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	<title>Creo Quality: Catalyst. Connect. Create.</title>
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	<link>http://www.creoquality.com</link>
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		<title>Medical Device Product Development Is A Linear Process</title>
		<link>http://www.creoquality.com/2013/05/medical-device-product-development-is-a-linear-process/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=medical-device-product-development-is-a-linear-process</link>
		<comments>http://www.creoquality.com/2013/05/medical-device-product-development-is-a-linear-process/#comments</comments>
		<pubDate>Thu, 16 May 2013 12:37:20 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Ask CQ]]></category>
		<category><![CDATA[Design Control]]></category>
		<category><![CDATA[Project Management]]></category>
		<category><![CDATA[Project Phases]]></category>
		<category><![CDATA[Strategy vs. Tactics]]></category>
		<category><![CDATA[medical device]]></category>
		<category><![CDATA[procedure]]></category>
		<category><![CDATA[product development]]></category>
		<category><![CDATA[project phases]]></category>
		<category><![CDATA[stage gate]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5663</guid>
		<description><![CDATA[If you believe this title, you have not worked on many medical device product development projects. But interestingly, FDA design control regulations and ISO 13485 design &#38; development requirements convey the process as a linear progression. And most every product development and design control procedures I&#8217;ve read (and written) also lay out medical device product [...]]]></description>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Time to Play Design Control Catch Up</title>
		<link>http://www.creoquality.com/2013/05/time-to-play-design-control-catch-up/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=time-to-play-design-control-catch-up</link>
		<comments>http://www.creoquality.com/2013/05/time-to-play-design-control-catch-up/#comments</comments>
		<pubDate>Tue, 14 May 2013 12:25:22 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Ask CQ]]></category>
		<category><![CDATA[Design Control]]></category>
		<category><![CDATA[Project Management]]></category>
		<category><![CDATA[Project Phases]]></category>
		<category><![CDATA[start-up]]></category>
		<category><![CDATA[820.30]]></category>
		<category><![CDATA[FDA Design Control]]></category>
		<category><![CDATA[medical device]]></category>
		<category><![CDATA[product development]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5661</guid>
		<description><![CDATA[I&#8217;ve written plenty of design control procedures. I understand FDA design control regulations very well. I&#8217;ve trained dozens of engineers and medical device professionals on the &#8220;rules&#8221; of design control. When to document, how to document, why to document. And now I&#8217;m up to my eyeballs on a startup medical device product development project realizing [...]]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/05/time-to-play-design-control-catch-up/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>How Hard Is It To Tell Me How Much?</title>
		<link>http://www.creoquality.com/2013/05/how-hard-is-it-to-tell-me-how-much/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=how-hard-is-it-to-tell-me-how-much</link>
		<comments>http://www.creoquality.com/2013/05/how-hard-is-it-to-tell-me-how-much/#comments</comments>
		<pubDate>Tue, 07 May 2013 12:39:35 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Ask CQ]]></category>
		<category><![CDATA[Project Management]]></category>
		<category><![CDATA[start-up]]></category>
		<category><![CDATA[medical device project development]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5652</guid>
		<description><![CDATA[If you ask me how much it will cost to develop a FDA compliant quality system, I can tell you. If you ask me how much it will cost to manage a medical device product development project, I can tell you. So why is it so difficult for other medical device service providers to provide [...]]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/05/how-hard-is-it-to-tell-me-how-much/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Most Project Management Tools Suck</title>
		<link>http://www.creoquality.com/2013/05/most-project-management-tools-suck/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=most-project-management-tools-suck</link>
		<comments>http://www.creoquality.com/2013/05/most-project-management-tools-suck/#comments</comments>
		<pubDate>Mon, 06 May 2013 12:29:01 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Project Management]]></category>
		<category><![CDATA[MS Project]]></category>
		<category><![CDATA[Smartshet]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5649</guid>
