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By Mollie Shields-Uehling, President and CEO,
SAFE-BioPharma Association 

 As a global standards organization, SAFE-BioPharma has a unique perspective into developing and future IT trends in the life sciences, especially as they relate to use of our global digital identity and digital signature standard. Our staff works closely with member companies which are using the standard in a growing range of applications. We also work closely with non-member organizations to help them develop proof-of-concept studies and pilots utilizing the standard.

Based on these activities we have been able to identify three IT trends that will shape the life sciences in 2012.

1. STANDARDS-BASED INTEROPERABLE DIGITAL IDENTITIES

Industry leaders are rapidly increasing use of these unique digital identities among employees, collaborators, and clinical investigators. Issued once every three years, they take the place of multiple on line identities and can be used to control access to information and physical facilities. They also provide the ability to apply legally-binding digital signatures to electronic documents. The benefit of interoperability is that the digital identity is recognized and accepted by US government agencies, by other companies

2. CLOUD COMPUTING IN CLINICAL TRIALS

As demonstrated in a study between the National Cancer Institute and company-based cancer researchers, significant time and cost savings are realized when trial-related documents are accessed from the cloud rather than delivered by courier or mail. Interoperable digital identities (NCI researchers using government provided digital credentials; company researchers using SAFE-BioPharma digital credentials) give researchers access to the cloud-based electronic documents as well as the capability to apply legally-binding digital signatures. (Read The Paperless, Cloud-Based Clinical Trial; It’s Happening Now )

3. ELECTRONIC TRIAL MASTER FILES

Trial Master Files - the central record containing the files associated with clinical trials - are one of the last areas where clinical development records are primarily paper-based. Multiple pilot studies scheduled to start in the next few months indicate that pharmaceutical companies are preparing to make the process electronic. Companies will use SAFE-BioPharma digital identities to manage access to documents and to provide participants with the ability to apply legally-binding digital signatures.

The global SAFE-BioPharma digital identity and digital signature standard is used throughout the biopharmaceutical and healthcare communities to meet specific security and confidentiality needs. It was created with participation from the US Food and Drug Administration and the European Medicines Agency. The standard and its ongoing development is managed by SAFE-BioPharma Association, a non-profit supported by its members. For more information visit http://www.safe-biopharma.org/.

Mollie Shield-Uehling is President and CEO of SAFE-BioPharma Association. In this role she directs the business and strategic activities of SAFE-BioPharma Association. She has more than 20 years of international trade and biopharmaceutical industry experience. She is a member of the association’s Board of Directors.

Last month, I had the opportunity to chair the Global Pharma Sourcing Conference in Philadelphia. A recurring theme of the conference was the need to rigorously supervise and certify suppliers by implementing “trust, but verify” strategies. This got me thinking about the Kosher supervision and certification in the Food and Over the Counter (OTC) supply chain.

To learn more about how to keep a Kosher supply chain, I spoke with Rabbi Eliyahu Safran, Vice President - Communications and Marketing at Orthodox Union (OU) Kosher. OU is non-profit communal organization founded in 1898 and the world’s largest and most widely recognized kosher certification agency.

The Organization certifies more than 500,000 products produced in over 8,000 plants around the world. In today’s global environment, the OU certifies close to 300 facilities in China, as well as facilities in Argentina, India, Egypt and Turkey and some 80 other nations.

“Many of the brands you trust, rely on the OU for their kosher certification, including: ADM, Cargill, Coca Cola, DSM, General Mills, Hebei Welcome Pharmaceutical, H.J. Heinz, Hershey’s, Kraft/Nabisco, McCormick & Co., Nestlé, Novartis, Procter & Gamble, Pillsbury, Quest, Reynolds Aluminum, Rhodia, Unilever, and thousands more,” explained Rabbi Safran.

Contrary to popular belief, obtaining kosher certification does not involve a Rabbinical blessing over food products, or the manufacturing plants. So what is Kosher? The word kosher means proper or acceptable and it has entered the English vernacular with that meaning.

“Kosher laws have their origin in the Bible, and are detailed in the code of Jewish law. Kosher regulations are about the process, the purity and the traceability of ingredients. You may be surprised at the extent of Kosher regulations.” explained Rabbi Safran. “Kosherizing a food production or industrial facility requires a structured and meticulous process including equipment sterilization,” he added.

The OU inspects every facility where certified products are manufactured. It also requires the use of authorized ingredients from approved and qualified sources. To ensure compliance to its standards, the OU conducts unannounced, periodic inspections. “Our responsibility is making sure that things are done right. We answer to a higher authority, and are not motivated by profit,” said Rabbi Safran.

