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	<title> &#187; Medical</title>
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	<description>Embedded Topics and Best Practices</description>
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		<title>Establishing a value for Market Intelligence? Can you avoid the Coming Embedded Tsunami?</title>
		<link>http://www.embeddedmarketintelligence.com/2010/11/09/establishing-a-value-for-market-intelligence-can-you-avoid-the-coming-embedded-tsunami/</link>
		<comments>http://www.embeddedmarketintelligence.com/2010/11/09/establishing-a-value-for-market-intelligence-can-you-avoid-the-coming-embedded-tsunami/#comments</comments>
		<pubDate>Tue, 09 Nov 2010 15:58:10 +0000</pubDate>
		<dc:creator>Jerry Krasner</dc:creator>
				<category><![CDATA[Best Practices]]></category>
		<category><![CDATA[Market Intelligence]]></category>
		<category><![CDATA[Marketing and Sales]]></category>
		<category><![CDATA[Medical]]></category>
		<category><![CDATA[Personal Views and Philosophy]]></category>
		<category><![CDATA[Perspective]]></category>

		<guid isPermaLink="false">http://www.embeddedmarketintelligence.com/?p=608</guid>
		<description><![CDATA[We all can agree that good market information is essential for a company’s growth, competitive and strategic planning and sales support.                     But what is worse &#8211; bad information or no information whatsoever?                 I recently read a story about an explorer looking for artifacts [...]]]></description>
			<content:encoded><![CDATA[<p align="center"><strong>We all can agree that good market information is essential for a company’s growth, competitive and strategic planning and sales support.</strong></p>
<p><strong> <img class="alignleft size-thumbnail wp-image-612" title="Giving up" src="http://www.embeddedmarketintelligence.com/wp-content/uploads/2010/11/Giving-up3-150x150.jpg" alt="Giving up" width="150" height="150" /></strong></p>
<p> </p>
<p>        </p>
<p>       <strong>But what is worse &#8211; bad information or no information whatsoever?</strong></p>
<p><strong> </strong></p>
<p><strong> </strong></p>
<p><strong> </strong></p>
<p><em> </em></p>
<p><em> </em></p>
<p><em> </em></p>
<p><em> </em></p>
<p><em> </em></p>
<blockquote><p><em>I recently read a story about an explorer looking for artifacts along the Amazon River when he happened upon some 50 or more tribesmen each carrying spears. Fearing for his life he cried out “Dear Lord I’m totally screwed”. A dark cloud appeared and a loud voice cried out, “you are NOT screwed – pick up the stone in front of you and kill the chief.” The man picked up and threw the stone hitting the chief in the head, killing him instantly. </em></p>
<p><em>The explorer looked up to see more than 50 tribesmen running at him aiming their spears at him. Looking up to the dark cloud, he heard the voice say “NOW you’re screwed!”</em></p></blockquote>
<p> </p>
<p>This is what Dolores and I ponder when we are publishing survey-based market intelligence and using it to address opportunities and threats that confront our subscribers. Giving advice is easy &#8211; giving &#8220;good&#8221; advice based on statistically accurate comprehensive surveys is <em>essential</em>.  </p>
<p> </p>
<p>We carefully track what we and what others publish and how close each of us comes to correctly forecasting the marketplace. As Dolores is relatively new to our industry, she is finding it hard to understand why market research groups that have been grossly wrong made much more money than we did. Dolores was beside herself asking what happened to those companies that got it wrong. The answer is nothing – newer companies bought their research and the analysts that were wrong found new lines of work. We, on the other hand, have been here for 15 years and plan to be here a lot longer.</p>
<p> </p>
<p>Before we get to our forecasts, let me provide some background. Perhaps some of you can help me answer some of Dolores&#8217; questions &#8211; questions that I wish I could answer. Times have changed since I was on your side of the industry.</p>
<p> </p>
<p><em> </em><strong>A bit of background:</strong></p>
<p> </p>
<p>Dolores moved from education to the dreaded private sector when we became engaged some 5 years ago. Though having sufficient credits to complete a Ph.D. in performance analysis for validating student progress (skills that would bide her well at EMF), she was already at the highest pay level she could attain and she was more interested in seeing student improvement first hand, rather than theorizing about it and writing papers for her peers.</p>
<p> </p>
<p>The professional environment in which she performed was union-based and raises were predicated on time on the job, degrees and post-graduate credits – actual performance was not a consideration and tenure was earned in as little as 3 years.</p>
<p> </p>
<p>Her transition to our performance-based world was easy – she studied hard and attended many conferences and technical presentations over the years, yet her background in data analysis and performance outcomes supported her curiosity regarding how businesses grow or fail based on how they use available information for strategic planning, competitive analysis and sales support. Not only was she able to support my data-mining efforts with her experience, but she is able to ask embarrassing questions of me when she read (and schoolmarmed) my reports.</p>
<p> </p>
<p>As embedded professionals, perhaps you can relate to the questions she has asked &#8211; and maybe provide us some feedback.</p>
<p> </p>