		<description><![CDATA[I recently read Steve Vinson&#8217;s post &#8220;I hate MS Project&#8221; and kind of have to agree. Here are a couple of my reasons: It&#8217;s kind of expensive I&#8217;ve never worked on a project where every team member had access to MS Project Saving files as PDFs and other non-MS Project formats is kind of a [...]]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/05/most-project-management-tools-suck/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Project Management Requires Zero Complaceny</title>
		<link>http://www.creoquality.com/2013/05/project-management-requires-zero-complaceny/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=project-management-requires-zero-complaceny</link>
		<comments>http://www.creoquality.com/2013/05/project-management-requires-zero-complaceny/#comments</comments>
		<pubDate>Wed, 01 May 2013 12:44:06 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Ask CQ]]></category>
		<category><![CDATA[Project Management]]></category>
		<category><![CDATA[product development]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5647</guid>
		<description><![CDATA[A project manager should never get too comfortable and complacent. The moment you do, your project has more than likely veered off track somewhere. And even if you are completely engaged, a little bit paranoid, and on top of things, your project will more than likely encounter plenty of obstacles. Don&#8217;t let comfort settle in [...]]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/05/project-management-requires-zero-complaceny/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Medical Device Prototyping &#8211; A Sometimes Viscous Cycle</title>
		<link>http://www.creoquality.com/2013/04/medical-device-prototyping-a-sometimes-viscous-cycle/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=medical-device-prototyping-a-sometimes-viscous-cycle</link>
		<comments>http://www.creoquality.com/2013/04/medical-device-prototyping-a-sometimes-viscous-cycle/#comments</comments>
		<pubDate>Tue, 30 Apr 2013 11:49:53 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Medical Device - General]]></category>
		<category><![CDATA[Product Development - General]]></category>
		<category><![CDATA[start-up]]></category>
		<category><![CDATA[3D prototype]]></category>
		<category><![CDATA[medical device]]></category>
		<category><![CDATA[product development]]></category>
		<category><![CDATA[Project Management]]></category>
		<category><![CDATA[Proof of concept]]></category>
		<category><![CDATA[prototype]]></category>
		<category><![CDATA[prototyping]]></category>
		<category><![CDATA[SLA]]></category>
		<category><![CDATA[stereolithography]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5644</guid>
		<description><![CDATA[I&#8217;ve talked quite a bit about the importance of prototyping in the past. I&#8217;m really appreciating the value of having (or not having) a prototype with the current medical device startup I&#8217;m working with. And let me say, that while having a prototype is very useful, having a prototype that is the wrong dimensions may [...]]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/04/medical-device-prototyping-a-sometimes-viscous-cycle/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Lack of Communication Leads to Project Death</title>
		<link>http://www.creoquality.com/2013/04/lack-of-communication-leads-to-project-death/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=lack-of-communication-leads-to-project-death</link>
		<comments>http://www.creoquality.com/2013/04/lack-of-communication-leads-to-project-death/#comments</comments>
		<pubDate>Wed, 24 Apr 2013 12:25:08 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Ask CQ]]></category>
		<category><![CDATA[Product Development - General]]></category>
		<category><![CDATA[Project Management]]></category>
		<category><![CDATA[communication]]></category>
		<category><![CDATA[product development]]></category>
		<category><![CDATA[Project manager]]></category>
		<category><![CDATA[project mangement]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5639</guid>
		<description><![CDATA[Communication is so critical to medical device product development. http://www.youtube.com/watch?v=AbIk7I4qyGk Communicate early. Communicate often.]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/04/lack-of-communication-leads-to-project-death/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>But My Project Team Won&#8217;t Talk to Me</title>
		<link>http://www.creoquality.com/2013/04/but-my-project-team-wont-talk-to-me/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=but-my-project-team-wont-talk-to-me</link>
		<comments>http://www.creoquality.com/2013/04/but-my-project-team-wont-talk-to-me/#comments</comments>
		<pubDate>Tue, 23 Apr 2013 11:16:10 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Project Management]]></category>
		<category><![CDATA[communication]]></category>