To achieve this goal, the OU employs over 600 Rabbinic Field Representatives located throughout the world - from Europe to Australia, from the China to South Africa. OU Field Representatives are proficient in modern manufacturing techniques, chemical & biological processes, as well as the intricacies of Jewish Kosher law. The agency’s New York headquarters staff consists of over 50 Rabbinic Coordinators supported by ingredients registry staff, ingredient specialists, flavor analysts and other support staff. To keep track of supply chain and product information the OU utilizes a comprehensive state-of-the-art computerized database that contains information on more than 250,000 food ingredients.

Like our industry, the OU uses a “Risk Based Approach” in its auditing process. “A facility producing a simple product, like spring water, may be inspected a couple of times a year. On the other hand, a product with a complex formula and many ingredients, or one with Red Flag Ingredients (like Glycerin) would be inspected a lot more frequently ” said Rabbi Safran. “For some high risk products, the OU has round the clock constant supervision of the facility” he added.

Partnering with the OU enables companies to leverage the organization’s vast resources. OU staff has a thorough understanding of manufacturing processes, ingredients, chemistry of additives and the procedures manufacturers employ in converting raw materials to finished products and incorporating all these resources in the kosher certification process. OU maintains a comprehensive database of approved and certified suppliers. Manufacturers rely on OU for recommendations on kosher ingredient as well new sources of raw materials and pre-certified alternate suppliers.

In recent years, over the counter Pharmaceutical and Nutritional companies have reached out to OU to obtain certification. Novartis was the first mainstream Pharmaceutical Company to achieve OU certification for its Triaminic Cough Syrup. The company has since added Maalox and Benefiber to the family of OU certified products.

Mead Johnson has OU certified many of its Enfamil, ProSobee and Poly-Vi-Sol Multivitamin products. OU also certifies products from Perrigo Holland, Maxx Performance, Robell Research, Health Management Resources and Soluble Products.

“Although we live in a society where trends come and go, as long as people need to eat, they are going to buy products that assure quality and integrity. As a result, they will look to the OU symbol as a clear indicator of both,” concluded Rabbi Safran.

So the next time you get a shipment from a supplier, maybe you should check if they keep a “Kosher” Supply Chain.

Last week I received an email from Jerry Hultin, President of NYU-Poly (my Alma matter) that included an interesting video “An Animated Year: Welcoming 2012 with a Look Back at 2011.”  As I looked at the video, I began to reflect Axendia’s accomplishments for 2011 as we set goals for the New Year.

I pondered how to measure accomplishments in today’s web-centric and interconnected world? I decided to go to the authoritative source and Googled “Axendia.” In 0.19 seconds I got about 7,320 results across 46 pages. That is one way to measure accomplishments.

Another way is to measure the contributions we have made and the commitment to our mission: “to be trusted advisors to Industry Executives on Business, Technology and Regulatory issues.” 

In 2011, we’ve had the privilege to advise executives at Life-Science, Healthcare and Food companies ranging from startups to Fortune 100 companies. We have also had the opportunity to counsel for leading technology and service providers. Read what some of our clients had to say about Axendia.

We began blogging at Life-Science Panorama in 2006, before blogging was cool. Five+ years and 160 articles later, we have nearly 2500 subscribers. Today, you can also follow us on Twitter and LinkedIn.

In 2011, findings from our research were presented in testimony to the Senate Committee on the Health, Education, Labor and Pensions (HELP) hearing on “Securing the Pharmaceutical Supply Chain.”

In addition to the Senate, Axendia’s Life Science Supply Chain research has made an impact on the following organizations:

• The Pew Health Group white paper: “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs”

• CBS’ 60 Minutes segment by Dr. Sanjay Gupta titled “The difficult fight against counterfeit drugs.”

• Dr. Roger Williams, CEO of the US Pharmacopeial Convention referenced our findings in his article: “Ensuring Drug Quality: A Complex Task in a Globalized Era” 

We have conducted Primary Research, published numerous whitepapers, authored a multitude of articles and presented at leading industry conferences, and had the privilege of chairing Advamed’s Executive Workshop “Bringing Devices to the US Market” 4 years in a row.

Giving the Gift of Childhood
Continuing a 5 year old tradition, we have donated our entire holiday gift budget to the Children’s Hospital of Philadelphia (CHOP) Foundation. We believe that a healthy childhood is a gift. With this donation, we are helping CHOP continue their work to improve the health of children.
We are so pleased at the positive feedback we received, here are a few samples.

• It was heartwarming to read how you have been doing this for the last 5 years and you are SO RIGHT about how the value of that gift is SO MUCH MORE than getting a nice Holiday Card… Your contribution will have much longer term positive impact on many children and their families and what more can you ask for than that. In fact you’ve inspired me to reach out to the Foundation to make a personal gift that will hopefully have a similar impact.
• I wish everyone did this! Thanks for making a difference rather than giving another gift.
• This is one of the nicest gifts of the year. Thank you!
  

