November 9th, 2008 by jspeer
Abbott recently presented some preliminary two-year results on its bioabsorbable stent study. The results show that the stent “successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries.” Read the press release.
Maybe this is the “leapfrog” technology for treating coronary artery disease?
Posted in All, Medical Device - General | No Comments »
November 9th, 2008 by jspeer
Integrated Medical Systems recently received FDA clearance for the MedEx 1000–a portable ICU. The MedEx 1000 include capabilities for Physiological Monitoring (electrocardiogram, invasive pressure monitoring, non-invasive blood pressure monitoring, temperature, pulse rate, blood oxygen saturation, and heart rate); low rate and high rate infusion pumps; a fluid warmer; a ventilator with carbon dioxide and oxygen monitoring capabilities; and the ability to deliver oxygen to a patient (using an external oxygen cylinder or oxygen concentrator).
Seems like this product could have quite a bit of utility in rural settings, disaster response, military, and field use.
Posted in All, Medical Device - General | No Comments »
November 9th, 2008 by jspeer
MD&DI recently had a Q&A article with Peter Carstensen, former human factors authority for CDRH. Some several great questions were posed, including:
- What are some of the most common mistakes device firms make regarding human factors and usability design?
- How should a medical device company structure its human factors program?
- How should human factors work be integrated with design controls?
When asked “Why should a medical device company have a human factors program in place?”, Carstensen’s initial response was “Because it’s the law”. While he is right, just doing something because it’s the law is not the only reason. A robust human factors program will help ensure that the product meet user needs.
Posted in All, Medical Device - General | No Comments »
November 9th, 2008 by jspeer
A couple weeks ago, a German man underwent surgery for a double arm transplant. The surgery took over 15 hours and required a team of 40 people! He is the first person in the world to receive a double arm transplant. What’s most amazing to me is that he lost his arms six years ago after a terrible farming accident.
Read more here, here, and see some fascinating pictures here.
Posted in All, Misc | No Comments »
November 5th, 2008 by jspeer
Creo Quality started in October 2006 with our first client, SonarMed. We worked with this exciting medical device start-up for over two years. As of October 31, 2008, CQ and SonarMed parted ways. It was a great ride and wonderful launch for the Creo Quality business. SonarMed is moving forward and still in pursuit of an elusive 510(k) submission. I wish them all the best!
Posted in All, Indiana Life Sciences | No Comments »
November 5th, 2008 by jspeer
Is Nike getting into the prosthetic business? Maybe. I saw a post about this on Yanko Design a few weeks ago. Check it out!
Posted in All, Medical Device - General | No Comments »
October 26th, 2008 by jspeer
Cricothyrotomy (or cricothyroidotomy) devices are used to gain emergency access to a patient airway when standard endotracheal intubation cannot be performed. During my career at Cook, I helped develop and bring to market a couple cricothyrotomy devices, most notably the Cuffed Melker.
Cric devices are generally regarded as “insurance policies”. Hopefully, a clinician will never need to resort to a cricothyrotomy procedure. Because of this, cric devices should be somewhat intuitive and not require a great deal of training. We believed the Melker device fit this criteria because it utlizes the standard Seldinger technique (needle, guidewire, catheter) for insertion and physicians use this technique daily to place IVs, central lines, etc.
Pyng Medical has developed a new product: Complete Rapid Illuminated Cricothyrotomy (CRIC) Kit. The device looks interesting. Not sure how easy or difficult it is to use, however.
Posted in All, Medical Device - General | No Comments »
October 22nd, 2008 by jspeer
Several months ago, I shared news about the formation of the Indiana Medical Device Service Provider Network. We’ve had four meetings and are beginning to make progress at defining the scope and mission of this group. We also settled on a new name: INpact. We have a website and will be updating this over the next few weeks.
Right now, we have open voting for INpact’s logo. The choices are:
1: 
2: 
3: 
4: 
Which is your favorite?
Posted in All, Indiana Life Sciences | No Comments »
