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Category Archives: BioEngineering

Blog Briefs: A great resource: The National Academies Press makes all pdf books free!

About Blog Briefs: Having become too busy to write a lot, I have decided to blog briefly, throwing out news and opinions that might interest people who stop by. Moving on...

The National Academies Press!

It is highly unlikely that you haven't heard about the NAP, a confluence of various US organizations that publish several reports a year. Whether you are in sciences, engineering, entrepreneurship or policy making, you would use any valuable information that comes your way for free, right? Well, I read this press release, and jumped on the NAP site to find out that there are over 4,000 books that are now downloadable for free!

I tested one and found it really simple to access a book by subject and launch the download. While you could register and access some of their deals and such, you could also just proceed as a guest..

Link: http://nap.edu

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Elan was recently asked: Your workers or your private jet..guess what they chose?

A quick note: This month has seen me suffer a lot through the loss of my favorite feline Squeaky. This was predated with our failed efforts at using veterinary medicine to save him. I will be writing about this and my plans in detail. In addition, new deadlines and an extremely tight schedule are making posting quite tough!

Elan: This name means eagerness and earnest..as it turns out, the Irish pharmaceutical company chose to turn it into irony...

Companies like Elan are a staunch reminder that nothing has changed. Business, is as usual - an old boy's club. All everyone did was hold their breath for a little while and now, we are back to business. It doesn't matter that Boston Scientific just needs to pay $196mn. for the Guidant mess. Yeah, don't hold your breath with the lawsuit the Justice Department has filed.

It also doesn't matter that J&J's quality problems haven't found a bottom yet.

And yet, Elan comes out swinging as the worst. As it turns out, not only did they fire a bunch of their R&D folks, but flew on their private jet to let investors know how they are "saving money" and "on track" for 2011 growth..!

The result?

One irked investor claimed that while this was troublesome, Elan was a great company with a great molecule. Bravo!

Of course I could go on and on about the need for ethics and shareholder activism, but I thought I would just stop here, and rush back to dinner giving you some pause for thought..

"Do you really think pharmaceutical and medical device companies are going in the right direction?"

No, this is not about innovation that the President preaches, as if all that is holding innovation back is people's desire to jump out and start sketching on the white board...

Can companies survive, let alone thrive with such poor ethics and morals?

Until next month...

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What will your 2011 medical device design resolutions be?

Well, 2011 is here, in some places already and where I am, it is slowly rolling in. Other than a couple of major resolutions/goals, I hit most of my spots in 2010, at least partly. I had similar results in 2009 and so on, so I am not averse to making goals and giving them a shot.

Remember goals are dreams with deadlines - and no, it's not corny. Maybe you have worn a bit with all the goal setting, but hey, what is wrong with dreaming and throwing some numbers or expectations on them? So, give it a shot!

Medical Device Design: You could be in sales, marketing or in non-profits that moan and groan about regulations all day - all important functions, but I thought I would make this post just about medical device design. After all, this is an example post and I am sure you can make your own goals up!

Oh, and look out for Goal 0 at the end!

Goal 1: Reveal your passions - to your conscious self!

Are you sure that medical devices is/are your passion? If so, what's your motivation? A personal event? Just the science, the challenge? Whatever it is, get to know it. And yeah, if you have been in it for a while and/or you have had some passion fatigue, it is still not a bad idea to take a couple of minutes recharging the "why" and the "how" of your participation in this mess...

Goal 2: Understand the disease/diagnostic/treatment area thoroughly

You probably already know this. You cannot effectively design for atrial fibrillation if you don't understand what the underlying disease is. And yes, sometimes we do not know exactly why something happens, but it is important to keep up with the latest and greatest theories and hypotheses behind a disease condition.

Yes, you may only be working on lung resection, but it behooves you to look into the cancer stem cell theory. You would be surprised at what you can glean.

Goal 3: Understand anatomy and physiology

Of course, goes without saying right? Just take care of it - maybe you should be taking a class, or taking that class again, or just going through the flash cards a second time...

Goal 4: What's that darn CFR 21, code say what?

Ah yes, those regulations. Well, maybe this year, we won't let someone else take care of it, especially since things are changing. The more you know, the better. And remember, the world and our times are changing. Don't stop with the US - look at EU, Japan and the developing world...

Goal 5: Read, read and then read again, learn and teach!

No matter how much you know, there is always room to grow. What do you know - that rhymes! There is so much to read out there - blogs, websites, regulations and so much more. How about a class on DFM? Maybe something about sustainability. Whatever it is that allows you to grow through change, go ahead....

Goal 0: Perk up!

