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According to our research on Global Supply chain Visibility, Control and Collaboration in Life-Sciences, 7 out of 10 industry executives are concerned about of product counterfeiting and diversion.

The Whitepaper recommended that stakeholders expand the use of existing track & trace technologies to include business intelligence and analytical tools.  DHL Same Day, the special services group within DHL Express, has taken the initiative in developing a modular device - DHL Smart Sentry, which provides both condition and location monitoring for high value shipments throughout the supply chain.

To learn more about this offering, I recently spoke with Matt Groppe, Director, Global Sales, DHL Same Day.  Matt covered how the DHL Smart Sentry program can serve the needs of the Life Science industry. According to Matt, “the unique feature of this solution for our Life Science customers is our ability to provide real time monitoring for sensitive product and specimens for both air and ground movements. ”

He continued: “Many of our customers are looking beyond traditional temperature monitoring to track humidity and how often a shipment has been opened during transit. Conditions such as pressure, humidity, shock and vibration also add new measurements to evaluate packaging options. As regulatory and governing bodies hold pharmaceutical companies to more strict policies, it has become critical for companies to seek enhanced methods of monitoring product conditions. In the current environment, you can only see shipment history and react to packaging in distress only after the fact. Now, actions can be taken to secure arrival conditions at destination.”

As part of the deployment of the Smart Sentry service, DHL Global Same Day analytics team monitors shipments’ status 24/7. Customers can track the condition of the package on demand via a secure web portal or by setting up min / max ranges for notifications only if thresholds are on the verge of being exceeded.

Since many customers have their own packaging Smart Sentry can be added to existing supply chain monitoring systems to provide continuous feedback as the product moves through the global supply chain thus identifying when product or packaging has been tampered with or diverted.

Matt provided an example of the value and the peace of mind that Smart Sentry can provide: Real-time location monitoring for air shipments are key for many laboratories as it is critical to know where their specimen is at all times. Laboratories are sometimes moving specimens that have spent considerable time in development and would cost thousands of dollars to replace.

Real-time monitoring solution such as DHL Smart Sentry can fill a void in securing the safety of global shipments and minimizing the risk for product adulteration or counterfeits entering the supply chain.

In 1966 the Star Trek television series introduced us to the Medical Tricorder - a hand held device used by doctors to diagnose diseases and collect vital medical information about a patient.   Forty-five years later this object of an active imagination may in fact become reality.

The X PRIZE Foundation and Qualcomm Foundation recently announced the Qualcomm Tricorder X Prize - a $10 million global competition to develop devices that will give consumers access to their state of health by using mobile technology.  Some of the technology needed to meet this goal has already been developed.

I recently had the opportunity to chat with Rick Valencia, VP and GM of Qualcomm Life about the Tricorder X Prize, Qualcomm Life’s 2net^TM Platform and its impact on Healthcare.

“Up to 90% of health care spending today goes to managing chronic diseases,” commented Valencia.   There is a shift to a new model of health care delivery based on Accountable Care Organizations (ACOs).  The ACO mission is to keep patients healthier (and out of hospitals) through coordinated care.  Mobile communication devices play an important role in supporting this shift and making this goal more realistic.  “Hospital readmissions are a $25B problem in this country,” added Rick - enabling mobile devices to transmit medical data to health care practitioners on a periodic basis would enable early intervention.   Lower readmission costs will enable the market to support transformation to new health care models.

“Qualcomm’s 2net Platform and Hub were developed to be used in connection with wireless medical devices to support this transformation, “Rick stated.  It is important to note that both the 2net Platform and Hub are listed with the FDA as Class I Medical Device Data Systems (MDDS), which makes Qualcomm a medical device manufacturer.  The 2net Platform allows medical devices to connect via USB, Bluetooth or Wi-Fi to so that their data can be available across the continuum of care - an issue with managing chronic diseases.

“The beauty of the 2net ecosystem is that it provides medical device manufacturers with a one stop shop for wireless enablement of their devices.  It is also an open forum that encourages the creation of new healthcare apps,” noted Rick.  Using the 2net technology, data could be aggregated and analyzed for trends or anomalies.  The Platform connects patients with caregivers, family, and clinicians providing timely feedback.

Rick also pointed out that there are several benefits to device manufacturers around implementing this new technology:

• It provides a means of getting data out of devices outside of the clinical setting:
• It creates an interoperable ecosystem with medical devices, mobile medical applications and health service providers like hospitals; and
• It provides system support for tracking and tracing.

“Wireless technology is the biggest platform on earth.  We need to leverage it in health care,” declared Rick.  That is reason why the Qualcomm Foundation joined with X PRIZE to challenge the industry to develop a global customer platform.

I concur with Rick, mobile devices are the most exiting tools available today to improve health care.

By Desmond Hunt, Ph.D., Senior Scientific Liaison at USP

As the pharmaceutical industry continues to globalize, the challenges of securing complex supply chains and protecting patients from counterfeit medicines have mounted, as have the consequences of lapses in security or proper handling. In an effort to encourage comprehensive public standards across the pharmaceutical industry, the U.S. Pharmacopeial Convention (USP) is proposing a set of recommended best practices that will help ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited, and are transported to their intended destination with their quality intact.

