New Microscopic Technique Should Prove Useful in Nanotechnology Field

As we continue to explore the nanotechnology field for biomedical applications accurately measuring these miniscule components will be essential for designing, and manufacturing.  Designers need to know what the variability is on the manufacturing process.  Manufacturers need to know what type of statistical variability there is within the manufacturing process and therefore the specification limits.  Helium ion microscopy appears to be a technology that can meet these needs.

Helium Microscopy

Biotechnology: Artificial Trachea Grown From Stem Cells And Implanted

Harvard Biosciences and a team of international surgeons and scientists have successfully collaborated to create and implant a bioartificial trachea. The trachea was created by growing stem cells onto a spongy scaffold with appropriate physical properties. The growth phase of the process took between 10 to 12 days and included chemical or physical triggers to guide stem cell differentiation . The accomplishment was made by applying an extension of the processes originally developed and demonstrated by an international group of researchers.   In this case an artificial scaffold replaced donor tissues.
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Original Biomaterials article describing research

A double-chamber rotating bioreactor for the development of tissue-engineered hollow organs: From concept to clinical trial

Collection of news articles at Harvard Bioscience Webpage describing latest advance

Breakthroughs in Regenerative Medicine!

Top Ten Companies Patenting Multicell Organisms ( Life ) or Parts

So why do we want to know who is patenting multicellular organisms or their parts?  That will depend on whether the reader is interested in getting into a company that is actively considering commercialization possibilities in this particular area or a Research/Development  Engineer trying to determine who is actively patenting for competitive intelligence purposes.  Agricultural companies are particularly active in this area.  Next several posts will cover top ten schools and corporations in the area of medical devices, prosthetics, drugs, etc.  These articles will be of interest to any job seekers who want to narrow down their list of possibilities.  The following companies have the highest number of total patents over the last 5 years.  The actual numbers of patents and patent titles over a five year period are available for all the companies listed plus many others for a nominal fee.  There seem to be quite a number of individually owned patents in this area.  Contact Me If You Are Interested

ASSIGNEE
Monsanto Technology, LLC
Pioneer Hi-Bred International, Inc.
Stine Seed Farm, Inc.
Syngenta Participations AG
E. I. Du Pont De Nemours And Company
Individually Owned Patent
Mertec LLC
Basf Plant Science GMBH
D&Pl Technology Holding Corp.
Seminis Vegetable Seeds, Inc.
Agrigenetics, Inc.

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Regulatory: FDA Is Equipping The Park Doctrine

The FDA has become increasingly active in its determination to discipline apparently unrepentant pharmaceutical firms.  Now its getting personal, again.  After years of neglect the usefulness of the Park Doctrine has been rediscovered by the FDA.  The evidence needed to apply it to a “responsible corporate official” appears to be nil.  The definition of a “responsible corporate official” is nearly as vague.  It would seem to be a good time for anyone attempting to skirt FDA regulations to tread lightly.   Although the initial violation of the Federal Food, Drug, and Cosmetic Act is considered a misdemeanor a second violation is a felony.  It should be noted that transgressions in the Food and Cosmetics areas are also included by default if not intent.

From 6-5-3 – Special Procedures and Considerations for Park Doctrine

Recommending Park Doctrine Prosecutions

The Park Doctrine, as established by Supreme Court case law, provides that a responsible corporate official can be held liable for a first time misdemeanor (and possible subsequent felony) under the Federal Food, Drug, and Cosmetic Act (“the Act”) without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense. A Park Doctrine prosecution, for the purposes of this section, refers to a recommended prosecution of a responsible corporate official for a misdemeanor violation of the Act.

Misdemeanor prosecution under the Act can be a valuable enforcement tool. Such prosecutions are referred to the Department of Justice. Once a person has been convicted of a misdemeanor under the Act, any subsequent violation of the Act is a felony, even without proof that the defendant acted with the intent to defraud or mislead. Misdemeanor prosecutions, particularly those against responsible corporate officials, can have a strong deterrent effect on the defendants and other regulated entities. In some cases, a misdemeanor conviction of an individual may serve as the basis for debarment by FDA.

When considering whether to recommend a misdemeanor prosecution against a corporate official, consider the individual’s position in the company and relationship to the violation, and whether the official had the authority to correct or prevent the violation. Knowledge of and actual participation in the violation are not a prerequisite to a misdemeanor prosecution but are factors that may be relevant when deciding whether to recommend charging a misdemeanor violation.

Other factors to consider include but are not limited to:

  1. Whether the violation involves actual or potential harm to the public;
  2. Whether the violation is obvious;
  3. Whether the violation reflects a pattern of illegal behavior and/or failure to heed prior warnings;
  4. Whether the violation is widespread;
  5. Whether the violation is serious;
  6. The quality of the legal and factual support for the proposed prosecution; and
  7. Whether the proposed prosecution is a prudent use of agency resources.