Yes, someone got greedy, then they got bailed out and the economy is bad, the regulations are killing innovation (really, really, not), China is growing, and on and on and on it goes. If you have bought into any of this nonsense as the reason to sit and wait for "things to pick up", well, guess what, by the time you realize things actually have and by the time you start jogging, someone else will be running.

Write that executive summary, sharpen that presentation, test that prototype, get that resume reviewed - just get moving. What do they say - "Don't do something, just stand there!", right?

This is why Goal 0 is down here - because, let's end all this negativity, and this year on a high note, and that is how 2011 should begin. Yes, you will read this in 2011, so what?

This is time for change, time to push, time to run, walk, trod, jog and somehow get to that extra mile, maybe a mile and a half...and hopefully we see each other!

Wishing you all the success in 2011 and beyond!

Image Source: http://www.psdgraphics.com/file/happy-new-year-2011.jpg

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A heartwarming story, a foundation and a few medical device challenges for the future

It bodes well for my spirit to take a break from the usual tug-of-war nonsense between the regulators and the regulated and all that other stuff and rehash a great story from San Jose Mercury News about a man who has found new life through a new limb...

The Story

San Jose Mercury News carried a very intriguing and interesting story about Johnny Nguyen, a local man who went through a terrific accident and suffered from severe burn injuries and had to lose his left arm, an elbow and all the fingers of his right arm in the consequential surgeries.

You should really read the rest of the story in the article referenced below. It is well written with a human touch, something that is rare in journalism nowadays.

Finding a prosthetic

Postulated severally in science fiction and future facing non-fiction, the 21st century is a time where losing a limb doesn't necessarily have to be permanent. However, this is easier said than done.

For one, development of efficient prosthetic devices that mimic a functional human arm, as opposed to a rudimentary hook (which is what Johnny started wearing initially following his surgeries) is very expensive.

Secondly, one has to find a way to afford these devices. Here are a couple of observations I made from the article, which, of course I cannot substantiate with proof from elsewhere:

1. Johnny's friends tried to contact several organizations that make such prosthetic devices. Enigmatically, the article mentions that the company from Scotland responded. I wonder what happened to all the US companies that were contacted. I also wonder how many companies develop prosthetic devices in the US....if there are enough companies developing such prosthetic devices locally, why have they not responded?

2. Johnny appears to have been someone that interested the company that did pay for his device, so that they could use his case to study how to use the prosthetic devices in situations involving other fire injury victims. Given the paucity of people within the US that normally sign up for any experimental therapies or in many cases, clinical trials at all, shouldn't local companies scramble to enroll people like Johnny as quickly as possible?

Bionic Touch Foundation

Johnny's friends who successfully teamed up to get him his prosthetic have realized the challenge that the device is going to be expensive for most people who will need them. They have a lofty goal of helping anyone in need of finding an upper limb. They are also offering academic help with regards to the writing needs of those who are looking for a prosthetic. All their efforts deserve a sound pat on the back.

Future Device Challenges

Now that we have gotten all the inspiring stuff out of the way, I thought it might be worthwhile taking a look at some of the challenges facing people who NEED the medical devices and not the ones that MAKE them. The ones that make them, have enough help from dubious "non-profits" already!

Most of the challenges have been discussed previously, but I thought there would be no harm in presenting them again:

1. Accepting the need for trials and experiments: If there is one place where people seem to especially fail, it is in enrolling in new trials. If enough people do not provide support to new procedures and new experiments, science, engineering and medicine cannot progress adequately. Treat yourself less as a victim, and more as a patient and try to find out how you can help yourself and at the same time, if possible, lay the course for the future.

2. Advocacy: I know, I am not making my points in an ideal order, but if more people had paid attention to the healthcare reform debate rather than saying "eh, politics is not for me", maybe things would be better. The cost of devices is dictated by several factors and many of these can be controlled by a conscious citizenry. In other countries, similar struggles will start soon enough. Keep your eyes and ears open, and act, not react. I came across a Chinese proverb that says, "Dig the well before you are thirsty" - enough said!

3. Identify the true leaders among companies: If it takes a company from Scotland to respond to customers with the customer's interest in mind, so be it. Such a company has risen above it's former peers and should be recognized thus. It is also really important to point out which companies fail to respond to customers, at least to provide information. This will let people make their own judgment on who leads and who follows the 90-day magical number dance...

4. Fundraising: All said and done, there will always be therapies and devices that will be necessary, will ride ahead of the reimbursement curve and will be expensive no matter what. Patients and their friends must look to creative ways to engage the local community and the wider populace in raising funds. Look to stories of success to emulate and improve upon with brainstorming.