<p>It usually begins with “I’m sure that this is a stupid question, but …” If I can’t explain it to her, then I probably didn’t think it through sufficiently.</p>
<p><strong> </strong></p>
<p>Here are some of the many questions that she asks about companies in the embedded industry that I have a hard time answering:</p>
<p> </p>
<p>1)     Why do companies with very smart people spend hundreds of thousands of dollars on sales development and much less on marketing?</p>
<p>2)     Why to companies that understand the value of marketing for sales and competitive positioning – and spend in some cases millions of dollars in their marketing efforts &#8211; spend very little on detailed, relevant and comprehensive market intelligence information?</p>
<p>3)     Why do these very smart people choose to ignore clear market signs (even when made aware of them) that can significantly impact current markets, future revenue streams and company survival?</p>
<p>4)     Why do so many European-based company CEOs micromanage their executives instead of hiring the best and freeing them up to success? Is this a better approach to corporate controls?</p>
<p> </p>
<p>Forgive what might be construed as a commercial – what really drives her buggy is that she asks me (and not infrequently potential subscribers) “Tell me what I’m missing here; Companies can have access to detailed data that they can use for sales promotion, strategic planning, and competitive analysis for less than one-fourth what they pay for an administrative assistant. Moreover, they can have access to the information that the US military and many prime contractors have about them in order to better respond. Why isn’t someone fired?”</p>
<p> </p>
<p> </p>
<p> <strong>What’s on the Embedded Horizon?  </strong><strong>EMF&#8217;s look at markets that are in transition &#8211; creating opportunities as well as threats</strong></p>
<p> </p>
<p><strong>Looking at Mobile Devices and Consumer Electronics</strong></p>
<p> </p>
<p>If you are in – or looking to get into &#8211; this market segment you will find plentiful opportunities and incredible challenges. New processors and new platforms are appearing regularly and the fickle user base will drop you without hesitation. Now that analog TV signals have gone the way of the Platypus, the FCC is assigning these “white channels” for public use. Herein we will see long range WiFi, and enhanced data handling capabilities that will provide new and dazzling apps that will drive newer markets. Time-to-market will be a crucial consideration, so the ability to reuse code and to apply such code to new interfaces and hardware will determine who will win and who will lose.</p>
<p> </p>
<p>Do you provide mobile or consumer electronic products or applications? Do you know what processors, OSes and platforms provide better and timelier design outcomes? Does it matter to you? Is your resume up to date?</p>
<p> </p>
<p><strong>Looking at Medical Devices</strong></p>
<p> </p>
<p>If we separate medical devices into two cadres; one that supports devices that are attended to by medical staff (ultrasound, CAT scans, renal dialysis, etc.), the other that needs to operate independently of medical support staff (patient monitoring) we see that the same technology that keep military and commercial aircraft operating under secure and mission critical conditions is <em>overkill </em>for medical applications.</p>
<p> </p>
<p>Did you know?</p>
<p> </p>
<ul>
<li>The medical device marketplace has been growing at a double digit rate – and new considerations should enhance opportunities for embedded vendors in 2011 – IF they take the time to correctly understand the selling points</li>
<li>Considerable attention has been given to the medical marketplace by vendors seeking a safe haven from the expected decline in mil/aero. EMF believes that many such vendors don’t understand the market segment, how to sell to it, or what the users need and will purchase</li>
<li>It would be funny if it wasn’t sad that certain leading RTOS vendors are pushing their certified high power, mission critical OSes towards an industry that develops products whose defining frequency requirements are less than 100 Hz</li>
<li>New CDRH/FDA initiatives are acting to create opportunities and threats.</li>
</ul>
<p> </p>
<p>Having brought many products through the 510k process and to market, and understanding the purchasing value system within the medical device marketplace, I am amused at the hundreds of thousands of dollars that vendors throw away on pursuing meaningless approaches to this marketplace. Dolores gets the “everything looks like a nail theory” and it was hard for her to keep a straight face when one colleague who is a vendor’s VP told us that it took them a year (and mucho dinero) to discover that what we gave them for free was correct.</p>
<p> </p>
<p><strong>The Coming Tsunami</strong></p>
<p>The Aerospace and Defense Industries of the United States are poised to undergo one of the most significant changes since the end of the Cold War; perhaps the most significant since World War II. We believe that observers (embedded vendors included) who expect small changes are mistaken, thereby fostering a false and dangerous sense of security across much of the industry and government.</p>
<p> </p>
<p>The impact to our economy goes far beyond our current financial problems and involves fundamental structural changes taking place in the industry and in the market. As in prior shifts of this nature, there will be winners and losers – however these shifts may be profound, creating more dramatic winners and losers than in the last cycle.</p>
<p> </p>
<p>The impact of major primes shifting financial challenges to their vendors (and by association to embedded sub-vendors) will reach down into the value chain, in some cases devastating naïve second and third tier vendors.</p>
