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 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

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.

The dynamics in the Healthcare market are changing. Healthcare organizations must provide high-quality patient care and improve clinical outcomes, while at the same time reduce the overall cost of providing high quality care and ensure compliance with all applicable regulations.

Watch this video to see how Smarter Healthcare can help to lower costs from the inside out

Learn more about this IBM offering at: http://ibmtvdemo.edgesuite.net/software/tivoli/demos/RTAL_LP/index.html

“Global Supply Chain Visibility, Control & Collaboration; Regulatory Necessity, Business Imperative“  

The dynamics of the Global Supply Chain are driving the Life Science ecosystem to seek innovative approaches which improve product safety while at the same time reducing costs and risks. To attain the sustained benefits of globalization, the Life Science ecosystem must implement a new paradigm to manage Global Supply Chains. This was a key finding of a major study of Pharmaceutical Drug, Medical Device and Bio-Pharmaceutical Industry Executives released today by the analyst and strategic advisory firm Axendia, Inc. 

Life Science Stakeholders must implement strategies which capitalize on the benefits of globalization, while proactively reducing and controlling risks.  This calls for changing the business, technology and regulatory models traditionally used by the Industry.

To this end, the research report recommends the Life Science ecosystem implement:

• On-Demand-Visibility
• Control Over the Global Supply Network
• Collaboration Strategies

The complete findings of this research study are available today in a new report entitled, “Global Supply Chain Visibility, Control & Collaboration: Business Imperative, Regulatory Necessity”.

Read the Research Alert 

For more information about this report visit the research home page at: http://lsp.axendia.com/global-supply-chain/

Axendia Launches Life Sciences Global Supply Chain Research Study

The globalization of manufacturing and supply of medical products has created unique and demanding challenges for the Life Sciences industry and the U.S. Food and Drug Administration alike.  In light of recent adverse events, Industry and regulators are preparing to take significant steps to secure the Global Supply Chain.

Axendia, Inc., today announced that it has launched a research study entitled, “Global Supply Chain Visibility and Security; Business Necessity, Regulatory Imperative”.   This research seeks to identify and analyze trends, requirements, and initiatives Life-Science companies are undertaking to gain deeper visibility and controls over Global Supply and Value Chains.

The study will focus on:

• Assessing current and desired states of Life Science supply chains
• Identifying key challenges facing global and outsourced ecosystems
• Outlining innovative strategies and system to enable and guide this transformation
• Provide a roadmap to achieve Global Supply Chain Visibility and Security

Axendia researchers will seek insight from industry leaders and regulators on innovative strategies and technologies, enabling supply chain visibility and security, risk mitigate, and increased business success.

The results of this study will be presented in a report detailing current and best practices in Global Supply Chain Visibility and Security in Life Sciences. The research report will include tables and charts supporting research findings. Axendia will conduct the study research, analysis and report, and retain full editorial control.

I recently had the opportunity to chat with Tom Lentz at The Johns Hopkins Hospital. Tom is Manager of IT and Finance for the Facilities Department at Hopkins.

During our discussion, I shared Axendia’s research and analysis on “Lowering the Cost of Healthcare from Inside Out”. We also discussed current pressures facing healthcare providers including the need to improve clinical outcomes and reduce costs, while ensuring compliance with a applicable regulations. In addition, the proliferation of Medical Technologies has created a new level of complexity and risks for Healthcare organizations.

To respond to these new challenges, healthcare providers are seeking ways to effectively manage a sophisticated mix of clinical, biomedical and facilities systems and equipment.

During our session, Tom discussed how The Johns Hopkins Hospital uses its Integrated Asset and Service Management system to:

• Improve uptime to support patient care
• Control costs for procurement, maintenance, labor and materials
• Support regulatory compliance and reporting activities
• Improve internal controls with automated workflows
• Gain efficiencies by mobilizing asset management

You can participate in our conversation with Tom Lentz from The Johns Hopkins Health System, by attending our upcoming IBM / Axendia Webcast on May 18, 2010 at 9:00 AM PT / 12:00 PM ET.

To register visit: https://event.on24.com/eventRegistration/EventLobbyServlet?target=registration.jsp&eventid=201849&sessionid=1&key=76A9806CBA8B4D4E34E12787C2F454B3&partnerref=IBM02&sourcepage=register

This webcast is the second installment in our series “Lowering the cost of Healthcare from Inside Out”. You can view the inaugural webcast in this series on-demand, by visiting: http://LSP.axendia.com/2010/01/27/lowering-the-cost-of-healthcare-from-inside-out/

I hope you can join our discussion next week.

Last month’s article in Life-Science Panorama entitled “Hospitals & Medical Device Manufacturers Address Interoperability with New Standard” discussed the emergence of standards and regulations around communications involving medical devices.  The article  offered what was to me a surprising claim:  “The use of these networked medical devices in a clinical context … will soon be subject to national or regional regulations [and] may not be marketed without evidence of interoperability, that is, they must not compromise the organization’s delivery of health care.” 

Having been involved with medical device interoperability standardization efforts for over a decade and watched approaches to the problem and players interested in it come and go as time went by, not much actually surprises me anymore.  But it’s quite a leap and a bit of a shock to go from “evidence of interoperability” to “[not compromising the] delivery of health care.”  Strictly speaking, interoperability is about the capability of devices to communicate with each other and make use of the shared data and nothing else.  Other properties will arguably play greater roles in assuring system integrity, e.g., reliability, usability, maintainability, availability, etc.  Interoperability is not synonymous with risk management, nor does it guarantee it. 

