13Jun/06

Convergence in Healthcare

By Daniel R. Matlis 

The Life-Sciences industry is undergoing a metamorphosis. Historically separate disciplines, like pharmaceuticals, devices, diagnostics, biotech, and even nanotech, are converging.

This trend will accelerate as personalized medicine and genetic therapies evolve. In the not to distant future, your Doctor will be able to target specific medical treatments to address your condition based on your unique DNA.

This shift to convergence medicine is already underway with the combination of traditional pharmaceuticals and medical devices.  Products like drug coated stents and antibacterial sutures are breaking down the traditional barriers in healthcare.

Today, pharmaceutical companies are looking to biotech firms for innovation and new ways to treat conditions.

Read more about this trend and my opinion on it in Chemicals to Cell Culture published in this month’s issue of Intech Magazine.

06Jun/06

FDA Issues Guidelines for Using Statistics in Device Trials Speak Now or Forever Hold your Peace

By Daniel R. Matlis 

Do you know that tense moment during the wedding ceremony, when the officiant says “speak now or forever hold your peace?” What happens if someone objects? Usually there are two outcomes, either the wedding is off or a brawl breaks out.

This is NOT one of those moments, and in this case, I would encourage you to speak your peace.

On May 23, 2006, 2 days after my son was born, The FDA released for comment a Draft Guidance for Industry and FDA Staff on the Use of Bayesian Statistics in Medical Device Clinical Trials.
 

This Guidance is part of the U.S. Food and Drug Administration (FDA) Medical Device Innovation Initiative. This initiative is aimed at making new medical devices available more quickly for patients.

“We must keep up with the rapid developments in science and technology to ensure that patients have access to the most advanced treatments available,” said FDA Acting Commissioner Andrew C. von Eschenbach, M.D. “By working with industry early in the evaluation process, we hope to foster development and speed up the approval of safe and effective innovative devices.” 

The Medical Device Innovation builds on the successes of MDUFMA and further modernizes the medical device review process in order to improve patient health and safety.

As part of this initiative, the Center for Devices and Radiological Health (CDRH) will expand current efforts to promote scientific innovation in product development, focus device research on cutting edge science, modernize the review of innovative devices, and facilitate a least burdensome approach to clinical trials.
In addition, this initiative includes:
 

  • Providing Regulatory Clarity Through Guidance Development
  • Investment in Critical Path
  • Conducting Stakeholder Outreach and Improve Communications
  • Laboratory Research to Support Efforts to Improve the Device Development Process
  • Implementation of a Quality Review Program
  • Leveraging Information Technology Solutions
  • Expanding Clinical and Scientific Expertise at FDA

The comments period expires 90 days from publication in the Federal Register announcing the availability of the draft guidance.

You can submit written comments (usually after checking with Legal and/or Compliance) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  You can also submit electronic comments http://www.fda.gov/dockets/ecomments. All comments should be identified with docket number 2006D-0191.

So this is your chance, Speak Now or Forever Hold your Peace.

Well, maybe not forever, but at least until the next guidance document comes along.

19May/06

Want to Buy a Bridge? The Promise of Service-Oriented Architecture

By Daniel R. Matlis  

This is an excerpt of my recently published article in Medical Product Outsourcing

Medical device companies have been implementing manufacturing information systems for more than 30 years. These systems were often part of automated manufacturing initiatives aimed at increasing product quality and lowering manufacturing costs.  For many years, device manufacturers have desired the ability to make production information, processes and resources more transparent. Companies have often looked for ways to unlock operational data to empower decision makers—from operators to plant managers and corporate executives—to make informed, timely decisions.

This level of integration has eluded companies…until now. Today, software manufacturers are moving away from proprietary systems and interfaces and are working together to develop open standards. These connectivity standards have lead to the development of a new class of software, known as middleware. This standards-based software enables the collection, analysis and presentation of critical, real-time data to decision makers throughout an organization. Known as Service-Oriented Architecture (SOA), this technology provides a bridge that allows for the connection of data islands in an efficient and effective manner.  Read the complete article    

12May/06

Don’t forget the Process in PAT

By Daniel R. Matlis  

Do an internet search on Process Analytical Technology and you will be bombarded with sites for companies selling sensors, software and systems claiming to meet FDA’s PAT requirements.
I’m an engineer, and I like gadgets as much as the next person, but technology ought to enable change, not drive it.
Today I see companies following two distinct paths to PAT; one is technological, the other philosophical.

The technological approach to PAT, calls for the implementation of dedicated PAT systems.  This approach generally revolves around a specific technology or set of technology products and relies on a “silver bullet” to achieve the benefits of PAT. This is often driven by sensing or process analysis tools such as SPC, process modeling and process optimization.

This approach often involves the implementation of dedicated data acquisition tools and historians to gather and analyze the data in an information-only, non-validated environment.

The second and more holistic approach requires the development of a PAT philosophy and process across the enterprise. This approach sees technology as a tool to achieving process excellence as opposed to the end goal.

It is founded on mining the vast amounts of underutilized data currently available in automation manufacturing systems, such as SCADA, CIM, Historian, Batch, EBR and MES, It also looks to systems such as LIMS and ERP to correlate process and market data to identify key performance indicators and key process parameters based on historical information. This approach mines the vast amount of existing raw data and transforms it into actionable information through deep process understanding and data modeling.

To achieve the benefits of PAT, Life-Science companies need to design, analyze and control manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. 

Implementing technology before achieving process understanding is like putting the cart in front of the horse.

10May/06

RFID on Prescription Drugs

By Daniel R. Matlis  

On the May 9th issue of Information Week, Mitch Wagner provides some simple and elegant solutions on his article entitled “A Simple Fix For RFID Privacy

In a previous article Levi Strauss proposal to use RFID tags on their Jeans was condemned by privacy advocates. He states “I’m not sure what the heck they’re worried about. I mean, how can you be concerned about privacy protection for information that’s already written on people’s butts?”

Although people may not be concerned about RFID tags in Levi’s Jeans, they ought to be concerned about RFID tags on prescription drugs.

The Food and drug administration (FDA) has issued a report recommending the widespread use of RFID technology throughout the pharmaceutical industry by 2007. The goal is to stem the tide of counterfeit drugs currently available though the internet.

RFID will play a key role in securing our nations drug supply. I can see a day were RFID tags will be the electronic equivalents of tamper proof seals, allowing consumers to rapidly identify counterfeit and fraudulent drugs.

However, there are significant privacy issues that must be addressed.

Would you want anyone with a rogue RFID reader finding out which prescription drugs you are taking?

I certainly would not.