Category Archives: Business

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On May 23, 2006, 2 days after my son was born, The FDA released for comment a Draft Guidance for Industry and FDA Staff on the Use of Bayesian Statistics in Medical Device Clinical Trials.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The comments period expires 90 days from publication in the Federal Register announcing the availability of the draft guidance.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.

04May/06

Should I Build or Should I Buy?

By Daniel R. Matlis  

If I had a penny for every time I’ve been asked this question…

A company is looking for a customer complaints/ CAPA system. They are considering Building it with MS Access or Buying an off the shelf product?

Are there any special issues with validating such a system compare to in MS Access?

Building FDA compliant applications on MS Access can be problematic. It is especially challenging to meet industry and FDA security requirements with Access as the back-end database.

From a compliance standpoint, building custom software requires you to develop all the documentation for you system from scratch. You must also perform unit, integration and system testing for the application before you move to the qualification of the system (all the Qs).

Compliant Management and CAPA are required by the FDA. As a result, there are a number of mature Commercial Off The Shelf (COTS) products widely used in the industry.

In this particular case I would recommend a BUY with two caveats:

First, make sure you assess and evaluate the vendor’s product to ensure it meets your business needs.

Second, you assess the supplier’s quality system and Life-Cycle practices to ensure they meet your standards. Make sure you perform this supplier assessment BEFORE you buy.

Build a tree-house, buy CAPA software.

02May/06

One Size Does Not Fit All

By Daniel R. Matlis  

My friends at MRO sent me an interesting whitepaper to review entitled “Understanding the Real Risk for Asset Intensive Industries”. In this Paper they make an excellent case for a Rational Suite of applications instead of a single monolithic system to run the enterprise.

I started thinking, we want our clothes to be a good fit, why not our software applications?

How did we end up with one size fits all software?

In the Late 80’s computers began to appear on desktops in offices, labs and shop floors in Life-Sciences companies.  Pretty soon servers had hatched under every department manager’s desk. These stand alone department servers run homegrown applications often developed in programs like Lotus123, FoxPro and Paradox. These applications were not always validated, and over time some grew to run entire departments. In the mid 90s Life-Science companies and the Regulators realized the extent of computerization in the industry. MIS departments were directed to take control over the IT infrastructure and bring order to the digital chaos.

The result was often the implementations of monolithic systems like MRP and LIMS. Although I believe that enterprise applications play a key role in today’s Life-Sciences Companies, experience has shown that “one size does NOT fit all”.

With the advent of Service Oriented Architectures and Web Services (what IBM used to call the universal business adaptor), it is now possible to seamlessly integrate best of breed applications that fit your business needs without increasing the total cost of ownership.

I’ll take those shoes in a 9 please. What’s your size?