Category Archives: BioEngineering

Preface: Again, I apologize to everyone for the paucity in posts. As some of you might know, I have been working incessantly on a project and that has kept me from being able to gain any traction on blogging here. As the blogging gets tougher, I have decided to add a tweet specific to the blog so that I can still share quick updates on devices and such.

You can follow "devicology" on twitter:

Of course, there are not many tweets there yet, but watch the space for more.

Looking for innovative ideas?

Ideas, they say are dime a dozen. Well, who is to say what the current exchange rate is? If you are looking at a start-up or even a project that needs you to design a device, a mechanism, a set of mechanisms and/or processes and methods, you need innovative ideas. Many times you need to be innovative to beat your competition, and sometimes, simply because the solution demands creative thinking.

But, how do we get good ideas? Some people seem to have a practiced way of getting to ideas, so is "ideation" something that you are born with?

Wrong!

Brainstorming!

Brainstorming is the best way to open up your creativity and come up with innovative ideas for your projects, your companies and so on.

While there are many opinions floating around, the baseline is simple - encourage creativity and "out of the box" thinking, do not judge while the session is still on and do not "direct" the meeting.

Of course, I have a few other ideas that I would like to throw in - keep the topics broad first, narrow them later, or in later sessions, provide avenues for creative exploration through colors, toys and such, and feed your people!

Brainstorming is an exercise - so the more you train appropriately that is, the better you can get at it. Take it from me, I have seen this lead project ideas to great success in many different situations - this is the point of the workshop - practice, exercise!

Set at the Crossroads Cafe in San Francisco on September 13, 2010 thanks to the efforts of Eri Gentry, the founder of BioCurious ( http://biocurious.org/index.php?title=Main_Page ), we will discuss the rules for a couple of minutes, brainstorm a broad topic as a group exercise and then given enough interest, we will break into smaller groups and discuss further topics.

Here is the link for the event:

http://www.meetup.com/BioCurious/calendar/14576734/

I hope you can join us!

About BioCurious:

BioCurious is THE DIYBio group for Silicon Valley and in general, the Bay Area. Currently the group is seeking funding to find a near permanent home. You can find out more about them here:

Yours truly's previous FDA regulation class and pitch appear in the video as well...

Preface: Once again, I have to apologize for not being able to blog here, and this time it involves travel to the Seattle area, but I hope to get on my feet soon.

Introduction: I have signed up to receive updates from the local Congresswoman Anna Eshoo. Today, she forwarded me this set of rights, billed as, so to speak, "The Healthcare bill of rights". I thought it is fairly important for anyone involved in healthcare to go through them, so I am going to share them with you.

Oh, and these are the rights that the Republicans and the Tea Party would like to repeal, just so you know.

* Your health coverage cannot be arbitrarily cancelled.
The new law prohibits insurance plans from rescinding your coverage when you get sick, except in cases of fraud or an intentional misrepresentation of facts. (Applies to all insurance plans.)

* Your child cannot be denied coverage due to a pre-existing condition.
Insurance plans are prohibited from both denying coverage and limiting benefits for children based on a pre-existing condition. This applies to all employer plans and new individual plans.

* Your health plan cannot put a lifetime limit on your health coverage.
The new law outlaws lifetime limits. No longer will a family go broke or lose their home just because a loved one has an accident or becomes ill. This applies to all insurance plans.

* Your health plan’s annual limits will phase out.
Over the next three years, the new law phases out annual limits ensuring that the coverage of hundreds of thousands of Americans will no longer be cut off right when they need it most. This applies to all employer plans and new individual plans.

* Your child can stay on your health plan up to age 26.
Insurance plans that offer family coverage will be required to allow young people up to their 26th birthday to remain on their parents’ insurance plan, at the parent’s choice. This applies to young people who do not have access to their own employer-sponsored coverage.

* You have the right to choose your own doctor.
Patients are guaranteed their choice of primary care doctor within their plan’s network of doctors, including OB-GYNs and pediatricians without a referral. This applies to new plans.

* You have the right to access out-of-network emergency room care.
Insurance plans will not be able to charge higher cost-sharing for emergency services that are obtained outside of a plan’s network. This applies to new plans.

* You have the right to appeal denied coverage.
Insurance companies are prohibited from denying coverage for needed care without a chance to appeal to an independent third party. This applies to new plans.

Commentary: Essentially, I think this is a good set of rights and a good start. It will help coverage, and increase revenues for medical device companies, regardless of what Advamed would like to have you believe. In the long run, this will serve as a model of comparison for developing nations trying to implement healthcare reform.

Of course, post elections we will see some cheesy attempts to repeal the law, more display of testosterone and so on...until next time!

Hello everyone!

