Smartphone diagnostic creating portable eye exam | MedCity News

Yet another smartphone medical device, this time a portable eye exam for use in developing countries. Very cool. There is enormous need and potential for inexpensive, portable diagnostics in the developing world.

I’m particularly impressed with how the current generation of entrepreneurs has decided to avoid costly custom technology solutions and instead leverage the multiple billions of dollars previously invested in IT. This device connects to the web and not only does the diagnosis but it shows the patient eyeglass stores.

Read more: Vinod Khosla-backed smartphone diagnostic creating portable eye exam raises $2M | MedCity News.

How Restyling the Mundane Medical Record Could Improve Health Care | Wired Design | Wired.com

This is an interesting study in design and healthcare IT but lacks a clear roadmap for successful implementation – something that businesses require but design competitions can ignore.

“The results of a contest sponsored by the White House shows how powerful a dose of design can be in treating what ails our medical system.

Electronic medical records (EMR) are extremely useful tools and can help improve patient care and reduce costs — if designed and used properly. Unfortunately, good design is hard to come by in this market. Health IT data standards, privacy laws, and impenetrable health systems complicate an already challenging design process and usually lead to lackluster products.”

As the article refers to it, the “mundane” electronic medical record is becoming increasingly important as more test results, physician notes, imaging results, and patient records exist only in digital format. And everyone probably remembers the financial incentives that the Affordable Care Act dangled in front of physicians to persuade them to adopt EMR technology.

One of the key questions is who is the customer for an EMR? That’s complicated…but that’s who gets the attention from the EMR vendors, because they pay the bill. Sometimes it’s the physician or practice who pays for the system, sometimes it’s a healthcare system like Providence or Group Health here in Seattle, and sometimes the patient can be the (non-paying) customer. After all, the data belongs to the patient, right? But from the perspective of the entity paying for the EMR, does patient satisfaction really matter? Just like many things in healthcare (and technology for that matter), the consumer is the product, not the customer.

Some of the biggest issues preventing widespread acceptance of EMRs and more enthusiastic innovation in the market segment, in my opinion, are interoperability among disparate systems, lack of standards, data portability, and switching costs for the EMR owner. EMR vendors have not historically made it easy and simple to transfer records among competing systems while there is a confusing absence of standard fields and features from vendor to vendor. Patients switching to a competing system because of relocation or changing insurance plans or new specialists or switching primary care providers often have a difficult time accessing old records in the new system. Finally, physicians who switch to new EMRs have reported having to pay high costs to import and remap their old EMR data into a new system, a cost that has been referred to as “ransom.”

The benefits to EMRs are many, as the article suggests: easier management of chronic diseases, improved communications, better patient compliance, fewer medical errors, reduced waste because of duplicate and uncessessary tests, and lower overall costs to the healthcare system. Benefits to the advanced EMR concepts discussed in this article are potentially even more valuable. Will we see them in the near future? As a consumer and occasional patient, I sincerely hope so. As an industry observer, “the doctor will be with you shortly.”

Read more: How Restyling the Mundane Medical Record Could Improve Health Care | Wired Design | Wired.com.

I’ll be discussing more about the different types of customers involved in medical device commercialization in the next post in my ongoing series, Commercialization 101.

Google Glass in healthcare

Google Glass has created lots of buzz recently, much of it negative. People seem to be reacting to the “Borg” look and a perceived invasion of privacy. I believe it’s Google’s way of inoculating our culture with what is a beta product, after all, and something they will continue to refine.

I worked for a company that developed and marketed a head-worn, head-up “augmented vision” display. We focused on mobile “knowledge workers,” including physicians and surgeons. There was much interest but the technology was not sufficiently refined (this was 10 years ago) and we could not meet user expectations.

I believe Google and others will perfect this aspect of wearable technology and that vertical markets like healthcare will be among the first to adopt. Wouldn’t you rather have your doctor looking at you than staring at a tablet during your visit, even if she is wearing a weird set of glasses? How about giving a surgeon and anesthesiologist the ability to monitor multiple readouts simultaneously, all without diverting their attention from the patient? There are many opportunities for new products, new applications, and new companies using this technology.

photo from http://www.forbes.com/sites/johnnosta/2013/06/21/google-glass-in-the-operating-room/
Rafael Grossmann, MD, FACS at Google Glass’s first surgical appearance (image from Forbes.com)

Lastly, there is a terrific video (in my opinion) from the Cleveland Clinic in the second link that gives a glimpse into what this technology may deliver someday. It’s quite moving and worth five minutes for anyone involved in any aspect of healthcare.