Supply chain integrity involves minimizing risks that arise anywhere along the supply chain, from sourcing pharmaceutical raw materials to their manufacture and distribution. The new standard being proposed is not mandatory, and is contained in the proposed USP General Chapter <1083> Good Distribution Practices-Supply Chain Integrity. The proposal is intended to serve as a guideline document outlining the essential elements of an effective strategy. The proposed standard covers four main areas: importation, counterfeit drugs and medical devices, best practices to combat counterfeit drugs and medical devices, and diversion and theft.

The draft general chapter and comments submitted to USP will be a central topic of a Supply Chain Integrity Workshop that USP is convening May 22-23, 2012, in Rockville, Md. This will be a further opportunity to provide input, including whether additional information needs to be included in the chapter.

Some highlights of the workshop include:

• Supply Chain Members: Role, Responsibilities and Risks
• The Role of Logistic and Transportation Providers in Supply Chain Integrity
• FDA Update: Track and Trace
• Technologies: Impact and Implementation Issues for Wholesalers, Pharmacies, Pharmacists
• Regulations and Guidances Impacting the Supply Chain

More information about the workshop is available at www.usp.org/meetings-courses/workshops/supply-chain-integrity-workshop.

By Daniel R. Matlis

Last year, I had breakfast with Dave Johnson, CEO of ConvaTec Inc. at “CEO Unplugged,” During the session; Mr. Johnson discussed the business and regulatory challenges the Medical Technology industry is facing today.  In this environment, “I sleep like a baby - I wake up every 2 hours and cry,” he said.

Over the last year, I have had the opportunity to ask Medical Device industry executives, outsourcers and regulators what keeps them up at night?

The answer boils down this: “The increasing pace of globalization and outsourcing in the Medical Device industry has created demanding challenges for brand owners, their partners, and regulators alike.”

To identify key pain-points and innovative strategies that brand owners, their partners, and regulators are undertaking to cope in this new environment, Axendia is launching a research study.

This research will evaluate the impact of globalization and outsourcing across the entire Medical Device life cycle (from R&D design, supply chain, manufacturing and distribution). The study will provide insights into how industry leaders and regulators are utilizing innovative strategies and systems to improve visibility, control, and collaboration.  It will also provide a roadmap to enable organization to mitigate risk and increase business success.

To support this project, the research team is seeking input from industry practitioners representing the broad spectrum of companies in the Medical Device sector - including organizations of all sizes and every geographic region across the broad spectrum of Medical Device products.

To provide your input for this important industry research and share your perspectives on Medical Device issues and trends, please complete the survey by clicking on this link: http://svy.mk/2012-Med-Dev-Survey

The results of this study will be published in a comprehensive research report and presented at the MedicalDeviceSummit conference scheduled for May 9th and 10th in Chicago, IL.

Industry practitioners who complete the survey will be eligible to receive a copy of the Research Report once it is completed.  Individual responses will remain confidential; responses will be aggregated to formulate the report findings.

We look forward to your contribution on this important research.  Please complete the survey by clicking on this link: http://svy.mk/2012-Med-Dev-Survey

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.

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.

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.

When I think of Jerusalem, iconic images of religious and historic sites come to mind. Last month, I had the pleasure of visiting Jerusalem. There I met with Chen Levin, Executive Director of BioJerusalem, and learned that Jerusalem is working to become the Bio-Pharmaceutical capital of Israel.

BioJerusalem, an initiative of the Jerusalem Development Authority, was founded in 2006 by Dr. Shirley Kutner to help fuel the economic development of Jerusalem by leveraging the vast Life Sciences resources available in the city. BioJerusalem is committed to growing Jerusalem into a thriving Life Sciences center of sustainable enterprises and solid investments, grounded on cutting edge innovation.

Dr. Kutner is now in the Philadelphia region, where we’ve had the opportunity to collaborate on a number of Life-Science committees and projects. She is currently leading the strategic planning for the creation of the Regional Health Innovation Partnership based on BioJerusalem’s model.

“If you are in the basic sciences and research, the names Hebrew University and Hadassah have a strong meaning for you. Over 50% of clinical research in Israel is performed at Hadassah & Shaare Zedek hospitals and 43% of the biomedical research is performed at the Hebrew University all based in Jerusalem,” commented Chen Levin. “Two blockbuster drugs, Exelon used to treat of Alzheimer’s and Doxil used to treat of cancer, originated from the Hebrew University of Jerusalem,” she added.

“If you look on the Industry side, over 150 pharmaceutical, biotech and medical device companies are already operating in Jerusalem,” Levin told me.

Teva Pharmaceuticals, which was founded in Jerusalem in 1901, operates 2 large manufacturing facilities in the city. In addition, Omrix Biopharmaceuticals, - which was acquired by Johnson & Johnson in 2008 for $438 million, BioLineRx, Medinol and Gamida Cell have operations in Jerusalem. The Life Science sector employs 32,000 people, which represents 12% of the Jerusalem’s workforce.