William Shakespeare wrote “What’s past is prologue.” I hope that in 2011 we have continued to earn your trust, and that in 2012 Axendia will continue to be source of trusted advice for you.

Thank you for your support and I look forward to continuing to build long-term relationships based on Axendia’s core values: Respect, Integrity and Passion.

Interoperable digital identities are poised to help the global biopharmaceutical industry harness the full power of cloud computing. One major outcome will be more efficient and less costly clinical trials.

An ongoing study involving cancer researchers at the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI/CTEP) and counterparts at Bristol-Myers Squibb and Sanofi provides a window into the future of this process.

NCI/CTEP is the world’s largest sponsor of cancer treatment clinical trials. In 2010, it generated almost 100,000 pages to get clinical trials underway.

The study eliminated paper from the clinical trial start-up process by placing documents in the cloud and giving the researchers access using their digital identity credentials. These credentials also gave the researchers the ability to apply digital signatures to the electronic documents.

As a result, dramatic time savings occurred for all document flows requiring multiple signatures or signatures from people working off-site. Because cloud-based digital signatures were used, there was an audit trail of when the document was uploaded, of the email that was sent to alert the signatory that the document was available for signature, and when the document was actually signed.

The success of the study was based on the use of digital identities that are interoperable. Interoperable digital identities also will be at the foundation of future cost and time savings in the entire clinical trial process.

By way of explanation, these identities are digital credentials that are closely linked to the user’s proven identity and installed on a computer, cell phone or other device. They become interoperable when the entities that issue them have gone through a process that assures they can be trusted by governments, in other companies and in other industries.

That’s where the SAFE-BioPharma digital identity standard plays its critical role.  The standard — developed by a consortium of biopharmaceutical and related companies with participation from the US Food and Drug Administration and the European Medicines Agency - provides standardized ways to manage and verify digital identities and to apply legally binding digital signatures to electronic documents.

Unlike simple electronic signatures, SAFE-BioPharma digital signatures cryptographically guarantee the integrity of every document. And unlike some solutions that bill themselves as “digital” SAFE-BioPharma signatures are based on interoperable identities. They are trusted by government agencies and by other important collaborators outside the organization’s firewall.

This combination of factors - trust, interoperability and the ability to sign electronic documents in a legally-binding way - has made identity credentials based on the SAFE-BioPharma standard critical where used.

The NCI/Bristol-Myers Sqibb/Sanofi study started in 2010. BMS and Sanofi researchers are using SAFE-BioPharma digital identity credentials and NCI researchers are using digital identity credentials issued by the federal government. Because of their interoperability, all were able to access, sign and exchange documents using cloud computing.

As one sign of efficiency, NCI informally calculated that each digital signature used in the study saved about 2.2 hours over conventional “wet” signatures.

As the study moves to production, we are enhancing the signing application to fit into NCI processes with even greater efficiency.

I’m confident that lessons from this study will have a long range impact on the clinical trial process. Readers who are interested should download the white paper documenting its development and success (http://www.safe-biopharma.org/whitepaperform.htm).

There is a famous quote: “It depends on what the meaning of the word ‘is’ is.”  The impact of Health Information Technology (HIT) on Patient Safety hinges on what the meaning of the word ‘HIT’ is. (Read: The Inside Scoop on FDA Healthcare IT Regulation )

On November 8, 2011 the Institute of Medicine (IOM) released a report entitled “Health IT and Patient Safety: Building Safer systems for Better Care.”  The Department of Health and Human Services (HHS) had asked the IOM to evaluate health IT safety concerns and to recommend ways that both the government and private sectors can make patient care safer using health IT.

“Just as the potential benefits of health IT are great, so are the possible harms to patient safety if these technologies are not being properly designed and used,” said Gail L. Warden, president emeritus of Henry Ford Health System and chair of the committee that wrote the report. “To protect patients, industry and government have a shared responsibility to ensure greater transparency, accountability, and reporting of health IT-related medical errors.”
One of the obstacles to improved patient safety that must be overcome is the contractual restrictions of sharing safety-related information between technology vendors and health care providers. Another is the realization that products are not used in isolation. Rather, they are part of a larger sociotechnical system includes, people (clinicians & patients), organizations, processes and the external environment. Safety emerges from the interactions of these factors.

One of the immediate concerns after reviewing the IOM report is that the definition of HIT and a medical device is unclear.  In the report IOM recommends that HHS implement a plan to address the following recommendations:

It is evident that the IOM puts a good deal of thought in responding to HHS’s request and came up with some reasoned recommendations. A key challenge for implementing IOM’s proposed plan is definitions. For example, should Electronic Medical Record systems (EMR) systems, be regulated as medical devices or are they General Purpose IT systems? (See http://lsp.axendia.com/MDDS)

Testimony by CDRH Director Shuren at the Health Information Technology (HIT) Policy Committee and provides FDA’s perspective on potential approaches to address HIT-related safety concerns. As part of this testimony Dr. Shuren used the following examples of adverse events for HIT under FDA’s Jurisdiction.

