working Group (RCWG) where he worked with the eight (8) regional entities and NERC on setting strategic priorities for registration and certification within North America.

Prior to NPCC, Trey served as Manager, Reliability Compliance at Northeast Utilities where he was the lead manager representing Northeast Utilities’ Operating Companies’ strategic and operational interests with the North American Electric Reliability Council (NERC). While at Northeast Utilities, he was in charge of oversight of all matters related to reliability rules, including rules development, internal compliance assessments, compliance reporting, compliance audits conducted by sanctioned regulatory authorities, and developed and maintained all necessary records demonstrating Northeast Utilities’ compliance on a system-wide basis.   Trey was also a representative on the NERC Compliance and Certification Committee (CCC), which is a stakeholder body working closely with NERC and Regional Entities.

Trey comes to AssurX with an extensive background in energy and utilities having spent the past 20 years in various engineering and compliance positions in the industry; including in nuclear power generations and transmission. He will contribute his leadership skills in expanding AssurX’s compliance products and services in North America’s energy and utilities industry.

You can follow Trey on Twitter: http://twitter.com/CATSWebER

 

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FDA CDRH to Hold Series of Webinars on Electronic Medical Device Reporting

We recently blogged about electronic medical device report (eMDR) submissions to CDRH setting new records in 2010. Looks like the FDA would like to get more medical device companies on the bandwagon by offering a series of monthly interactive Webinars. An email sent today from Eugene Reilly states:

Many MDR reporters are already submitting MDRs electronically, but many still have not taken the plunge. If you’re one of those, why wait?  Find out all you need to know to take the mystery out of electronic reporting at one of our upcoming interactive webinars and meet CDRH’s eMDR Team:

Friday, April 29, 2011
1:00 PM–5:00 PM EDT (1:00–1:30: Technical webinar issues/questions handled.)

Friday, June 03, 2011
1:00 PM–5:00 PM EDT (1:00–1:30: Technical webinar issues/questions handled.)

Friday, August 05, 2011
1:00 PM–5:00 PM EDT (1:00–1:30: Technical webinar issues/questions handled.)

Friday, September 30, 2011
1:00 PM–5:00 PM EDT (1:00–1:30: Technical webinar issues/questions handled.)

Friday, November 18, 2011
1:00 PM–5:00 PM EDT (1:00–1:30: Technical webinar issues/questions handled.)

CDRH’s Webinar Connection Information:
We encourage participants to test your connection prior to the webinar. Participants will not be able to enter the actual meeting until the host has logged in on the day of the event.

To join the meeting (Please use your email address to join the Adobe Connect session. We will use this email address to send follow-up information.):
https://collaboration.fda.gov/cdrhemdr/

To test your connection: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm

To get a quick overview:
http://www.adobe.com/go/connectpro_overview

Questions? Please feel free to e-mail us at eMDR@fda.hhs.gov

No news yet on a mandate.

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The Top 10 FERC Enforceable Standards in 2010

Last year we blogged about the top 10 FERC enforceable actions for the NERC standards, with PRC-005-1 violations leading the pack. As you can see in the chart below, 8 out of the top 10 violations are CIP related. So, what changed?

FERC Top 10 Enforceable 2010

According to Trey Kirkpatrick, VP, Energy and Utilities Compliance for AssurX, “With the emergence of the CIP standards into the NERC and Regional Entities CMEP program, registered entities are self-reporting more CIP violations.  The entities are finding that documentation of personnel training and system security management continue to be an area for improvement. The registered entities are taking action with proper mitigation plans that are approved by the Regional Entities and NERC. They are also continuing to learn from other areas such as; nuclear power and health sciences how to instill a ‘Culture of Compliance’ in their workforce.”

And, as stated in NERC’s February 2011 Newsletter:

The Department of Energy (DOE) is launching an initiative to enhance cyber security on the electric grid. The initiative, led by the Department¹s Office of Electricity Delivery and Energy Reliability (OE), the National Institute of Standards and Technology (NIST), and the North American Electric Reliability Corporation (NERC), will be an open collaboration with representatives from across the public and private sectors to develop a cybersecurity risk management process guideline for the electric sector.

The Regional Entities and NERC are also performing more on-site audits and spot-checks. They are discovering implementation inconsistencies between entities and are sharing those lessons learned with FERC and the registered entities.  NERC has standard teams currently revising the next version of the CIP standards.  AssurX will continue to follow these revisions in updates to our readers in future blogs.

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Electronic Medical Device Report (eMDR) Submissions to CDRH in 2010 Sets New Record

As we predicted a few months ago, 2010 proved to be a record setting year for CDRH electronic submissions. The pace of submissions picked up significantly in the 2nd half of 2010, with October being the highest submission month (18,096).  Several years ago the device industry was criticized for not embracing electronic submission technology, but now is in a commanding lead over the rest of FDA’s divisions including CDER.

CDRH 2010 Monthly Statistics

Source: FDA

Looking at the numbers from 2006 – 2010 below, it looks like the device industry has embraced this paperless technology and will continue to grow as the mandate looms in 2011.