<p> </p>
<p>To make matters more challenging for industry, as spending draws down, the effect on industry will be dramatic beyond the proportions of top line reductions.  This will be caused by a squeeze on the so called “Investment Accounts.”  These Investment Accounts are the funds used for product development and buying equipment.</p>
<p> </p>
<p>Embedded vendors that offer “high end” OSes and tools will be hardest hit as reductions in DoD discretionary funding and the actions of prime contractors to absorb overhead within the limits of their financial structure.</p>
<p> </p>
<p>We expect to see reductions in outsourcing to and purchasing from embedded markets defined as “mission critical” and that involve MILS security, DO-178B, and virtualization technologies as these anticipated contractions take place over the ensuing 2-3 year period. Many high-end vendors are already looking to alternative markets to shore up expected reductions – but most lack the data to determine which markets they can competitively serve.</p>
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		<title>Meeting CDRH/FDA Guidelines for Medical Device Companies</title>
		<link>http://www.embeddedmarketintelligence.com/2010/04/30/meeting-cdrhfda-guidelines-for-medical-device-companies/</link>
		<comments>http://www.embeddedmarketintelligence.com/2010/04/30/meeting-cdrhfda-guidelines-for-medical-device-companies/#comments</comments>
		<pubDate>Sat, 01 May 2010 00:26:25 +0000</pubDate>
		<dc:creator>Jerry Krasner</dc:creator>
				<category><![CDATA[Best Practices]]></category>
		<category><![CDATA[Market Intelligence]]></category>
		<category><![CDATA[Medical]]></category>
		<category><![CDATA[Perspective]]></category>

		<guid isPermaLink="false">http://www.embeddedmarketintelligence.com/?p=52</guid>
		<description><![CDATA[You Better Design Right, You Better Not Fail, if You Don’t Follow These Guidelines Your CEO’s going to Jail; The FDA/CDRH is Watching You Now (Sung to Santa Claus is coming to town)   Yes indeed – and it’s about time. The FDA’s Center for Devices and Radiological Health (CDRH) reported that in 2006, 21% [...]]]></description>
			<content:encoded><![CDATA[<p><strong><em>You Better Design Right, You Better Not Fail, if You Don’t Follow These Guidelines Your CEO’s going to Jail; The FDA/CDRH is Watching You Now</em></strong></p>
<p>(Sung to Santa Claus is coming to town)</p>
<p><img class="alignleft size-thumbnail wp-image-279" title="BP Cuff" src="http://www.embeddedmarketintelligence.com/wp-content/uploads/2009/12/BP-Cuff-150x150.jpg" alt="BP Cuff" width="150" height="150" /></p>
<p> </p>
<p>Yes indeed – and it’s about time.</p>
<p>The FDA’s Center for Devices and Radiological Health (CDRH) reported that in 2006, 21% of all medical device recalls were for software defects – it is also estimated that one-in-three software-based products is recalled. They haven’t updated this data since, but one can assume that it might have gotten worse.</p>
<p>Medical device developers and company CEOs should be aware that this is an unacceptable situation and that it is going to rapidly change. Those that don’t get it straight won’t be around when the dust settles.</p>
<p>Is there enough aspirin to relieve the headaches that our government is giving medical device manufacturers? Moreover, is it deserved? The answer – depending on the specific question &#8211; is yes and no.</p>
<p>The Obama administration under pressure from Congress has combined the medical device industry with the drug industry as one, and has proposed taxing both industries to pay for universal health insurance (Obama Care). Hopefully thoughtful senators and representatives will see that these taxes will be passed down to patients and other users and will also impact the elderly who most require such devices and can ill afford them &#8211; then again it is more realistic to depend on the Easter bunny. But logic is no relief for the headache &#8211; particularly when it comes to Washington politicians. It’s no fun being a medical device executive today.</p>
<p>On July 31, 2008 a Senate Bill cosponsored by Senators Edward Kennedy (D – MA) and Chuck Grassley (R– IA) was filed that  would require senior officers or directors of drug and medical device companies to certify under penalty of perjury that all information submitted for a product’s approval is accurate and in compliance with federal regulations.</p>
<p>The Drug and Medical Device Accountability Act Bill expired at the end of the two year Senate session on December 31, 2008, but was refiled in the <a title="2009 Drug &amp; Medical Device Accountability Act" href="http://www.washingtonwatch.com/bills/show/111_SN_882.html " target="_blank">Senate (2009) </a>with the hope of amending the current legislation by the end of October 2009. This is an important piece of legislation, and medical device executives should get their house in order to accommodate the provisions.</p>
<p>The Bill provided that product applications later found to have contained false or misleading information would be subject to stiff fines (up to $5,000,000), assessed both to companies and their senior officers, who, in addition, could face jail sentences of up to 20 years. These are serious issues. Currently the CDRH has a forensic group that looks at device software <em>only</em> after a device has been recalled.</p>
<p>This is a bad time, and a very costly time (regardless of the Act) for a medical device manufacturer – particularly if software development hadn’t been given the detailed oversight of using best practices. The new Obama tax on medical devices &#8211; used to pay for Obama Care &#8211; is allready a blow to the industry and to smaller medical device manufacturers.</p>