• An EMR system was connected to a patient monitoring system to chart vital signs. The system required a hospital staff member to download the vital signs, verify them, and electronically post them in the patient’s chart. Hospital staff reported that, several times, vital signs have been downloaded, viewed, and approved, and have subsequently disappeared from the system.

• Mean pressure values displayed on a patient’s physiological monitors did not match the mean pressures computed by the EMR system after systolic and diastolic values were entered.

• An improper database configuration caused manual patient allergy data entries to be overwritten during automatic updates of patient data from the hospital information system.

According to HIMMS Medical Device Meaningful Use Matrix:
“the Food and Drug Administration (FDA) has asserted that EHRs are Class 2 medical devices over which FDA has regulatory authority. The relationship between the FDA and the ONC is evolving and it is still unclear to what extent EHR systems will be regulated, yet it is important that the user devise a comprehensive program to evaluate and monitor HIT, in particular those HIT systems that integrate medical devices as part of the data collection process. It is important that one can measure the quality of care, not just the delivery.”

The impact of Health Information Technology (HIT) on Patient Safety depends on what the meaning of the word ‘HIT’ is.  Healthcare IT will play a progressively critical role in the delivery of Healthcare. ONC has encouraged the adoption of certified EHRs through its meaningful use criteria and authorized certification organization. As we become increasingly reliant on state of the art medical technology and HIT systems we must be mindful to mitigate the risks they may inject into the Healthcare ecosystem. The primary goal of HIT must be increased patient care safety and improved outcomes.

As wireless technology began converging with Health Care and consumer devices, the Wireless-Life Sciences Alliance (WLSA) was organized to bring together business leaders and researchers in Healthcare and Technology. WLSA’s mission is to improve access to affordable high quality healthcare, globally, by accelerating innovation in wireless connected medical devices, services and applications. WLSA focuses on identifying collaboration opportunities within the wireless health and consumer sectors. As a result, members of the association represent a very diverse group of companies including AT&T, Qualcomm, CareFusion, Johnson & Johnson, Procter & Gamble, Ascension Health, Sanofi, 3M and California Healthcare Foundation.

I recently had the opportunity to speak with Robert B. McCray, President & CEO of the WLSA, to discuss the impact the convergence of medical technology, connectivity and consumer devices is having on the delivery of healthcare. Mr. McCray has over 25 years of experience as a business owner, senior operating executive, legal and transactional advisor to private and public companies including the Healthcare industry.

A crucial area for the applicability of this convergence is the management of chronic diseases such as asthma and diabetes. “The first challenge here is how you capture the information needed to manage chronic disease in a way that’s really effective.” said Mr. McCray. “This quickly drives you toward a discussion of how to gather these data more passively, kind of ‘invisibly’ to the consumer.”

A great example of the use of convergence to support this challenge is Ford’s In-Car Health and Wellness Solutions. Researchers at Ford, in partnership with Medtronic and WellDoc, have developed a series of in-car health and wellness apps and services aimed at monitoring people with chronic illnesses or medical disorders so they can manage their condition while on the go. Ford leveraged SYNC® and its ability to connect devices via Bluetooth, access cloud-based Internet services and control smartphone apps, to develop voice-controlled in-car connections to an array of health aids from glucose monitoring devices to diabetes management services, asthma management tools and web-based allergen alert solutions.

“We had one of the cars on site at the Wireless Health 2011 Conference last month” Mr. McCray noted “We’re using the announcement that Ford made with Medtronic and WellDoc about their connected car with the diabetes and asthma applications as a focal point, since that’s the first time they’ve shown it in public.” At the conference, Ford’s senior technical leader, K. Venkatesh Prasad, discussed these innovations on a “Health and Wellness Connectivity Services on the Go” panel discussion with Anand Iyer, COO of WellDoc, and H. James Dallas, SVP at Medtronic.

The announcement begs the question: Is the Ford Car a medical device? “As much as the question is fun to ask, I am sure that Ford will not market the vehicle as a 3000-lb. medical device. It is an example of creative thinking applied to the problem of how to gather information when convenient for consumers,” said Mr. McCray. (see The Inside Scoop on FDA Healthcare IT Regulation )

According to Mr. McCray, the Healthcare industry needs to “take advantage of the consumer electronic technology to drive costs down through volume and by using existing tools, such as phones and global wireless systems, and really repurpose existing technology to meet healthcare goals.”