CDRH 2006 - 2010 ESG Submission Totals

Source: FDA

It will be interesting to see if the rate of growth will continue at this rapid pace, or will level off. We’ll keep you posted.

More information about electronic medical device reporting solutions.

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Handling a Warning Letter: If At First You Don’t Succeed…

Last year, we blogged about the most common drug and device GMP 483 items and how to respond to them in writing.  But what if your response is judged inadequate or the FDA otherwise issues a Warning Letter? First off, understand that the agency even at this point is strongly hoping you will voluntarily take the corrective action required so they can settle this case and move on to something else. They are intended to elicit voluntary correction.

However, if you fail to address the issues raised in a Warning Letter, your company can face some serious repercussions, including: recall, seizure, injunction, monetary fine, debarment, disqualification, license suspension or revocation, and prosecution.

The issuance of a Warning Letter certainly raises the stakes after a 483. The violations it contains represent concerns not only of an investigator, but of the District and/or Center Compliance Officers.

Responding to a Warning Letter

Your first action after you receive a Warning Letter should be to immediately notify top management of the letter and give them an idea of the scope of the problem. You should also contact the FDA’s District Director or Compliance Officer. In your written response to them, you should acknowledge your obligation to comply with the law, discuss the impact the issues raised will have on product quality, address any broader or systemic corrections the Warning Letter may have raised, and offer your corrective actions and timetable for completing them.

Ask to meet with the FDA. That meeting is important for a number of reasons, including:

  • Ensuring there is common understanding of GMP concerns
  • Verifying the adequacy of proposed corrections
  • Revealing if further action is planned by the FDA
  • Achieving agreement on how to proceed
  • Providing a written summary, including any clarifications and additional commitments from either side
  • Setting a timetable for periodic updates on progress

Your company can avoid “unnecessary problems” with the FDA as long as your response avoids the following: unrealistic goals, blaming everything on a lack of training, trivializing the product complaints, failing to proofread your correspondence, citing other firms’ practices as an excuse for your own, and failing to implement promised corrections.

Attorney Peter Reichard with Sheppard Mullin works closely with drug and device companies and former FDA officials. He stressed that your Warning Letter response should focus on how you are addressing the problem. “Companies have a tendency to try and explain something, but the FDA is not interested in that,” he says. “They just want to know your plan and that you followed up,” he says.

Part of that plan, Reichard says, is to put together a Warning Letter response team that goes beyond regulatory personnel. Include those involved in business and legal issues and those who keep a handle on resources and expenditures, he advised.

Avoiding Warning Letters

The only proven technique for avoiding enforcement actions [is] establishing an effective Quality System.  And the FDA defines “establish” in this instance as a Quality System that is defined, documented and implemented.

Companies that have SOPs and teams in place to handle process problems tend to do a better job of avoiding Warning Letters, agreed Adam Bloom, an attorney in Reed Smith’s Life Sciences practice.

But the absolute “worst-case” scenario is to become a repeat offender in the eyes of the FDA, he said. “If you said you would fix something, and they come back a year or two later and find the same problems,” they will view you harshly, he added.

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Device Makers Smash Record in 2010 with eMDR Submissions to FDA

In July of this year, we blogged about how the mid-year electronic medical device reporting submissions had soared to record levels. Now it looks like it’s actually going to be a record breaking year. The FDA has seen record breaking submissions by CDRH, for the first time being outpaced by CDER by almost twofold. In the past few years, CDER submissions to FDA far exceeded those by CDRH.

As you’ll see in the chart below, submissions to CDRH  have grown significantly in 2010.

But what’s even more eye-popping is the comparison of electronic submissions to CDRH for 2009 vs. 2010 (through October) shown in the chart below.

So what’s driving this surge? Many contributing factors can play into these numbers. Many companies have embraced FDA’s options for electronic submissions, and many have implemented commercial off-the-shelf electronic medical device reporting (eMDR) software as part of their overall complaint handling and quality management system. Other factors could include increased vigilance over reportable submissions, numerous new devices that have come to market, anticipation of electronic submissions mandate by FDA, as well as increased device scrutiny from FDA, health professionals and the public at large. Even though we didn’t see the expected mandate on eMDR in 2010, it is listed on CDRH’s priorities for 2011.

Some industry analysts say that device makers, generally smaller entities than pharmaceutical companies, had been slower to embrace eMDR because they didn’t have the same money or staff. But those days are clearly over.

We’ll revisit the 2010 numbers again in January 2011.

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Expandable Software, Inc. and AssurX, Inc. Launch Integrated Solution with Expandable ERP and CATSWeb Quality Management System

ERP and quality management integration drives life science manufacturer’s solution for managing regulatory compliance

Expandable Software, Inc.Santa Clara, CA, Morgan Hill, CA – Expandable Software, Inc., a developer of ERP software and AssurX, Inc., provider of quality management and regulatory compliance solutions announced the launch of joint products and a partnership that brings critical regulatory compliance solutions to medical device and life science manufacturers. This enterprise-level global solution and partnership has already proven fruitful with a first joint medical device customer, ReVision Optics (RVO).