<p>The “Drug and Medical Device Accountability Act” will change the medical devices industry similarly to how the Sarbanes-Oxley bill impacted corporate accountability. Laws being what they are, we should expect overkill from its enactment. This is why medical device company’s senior management should take time to rethink their strategic approach to the delivery of their products.</p>
<p><a title="Embedded Market Forecasters" href="http://www.embeddedforecast.com" target="_blank">EMF </a>has available a report presenting alternative paths for developers to produce quality software for medical devices, minimize product recalls, and affordably provide comprehensive audit trails for CDRH inspectors (<em><a href="http://www.embeddedforecast.com/emf-briefs.php" target="_self">Critical Issues Confronting Medical Device Manufacturers</a></em>). Keeping the company alive and your CEO out of jail are bonuses.</p>
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		<title>2010 Embedded Systems Conference – Silicon Valley (ESC)</title>
		<link>http://www.embeddedmarketintelligence.com/2010/04/30/2010-embedded-systems-conference-%e2%80%93-silicon-valley-esc/</link>
		<comments>http://www.embeddedmarketintelligence.com/2010/04/30/2010-embedded-systems-conference-%e2%80%93-silicon-valley-esc/#comments</comments>
		<pubDate>Fri, 30 Apr 2010 23:53:28 +0000</pubDate>
		<dc:creator>Jerry Krasner</dc:creator>
				<category><![CDATA[Best Practices]]></category>
		<category><![CDATA[Development Tools]]></category>
		<category><![CDATA[Market Intelligence]]></category>
		<category><![CDATA[Marketing and Sales]]></category>
		<category><![CDATA[Medical]]></category>

		<guid isPermaLink="false">http://www.embeddedmarketintelligence.com/?p=492</guid>
		<description><![CDATA[Fearless and no longer loathing in San Jose (with apologies to the late Hunter Thompson)     Dolores and I made our annual trip to the Left Coast to attend the annual Embedded Systems Conference last week. It was the best ESC West in many years – more booths; larger booths; good floor traffic; interesting [...]]]></description>
			<content:encoded><![CDATA[<p><strong>Fearless and no longer loathing in San Jose (with apologies to the late Hunter Thompson)</strong></p>
<p> <img class="alignleft size-thumbnail wp-image-504" title="aim-high" src="http://www.embeddedmarketintelligence.com/wp-content/uploads/2010/04/aim-high1-150x150.jpg" alt="aim-high" width="150" height="150" /></p>
<p> </p>
<p>Dolores and I made our annual trip to the Left Coast to attend the annual Embedded Systems Conference last week. It was the best ESC West in many years – more booths; larger booths; good floor traffic; interesting announcements and new to embedded players.</p>
<p> </p>
<p>I’m not sure how Rich Nass does it – but the keynote speaker was again excellent. This time Michio Kaku, the co-founder of string theory and TV science presenter was the speaker and was charming, funny (but Seinfeld can breathe easy), informative and delightful. We joined the mass exodus to avoid the obligatory hour dedicated for the Microsoft Embedded Group (aka MS Purgatory – otherwise known as <em>We B Arrogant</em>). Granted that Microsoft contributes a lot of $$ to these very important events &#8211; for which I am grateful – but give me a friggin break MS, Windows 7 is not the promised land for the embedded world.</p>
<p> </p>
<p>This was the year that the chip companies made confessions of love to many OS companies. Freescale made announcements with such stalwarts as Green Hills, while Intel teamed with LynuxWorks for an ill chosen medical product. ARM was very impressive as was Microchip, while Xilinx ran away with the FPGA application announcements. Xilinx for the 7<sup>th</sup> consecutive year (by <a title="Embedded Market Forecasters" href="http://www.embeddedforecast.com" target="_self">EMF survey data</a>) was the most used FPGA in the embedded space (and had the best ROI).</p>
<p> </p>
<p>Green Hills also made a networking arrangement with Cavium (who recently acquired MontaVista and MV Linux) which caused us to ask if Dan O’Dowd (who has publicly claimed that anyone who used Linux was brain dead – or worse) had to be drugged or restrained to cut a deal with a Linux company. We checked the stock market for Prozac manufacturers to see if consumption was up in Santa Barbara. All chuckles aside – it was an excellent deal for Green Hills.</p>
<p> </p>
<p>It surprised and impressed us that Green Hills made behind the scenes moves that portend for significant growth and positioning against Wind River by hiring two individuals that bring another dimension to the competitive marketplace that will be to their advantage. Although I’m not obliged to keep such under wraps, I do respect the Green Hills folks and will keep these details to ourselves – other than to mention that they are the first of the usual suspects to clearly see the light.</p>
<p> <span id="more-492"></span></p>
<p>Also impressive was the traffic through the VersaLogic and Synopsys booths. Although Kontron had the large booth, VL garnered significant leads. Also the large Express Logic booth had standing room only for their presentations – recognition of how ThreadX continues to grow. Micrium, though having a smaller booth had significant traffic as well. This shows that the smaller OS companies are making progress against the larger incumbents.</p>
<p> </p>