Mr. McCray also pointed out that “healthcare and medicine are moving very rapidly from analog to digital systems. In every other sector where this shift has happened, it has transformed the sector. It is my analysis that fundamentally, knowledge makes purchasers more powerful. This drives down the costs of knowledge and decreases its value to incumbents. For healthcare, I translate that into the value of diagnoses declining rapidly and freeing up more time to be spent on therapeutics and treatments, which is going to lead to really happier customers.”

I asked Mr. McCray: What does he see as barriers to the implementation or adoption of these technologies, whether they are Regulatory, cultural, usability, interoperability or others? What are the kinds of things that he sees hindering adoption?

According to Mr. McCray, “The key barriers are institutional. They are partially due to regulatory structures such as the control of professions over licensure and the state-by-state regulatory system that we have with respect to healthcare services. Professions don’t like competition. There are opportunities to rationalize how you deliver services and deliver diagnoses, but you can’t cross state lines if there are professions involved. And then, the FDA, too, is concerned about the potential that the technology will have on public health or the potential of bad publicity because someone home alone didn’t get the signal on her monitor. If they are worried about that and don’t let that kind of device go to market or make it really expensive, then we are just not going to realize the potential benefits. You can have the best technology and the life science know-how bundled up, but if you cannot figure out how to engage the consumer, it simply will not work and your market will not develop.”

There is certainly a revolution going on in healthcare, with the converging capabilities of technology and knowledge and the ability to get it out there. There are already wireless health applications and products in the market today that are saving lives. According to Mr. McCray, “They are not on a separate revenue line. The best example that I am aware of is what Medtronic, Boston, and St. Jude have done with their implanted defibrillators and their monitors.” A study involving patients with implanted cardiac defibrillators demonstrated that the five-year survival rate for patients followed up with only in office visits was 50 percent lower than for patients who were followed up on the network using a connected bedside monitor. (Long-Term Outcome After ICD and CRT Implantation and Influence of Remote Device Follow-Up; The ALTITUDE Survival Study. Leslie A. Saxon, MD; et al.
Circulation. 2010; 122: 2359-2367 Published online before print November 22, 2010, doi: 10.1161/CIRCULATIONAHA.110.960633).

We concluded the interview with Mr. McCray’s forecast on this trend.
“We have the opportunity to move the needle on the key issues of access to care, access to affordable care, and access to quality care on a global basis. It’s the biggest business opportunity in the world and the biggest need in the world. And that comes out of five billion cell phone subscribers or more, six or seven billion people on the planet in range of cell service, even if they don’t have their own phone. This is the biggest distribution channel that’s ever existed. With the digitization of content, to and from devices and people, we can take advantage of that distribution channel and use the knowledge that has been built up in the U.S. and other research centers in rich countries and apply it to billions of new people around the world. Price, where they can afford it, is going to make care and services more affordable in the rich countries that need it due to the economic conditions and budget challenges that we are all facing. So to me, it is the biggest thing in the world, and it is a problem that we can actually tackle. Clean water is something that billions of people in the world need, but there’s nothing you can do globally to tackle clean water. You just have to knock that out neighborhood by neighborhood. But with healthcare, powered digitization and wireless connectivity converging, we can actually move the needle and tackle markets of billions of people. That’s pretty exciting stuff. If I were thirty years old, I’d pick this sector again. More fun for the next thirty years than the last, probably.”

Healthcare delivery has become increasingly reliant on state of the art medical devices and the Healthcare Information Technology (HIT) systems used to integrate them. To address the increased reliance on connected systems, the FDA has taken a series of actions to regulate HIT as a Medical Device Data System (MDDS).  The Agency has also issued draft guidance to industry on what it calls “Mobile Medical Apps” <>. FDA’s classification of Healthcare Information Technology (HIT) systems as a Class I medical device has driven IT giants like IBM, Microsoft and Cisco to register with FDA as medical device manufacturers. It has also prompted leading Healthcare providers including Partners Healthcare System, Intermountain Healthcare to register as Medical Device manufacturers.

To gain a better understanding of the FDA’s rationale and strategy for regulating HIT, I interviewed Casper Uldriks, FDA’s Associate Director for Regulatory Guidance and Government Affairs (RET) and currently Counsel at OFW Law in Washington, DC. Mr. Uldriks is a recognized expert on the FDA’s statutory provisions and regulatory programs for medical devices and was involved in the development of the Medical Device Data System (MDDS) rule.

According to Mr. Uldriks “Healthcare information technology presents an increasingly complex set of issues for FDA. The regulation of MDDS involves an issue that FDA has addressed for a couple of decades in terms of whether paper or electronic records were acceptable for the purposes of records and reports required by statute and regulations. Likewise, the use of electronic format for storing medical information has been used for decades. The MDDS rule established the scope of FDA’s regulation of IT usage in that regard. More importantly, the MDDS rule sets a boundary for what will not be regulated in the fairly benign way MDDS is. Software used beyond information storage and transfer faces greater regulatory burden steps outside the MDDS boundary.”