First, the update:

Yours truly is engrossed in more than one project, and has taken quite a break (I haven't posted in almost 2 months if you haven't noticed). I kept telling myself I will get back to blogging, but I have decided that isn't happening anytime soon. So, I thought I am going to jump in and start blogging again. I am also going to announce the "Summer of Blogging" shortly, but enough with the egotism...

Prototyping Tip - Don't throw away your failures!

Yours sincerely (thought I will try a variation on the previous paragraph, ahem) has recently had a chance to do a lot of prototyping - you know strutting around the lab, hurting yourself with things that look nothing like what your final product is going to be?

Anyway, cynicism aside, prototyping is always so much fun, next only to storming the brain for ideas of course. Part of the pleasure of prototyping is that you are typically breaking new ground, so many mistakes may occur.

20,000 non-bulb materials - the Edison cliche

Edison was arguably the biggest patent troll according to some people, intimidating peers and stifling innovation. However, he left a lot for us to delve in terms of cogitating about persistence, prototyping and such.

Though we may never know exactly what he said about never giving up on the path to inventing the light-bulb, but persistence in innovation is necessary. One has to stare failure in it's face and move on!

However, do we simply record our failures and discard them?

No! From your failures, you can learn a lot:

1. What exactly is the definition of failure in your prototype? Did it not fail to turn out at all? Did it fail to appear unlike what was expected out of it? Did the prototype fail in terms of functionality?

2. If your prototype failed under process/manufacture/putting it together, can you repeat it? Can you identify the flaws in your development process?

3. If your prototype failed functionally, what led to the failure? Is your failure related to how you built the device/application etc., or is it related to how you used it?

Record it anyway!

The very first thing you should be doing is answering those questions and recording those answers. These answers should go in your lab notebook. Two weeks from now, or six months from now, you don't want to be asking yourself what was going on.

Patent it anyway

A couple of years ago, I attended a meeting of the "Bio2Device" group locally and Karen Talmadge, the wizard of Kyphoplasty mentioned something to the following effect: "Don't simply patent your way of doing it, patent all the ways that could cause the same effect". In a simple sense, if you are thinking about using radiofrequency to burn the tumor, don't stop there - think of microwaves, photo therapy, embolization and so on...I hope you get the point. You may not get everything granted, so make sure your claims are constructed properly and you try to reduce things to practice appropriately.

The reason I brought this up, is because your prototype may not work because at the moment, you may not have the right method of building it, or the right set of steps to accomplish the functionality required of your device - and you can fend off someone else who might want to compete with you using one of your discarded ideas!

Lather, Rinse and Repeat

Finally, try to re-work your prototype! Don't take one failure as the final answer. If you made enough effort, maybe you will get it to work, or you will find out why it won't work...very valuable information!

Yes, that's right...someone thought of a hacker-space for Biotechnology and Medical Device players! And, curiously enough, they named it "Biocurious". Yes, get over what the name reminds you about - after all, as a clever marketing ploy, it does make you sit up and notice..

Biocurious was founded by Eri Gentry, and it currently operates out of a garage while awaiting more founding support to mature into a full blown facility somewhere in the San Francisco Bay Area. Having been spoiled with hacker spaces, Maker Faires, Tech Shops and the like, yours truly, among many others has become very attracted to the idea.

Playing in the life science space is never as easy as developing a Facebook app and raking in millions, and it probably never will be. A lot of biotechnology labs and incubators have popped all over the place. They plan to take huge chunks of your company and cash, mostly because it does get that expensive sometimes.

Do-It-Yourself, cheaper...

A hacker space for life science companies is the appropriate experiment at this point. If you look at big pharmaceutical companies, they are stuck in their own rut of Ms and As with no real focus on any innovation. Venture Capital companies are minimizing risk by investing in "safe bets" while entrepreneurs pine away.

Imagine how much of an impetus it would be if you could rent a space very cheap, rent and share equipment and "schmooze" with like-minded folks. Biocurious is positioned appropriately to achieve this. You could be a serious entrepreneur, or someone who wants to make your cat fluorescent (okay, the last one is just a cruel joke), and you would find Biocurious the right space for you.

Of course Biocurious is well founded on the principles of "Safety First", open source and all that is well and good with hacker spaces.

To learn more, go here: http://biocurious.org/index.php?title=Main_Page

Education for hobbyists and entrepreneurs alike

Apart from providing space, equipment support, safety and good vibes, Biocurious also provides a framework for hobbyists and entrepreneurs to teach each other. You can see the list here:

http://biocurious.org/index.php?title=Classes

As you can see, I have volunteered to teach a class on FDA regulations, for life science companies and medical device companies alike. So, let's take a look. I am going to copy and paste the summary of what I wrote in there later, but here's the gist.

Introduction to FDA Regulations

This is an introductory class. So, if you know little or nothing, or simply want to come and help out Biocurious with more than the suggested minimum of $10 (I am not getting any of this!), then come and have a listen.