<p>We were also impressed with our discussions with MontaVista. They had requested some specific questions be placed in the 2010 EMF Survey of Embedded Developers – questions that we didn’t clearly understand, but as we had the room for them we included such. They explained to us how these questions allowed them to quantify actual BOM costs for open source Linux and how this enhanced their market strategy. As they are the only commercial Linux company to provide a mid-development migration path for RYO Linux developers to roll into their MV6 product, we were delighted to learn how they used our data to arrive at their findings (we learn a lot from our subscribers).</p>
<p> </p>
<p>A year ago Glenn Perry was handed the reins of Mentor’s group from Neil Henderson. Glenn at that time laid out what we thought was an overly ambitious agenda – we were wrong. Although much of our discussions were for internal consumption only, we can tell you that they have made impressive gains and are on the verge of major gains.</p>
<p> </p>
<p>It is becoming clear that discretionary DoD funding levels are falling and OS companies have been running to the medical devices industry to compensate. As most companies are in love with their products and feel that they have the cure for the imaginary disease that they feel will cure and enhance the medical devices marketplace. Having built a number of medical device companies (taken two public) and having successfully filed a very large number of 510k applications, I found it interesting that no one wanted to listen to what we feel are the needs of medical device manufacturers and where the sales process differs from different verticals (most want to believe that medical and defense verticals have the same requirements).</p>
<p> </p>
<p>It is interesting to have discussions with companies (they know who they are and I won’t embarrass them) to learn how many hundreds-of-thousands of $$ they have wasted being off message on who they were targeting and what they were offering. For such brilliant folks, they forgot the basics of market intelligence.</p>
<p> </p>
<p>IBM Rational was in attendance and on-target and impressive as always. Artisan didn’t show with their MDD offering which was probably a good idea on their part. General Dorriot – the head of the original funding group of Digital Equipment Company – once wrote “bad ideas like dead horses should be buried with a minimum of ceremony”. Atego, the renamed Artisan group that includes Aonix, was represented by Gary Cato – a wonderful and incredibly patient and competent guy who made the rounds with spirit. As in the play Death of a Salesman, Gary is finding limited success notwithstanding that he’s firing at targets with limited ammunition. He has my vote as the most unsung hero at the show.</p>
<p>For those of our readers that are in or interested in the medical devices arena, EMF has produced a market brief, Critical Issues Confronting Medical Device Manufacturers – EMF Guide for Medical Device Developers</p>
<p><a href="http://www.embeddedforecast.com/emf-briefs.php">http://www.embeddedforecast.com/emf-briefs.php</a></p>
<h3><a href="http://www.embeddedforecast.com/emf-briefs.php"></a></h3>
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		<title>Medical Device Industry Redux: How Obama Care is penalizing the Industry</title>
		<link>http://www.embeddedmarketintelligence.com/2010/03/31/medical-device-industry-redux-how-obama-care-is-penalizing-the-industry/</link>
		<comments>http://www.embeddedmarketintelligence.com/2010/03/31/medical-device-industry-redux-how-obama-care-is-penalizing-the-industry/#comments</comments>
		<pubDate>Wed, 31 Mar 2010 20:44:54 +0000</pubDate>
		<dc:creator>Jerry Krasner</dc:creator>
				<category><![CDATA[Market Intelligence]]></category>
		<category><![CDATA[Medical]]></category>
		<category><![CDATA[Personal Views and Philosophy]]></category>

		<guid isPermaLink="false">http://www.embeddedmarketintelligence.com/?p=459</guid>
		<description><![CDATA[Massachusetts medical device companies are threatening to move their manufacturing and development facilities out of the US entirely. This is interesting given that our governor is a pal of the president. Our governor is “shocked” that hundreds of Massachusetts based life sciences companies would leave or export much of their business out of the country.]]></description>
			<content:encoded><![CDATA[<p><strong>Failure is an Option</strong> – what Joe Biden should have said instead of dropping the F-Bomb</p>
<p><img class="alignleft size-thumbnail wp-image-469" title="HealthCare2" src="http://www.embeddedmarketintelligence.com/wp-content/uploads/2010/03/HealthCare21-150x150.jpg" alt="HealthCare2" width="150" height="150" />A few months back I gleefully reported what the voters of Massachusetts did for the medical device industry by electing Scott Brown as our new Senator. The US Senate had cobbled together a poor Health Care Bill in order to send it onto the House of Representatives assured that the Republicans would not win Kennedy’s seat and gain the blocking vote. It was, by admission of many Democratic Senators, a terrible bill – but that it would be cleaned up in a House-Senate conference. </p>
<p>With Senator Brown finally seated it seemed to be a no-brainer that the Health Care Bill would have to be dropped or reconfigured as it would not stand a filibuster challenge.</p>
<p>I was one of those relieved given my concern for my beloved medical device industry which was going to be the scapegoat of the current administration and be severely taxed for no other reason than its name sounded a lot like the pharmaceutical industry. I felt that we had ducked a massive bullet.</p>