In 2005, the Israeli government allocated 280 million NIS (~ 93 million USD) to the Jerusalem Economic Development Program to be distributed over seven years, for the economic development of the city. As a result, a number of leading companies have expanded their presence in Jerusalem since 2005. Here are some examples:

• Teva Pharmaceutical has opened a new plant in Har Hotzvim with an investment of $80 million. Teva operates 2 plants in Jerusalem, which together employ ~1,000 people.
• Omrix Biopharmaceuticals constructed its main manufacturing site in Jerusalem. The company is building new facilities with an investment of approximately $20 million, which will employ 60 people.
• Rafa Laboratories has 5% of the Israeli pharmaceutical market, with annual sales of approximately $70 million. The company was founded in Jerusalem in 1937, and is building a new 10,000 square meter plant with an investment of ~ $38 million. The plant is expected to be finished in 2013 and will employ 300 people.
• Sigma Aldrich - Opened a new plant in Har Hotzvim in 2010, and is now planning another expansion. Sigma has 2 plants in Jerusalem which together employ 100 people.

To continue to support the momentum of the Life Science cluster in Jerusalem, the Israeli Government approved the Marom (Hebrew for uplift) Program in May 2011. The program offers financial incentives including:

• Grants for Life-Science companies 
• Creation of subsidizes laboratories facilities for start-up companies
• Grants for companies that supply R&D services to biotech companies
• Grants for encouraging doctors in hospitals to perform applied translational research

So why should Life Science companies establish a presence in Jerusalem?

“The main considerations for companies looking to establish a presence is the nature of the collaboration, the quality of the research and development taking place, and we have an edge in all of those areas here in Jerusalem. In addition we offer the most financial incentives in all of Israel. We’d like to see companies establish themselves in Jerusalem and take advantage of our leading edge research and development, whether they are Israeli companies, foreign companies or a collaboration.” said Levin.

Winston Churchill said that “Democracy is the worst form of government except all the others that have been tried.” Similar arguments have been made by most constituents in the Medical Device ecosystem about the 510(k) process. Seeking ways to improve the 510(k) process the FDA’s Center for Devices and Radiological Health (CDRH) commissioned the Institute of Medicine (IOM) to evaluate and provide recommendations for improving this process.

On July 29, 2011, the IOM released its long awaited report on FDA’s 510(k) clearance process. The IOM report concludes that “the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM recommends that the “FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the Device Life Cycle.”

The response from both FDA and industry was swift and direct. Although all seem to agree that the 510(k) process needs to be improved neither the FDA nor industry stakeholders are willing to start from scratch to implement them.

Jeffrey Shuren, MD, Director of CDRH, noted that: “FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.”

Comments from industry groups were more forceful in their disapproval of the IOM report recommendation.  Medical Device Manufacturers Association (MDMA) President and CEO Mark Leahey stated in part “…we completely disagree that the 510(k) pathway is ‘flawed’ and that the FDA needs to eliminate it. While we are pleased that the IOM recognizes the crucial role medical devices have in health care, it is also important to remember that studies prove the 510(k) process has a strong track record on patient safety, and a complete overhaul of the system is simply not warranted.”

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed) was more specific in his statement: “The report’s conclusions do not deserve serious consideration from the Congress or the Administration. It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure. This would be a disservice to patients and the public health.”

Where do we go from here?

Most constituents agree that improvements to the current 510(k) process are needed.
IOM’s recommendations for the “Ideal Medical-Device Regulatory System” are a worthy goal to strive for. The IOM committee defined the following six attributes of an Ideal Medical-Device Regulatory System (not presented in any priority order)

• The process should be based on sound science.
• The process should be clear, predictable, straightforward, and fair.
• The process should be self-sustaining and self-improving.
• The process should facilitate innovation that improves public health by making medical devices available in a timely manner and ensuring their safety and effectiveness throughout their Life Cycle.
• The process should use relevant and appropriate regulatory authorities and standards throughout the Life Cycle of devices to ensure safety and effectiveness.
• The process should be risk-based.

The IOM’s proposed “approach” for the Ideal Medical-Device Regulatory System sounds a lot like FDA’s Total Product Life Cycle approach. The Top priority in CDRH’s 2011 Strategy is the full implementation of a Total Product Life Cycle approach. To support this effort, The Agency plans to integrate premarket, postmarket, and compliance information and functions to take into consideration all of the relevant information available to the Center at any stage of a product’s Life Cycle to assure the safety, efficacy, and quality of medical devices. (See: Is Industry Ready To Meet FDA CDRH Top Strategic Priority)

FDA’s 5 year plan further asserts its commitment to a Life Cycle approach. To this end, FDA is working to take steps to facilitate the seamless incorporation of new scientific information available throughout the Total Product Life Cycle into regulatory decision making.

So rather than throwing out the baby with the bathwater, I would suggest that all constituents collaborate to improve the 510(k) process to:

• Provide reasonable assurance that marketed devices, throughout their Life Cycles, are safe and effective according to current standards for the clinical indication at the time of use. 
• Facilitate innovation by allowing prompt access of devices to the market.