If you are wondering what you should do after receiving a Form-483 report, this may not be for you...

The idea is not to rant about how the FDA is out to kill innovation or any of that stuff. Our goal in this class will be to develop an idea of the ways and means by which you can work within the regulatory framework from the very beginning of your drug/device/biologic/diagnostic development process.

The goal is to layout the regulatory map and discuss any questions and answers.

Although it mostly repeats, here is the class summary:

The Business of Drug and Device Development – what you need to know about regulation and the approval process

Tuesday, June 22nd | 6:00 - 9:00 PM

Srihari Yamanoor

As an entrepreneur, one of the most important balls you will juggle will be regulation. As you get more serious about your endeavor and seek funds you will notice that investors and others will seek out your “regulatory plan”. It is key to develop a thorough understanding of the regulatory process, what the FDA looks for, and the strategies companies adopt to ensure as smooth an approval process as possible.

The class will discuss the approval processes primarily focused on drugs and medical devices. We will talk about the different stages of the approval process involved in therapeutics. This will be followed by a discussion on medical device approval process. We will discuss the various classes of medical devices, how to determine the classification of your device.

Frequently, your devices and drugs will go through clinical trials in Europe, Mexico and other locations. We will discuss the need for this, how to initiate clinical trials in these locations, and how to work with the FDA throughout the process to ensure that the trials meet the standards for safety and effectiveness, essential for approval.

We will also discuss the regulatory process that is in flux at the FDA.

Cost: $10 suggested contribution. All proceeds will be used to support the lab.

Stop By!

So, once again, if you are local to the Bay Area, consider marking off June 22nd on your calendar and stopping by! If you have any questions, let me know. I hope to see you come there and support Biocurious!!

Here is the link again: http://biocurious.org/index.php?title=Classes

Recently, I was contacted by Zach Kaplan, the CEO of "inventables.com", a clean, fast website that allows you to look for specific materials and technologies. They have a significant medical section that I did find interesting. It is not an exhaustive link, mind you, but I think it has great potential to get there.

To keep things very simple, I tested out some very simple keyword searches:

1. My favorite (not) "stent"

2. Bone cement

3. Camera (a pleasant surprise on the results) and so on.

With these tests I found some valuable information on the certain materials and manufacturing technologies. If you have been in the industry for a while, you may react with a yawn, but if you are new, I believe the site holds quite a bit of promise. Things load fast and the information is there to tag you.

When I hit larger terms such as phlebotomy or atria or even something mundane as heart, I did not get good results. I won't blame the website though, it is a factor of learning to search for stuff. As it is, many times, when you are working on device projects, you are at a loss as to where to start the search. The thing to note is, having inventables as one of the places to go to, might not be a bad idea.

When you do get search results, you are now in touch with vendors. If you are a small vendor trying to reach a wider market, this may not be a bad idea at all. I am sure there is a path to organic evolution where we will land on the right search results that will lead to the right products and/or information.

Conclusion:

I think like many of those emerging tools, inventables shows great potential!

Reference:

https://www.inventables.com/

Whether you are working on a medical device company, a biotechnology company or a pharmaceutical company, and regardless of your size, you will always need resources. You may not want to "fly" someone in a few times a year and fret about the bills. Everyone talks about networking, but it is always good to have a backbone to rely on.

Recently, I was contacted by Jill Zimmerman, the director of marketing and communications at MedTech, a non-profit trade association serving bioscience companies in New York. MedTech has an interesting model. There is a very clearly laid out strategy to serve bioscience companies in New York. Memberships are collected from participating organizations, rather than from individuals, which I guess makes for a more sustainable model with better outreach.

MedTech also has an impressive strategy to serve it's members, including public outreach, marketing and promotion of the industry and networking.

http://www.medtech.org/media/documents/2009/3/MedTech_Vision_Mission_Strategic_Priorities.pdf

So, if you are moving to the New York Area and starting afresh, it may not be a bad idea to check out and see if your organization already participates in MedTech.

Events and Such

You can never have enough life science events, ever. So, looking at the rather impressive roster of events that MedTech, I am a bit jealous, positively speaking :).

You can find out more here:

http://www.medtech.org/events/list.aspx?cat=0

If you are new to CAPA or just need a refresher, events like this might be for you:

http://www.medtech.org/news/mediaroom.aspx?recid=1566

They also listed a webcast coming up for 5/12. I almost never have time for these things even though I promise myself I will. I still signed up, and will try my best to make it to this one.

Conclusion

Networking in interdisciplinary bioscience fields is very, very important. Find organizations such as MedTech that serve you locally, and when you find them, don't let go. Do you know of other resources that would be useful to folks? Please share them with me!

Reference:

http://www.medtech.org/