Read more: Inside The Operating Room With Google Glass – Forbes.

Read/see more: #ifIhadGlass: Google’s new gadget could turn Cleveland Clinic’s empathy video into reality | MedCity News.

 

The value of curmudgeons and why health systems and startups should engage them | MedCity News

We all tend to seek people who agree with our brilliant ideas. It’s human nature to avoid the naysayers and skeptics. There is a significant danger of group think if you apply this filter too energetically, however.

I’ve found that the best tactic for engaging physicians or nurses as advisory board members or informal advisors is to have a mix of ages and experience levels. Too often, the key opinion leaders are too busy to give practical advice – but they are needed for their names and tacit endorsements. And they will point out obvious blunders.

The younger physicians and residents are often extremely energetic and idealistic but can be naive about what it takes to bring about change in an often byzantine hospital or healthcare system. Sometimes they just don’t have enough practical experience to offer meaningful advice about adoption of a new technology, although they are extremely sharp about technology and the latest research.

It helps to engage one or two mid to late-career curmudgeons as the article suggests. These people have seen more than one battle and in many cases, more than one war, metaphorically speaking. If you can gain their trust, they will tell you the flaws in your go to market plan and what needs to change. Of course, it helps to develop a tougher hide before asking for feedback from “grizzled veterans” as you will quickly learn that your “brilliant ideas” are anything but!

“…anyone who wants to make changes from a hospital system to a scrappy startup would do well to bend the ear of a curmudgeon, be they a nurse, provider or health care professional affected by a proposed change or innovation they want to make. They may be surprised by the results.

Why? Because curmudgeons are more likely to express their opinion about whether a new system or initiative will or won’t work and why. If a new interface would interfere with workflows, for example, they will often be the first to speak up. They are frequently the toughest critics. You may not get showered with praise from them but if you engage them early on and make it clear their opinions are valued you may end up making your app, EHR, etc. much better than it might otherwise be.”

Read more: The value of curmudgeons and why health systems and startups should engage them | MedCity News.

What’s Your Value Proposition? Medical Device Commercialization 101

PurchaseFirst of all, do you know what I mean by value proposition? It’s a pretty straightforward concept. Essentially, it’s why people or companies buy from you. They give you money, you give them…something in return.

That’s where some people go astray. You must think like a customer and put yourself in the mind of your customer now. As the old cliche goes, guys at Home Depot aren’t really buying drills, they are buying the ability to put a hole in something. I’d also argue that they’re buying a few moments of peace and quiet in “guy land.”

So it’s more than just the laundry list of features you or your product manager or your product engineer say comprises your product or software or (heaven forbid) “solution.” To keep things simple, I’ll be referring to all of these categories as “products.”

Customers buy products because their perceived value of the product equals or exceeds the sum of the investment required to acquire it plus all of the risks associated with purchase and use of the products. This formula is highly individualized and probably not very useful except in the abstract.

We can break it down to simplify. First of all, value is the sum of all of the benefits a customer gets from buying and using your product. Those may include:

  • Solving a problem 
  • Preventing a problem 
  • Saving money 
  • Avoiding loss (not quite the same as saving money) 
  • Reputation/ego enhancement (think iPhone) 
  • Meeting a standard, requirement, or law 
  • Assurance of risk reduction – guarantee, warranty, trade-in value, etc.

Next, the investment required for acquisition might include:

  • Cash price
  • Lease, loan, or other financing terms
  • Opportunity cost of the money being spent
  • Installation cost
  • Training cost
  • Write-off cost of product being replaced
  • Cost to research the acquisition (can be substantial for capital purchases)
  • Ongoing support and maintenance costs

Finally, the risks of buying a product from you could include, among other things:

  • Incompatibility with existing systems or processes
  • Failure to perform to requirements (poor quality)
  • Failure to perform consistently (poor reliability)
  • Support (training, repair, maintenance, updates) not available or not to expectations

Now you can see all of the factors that make up a decision to purchase.

The value proposition is that the Purchase only occurs when Benefits are equal to or greater than the Costs plus the Risks of acquisition.

Your job then, as a startup CEO, Product Manager, or Business Unit Head, is to identify the benefits that your target customers need, then turn them into physical features, then price the product attractively while still making a fair profit, and also design programs and safeguards to mitigate the customer’s risk.

Seems simple? I don’t think so, either.

By the way, these concepts apply just as well to businesses as to individual consumers. After all, businesses are nothing but individuals working together.