There seems to be some confusion among IT providers and Healthcare organizations regarding what FDA considers MDDS vs. General-purpose IT infrastructure. I asked Mr. Uldriks: How would he advise Manufacturers of General-purpose IT and Healthcare providers to evaluate HIT against MDDS regulatory requirements?

“The MDDS rule established the scope of FDA’s regulation of HIT usage in Healthcare environments, said Mr. Uldriks. “In those instances where MDDS functions and general IT functions cannot be differentiated or segregated, the use of a general IT function cannot preempt the purpose of FDA’s regulation as an MDDS system. The logic should be: If I put any medical information in a general IT function, I am subject to FDA regulation,” he added.

He commented that “Unfortunately, the general thinking seems to be: If I put everything into a general IT function, I escape FDA regulation. That is standing the regulation on its head!”

Beyond MDDS
HIT Systems used beyond medical device data storage, transfer, conversion and display faces greater regulatory burden and steps outside the MDDS boundary. “Systems requiring compliance above and beyond MDDS include operational functions that go beyond what information the healthcare practitioner considers (the information in the chart) to how they make their decision — the information operates within particular parameters established by the hospital which in turn affects medical decisions,” said Mr. Uldriks.

“For example, the doctor must use a treatment order through a software system established by the software manufacturer and the hospital. This could be seen as a customized system, like selecting the extra options for the base model of a car. (Not everybody wants a moon roof.) The options are selected to fit the buyer’s preferences, or needs. The question here is: Who is responsible as a manufacturer? Based on the activities involved, both the software platform manufacturer and the hospital can be manufacturers. ” stated Mr. Uldriks.

There is an App for That
Mobile Medical Applications (MMA) present a new frontier for FDA regulations. According to FDA, if a mobile app is intended for use in performing a medical device function it is a medical device. “A key concern for regulators is that the people developing the program may not be aware of how the MMA is actually used and under what circumstances. MMA seems like an over-the-counter device [available in an App store], so labeling alone, amongst other issues, becomes an almost unmanageable regulatory hurdle. Compatibility with interactive systems also presents potential problems. This is a new issue in many ways, particularly with the over-the-counter aspect, with regulatory impact unclear,” said Mr. Uldriks.

“Another concern that is getting more attention is the security of MMA software as the “hacking” of software and internet systems becomes more widespread. Is there some way to ensure that someone doesn’t hack into a pacemaker and cause it to suddenly stop functioning? How does the source of the MMA manage that kind of activity?” he added.

What Does the Future Hold?
“The issues we discussed will become very complex when someone tries to bring a device to market that is includes software that requires a Premarket Approval application (PMA). The easiest way to envision such a device is if the device actually makes a clinical decision rather than the doctor. For example, if these criteria are met (A, B, C and D) then perform a clinical treatment that is predicated on A, B, C, and D. The problem is that there may be an E factor that would be contrary to a Z treatment decision. This becomes a more complex issue with devices that operate with other devices based on integrated software systems. The inadequacy of one device may affect any of the other devices operating in tandem with one device’s defective software. This may require extensive verification and/or validation.” Mr. Uldriks added.

In the TV series Star Trek: Voyager, the ship’s Chief Medical Officer was a computer program called the Emergency Medical Hologram (EMH).

That’s all Science Fiction….it will never happen, you say? (Read: IBM’s Watson Supercomputer Could Help Doctors Improve Healthcare )

Last month, WellPoint and IBM announced an agreement to put Watson to work in Health Care. “Watson’s ability to analyze the meaning and context of human language, and quickly process vast amounts of information to suggest options targeted to a patient’s circumstances, can assist decision makers, such as physicians and nurses, in identifying the most likely diagnosis and treatment options for their patients…Watson is expected to serve as a powerful tool in the physician’s decision making process,” stated the press release.

Final Thoughts
“This appears like a game of technology tag with FDA trying to tag software technology. As is true for almost any federal agency, FDA runs as fast as it can, but always on the heels of its target,” concluded Casper Uldriks.

Medical Technology will play a progressively critical role in the delivery of Healthcare. As we become increasingly reliant on state of the art medical devices and HIT systems we must be mindful to mitigate the risks they may inject into the Healthcare ecosystem.

This article is part of a series providing a digest of interactions with Industry thought-leaders.

For the impact of the MDDS rule on Hospitals & Healthcare Providers read: When is a Hospital a Medical Device Manufacturer?

For the impact of MDDS on IT systems marketed to Healthcare providers read: The Impact of MDDS on Healthcare IT Suppliers, a Thought Leaders Perspective.