Revision Optics VUE+“As RVO prepares for expanded Vue+ commercialization, it is important that our quality systems grow and expand as we navigate through regulatory compliance processes,” said Ali Dahi, ReVision Optics’ V.P. Operations. “As we drive our business priorities in preparation for meeting these requirements, our choice of Expandable’s core ERP with integrated extension to CATSWeb help us incrementally bring functionality on line as our business dictates the need.”

The strategic partnership with AssurX reinforces Expandable’s commitment to providing a complete integrated solution for manufacturers competing in the life sciences industry.  Integration with CATSWeb delivers Expandable customers a powerful quality management solution that provides enterprise-wide visibility of quality issues and processes helping medical technology manufacturers meet the stringent requirements of the FDA and other governing bodies.

“What we’re offering Expandable customers is an extremely attractive entry point to a very robust quality management solution,” said Bob Swedroe, CEO of Expandable Software, Inc. “We’ve found that growing medical technology manufacturers have a distinct need for integrated quality management but often delay or forego the investment because of the typical high cost of commitment. Our partnership with AssurX is aimed at providing customers with a tier-one quality solution, integrated with Expandable ERP, that can be deployed by companies that are anywhere from pre-production to the high growth phase of their expansion cycle.

“Connecting the AssurX quality and compliance management system to the Expandable ERP system provides a complete solution for manufacturers, especially life science companies. This allows manufacturers already using the Expandable ERP system to realize the benefits of integrated quality and compliance process functionality. It also extends four pre-configured, 21 CFR Part 11 compliant processes to Expandable’s ERP customers: customer complaint handling, nonconformance tracking, supplier quality and corrective and preventive action (CAPA) management. We are thrilled that Expandable selected AssurX to provide this integrated functionality,” added Sal Lucido, Vice President, Enterprise Solutions, AssurX.

“Our product strategy is to provide a completely integrated enterprise-level solution that medical technology manufacturers can use to establish sound business practices early in their growth cycle,” said Dennis Payton, Expandable’s director of product marketing. “Our relationship with AssurX allows us to provide comprehensive solutions that meet the very demanding long-term needs of medical technology manufacturers at an investment level that is affordable for growing companies.”

About Revision Optics

ReVision Optics, Inc., (RVO) is a privately held corporation headquartered in Lake Forrest, California. The company’s main focus is the research and development of minimally invasive implantable devices for the restoration of reading vision.

ReVision Optics’ current product portfolio includes the Vue+ corneal microlens. Vue+ is a tiny contact lens-like device that is placed just beneath the surface of the eye. The lens is made from a proprietary, optically clear, biocompatible hydrogel that is similar in nature to the natural cornea. The lens is designed to slightly change the shape of the corneal curvature to improve near or reading vision, decreasing the need for reading glasses.

The company is actively pursuing regulatory approvals and market opportunities for the Vue+ worldwide. The Vue+ has received CE mark and is approved for sale in Europe. For more information, please visit www.revisionoptics.com.

*Caution, the Vue+ is an Investigational Device and is limited by United States federal law to investigational use only.

About AssurX

AssurX, Inc., provides highly regulated organizations with enterprise quality management and compliance solutions. With a choice of OnDemand (SaaS) or OnPremise (licensed) software delivery options, AssurX’s flexible, all-in-one system automates quality and compliance processes so issues can be centrally managed. It helps collect, organize, analyze and share information to better manage and improve quality and compliance performance everywhere in your enterprise. More information is available at www.assurx.com.

About Expandable

Expandable Software, Inc. develops, markets and supports an enterprise resource planning (ERP) software suite designed to help executives and managers of fast-growing companies maximize business performance by maintaining visibility and control of manufacturing operations. Expandable’s fully integrated accounting, engineering and manufacturing modules provide a solid back office foundation while CRM, e-business, and supply chain functions deliver front office tools to manage business relationships, and streamline transactions.

The Expandable system is targeted to medical device, high tech and other manufacturers who need a dependable business foundation that will support their growth all the way to the billion dollar mark.

Expandable is located in California’s Silicon Valley.  More information is available at www.expandable.com.

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Mid-year Electronic Medical Device Report (eMDR) Submissions to CDRH Soar to Record Levels

In January of this year, we took a look at the overall numbers for electronic medical device reporting (eMDR) submissions to the CDRH/FDA. As we predicted, those numbers have risen significantly in the first half of 2010, even though the final rule still has not been published, and probably won’t happen before the end of the summer. Comparing the first six months of 2009 vs. 2010 [see chart below], electronic submissions are up dramatically.

eMDR Submissions 2010 vs. 2009 - First Six Months - Source: FDA

The all-time monthly record was set in June 2010 with 7,755 electronic submissions, and for the first six months of this year they’re up 74% over total submissions in 2009 (21,296 total in 2009 vs. 36,962 first six months of 2010). Even without the eMDR final rule published, companies are taking advantage of paperless electronic submissions to FDA. As Indira Konduri, CDRH eSubmissions Program Manager once told us, it’s better to get on board with the FDA now, rather than wait. I’d take that advice and get it done now, before the final rule is published and everyone rushes to get on board.

It will be interesting to see what happens for the rest of the year.

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