5. Support Science and R&D: It is appalling that even in this day and age, science faces the same threat as it did in what some folks fondly like to try and forget as the "dark ages". Having politicians dictate science policy has very few tragic parallels in human behavior. Seek, demand and support sound science, research and funding that foster medical progress.

It is very heartening to read such stories of success, and one would hope to see fewer accidents and more success stories of the sort outlined here...

References:

1. San Jose Mercury News: http://www.mercurynews.com/ci_16932213?source=most_viewed&nclick_check=1

2. Bionic Touch Foundation: http://www.bionictouchfoundation.org/

3. Touch Bionics: http://www.touchbionics.com/

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Entrepreneurship Opportunities: The Health 2.0 challenge for 2011 is announced

Preface - the perspectives

Depending on your perspective about things going on around you, you can basically take one of two approaches - you could go the "Advamed/NFIB" route, constantly groaning loudly across the internet about how bad things are going to get with the FDA's half-hearted attempts at fixing it's fast and loose ways of approving poorly designed devices...or you could simply hunker down, accept the fact that the economy is bad, and the better approach, especially when there are gaps in between career moves, that you could "try"!

The Health 2.0 Jazz

The Health 2.0 challenge is yet another Government conspiracy. The Department of Health and Human Services t(hat plans to help Congress pull the plug on the Grandma that you abandoned in Florida) supported the Community Health Data Initiative (CHDI) in announcing the Health 2.0 challenge. It works really easy - you either submit a challenge, or join a team working on a challenge and try to solve the challenge, online and offline.

The online part is where you work on the problems on an ongoing basis. If you go to the code-a-thons, then you are working on the offline part.

Fees and such

There are fees involved, but it looks like the fees get waived if you are a start-up that hasn't raised more than $1mn, or if you are an established company with more than $1mn in revenues.

And there it is, the first code-a-thon is on January 29, 2011 in the San Francisco Bay Area. Other events appear to take place in Washington DC and Boston (a fresh break from the FDA's "public" meetings). Of course, if you are simply reading this for paranoia, here is something you should know - the first code-a-thon will happen at the Mountain View Google campus! Wink, wink!

I have never cherished repeating basic facts verbatim, so I encourage you to visit the link at the end of this article. 

The Opportunity

If you are in the business of mulling health data across the internet, or in the EMR/EHR/HIT space, then such challenges are a great way to showcase your skills, the creativity, thought process and other assets. Competitions, games, barcamps, business plan contests etc, are a great way for you to boost your confidence, hone your skills, showcase your talents, seamlessly integrate this with that and fit square pegs into round holes...you get the idea!

And finally -

If you are participating in the 2011 challenge, give me a holler. I still feel bad missing the last one.

Until next time!

Reference:

http://health2challenge.org/

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Quick Post: Are others (guests) allowed to post on this blog?

One of the many tools I use with this blog is "skribit". It is a really cool tool and I guess it's usage will grow over time. The tool, when installed as a widget allows readers and passers-by to leave notes on what they would see a blogger write about.

Of course, it appears that this tool seems to be growing gradually...or maybe not many of the readers here having been noticing..please do! Tell me what you want to write about (be decent now) and I will try to fit it in. It would be my pleasure to know what it is that people are looking for. I do look at the keyword searches that land people here, but that is not as accurate as someone saying.. "do this"!

To learn more about skribit, visit: http://skribit.com/

Are guest posts allowed?

Absolutely! We have already done this before, and I have learned a couple of lessons and I will state my sparse ground rules, but yes, given how busy I am, and my other web design and blogging demands, I would love guest posts!

The Rules

The first rule is, there are rules..alright, that's a bit much. Here goes:

1. Please keep things related to medical devices, biotechnology, bioengineering, entrepreneurship, synthetic biology or some such thing that people who read this blog might find relevant and interesting. It might be good if you and I discussed things beforehand.

2. No plagiarizing - no copying papers etc. Please provide sufficient references. You don't have to be an MLA expert or an "Endnote" jockey, just make sure you clearly mention where anything quoted comes from!

3. Keep it interesting and honest. Interesting is hard to define and is more a "post-production" revelation than anything else. Honesty is really important! If you want your product, service or company pitched, it is probably better to just ask me, and I will do it if it is credible and/or interesting. If you are posting for a class project, then mention it. Do let people know who you are and where any of your fiduciary responsibilities might be.

I always say, honesty may or may not be the best policy, but it is fairly good!

That's it -hopefully that was simple and useful. I will leave this as a sticky on the sidebar for future reference!

Until next time!

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