		<category><![CDATA[product development]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5636</guid>
		<description><![CDATA[Last week I was told by a project team member that I would receive a certain work product by yesterday. It didn&#8217;t happen. Friday, I was told by a team member that some minor updates were necessary and be ready by the end of the day. It didn&#8217;t happen. Yesterday, I called each individual team [...]]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/04/but-my-project-team-wont-talk-to-me/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Indiana Life Science Entrepreneur to Present at April INpact</title>
		<link>http://www.creoquality.com/2013/04/indiana-life-science-entrepreneur-to-present-at-april-inpact/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=indiana-life-science-entrepreneur-to-present-at-april-inpact</link>
		<comments>http://www.creoquality.com/2013/04/indiana-life-science-entrepreneur-to-present-at-april-inpact/#comments</comments>
		<pubDate>Fri, 19 Apr 2013 11:07:25 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Events]]></category>
		<category><![CDATA[Indiana Life Sciences]]></category>
		<category><![CDATA[inpact]]></category>
		<category><![CDATA[indiana]]></category>
		<category><![CDATA[life science]]></category>
		<category><![CDATA[medical device]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5618</guid>
		<description><![CDATA[Indiana has a rich presence of medical device, pharmaceutical, and other life science companies. There is also a surprising number of startups and entrepreneurs in this space. On April 25, 2013, Catherine Tanner, one of Indiana&#8217;s life science entrepreneurs, will share her story with INpact, a medical device networking group. Be sure to RSVP.]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/04/indiana-life-science-entrepreneur-to-present-at-april-inpact/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Product Development Happens Because of Teamwork</title>
		<link>http://www.creoquality.com/2013/04/product-development-happens-because-of-teamwork/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=product-development-happens-because-of-teamwork</link>
		<comments>http://www.creoquality.com/2013/04/product-development-happens-because-of-teamwork/#comments</comments>
		<pubDate>Tue, 16 Apr 2013 11:41:46 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Ask CQ]]></category>
		<category><![CDATA[Product Development - General]]></category>
		<category><![CDATA[Project Management]]></category>
		<category><![CDATA[medical device]]></category>
		<category><![CDATA[Planning]]></category>
		<category><![CDATA[product development]]></category>
		<category><![CDATA[project team]]></category>
		<category><![CDATA[startup]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5616</guid>
		<description><![CDATA[Okay, the title does sound a little cliche. But it really is true. As you might know based on recent posts, I&#8217;m neck deep engaged as project manager for a medical device startup. In the ~5 months since the project was initiated, it has felt like two completely different projects. This can be partially explained because [...]]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/04/product-development-happens-because-of-teamwork/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Ah, Medical Device Project Management</title>
		<link>http://www.creoquality.com/2013/04/ah-medical-device-project-management/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=ah-medical-device-project-management</link>
		<comments>http://www.creoquality.com/2013/04/ah-medical-device-project-management/#comments</comments>
		<pubDate>Wed, 10 Apr 2013 11:47:54 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Medical Device - General]]></category>
		<category><![CDATA[Product Development - General]]></category>
		<category><![CDATA[Project Management]]></category>
		<category><![CDATA[medical device]]></category>
		<category><![CDATA[product development]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5597</guid>
		<description><![CDATA[While updating project management activities for a medical device startup and updating blog posts, I decided to reflect back on past posts on the topic. What kind of medicine did I prescribe? And, am I taking any of it or ignoring the advice? Here are some posts on the topic of medical device project management: [...]]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/04/ah-medical-device-project-management/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>There Is A Plan. I Promise.</title>
		<link>http://www.creoquality.com/2013/04/there-is-a-plan-i-promise/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=there-is-a-plan-i-promise</link>
		<comments>http://www.creoquality.com/2013/04/there-is-a-plan-i-promise/#comments</comments>