<p>The gross distortions in favor of forcing through the bill under Reconciliation were mind-numbing. How the public could be convinced that spending more than a trillion dollars would result in a “massive middle class tax reduction” and how could taking $500 billion out of Medicare “strengthen” it?</p>
<p>Here’s what has happened and what we might expect – how much more damage can Congress inflict before the November elections?</p>
<p><span id="more-459"></span>Companies small to larger have written down expected charges to their bottom lines in order to comply with Sarbanes Oxley accounting practices. Caterpillar has charged their books a billion dollars while AT&amp;T and other companies have taken write-downs in the range of $30 &#8211; $500 million. Of course Congress wants to interrogate their executives whose crime seems to be that they are complying with the laws set forth by Congress itself. Company executives could go to jail if they failed to disclose to investors how their expenses might change.</p>
<p>So the country is beginning to see the financial impact of Obama Care.</p>
<p>Massachusetts medical device companies are threatening to move their manufacturing and development facilities out of the US entirely. This is interesting given that our governor is a pal of the president. Our governor is <em>“shocked”</em> that hundreds of Massachusetts based life sciences companies would leave or export much of their business out of the country.</p>
<p>Of course he should be concerned – the medical industry is one of the few segments of the Massachusetts economy creating jobs. Thousands of Massachusetts jobs are at risk – and our federal and state elected officials seemed surprised. Go figure.</p>
<p>With many embedded vendors targeting the medical devices industry to hedge against expected A&amp;D cutbacks, the consequences of the Health Care legislation couldn’t have come at a worse time. The financial impact of this legislation requires massive tax increases to pay for it, so if one group is given a safe haven from this taxation then other segments will be harder hit in order to cover the revenue needs.</p>
<p>Also, should the Supreme Court find that the legislative requirement that all US citizens <em>must</em> purchase health care (how can interstate transport laws pertain to those that don’t chose to buy?) is unconstitutional, the current congressional membership will certainly impose additional taxes on those already hit hard – and that would mean <em>we</em> the members of the medical device industry. We can’t expect that the members of congress would change their minds regarding the legislation given the sleazy way they forced the legislation through.</p>
<p>Of course should the mid-term elections change the constituency of the House of Representatives, they could choose not to fund the Program.</p>
<p>What is happening here in Massachusetts is happening across America. And those of you either currently in the embedded medical device industry or hoping to find new markets herein should pay careful attention.</p>
<p>Notwithstanding our weak global economy, the mindless imposition of new taxes (and the anticipation of additional taxes that are unknown to us at this time) can not only set our economy back further, but is likely to gut the embedded market segment that has shown the greatest growth in revenue and employment year-over-year.</p>
<p>Massachusetts Senator Scott Brown, who has filed an amendment that would repeal the tax, wrote “with unemployment in my state near 10%, placing a tax on medical devices is the absolute last thing we should be doing right now”. Our governor responded by saying health care reform is “very good for the people of America and the people of the commonwealth.”</p>
<p>Good luck Scott – November is only 8 months away.</p>
<p>I wonder how Schwarzenegger in California (whose state is harder hit than Massachusetts) is taking all of this. He’s not a buddy of our prez which might be a good thing.</p>
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		<title>Forecast 2010: What Is in Store for Embedded Developers</title>
		<link>http://www.embeddedmarketintelligence.com/2009/12/02/forecast-2010-what-is-in-store-for-embedded-developers/</link>
		<comments>http://www.embeddedmarketintelligence.com/2009/12/02/forecast-2010-what-is-in-store-for-embedded-developers/#comments</comments>
		<pubDate>Wed, 02 Dec 2009 17:39:17 +0000</pubDate>
		<dc:creator>Jerry Krasner</dc:creator>
				<category><![CDATA[Best Practices]]></category>
		<category><![CDATA[Development Tools]]></category>
		<category><![CDATA[Market Intelligence]]></category>
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		<category><![CDATA[Medical]]></category>
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		<description><![CDATA[Taking a “dog’s-eye” view of what we might expect in 2010      The year 2010 is just around the corner, and we are doing what we do best &#8212; forecasting. After all it&#8217;s our name. But we aren&#8217;t just guessing &#8212; we base our forecasts on historical facts and data. For the past 12 [...]]]></description>
			<content:encoded><![CDATA[<p align="center"><strong>Taking a “dog’s-eye” view of what we might expect in 2010</strong></p>
<p><img class="alignleft size-full wp-image-246" title="Light at end of tunnel" src="http://www.embeddedmarketintelligence.com/wp-content/uploads/2009/12/Light-at-end-of-tunnel1.bmp" alt="Light at end of tunnel" /></p>
<p> </p>
<p> </p>
<p> The year 2010 is just around the corner, and we are doing what we do best &#8212; forecasting. After all it&#8217;s our name. But we aren&#8217;t just guessing &#8212; we base our forecasts on historical facts and data. For the past 12 years, we have been tracking what developers are doing, what tools, OSes and processes they are utilizing and what their design experiences have been. We also report on what issues trouble them the most.</p>