Still, I agree that draft standard IEC 80001 “Application of risk management to information technology (IT) networks incorporating medical devices” is expected to play a key role in assuring the system integrity necessary to realize the visions that interoperability is expected to enable.  But is IEC 80001 sufficient?

“I pose the following to clinical engineers and biomedical equipment technicians: “What would make you comfortable with supporting a request to implement aspects of critical care device functionality on an IT network?” Would being told that the network had been designed and installed according to relevant process and standards be sufficient? Or … evidence that the result of application of the processes and standards addressed functional and non-functional requirements relevant to critical care.   How much evidence do you need to support an argument that worst case failure of an ICU monitoring system … could not place a patient, or hundreds of patients, at unacceptably increased risk?” [1]

It is notable that that the risk management principles of IEC 80001 are largely inherited from IEC 14971, a more general and process-based medical device risk management standard that has primarily been applied to stand alone devices and system from single manufacturers. 

“Imagine the implications as medical devices increase their use of and dependence on networked resources, particularly in light of the rate of change and heterogeneity of clinical applications and systems implementations. This begs the question of whether anyone has examined, let alone established, the validity of extrapolating 20th-century medical technology development, assessment, and regulatory practices for the 21st-century healthcare system.” [2]

There is not enough space here to do justice to addressing the implications of the above, but for anyone interested I recommend the National Academies Press’ Software for Dependable Systems: Sufficient Evidence?, which argues:

“…the pursuit of dependability in software systems should focus on the construction and evaluation of evidence…software is guilty until proven innocent…This approach is…becoming standard in the world of systems safety, in which an explicit safety case…is  usually required… …a software system may not be declared “dependable” based
on the method by which it was constructed…Those claiming dependability for their software should therefore make available the details of their claims, criteria, and evidence…The willingness of a supplier to provide such data, and the clarity and integrity of the data that the supplier provides, will be a strong indication of its attitude to dependability”

In other words, for sufficiently complex technology, good process alone is insufficient to ensure safety and dependability.  So again I ask:  Granted that 80001 is necessary, but is it sufficient? 

1. R Schrenker, “Sufficient Evidence – Making the Case for Safety”, Biomedical Instrumentation and Technology, November – December 2008.
2. R Schrenker, “Learning from Failure – The Teachings of Petroski”, Biomedical Instrumentation and Technology, September – October 2007.

The opinions expressed in this article are those of the author(s) and do not necessarily represent those of Life-Science Panorama, its editor or Axendia, Inc.

FDA’s or Industry’s Responsibility?

 During my opening remarks at the 4th Annual Manufacturing Execution System in Life-Sciences Conference, I discussed FDA’s proposed budget increase of 166 Million Dollars and 346 FTEs toward Medical Product Supply Chain Safety and Security Oversight.

The globalization of manufacturing and supply of medical products has created unique and demanding challenges for industry and FDA alike.  Yet, according to a recent Axendia study on QMS trends in Life-Sciences, only 34% of respondents reported view global quality data in real time.

In the complex and ever-changing environment driven by globalization, license holders and regulators must seek out new approaches to ensure the safety of medical products.  

The Industry’s Role:

In his Keynote, Gerald Migliaccio, Pfizer’s Vice President of Quality, EHS and Agility - Pfizer Global Manufacturing, addressed Supply Chain Security from an industry perspective.

“Supply chain security is the responsibility of all parties involved in procurement, sourcing, manufacturing, packaging and distribution of raw materials, intermediates and final product,” commented Mr. Migliaccio.  “Ultimately, the marketing authorization holder(industry) is responsible for assuring that all parties in the supply chain fulfill their responsibilities for delivering safe and effective medicines to customers” he added.

According to Mr. Migliaccio, strong supply chain security strategies benefits both patients and industry by:

• Preventing Adulteration
• Preventing and Detect Counterfeits
• Preventing Product Diversion

These strategies should include the following key elements:

• Financial viability of business partners throughout supply chain
• Ethical Business practices throughout supply chain
• Physical security
• Container/freight movement security
• Personnel security

Supply Chain Quality Systems:

• Supplier / contractor evaluation and selection
• Supplier / contractor management and oversight
• Supplier / contractor management of their supply chain

Counterfeit Prevention:

• Overt measures
• Covert and semi-covert measures
• Forensic covert measures
• Counterfeit Detection
• Surveillance programs
• Support for Law Enforcement agencies

Business Intelligence: 

• Proactive analysis of pricing and supply trends to predict potential areas of criminal activity

Internal and External Collaborations:

• Cross-functional collaboration between manufacturing, quality, security, logistics, marketing and others to drive Supply Chain Security efforts
• Industry collaboration through PhRMA, EFPIA, ISPE, and industry coalitions, such as RX-360
• Collaboration with suppliers, contract manufacturers, transporters and distributors
• Collaboration with Law Enforcement and Regulatory Authorities

The Agency’s Role: 

For its part, the FDA plans to increase its oversight of the Supply Chain to ensure safety and security.  This will prevent harm to the public by achieving greater compliance with safety standards, detecting and correcting safety risks.

• FDA is proposing a budget increase of $166,433,000 and 346 FTEs to improve medical product Supply Chain Safety and Security.
• FDA will increase medical product safety and security by enhancing oversight of entities in the supply chain.
• FDA will use traditional and innovative mechanisms that include FDA inspections and field exams, integrated federal-state oversight, and greater access to inspection data and results acquired from trusted foreign regulatory authorities.