Think of a medical practice considering the purchase of a new Electronic Medical Record system. They probably have an existing system with which they are not happy. Price is a factor but there are many, many other factors that will influence their decision.

Takeaways:

  1. Put yourself in the mind of your customer.
  2. Never forget that customers buy benefits.
  3. A purchase doesn’t occur until perceived value equals or exceeds perceived costs plus perceived risks.
  4. As the saying goes, perception is everything.

Next time, I’ll take a look at the different types of buyers involved in a medical device purchase.

 

 

Invisible Bike Helmet Inflates On Impact VIDEO – YouTube

OK, so this is not medical technology but it should prevent the need for physicians and hospitals. Also eliminates the dreaded “helmet head hair.” I would probably buy one when the price comes down. Nothing like cycling without a helmet – except for the fear of a concussion, of course!

Smart entrepreneurs – they started with a need and a market. Europeans famously do not wear helmets and they are just as vulnerable in crashes as the rest of us. They have plans for line and market extensions – horse riding, downhill skiing, hip protection for the elderly, and epilepsy seizure protection. Maybe the NFL should look into this…

Would be huge if they could get product placement during the Tour de France.

I would lose the Hövding name before expanding beyond Sweden – sounds like something from Ikea!

See the video: Hövding Invisible Bike Helmet Inflates On Impact VIDEO – YouTube.

Widespread Layoffs Leave MedTech Professionals Shaky on Job Security | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

Is the notorious medical device excise tax to blame? How about Obamacare? A hangover from the Great Recession? Austerity in Europe? CEO needs a new yacht?

In any event, it’s alarming to note, in an industry as robust and historically profitable as medical devices, that 40% of medical device industry professionals polled are either out of work or in a panic about their job security.

“… the byproduct of these seemingly endless medical device industry layoffs may just be the emergence of a culture of fear and a host of new problems with which companies may now have to contend.

Job cuts are cutting deep, and medical device companies need to work on healing that gaping wound for the health of the industry.”

Heads up, startup execs. You may be looking at a pretty deep talent pool as you go to market.

Read more: Widespread Layoffs Leave MedTech Professionals Shaky on Job Security | MDDI Medical Device and Diagnostic Industry News Products and Suppliers.

2013 Washington State Biomedical Device Summit

I attended this meeting yesterday, June 17 at the Bothell Campus of the University of Washington. Bothell is a hub of the Biomedical Device Innovation Zone.

There was an interesting keynote talk by Mark Leahey, CEO of the Medical Device Manufacturing Association (MDMA). He reported that lobbying in Washington, D.C. to repeal the 2.3% medical device excise tax is intense. He also told the group that efforts to improve the FDA regulatory clearance process are proceeding and that the 510(k) pre-market notification process does not need to be replaced, merely refreshed.

One welcome development was an announcement by Matt Smith, Chair of the Biomedical Device Innovation Zone that a medical device company incubator is being established at Lake Washington Institute of Technology in Kirkland. The incubator will have rapid prototyping capability  – machine shop, 3D printer, etc. – as well as space for several onsite startups and a number of virtual startups. This is great news – there are a number of startup incubators in Seattle focusing on biotech and software but none until now that specifically welcome medical devices!

The most interesting part of the summit was a panel discussion chaired by Chris Rivera, CEO of the Washington Biomedical and Biotechnology Association (WBBA). The panelists were executives in local healthcare organizations. Three of the panelists are also physicians and a fourth is a pharmacist. The message for industry is that the future of the healthcare industry is going to be focused on cost reduction – “cost, cost, cost” according to one panelist.

I did not know that the medical device industry accounts for only 6% of all healthcare costs in the U.S. As one panelist put it, even if you gave away all devices at cost, it would not bend the healthcare system cost curve. The highest expenses are in labor. Devices that eliminate labor or that connect systems requiring manual intervention will be winners in the future. Entrepreneurs and established device companies launching new products must show immediate cost savings, as the CFOs and actuaries are jaded by past promises and will no longer accept assertions that cost reductions will occur over a long period. One reason is that the typical patient tenure in a health insurance plan is only two years. That makes it difficult for an insurer to realize savings on an investment in new technologies or procedures without up-front savings.

An audience member asked a question about the structural costs of practicing “defensive medicine” where clinicians order extra tests and procedures to guard against malpractice judgments. Interestingly, the three physicians on the panel all asserted that, while significant, defensive medicine is not the biggest problem in healthcare economics in the U. S. and further, that  it will be impossible to ever eliminate defensive medicine, primarily because of the trial attorneys lobby in “the other Washington.”