In his recent speech to Congress, President Obama stated “…I agree that there are some rules and regulations that put an unnecessary burden on businesses at a time when they can least afford it. That’s why I ordered a review of all government regulations.”  The review and potential elimination of federal regulations would have significant impact on the Health and Life Science Industry.

In response to the President’s order, the Department of Health and Human Services (HHS) recently published their “Plan for Retrospective Review of Existing Rules” aimed at improving regulation and regulatory review. The HHS regulatory review plan focuses on the elimination of rules that are no longer justified or necessary and considers strengthening, complementing or modernizing rules where necessary and appropriate.

This article reviews Food and Drug Administration (FDA) & Centers for Medicare and Medicaid (CMS) regulations affected by HHS’s retrospective regulatory review and their effect on the Health and Life Science Industry.

CMS has been proactive in reviewing obsolete, unnecessary or burdensome requirements. The agency has recently identified opportunities to improve patient care and outcomes by removing these impediments. In May 2011 CMS issued a final rule permitting hospitals to use telemedicine to obtain services from a practitioner credentialed at a distant hospital. This change improves the ability of rural and critical access hospitals to provide a broader spectrum of care and services to their patients while reducing provider burden. According to the retrospective plan, CMS intends to publish additional rules in the near future to alleviate other identified bottlenecks.

On a related move, in April 2011 the FDA issued a final rule regarding the regulation of telemedicine equipment. The Medical Device Data System (MDDS) Rule classified most Healthcare IT infrastructure, including telemedicine devices, as Class I medical devices. MDDS requires manufacturers of such devices to meet certain regulatory requirements including Registration & Listing, compliance with Quality System regulation and Adverse Event reporting.  Since the MDDS rule went into effect, manufacturers of telemedicine systems including AMD Global Telemedicine, CISCO and Polycom have registered with the FDA as medical device manufacturers. Tying the two initiatives together means that CMS approved hospitals can use telemedicine but the hospitals must ensure that telemedicine devices comply with FDA rules.

Another area of review in recognition of changing technologies is FDA’s bar code rule. A request for comment was made August 11, 2011 to initiate the review of this rule and help the FDA evaluate alternative technologies. It will be interesting to see if the bar code rule will be replaced with ePedigree and RFID requirements.

As part of the regulatory review process, FDA plans to Increase the Use of Electronic Reports and Submissions. FDA is embarking on a major campaign to revise its regulations to increase use of electronic information in the way it conducts business. To support this effort, FDA requested $400 M in 2010 to transform operational and regulatory processes to increase use of electronic systems and information. This would not only speed processing of NDA’s and clinical study data among others, but also would be more in line with how businesses process information using eMDR and similar programs. On its immediate agenda are regulatory revisions to permit electronic submission of clinical study data for drug trials, post-market reporting for drugs and biological products, and registration and listing of drugs and medical devices. FDA is also looking to require electronic package inserts for human drug and biological products.

In another initiative, FDA is reviewing its current Good Manufacturing Practices (cGMP) regulations for drugs. These revisions would accommodate advances in technology and control of components. Taken together, FDA anticipates that the revisions would provide greater assurances of safety and quality and address some of the challenges presented by the globalization of the pharmaceutical industry.  FDA recognizes that changes to cGMP regulations do not generally reduce costs, though there is a presumption of unquantifiable public health benefits from improvements to good manufacturing practices. Examples of such benefits include supply chain security for drugs and establishment of preventive controls, which improve product safety and reduce the harms associated with poorly manufactured or produced products.

The implementation of HHS’s retrospective regulatory review appears to provide a needed push to streamline regulations and reduce obstacles while still ensuring the safety and welfare of patients. It is a move in the right direction.

By Daniel R. Matlis

I’m sure you have heard the philosophy question: If a tree falls in a forest and no one is around to hear it, does it make a sound? The engineer in me says YES, when the tree falls it will create sound waves.

As a Strategist, the corollary is: If a research report is published and no one is around to read it, does it make an impact?

I pondered this question when we released our research report: “Global Supply Chain Visibility, Control & Collaboration; Regulatory Necessity, Business Imperative.”

Last week, the Senate Committee on the Health, Education, Labor and Pensions (HELP) conducted a hearing on “Securing the Pharmaceutical Supply Chain.”  This hearing is part of the process to reauthorize the FDA user fee legislation and examine the safety and integrity of the pharmaceutical supply chain.

Allan Coukell, Director of Medical Programs at Pew Health Group testified as an expert witness at the hearing. The following excerpt from Mr. Coukell’s Senate testimony references findings from Axendia’s research report “Global Supply Chain Visibility, Control & Collaboration; Regulatory Necessity, Business Imperative.”

