Mobisante Grabs $4.2M for Mobile Ultrasound Tools | Xconomy

Congratulations, Mobisante! This is great news considering the challenging climate for early stage medical device companies seeking equity investment.

It’s also a classic example of The Innovator’s Dilemma (classic book about innovation by Harvard professor Clayton Christensen). Among others, Acuson, ATL, Philips, and Siemens were pioneers in medical ultrasound. They perfected the high end, clinic and hospital-based ultrasound machines we’ve all seen and/or experienced.

SonoSite disrupted the market in the late 1990s with a laptop-size portable ultrasound unit that was suitable for emergency use in and out of hospitals. It proved to be wildly popular.

Mobisante is now disrupting the market with solutions based on smartphones and tablets, extending the applicability and portability of ultrasound even farther.

Mobisante Grabs $4.2M for Mobile Ultrasound Tools | Xconomy.

“The one thing” – Medical Device Commercialization 101

This is the first in a series of posts in which I’ll discuss the many factors that go into a successful product development / commercialization / launch project.

I’ve given many lectures and presentations on product launches and marketing. When I ask this question at the beginning of the talk, I get a variety of answers. Keep in mind there are many things  businesses need but only one thing that is like oxygen to a living organism – that “every” business needs.

What’s the one thing every business needs? [scroll down]

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Customers!

Yes, you may have unique products, superior intellectual property, a great development team, world-class executives, perhaps even a NASDAQ stock listing. You may have efficient manufacturing, excellent internal communications, terrific PR, a slick website, and a green headquarters building. You may have ISO and cGMP-compliant processes, strategic partnerships, and cash in the bank.

Until and unless you have identified who will buy your product and why, you do not have a business.

A Top Ten List for EMR | Medicine for Real Blog

Terrific insight into the day-to-day frustrations of using healthcare information technology, from the perspective of a practicing U.S. anesthesiologist. Perhaps product managers and company executives for EMRs and other healthcare information systems already know of these issues and the “wish list” of requirements expressed by Dr. Leng. If so, it’s not evidenced by the user interfaces in these systems – most of which don’t (and can’t) talk to each other. One of the comments to this article suggested designing the user interface first and only then should the “back end” of the system be designed. I have a sneaking suspicion it’s usually the other way around.

“Today I’m doing anesthesia for colonoscopies and upper GI scopes.  Nowadays we have three board-certified anesthesiologists doing anesthesia for GI procedures every single day at my institution.  I’ll probably do 8 cases today.  I will sign into a computer or electronically sign something 32 times.  I have to type my user name and password into 3 different systems 24 times.  I’m doing essentially the same thing with each case, but each case has to have the same information entered separately.  I have to do these things, but my department also pays four full-time masters-level trained nurses to enter patient information and medical histories into the computer system, sometimes transcribed from a different computer system.  Ironically, I will also generate about 50 pages of paper, since the computer record has to be printed out.  Twice.”

Read more: http://medicineforreal.wordpress.com/2013/02/14/a-top-ten-list-for-emr/

Ghana seizes ‘faulty Chinese condoms’ | BBC News

A couple of interesting facts from this article and from my experience with a client:

Did you know that condoms are medical devices? (Class II = 510k)

We don’t hear or read much about it but there is a raging AIDS epidemic in sub-Saharan Africa. Millions of men, women, and children are afflicted. Among others, the World Health Organization, the Bill and Melinda Gates Foundation, and the U.S. Department of State are heavily involved in AIDS treatment and prevention in Africa.

One of the most effective HIV prevention methods is adult male circumcision, proven in several large randomized clinical trials in Africa. The substantial reduction in HIV susceptibility demonstrated in the clinical studies is described as providing the equivalent of vaccine-level protection, about a 60% reduction in HIV susceptibility.

The PEPFAR program (President’s Emergency Plan for AIDS Relief) was started by President George W. Bush and continued by President Obama. PEPFAR has spent more than $50 billion on AIDS and other infectious disease prevention and treatment to date. While not a panacea, PEPFAR estimates voluntary adult male circumcision will save $15 billion in HIV treatment and care expense, prevent more than 3 million HIV infections, and save hundreds of thousands of lives over the next 12 years.

BBC News – Ghana seizes ‘faulty Chinese condoms’.

Medical device VP: What healthcare customers ask us for before buying a new technology | MedCity News

These seem to be reasonable requests from customers when considering purchase of a new technology: provide objective, third party evidence of efficacy, show where and for how long a product has been beta-tested prior to launch, and give the customer some form of financial assurance that failed adoption won’t be 100% their risk.

Of course, given demands in most companies to realize a quick (and large) return on their investment, corners can be cut in all of these areas. My recommendation is that you build these sorts of customer-focused features, programs, and initiatives into your launch/product development plan and defend them as vigorously as possible during the commercialization process. You customers will thank you and your market share will reflect the goodwill.

Medical device VP: What healthcare customers ask us for before buying a new technology | MedCity News.

UChek’s Bizarre Response to an FDA Letter: An Unfolding Saga | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

This is a still-evolving story but a great read and a valuable lesson to novice medical device marketers and entrepreneurs: ignore the FDA at your peril. As the author points out, FDA regulations are laws. People do go to jail and companies can be shut down for violating them.

The company developed a mobile app that “reads” urinalysis test strips. In what seems to be an ill-considered decision, the company apparently decided to ignore FDA regulations regarding classification of mobile apps and diagnostic software. It also did not react well to an initial warning letter advising that the app was a Class II device. I wonder what will happen next?

UChek’s Bizarre Response to an FDA Letter: An Unfolding Saga | MDDI Medical Device and Diagnostic Industry News Products and Suppliers.

The Future of Mobile Technology in Medicine: Innovative Medical Apps | MedCity News

This is an important trend in new healthcare technology. The convergence of mobile technology, ubiquitous wireless networks, ever-more sophisticated and accurate sensors on mobile devices, and innovative apps developed by physicians and medical device entrepreneurs will result in earlier detection and diagnosis, better treatment decisions, and improved communications between providers and patients.

A few examples from the article among probably hundreds in development: skin mole assessment, burn management, brain ventricle cannulation trainer (for surgical residents), neuroanatomy trainer, and an intelligent log/monitor for diabetes patients

“…mobile technology is on its way to innovate healthcare delivery and the quality of the patient’s experience. Modern advancements in mobile technology are helping with chronic disease management by reminding patients to take their medication at the proper time and generally extending service to various neglected areas, thereby improving overall health outcomes.”

Read more: The Future of Mobile Technology in Medicine: Innovative Medical Apps | MedCity News.