<p>Now we are preparing our 2010 detailed and comprehensive EMF Executive Survey of Embedded Developers and Managers. We will be inviting you to take the survey to see how you our “loyal readers” compare with the larger statistically based responses (please contact us at <a href="mailto:surveys@embeddedforecast.co">surveys@embeddedforecast.com</a> if you are willing to participate). Respondents who take the survey will receive a complimentary copy of our survey overview (a $399 value).</p>
<p><span id="more-232"></span></p>
<p>With our unique Executive Dashboard tool we are able to crosstab and simultaneously compare (for tools, programming languages, processors used in designs, etc.) “time to market” as well as “percentages of developments completed ahead of schedule/behind schedule/and cancelled”. We also know how close to pre-design expectations developer’s final design results compared.</p>
<p>We do this analysis for OSes (commercial and roll your own), IDEs, modeling tools, communication middleware, static analysis tools, requirements management/change management/validation tools, etc. The Dashboard allows vendors to compare the use of their products to those of their competitor’s – and it permits developer/managers to make design decisions predicated on the experiences of fellow developers.</p>
<p>Every year we speak with users and vendors to get their take on what they are expecting, and every year the survey results frequently surprise us – one and all.</p>
<p>Mark Twain wrote, <em>“it’s not what you don’t know that can come back to bite you; it’s what you know for sure that ain’t true”.</em> So we are not only challenging ourselves – but all who care to offer what they “know for sure” to speculate along with us.</p>
<p>Let’s first look at embedded markets – which ones we predict grow and which will suffer.</p>
<p><strong><em>Winners</em></strong></p>
<p><strong>Medical</strong></p>
<p>The medical device marketplace has been growing at a double digit rate – and new considerations should enhance opportunities for embedded vendors in 2010 – IF they take the time to correctly understand the selling points</p>
<ul>
<li>Considerable attention has been given to the medical marketplace by vendors seeking a safe haven from the expected decline in mil/aero. EMF believes that many such vendors don’t understand the market segment, how to sell to it, or what the users need and will purchase</li>
<li>It would be funny if it wasn’t sad that certain leading RTOS vendors are pushing their certified high power, mission critical OSes towards an industry that develops products whose defining frequency requirements are less than 100 Hz</li>
</ul>
<p>A Senate Bill cosponsored by Senators Edward Kennedy (D – MA) and Chuck Grassley (R– IA) was filed (Drug and Medical Device Accountability Act of 2009) that  would require senior officers or directors of drug and medical device companies to certify under penalty of perjury that all information submitted for a product’s approval is accurate and in compliance with federal regulations. Product applications later found to have contained false or misleading information would be subject to stiff fines (up to $5,000,000), assessed both to companies and their senior officers, who, in addition, could face jail sentences of up to 20 years.</p>
<p>EMF will soon publish a report presenting alternative paths for developers to produce quality software for medical devices, minimize product recalls, and affordably provide comprehensive audit trails for CDRH inspectors. EMF has identified 15 major best practices points which medical device developers can follow to align them with CDRH (Center for Devices and Radiological Health – FDA) suggestions. </p>
<p><strong>Consumer Devices and Products</strong></p>
<p>There are three segments of the consumer electronics marketplace that are experiencing significant growth. Moreover with “smart devices” that will interact with IT based data reservoirs, the future for embedded technologies will involve this segment. EMF expects this market segment to grow the fastest and achieve large revenues. </p>
<p>The three are:</p>
<ul>
<li>Consumer electronics including cell technologies and gaming devices</li>
<li>Home entertainment</li>
<li>Hand held devices</li>
</ul>
<p><strong>Industrial Automation (IA)</strong> </p>
<p>IA is highly fragmented yet growing in many segments. Industrial automation, industrial controls, robotic factories, and automated assembly/manufacturing have huge security needs, testing requirements and process controls.</p>
<p>IA has grown to be the largest among the emerging embedded market segments.</p>
<p><em><strong>Losers</strong> </em></p>
<p><strong>Telecom/Datacom</strong></p>
<ul>
<li>Verizon’s rural assets following their acquisition of Alltel and the required divestiture have been bought by smaller rural service providers who are under no pressure to offer advanced services or do any network build-out. This means that less network equipment will be purchased. Of the larger service providers, both Sprint-Nextel and Qwest continue to show weakness and financial difficulty. These circumstances will have a dampening effect on telecom opportunities</li>
<li>Wireless subscription growth has diminished as the market nears saturation. Approximately 89% of teenage and adult Americans have at least one cell phone. Wireless service providers have limited options and have found that customers are not likely to pay for new data services</li>
<li>China is restructuring and consolidating their telecom services from six providers to three full service carriers. They are trying to break the monopoly that China Mobile has had</li>