Another panelist stated that companies with new products and procedures must approach hospitals and offer ways to mitigate the risk the hospital is taking by adopting the new technology. This idea is getting attention around the industry. Not sure exactly how it would work and how that would affect financial statements and projections in startups and even established companies. Does the hospital expect some sort of make-good guarantee if the technology’s promises fail to materialize? On the flip-side, does it expect to participate in the company’s success if the technology is even more successful than anticipated? Another panelist suggested that clinical articles about new technologies always include a discussion of financial projections in addition to the usual clinical and technological discussions. “Cost, cost, cost” indeed…

Interventional radiologists wring hands over the medical device tax | MassDevice

I don’t agree that an across-the-board tax would be a major obstacle for medical device companies to acquire innovative and effective new interventional radiology technologies. Yes, the tax reduces gross margins but as the article implies, the Affordable Care Act (aka Obamacare) is bringing millions of uninsured people/prospective patients into the healthcare system. So gross dollars (aka the bottom line) should increase.

Besides, it’s still a level playing field as the tax applies to all companies participating in the U.S. healthcare market. Yes, a few marginal technologies “on the bubble” may not make it to market but the radiologists are free to start their own companies and prove the bean-counters wrong.

The issue of whether the medical device tax is good or bad policy is a separate matter and is not what I’m addressing here.

The use of the term “hand-wringing” in the headline seems to fit, in my opinion.

“The 2.3% medical device tax may prevent “entrepreneurial interventional radiologists” from bringing new technologies to market, according to a commentary published by the Journal of Vascular & Interventional Radiology.”

Read more: Interventional radiologists wring hands over the medical device tax | MassDevice.

Supreme Court Justices, 9-0, Bar Patenting Human Genes – NYTimes.com

DNA A rare, unanimous decision from our ideologically divided Supreme Court affirms that natural things cannot be patented – a principle that has been part of patent law for more than one hundred years.

The Court upheld the right to patent methods to isolate genes and also complementary DNA (cDNA, an artificial construct).

Both sides, of course, claimed victory. The company, Myriad Genetics, stated it was pleased with the decision and that its business model is unaffected. Consumer advocates and researchers expect the price of breast cancer genetic testing to drop substantially and also hailed the ability of researchers to conduct experiments without fear of patent infringement lawsuits.

Interestingly, patent law in the European Union allows for the patenting of human genes.

As an individual, I am happy to know that my genome remains mine. As a business person, I will watch with great interest – what will happen next in this emerging industry?

“WASHINGTON — Isolated human genes may not be patented, the Supreme Court ruled unanimously on Thursday. The case concerned patents held by Myriad Genetics, a Utah company, on genes that correlate with increased risk of hereditary breast and ovarian cancer.”

Read more: Justices, 9-0, Bar Patenting Human Genes – NYTimes.com.

A Smartphone Spectrometer Diagnoses Disease At A Fraction Of The Price | Co.Exist: World changing ideas and innovation

Another example of the astonishingly rapid convergence of mobile technology and medical applications.

“Here’s another example of the trend: a spectrometer that costs as little as $200. An iPhone cradle, phone and app, it has the same level of diagnostic accuracy as a $50,000 machine, according to Brian Cunningham, a professor at the University of Illinois, who developed it with his students (see video).”

“In the future, it’ll be possible for someone to monitor themselves without having to go to a hospital. For example, that might be monitoring their cardiac disease or cancer treatment. They could do a simple test at home every day, and all that information could be monitored by their physician without them having to go in.”

Those slabs in our pockets are so much more than phones.

Read more: A Smartphone Spectrometer Diagnoses Disease At A Fraction Of The Price | Co.Exist: World changing ideas and innovation.

The Market – Medical Device Commercialization 101

OK, so you know that you need a customer in order to have a business. In fact, you usually need lots of customers to have a successful business. In this post, I’ll discuss that vague abstraction known as the market.

market

A market is a group of entities, sometimes people, sometimes organizations, sometimes both. In its simplest form, some of the entities in the market sell things and other entities buy things. Or you could say that some entities have problems they are trying to solve and they buy solutions from other entities.

There are an infinite – or at least an uncountable – number of markets in our economy.Think of your own personal life. You participate in many different markets, for example, music (and that could include CDs, digital downloads, streaming, concerts, and lessons among other things), food (including fresh, frozen, farmers’ markets, food trucks, fast food, restaurant dining, snacks, beer, wine, soda, and bottled water, etc.), and transportation (cars, bicycles, pedicabs, trains, airlines, hot air balloons, buses, taxis, limos, and so on).

