FDA says device products made using nanotechnology do not require special regulations or labeling. The report was released on July 25, 2007
A task force within the FDA concludes that although nanosized particles have very different properties to larger particles, there is no evidence that they pose a major safety risk at this time.
“We believe we do not have scientific evidence about nanosized materials posing safety questions that merit being mentioned on the label,” says Randall Lutter, FDA’s associate commissioner for policy and planning.
Some consumer groups fear that such tiny particles could have unforeseen health effects.
Reported in NewScientist:
A biopolymer produced from shrimp shells that is used in treating wounded soldiers will be put to a new test in August – aboard the space shuttle Endeavour.
A commercial experiment will assess how the material, chitosan, affects human immune cells in space, where they are less responsive than on the ground.
The U.S. Army equips its troops in Iraq with chitosan-laden bandages to speed blood clotting in fresh wounds and to stop bacterial infections. NASA does not expect astronauts to fight battles in space, but has to plan for accidents, and worries that slow healing or infection of wounds could imperil long-duration missions to Mars or other distant targets.
In March BCC research published a report on the U.S. market for biocompatible materials. You may have already seen some of this data but just in case you haven’t, the findings are as follows:
- The U.S. market for biocompatible materials is valued at $ 22.2 billion in 2007 and is expected to grow with a compound annual growth rate (CAGR) of 6.9% to reach $30.9 billion in 2012.
- Tissue replacements constitute the largest segment with a value of nearly $11.7 billion in 2007. This represents 52% of the total biomaterials market value. The tissue replacements will grow at a CAGR of 6.6% to reach over $16 billion in 2012.
- The smallest segment of the biomaterials market is biocompatible surface coatings with a value of $2.6 billion in 2007. This segment is expected to grow with a CAGR of 5.7% to $3.4 billion by 2012.
The full report is available for purchase.
The National ESCA and Surface Analysis Center is hosting a workshop for surface characterization of biomaterials at the University of Washington in Seattle form August 24-27, 2007. The program includes lectures and analysis demonstrations. Attendees will learn surface analysis methods and how to review such data from laboratories.
The workshop focuses on the following methods:
- Â Electron spectroscopy for Chemical analysis (ESCA)
- Secondary ion mass spectrometry (SIMS)
- Scanning Probe microscopy (SPM)
- Sum frequency generation (SFG)
- Near edge x-ray absorption fine structure (NEXAFS)
- Multivariate data analysis
- Contact angle measurements
- Surface modification
- Surface plasmon resonance (SPR)
If you are planning on attending, or have attended in the past, drop me a line. Is it a worthwhile program?
Biomaterials engineers are at the forefront of medical technology. For example, a blog I’ve been reading lately is running a 3-part series discussion on convergent technologies, which is directly related to this sector. Convergent technologies is more than combination devices. It is the creation of unique products through the harmonization of several disciplines, including biotech, pharmaceutical, and genomics, and nanotech. Its not enough anymore for the medical industry to know one thing and know it well. Biomatierals engineers must be familiar with all related disciplines.
How do you learn about new technologies and how do you incorporate them into your daily work?
Medical Device Technology (MDT) has a special supplement for in its May issue dealing with orthopedics. Of interest (to this industry) is an article on bioceramic implants. The article discusses the basics of the ceramic trends in orthopedic implants. Material composites, which the author says is crucial to the continued development of the sector, are a particular focus.
Disclaimer: MDT is a sister publication of MD&DI.