As the Supreme Court has recognized, it would be futile to attempt to define or indicate by way of illustration either the categories of persons that may bear a responsible relationship to a violation or the types of conduct that may be viewed as causing or contributing to a violation of the Act. In addition, these factors are intended solely for the guidance of FDA personnel, do not create or confer any rights or benefits for or on any person, and do not operate to bind FDA. Further, the absence of some factors does not mean that a referral is inappropriate where other factors are evident.”

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Biomedical Engineers and Mind Reading

Science fiction and fact are converging again as thought control technology matures in the engineering laboratories and commercially.  Advances in algorithm development, memory and cpu speed are producing more and more examples of solid advances in translation/transduction systems which monitor and use the brain’s EEG signals.  Starting with biofeedback experiments in the 60’s and 70’s this technical field has now matured to the point that thought to speech applications are beginning to be considered seriously.

Here are a few links to get your imagination going;

Monkey Controls Advanced Robot With Its Mind – 7 degree of Freedom

Ryerson students invent breakthrough brain-controlled prosthetic arm

Technique for Letting Brain Talk to Computer Now Tunes in Speech

Wikipedia: Neurosky

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Innovation: Don’t Be Afraid To Question The Accepted Theory

Apparently the gyroscopic and caster effects are not the only mechanical forces working on a bicycle to keep it upright as it rolls along.   According to a Cornell University based team a bicycle with a high center of gravity at the rear and low center of gravity up front can keep itself upright while rolling along a flat surface even if gyroscopic and caster effects are eliminated or cancelled. The explanation given is that once a suitably designed bicycle with the described characteristics, no caster and minimal gyroscopic effects, is set in motion the front end will always “fall” first and cause the bicycle to steer into the direction of the fall.

This is a striking example of how a commonly accepted engineering theory can turn out to be incomplete.  It shouldn’t be a surprise.  It happens in science all the time as old theories are found to be incomplete and new ones take their place.  This incomplete aspect of accepted theories can delay certain types of innovation.  Typically it takes a focused look by motivated engineers and scientists to tease out the most complete explanation and insights into the phenomenon in question.   Much of this learning is lost as experienced engineer retire and are not considered for lecturing or teaching positions.

I would also like to note that appropriate depth of theoretical and applied knowledge is very important to create an engineering solution.  Just knowing the correct equations to apply is not enough.  If that were the case then the CAD designed and FEA modeled automobiles of today would never have recalls for design defects.  An engineering team must see, feel and smell the results of their designs first hand in the laboratory to ascertain the limits of their engineering theories and tools.  Only then can they correct the identified shortcomings and eventually deliver a well designed product.

For a more complete explanation see below.

A Bicycle Can Be Self-Stable Without Gyroscopic or Caster Effects

Stable Bicycle

History of thoughts about bicycle self-stability

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J and J Battles Fallout Of Quality Slump

Bloomberg Businessweek recently published an article on the woes that Johnson and Johnson is having as a result of quality issues. Quality products are the hallmark of a successful company. A good reputation for quality is what keeps customers coming back. Whenever a company takes its eye off of the of the quality of its products its reputation suffers and bad things can happen unless corrected quickly. In the medical device and pharmaceutical world quality is defined by the FDA in terms of patient safety and the efficacy of the product. To be fair Johnson and Johnson is not the first health care corporation to have problems with quality.  Some big names have come up in the last several years including Merck, Abbott, Baxter, etc. Several years ago clearly recognizing the issue Baxter had a very large recruiting event for quality related positions. But if the report linked below is true J&J issues appear to be endemic and the CEO is doing all he can to deny it.  Not a good sign if it isn’t followed up with action.  Reportedly J&J has the where with all to weather the storm.   While the executives hand wave to the public I am sure that there are a lot of Johnson and Johnson employees feverishly developing plans for and reviewing quality systems and processes.  Maybe they will have their own quality recruiting event in the near future.

Addendum:

As I delved further into this story I came across a description of J and J’s response to another product issue in the “Vital Difference: Unleashing the Power of Sustained Corporate Success”. The product was Tylenol and the response by J&J at the time was very proactive and aggressive.  The authors of the book credited the response to J&J credo Our Credo – Johnson & Johnson .  The current apparently tepid response to a series of quality issues is puzzling given the Tylenol historical example.  It will be very revealing of current corporate culture to see how they continue to respond.  Given the current response I believe it is fair to ask whether Johnson & Johnson is the same corporation it was before 1982.

Here is the story;

Johnson & Johnson’s Quality Catastrophe

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