There are probably thousands or even tens of thousands of markets for medical devices. Hospitals and physicians purchase and prescribe many different products, services, and solutions to diagnose, treat, and maintain their patients.

Markets have competition. The entities selling solutions compete for buyers. Sometimes the competition is direct but it need not be. Innovative solutions and products often do not have direct competition, at least not initially. There is almost always, however, indirect competition or at least the status quo – what buyers are doing right now without the innovation. Never make the mistake of thinking or stating that your new widget or app “has no competition.” It diminishes your credibility and usually results in someone proving you wrong.

There are concentrated markets in which a handful of sellers control almost all sales. Think of the cable TV market in your town. If you are fortunate, there are two competitors. On the flip side, there are some highly competitive markets with many sellers. For example, consider the fairly new and still evolving market for “cloud” based archiving of your digital files. This is a highly competitive market with new entrants emerging almost daily with prices falling and offerings improving rapidly. It’s pretty obvious which type of market is better for buyers. Unless you have a significantly disruptive product and lots of financial resources, the competitive market is probably more attractive for you as a seller as well.

One more thing about markets – they are almost never homogeneous. There can be geographic differences among buyers as well as language, culture, economic (price stratification as well as terms of payment), demographics  (for example, gender, age, political leaning/affiliation, income level, socioeconomic status, technology adopter status, etc.), and many, many more. Any of these differences can be used to identify consumer market segments. There are other attributes in medical device markets such as hospital size, number of procedures performed per year, hospital market share, physician experience level, and so on.

Market segments are groups of buyers with at least one attribute in common so that your offering should have value or appeal to all members of the group, for example, “household decision-makers considering purchase or lease of an electric vehicle in the next three month”s or “family practice physicians in small to medium group practices interested in purchasing an electronic medical record system in 2013”. Further, the segment must be economically reachable via the same form of marketing communications or media promotion, e.g., direct mail, webinars, radio or TV advertising, or one of the various forms of Internet advertising.

Identifying your market is fairly easy. It’s almost always dictated by the indications for use of your product. Segmentation is tougher. There may be multiple segments for your offering. The challenge is selecting the segment(s) that are most competitive (and therefore open to new offerings) and reachable (so you don’t have to break the bank with marketing programs to reach the segment members).

The objective is to create awareness and interest in your solution/product, thereby generating sales leads. A portion of the leads will convert to actual sales, creating revenue to expand marketing and sales efforts and leading to profitability.

As part of your launch plan, you should talk to market participants in person, at conferences, and in surveys. Identify as many segmentation attributes as you can.

Takeaways:

  1. Try to select a competitive market unless you are launching something truly disruptive.
  2. Identify as many segments as possible.
  3. Pick segments based on their attractiveness for your business and your ability to reach segment members economically with marketing programs.

Next time, I’ll talk about identifying the different types of buyers in your segments. It’s much more complicated in B2B (business-to-business) markets like medical devices than in B2C (business-to-consumer) markets.

 

Colonoscopies Explain Why U.S. Leads the World in Health Expenditures | NYTimes.com

From The New York Times, June 1, 2013, The $2.7 Trillion Medical Bill – Colonoscopies Explain Why U.S. Leads the World in Health Expenditures

Average price of an angiogram in the U.S. $914, in Canada $35.
Average price of hip replacement surgery in the U.S. $40,634, in Spain $7,731.
Average price of a Lipitor prescription in the U.S. $124, in New Zealand $6.

There is probably no single reason for the mess that the U.S. healthcare system has evolved into. Colonoscopies illustrate a number of the things that have gone wrong. Colonoscopy has become the gold standard for colon cancer screening even though there are less costly and equally effective alternatives. Liability may play a part here although higher profitability is the more likely reason. Many physicians and hospitals routinely conduct the procedures using general anesthesia even though they can be safely performed with patient sedation. Prices vary widely across the country and seem to be tied more to maximizing reimbursement from insurers than to cost recovery.

This madness will stop eventually, but when and how?

“While the United States medical system is famous for drugs costing hundreds of thousands of dollars and heroic care at the end of life, it turns out that a more significant factor in the nation’s $2.7 trillion annual health care bill may not be the use of extraordinary services, but the high price tag of ordinary ones. “The U.S. just pays providers of health care much more for everything,” said Tom Sackville, chief executive of the health plans federation and a former British health minister.”