		<pubDate>Tue, 09 Apr 2013 12:36:51 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Ask CQ]]></category>
		<category><![CDATA[Medical Device - General]]></category>
		<category><![CDATA[Planning]]></category>
		<category><![CDATA[Project Management]]></category>
		<category><![CDATA[medical device]]></category>
		<category><![CDATA[product development]]></category>
		<category><![CDATA[startup]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5593</guid>
		<description><![CDATA[The last few weeks have been a little stressful and hectic. Yes, I&#8217;ve felt the pressure as a project manager for a medical device startup. Our efforts had been stalled for too long yet started to make some real progress a couple weeks ago. Right now, it feels like chaos. Organized chaos, maybe. There are [...]]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/04/there-is-a-plan-i-promise/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Medical Device Product Development Is Like Going to the Eye Doctor</title>
		<link>http://www.creoquality.com/2013/04/medical-device-product-development-is-like-going-to-the-eye-doctor/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=medical-device-product-development-is-like-going-to-the-eye-doctor</link>
		<comments>http://www.creoquality.com/2013/04/medical-device-product-development-is-like-going-to-the-eye-doctor/#comments</comments>
		<pubDate>Thu, 04 Apr 2013 12:37:07 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Ask CQ]]></category>
		<category><![CDATA[Medical Device - General]]></category>
		<category><![CDATA[Product Development - General]]></category>
		<category><![CDATA[start-up]]></category>
		<category><![CDATA[industrial design]]></category>
		<category><![CDATA[medical device]]></category>
		<category><![CDATA[product development]]></category>
		<category><![CDATA[startup]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5588</guid>
		<description><![CDATA[Have you ever been to the optometrist for an eye exam and been posed with the question which is better? Then the optometrist flips a lens or two while you stare at an eye chart. Sometimes the letters get clearer, other times blurrier. My latest medical device product development adventure feels sort of like an eye [...]]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/04/medical-device-product-development-is-like-going-to-the-eye-doctor/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>CQ Secret Weapon</title>
		<link>http://www.creoquality.com/2013/04/cq-secret-weapon/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=cq-secret-weapon</link>
		<comments>http://www.creoquality.com/2013/04/cq-secret-weapon/#comments</comments>
		<pubDate>Tue, 02 Apr 2013 12:18:11 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Misc]]></category>
		<category><![CDATA[creo quality]]></category>
		<category><![CDATA[medical device]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5549</guid>
		<description><![CDATA[Okay, I think it&#8217;s time to let you all know about a secret weapon at Creo Quality. Her name is Amanda Britton, and she&#8217;s been part of the CQ team now for three years. For most of this time, Amanda has assisted with bookkeeping and website updates. It became clear to me that her understanding [...]]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/04/cq-secret-weapon/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Medical Device Product Development &#8211; Keep It Simple</title>
		<link>http://www.creoquality.com/2013/04/medical-device-product-development-keep-it-simple/#utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=medical-device-product-development-keep-it-simple</link>
		<comments>http://www.creoquality.com/2013/04/medical-device-product-development-keep-it-simple/#comments</comments>
		<pubDate>Mon, 01 Apr 2013 12:18:08 +0000</pubDate>
		<dc:creator>Jon Speer</dc:creator>
				<category><![CDATA[All]]></category>
		<category><![CDATA[Medical Device - General]]></category>
		<category><![CDATA[Product Development - General]]></category>
		<category><![CDATA[Project Management]]></category>
		<category><![CDATA[Little Devices Group]]></category>
		<category><![CDATA[medical device]]></category>
		<category><![CDATA[product development]]></category>
		<category><![CDATA[Shift Labs]]></category>

		<guid isPermaLink="false">http://www.creoquality.com/?p=5540</guid>
		<description><![CDATA[Is it possible for medical device product development to be simple? Remember this post from a couple months ago sharing efforts from Shift Labs and the Little Devices Group? Each of these groups are good examples of trying to keep it simple. We are involved with a project that on the surface looked to be [...]]]></description>
		<wfw:commentRss>http://www.creoquality.com/2013/04/medical-device-product-development-keep-it-simple/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
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