<li>Fewer buyers make the segment more competitive and harder to get design wins. This filters down to embedded vendors that supply the communications OEMs and systems integrators</li>
</ul>
<p><strong>Mil/Aero</strong></p>
<ul>
<li>The Aerospace and Defense Industries of the United States are poised to undergo one of the most significant changes since the end of the Cold War; perhaps the most significant since World War II. We believe that observers (embedded vendors included) who expect small changes are mistaken, thereby fostering a false and dangerous sense of security across much of the industry and government</li>
<li>The impact to our economy goes far beyond our current financial problems and involves fundamental structural changes taking place in the industry and in the market. As in prior shifts of this nature, there will be winners and losers – however these shifts may be profound, creating more dramatic winners and losers than in the last cycle</li>
<li>That the DoD will experience an 18% to 40% reduction in discretionary funding is a certainty. Such luminaries as Ken Krieg, former Deputy Secretary for Defense Acquisition, and Booze &amp; Company have affirmed this to be the case. The ripple down effect from Tier I primes to Tier III embedded suppliers will be severe</li>
<li>According to the Congressional Budget Office, the share of the US gross domestic product (GDP) allocated to defense spending declined from 5.6% in the 80’s to 3.8% in the 90’s and 3.1% in the new millennium. This is expected to become worse in the ensuing few years </li>
</ul>
<p><strong>Automotive</strong> </p>
<p>The government bail out of GM and Chrysler and the attendant end-of-life for many auto brands has been devastating to this market segment. Moreover, the efforts of the current administration to engineer the government takeover of these industries by imposing requirements created by inexperienced bureaucrats is setting back technological innovation and the acquisition of embedded technologies for many years to come</p>
<p><strong>What we learned in 2009 and what we might expect in 2010</strong> </p>
<p><strong>Operating systems</strong> </p>
<p>2009 saw the continued use of embedded OSes as ThreadX, Nucleus and Micrium. ThreadX continued (for the 4<sup>th</sup> consecutive year) to show the best time to market and percent of designs competed on or ahead of schedule for a commercial OS while MontaVista Linux had the best ROI for a commercial Linux product. All commercial Linux products outperformed free Linux offerings. </p>
<p>It became abundantly clear that the smaller OSes have a significant role to play – and are preferable to the high power OSes for many applications. Linux has become pervasive across many embedded verticals. </p>
<p>It will be interesting to see what the 2010 EMF Embedded Developer Survey will teach us. </p>
<p><strong>Chips</strong></p>
<p>That we are heading into a multicore world is a certainty – we expect the 2010 survey to show this trend. What multicore needs is better development and testing tools than what is currently available. FPGA use and FPGA technologies have advanced to the point that they are becoming preferred over DSPs and commercial chips for many applications. Long term programs that are commonly found in military systems deployments have a vested interest in processor availability. FPGA vendors won’t play the end-of-life game that the larger processor companies play. Xilinx continues (consistent with the preceding 5 years) their lead over Altera for embedded use.</p>
<p>In 2010 EMF added a list of multicore processors to examine which are preferred. It will be interesting to see if ARM continues to gain ground over Intel’s Atom.</p>
<p><strong>Modeling Tools</strong> </p>
<p>Simulation-modeling tools have enjoyed the greatest growth of any embedded tools. We expect to see this trend continue. EMF has posted for free download several papers showing the <a title="MDD White Paper" href="http://www.embeddedforecast.com/whitepapers.php " target="_blank">advantages of using model driven development (MDD)</a>.   </p>
<p>Rhapsody, now an IBM Rational tool, continues to find applications for complex designs. MDD is the only technology for effectively dealing with systems and systems-within-systems developments and maintenance.<strong> </strong></p>
<p><strong>Other Embedded Offerings</strong></p>
<p>The embedded industry has long had frugality – or the notion of a free lunch – as a strategic initiative. The fallacy herein is that the “total cost of ownership” has been ignored at the altar of acquisition costs. </p>
<p>Principal among this aspect of the embedded marketplace is that of embedded communications middleware. The use of roll your own (RYO) middleware consumes more than 50% of the marketplace – notwithstanding the lack of scalability, the large cost of managing and supporting deployed systems, and the unnecessary complexity of such systems.</p>
<p>It will be interesting to see if RTI again is shown to have the best design outcomes and if RTI and OIS continue to outperform RYO communication middleware developments. </p>
<p>It will be interesting to see whether the use of requirements management, change management and static analysis tools become more prevalent in embedded development. </p>
<p>Finally, we will see which development and management practices produce the best design outcomes; which interconnect technologies are used; which programming languages are used; and which tools are purchased and used and which have been purchase but NOT used.</p>
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