“The United States spends about 18 percent of its gross domestic product on health care, nearly twice as much as most other developed countries. The Congressional Budget Office has said that if medical costs continue to grow unabated, “total spending on health care would eventually account for all of the country’s economic output.”” [emphasis added]

Read more: Colonoscopies Explain Why U.S. Leads the World in Health Expenditures – NYTimes.com.

The one thing that makes a company last forever | qz.com

According to Stanford Graduate School of Business professor Charles O’Reilly, long-lasting companies have a quality he calls “organizational ambidexterity” – the balancing of exploration and exploitation.

Escher hands drawing

“All companies hit rough patches from time to time. But only a few manage to survive decade after decade—some of them in a form that bears no resemblance to the original organization. Nokia began in 1865 as a riverside paper mill along the Tammerkoski Rapids in southwestern Finland. In the late 1880s, Johnson & Johnson got its start by manufacturing the first commercial sterile surgical dressings and first-aid kits. And in 1924, the founder of Toyota came out with his company’s first invention—an automatic loom.”

“You can’t just choose between exploiting your current opportunities and exploring new ones; you have to do both. And the companies that last for decades are able to do so time and time again.”

“The researchers looked specifically at what type of corporate culture was associated with growth in revenue and net income, and found that more adaptive cultures, or ones that emphasized speed and experimentation, did much better. “A culture that says, ‘We don’t have all the answers; we’ve got to try these experiments’—that’s the type of culture that promotes ambidexterity.””

This seems to be a remedy to The Innovator’s Dilemma which asserts that big companies fail because of their own inertia, giving way to aggressive if imperfect new entrants.

Being ambidextrous also calls for strong management that can articulate a vision and lead everyone to support the vision as well as aligning the company’s various businesses with the vision. Interestingly, Prof. O’Reilly maintains that large corporations have an advantage over startups because the large entities have resources to spare. Essentially, they can cover several bets while a startup is typically dedicated to a single direction in what is usually a “bet the company” move.

A couple of excellent examples in American business: GE and IBM. It remains to be seen if the likes of Microsoft and Apple are also ambidextrous.

Read more: http://qz.com/90969/companies-that-succeed-have-this-in-common/

This Electronic Temporary Tattoo Will Soon Be Tracking Your Health | Wired Design | Wired.com

This is a fascinating development in the evolution of body sensors that are continuously updating and collecting all sorts of physiological data. As simple and non-threatening as a temporary tattoo, they appear to have the potential to be relatively inexpensive at scale and are applicable for critical care use as well as consumer health monitoring and even gaming.

It’s unclear if the power source and connectivity are part of the sensor. If not, I’m sure that someday soon those too will be integrated.

This would be fun to commercialize. Just think of all of the novel applications and benefits something like this could provide.

“FitBit too bulky? Why not glue a sensor array to your skin?

The quantified self goes nanoscale with a stick-on silicon electrode network that could not only change the way we measure health metrics, but could enable a new form of user interface. And the researchers behind it aim to have the device available in the next few weeks through a spinoff company, MC10.”

photo of Electronic Sensor/Temporary Tattoo
Electronic Sensor/Temporary Tattoo one week after application

Read more: This Electronic Temporary Tattoo Will Soon Be Tracking Your Health | Wired Design | Wired.com.

Study: Medical devices spur complications for kids – FierceMedicalDevices

I’ve had direct experience with this dilemma: “most medical devices are designed for adults and have to be adapted for use in children”. Unfortunately, device commercialization comes down to a business case – is the target market big enough and lucrative enough to justify investment? Often, the answer for pediatric indications is “no”. There are also lengthy and expensive regulatory hurdles to overcome. Of course, as parents, we all want the kids’ version of the adult device with equivalent or better safety and efficacy at a reasonable price.

“”Medicine and pediatrics have made amazing advances over the last couple of decades that have resulted in children with congenital diseases and prematurity living longer, so this issue is a by-product of that success,” said Patrick Brady, MD, MSc, the lead author and a physician in the Division of Hospital Medicine at Cincinnati Children’s Hospital Medical Center.

Brady said medical devices are a major factor in improved survival for children with complex medical conditions. But he added there has been relatively little research into how medical devices may expose these children to additional risks, especially when considering the devices are foreign objects to the human body and subject to mechanical problems or causing infections. Also, researchers note that most medical devices are designed for adults and have to be adapted for use in children.”

There has to be a business opportunity in this somewhere…

Read more: Study: Medical devices spur complications for kids – FierceMedicalDevices.

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.