“A recent survey of pharmaceutical industry executives [by Axendia] determined that 70 percent had key suppliers in China and close to 60 percent in India. About half of those surveyed were from companies with annual revenues of one billion dollars or more. 94% of those surveyed saw their greatest supply chain risk as raw materials sourced outside the United States.”

In addition to the Senate, Axendia’s Life Science Supply Chain research has made an impact on the following organizations:

• The Pew Health Group white paper: “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs“
• CBS’ 60 Minutes segment by Dr. Sanjay Gupta titled “The difficult fight against counterfeit drugs.”  The segment producer interviewed me on findings from this research. 
•  Dr. Roger Williams, CEO of the US Pharmacopeial Convention referenced our findings in his article: “Ensuring Drug Quality: A Complex Task in a Globalized Era“

I am pleased to see that findings from this research study have made an impact on the Life Science ecosystem.

Thanks for being around to read this; I hope it made a positive impact.

To discuss how your organization can leverage the findings and recommendations from this research, please schedule a briefing by emailing info(at)axendia.com

At this year’s Camstar Customer Conference  Larry Dube, Vice President for Operations at NP Medical, presented a session entitled “quality (with a small q): Prevention, Analysis and Improvement.” Mr. Dube has a track record of successfully leading Medical Device organizations through cultural change and is a proponent of lean manufacturing.

NP Medical is an OEM supplier of drug and fluid access devices and components that ultimately help guard both patient and healthcare provider once incorporated into the world’s most precise medical device technologies.

I recently had the opportunity to speak with Mr. Dube about his approach to quality in the Medical Device industry. This article distills key points of our conversation.

In many organizations functional boundaries and silos have developed over the years regarding who is responsible for quality. Most Life-Science manufacturers are organized in well-defined and delineated functional areas, each with specific roles and responsibilities. Each of these functional areas have traditionally operated as silos or stove pipes, having their own well defined, independent and often unaligned goals, objectives and incentives. This level of independence has led to the “catapult effect”, where deliverables are thrown over the wall to the next functional area to deal with. See the article at http://axendia.com/blog/2007/06/13/tilting-at-windmills/

Mr. Dube’s perspective is that quality is everyone’s responsibility, not the exclusive domain of the Quality Department. “In some Medical Device companies, the organizational culture has developed in such a way that certain people are responsible for making the products and then they throw it all over the wall to somebody else to inspect it. In that scenario, the Quality Department ends up ultimately owning the responsibility for the product quality. This is just inefficient. I’m a big proponent of lean manufacturing and that is the antithesis of lean manufacturing,” he told me.

The implementing of a culture of quality (small “q”) throughout an organization, rather than leaving the entire responsibility to the Quality (large “Q”) Department is a major adjustment for many Life Science companies. As Mr. Dube commented: “It’s a big shift in ownership and mentality for the responsibility for quality; and changes the focus of the Quality Department to Quality Assurance.” This QA process is more akin to an auditing or verification process aimed at ensuring that processes remain within their validated parameters and specification rather than ongoing inspection of the product.

Driving this need for change at NP Medical is the high volume of product and the impossibility of testing hundreds of millions of units per year. To enable this culture shift, NP is implementing an MES strategy.

NP Medical plans to achieve several objectives with their MES implementation. First there are some savings from labor recapture (from replacing a manual paper-based process). More importantly, MES provides the capability to capture information automatically, monitor processes in real-time and the ability to react more quickly to process or product quality issues. According to Mr. Dube: “The sooner we can figure out that there’s something wrong, the easier it is to understand the root cause, and implement corrective actions.” And lastly, there is the savings from limiting scrap costs and tying up inventory.

The ultimate goal for NP Medical’s MES implementation is to have inspection by exception as opposed to inspections as the rule. Achieving this goal requires a phased approach: collect data, continue testing, compare data to test results, implement analytics software, look at correlation between certain process parameters and establish control limits. As a better understanding of the process develops it may require some modification to the automation equipment or tooling upgrades in order to provide the types of control needed. If a process parameter is important but unable to meet control limits, the design parameters may need to be revisited. And this is where the MES system can help as noted by Mr. Dube: “Just like it can help get to root causes of a particular problem, it can also help to justify making go/no go types of decisions. If I’m not getting what I expected out of this particular process I can stop.”

Moving to an MES environment is not just about implementing the technology. A company must have not only the resources needed to make this type of investment but also the willingness to commit to changing the organizational culture as well as long-term vision to implement based on long-term results. Unfortunately, there is generally an external trigger, some sort of compelling event (like an FDA audit or a product recall) that drives the decision to implement a technology solution.

Whatever the reason for implementing MES, a key outcome of the successful implementation of an MES strategy is that quality must become everyone’s job. “Putting information in the hands of the operators permits them to make assessments now and adjustments now and allows the transition to a corporate wide culture of quality to happen,” concluded Mr. Dube.