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What is Product Development?

February 21, 2012 By Leave a Comment

What is Product Development?   This is a question that has nagged at me since I started working for Creo Quality.  It certainly seems like something that I should know the answer to, since I am working for a company that deals in product development.  Alas, the answer had thus far eluded me.  So, I set out on a quest to determine for myself what Product Development actually was.  So far, I have talked to someone in the industry, checked out websites such as ehow.co and answers.com, and also looked at detailed papers that had been written by experts on the subject.  I learned about something called the Fuzzy Front End, and what the difference between is between breakthrough products as opposed to platform products and incremental products. I was surprised at the wealth of information that existed on the subject.

To start off, I asked Jon Speer, Creo Quality’s founder, a few key questions.  He spoke to me about the importance of planning and being able to define your objectives and have a process that is reproducible.  He also stressed that although planning is important, you don’t want to overplan and get caught up in the process of planning.  You must keep your objectives in mind and remember that every project has a beginning, middle, and end.

One of the papers I read was by Kenneth Crow and reiterated most of what Jon said and, like Jon, stressed the importance of the process being repeatable. An interesting point that he made was that the typical duration of most projects “range from six months to six years. As a result, development personnel don’t have the opportunity to learn from and to refine the development process through repeated use on an individual basis. With the rapid pace of technology evolution, the hiring of many young engineers in some industries, high turn-over rates, it is not unusual to see development personnel with keys roles in a development project, but who have not gone through a full development cycle on a prior project within their companies. In short, many development personnel have little understanding of or practical experience with any standard product development process in their companies”.  He uses this concept as one of the reasons the process must be reproducible. “The process must be characterized and documented. Unless it is, it will be difficult to assure understanding and agreement on what the process in fact is, difficult for all development personnel to understand the process in a consistent manner, and difficult to communicate that process to new personnel.”

I plan on continuing my search for the meaning of Product Development.  In future blogs, I will share with you what I have learned.  If you know any good sources of information, please feel free to contact me and share that knowledge with me.  This Product Development newbie could use all the help she can get.

 

 

Filed Under: All, Product Development - General Tagged With: , ,

FDA, What Exactly Are Your Plans?

February 20, 2012 By Leave a Comment

I have been reading about the FDA launching its Strategic Priorities for the CDRH for 2012. Here are the highpoints of the Priorities:

  1. Fully Implement a Total Product Life Cycle Approach
  2. Enhance Communication and Transparency
  3. Strengthen Its Workforce and Workplace
  4. Proactively Facilitate Innovation to Address Unmet Public Health Needs

At first glance they all seem to make sense.  As someone who is new to the workings of the FDA, my plan was to read the document over and not make any judgments, as I really lack the wisdom or knowhow on the subject to assume to criticize.  However, as I read through the document, it seemed to me that most of the goals under each Strategic priority are fairly ambiguous.  There was a lot of “improve” this, “develop” that, “implement a plan”, or “take steps towards”, which doesn’t clarify in any detail what is actually to be done.

I used to do a lot of work with the Dale Carnegie program.  One of Mr. Carnegie’s rules for goal setting was that the goal had to be specific, measureable, and attainable.  Although precise dates are mentioned for each goal in the CDRH’s plan, it seemed to me that there isn’t enough detail in the goals themselves to be able to measure if anything has actually been accomplished.

Again, this is just my first impression of something that I know little about, so take it for what you will. I applaud the FDA for its effort and hope that perhaps internally they do have the specifics in place.  In the meantime I will implement a plan for improving my attitude and take steps towards learning more about the FDA so that I will develop a better understanding of this organization- how’s that for a specific goal?

 

Filed Under: All, Medical Device - General, Product Development - General Tagged With: , , ,

February 22, 2012- Life Science PM Public Meeting

February 18, 2012 By Leave a Comment

 Life Science PM Public Meeting

Wednesday February 22nd, 2011 5pm – 7pm

Where

 351 W Tenth St.

Indianapolis, IN 46202

Risk Management with External Stakeholders –

Conversations on both sides of the partnership

Please join us for the LSPM February meeting.

Guest speaker Jenny Vessels, Owner/Consultant of

the Learning Purpose, LLC will discuss how to plan

for the worst and how to manage difficult

conversations when things don’t go as planned.

RSVP to

http://lspmfeb2012.eventbrite.com 

For questions, please contact Lou Begnel at lbegnel@gmail.com

or 317-332-9986

 

 

 

 

 

 

 

 

Filed Under: All, Events

Medical Device Companies Raising Prices to Offset Taxes

February 17, 2012 By Leave a Comment

MassDevice reports that many medical device executives surveyed indicated that they would be increasing prices of their products to offset the impending 2.3% medical device tax.

It was bound to happen.

I hear through the grapevine that the debate on the medical device tax is far from over.

Filed Under: All, Medical Device - General Tagged With: , , ,

Have You Checked Out Creo Quality on YouTube?

February 16, 2012 By Leave a Comment

I’ve noticed the power of video from our monthly email communications. We’re making an effort to include videos more often. In fact, in 2012, we have started providing monthly updates on CQ projects and activities. Be sure to check out the February 2012 update–lots of exciting projects!

Of course, we have plenty of other videos on Creo Quality’s YouTube channel. I hope you find something of value.

If you would like to be added to our email list, simply sign up. All we need is your name, email, and company.

Filed Under: All, Catalyst Tagged With: , ,

Acting More Like A Start-Up

February 15, 2012 By Leave a Comment

February 9, 2012 Dilbert:

The Official Dilbert Website featuring Scott Adams Dilbert strips, animations and more

 

Filed Under: All, Misc

Upcoming Business Plan Competitions

February 15, 2012 By Leave a Comment

2012 Propel Business Plan Competition (from iBio)

The fourth annual PROPEL Business Plan Competition at iBIO IndEx will highlight the many formation-stage and
early-stage life sciences companies of Illinois and the surrounding Midwest. Applicants for this highly selective
entrepreneurial competition will compete for a $10,000 cash award.

Timeline:

  • 3/12/2012 – Application Deadline
  • 4/5/2012 – Announcement & Notification of Finalists
  • 4/26/2012 – Finals at iBio IndEx

Taylor University Business Plan Competition (Upland, IN)

Any individual or group with a fundable business concept is eligible to compete under the following requirements:

A. The business is a legitimate start-up with no venture capital financing

  1. Individuals or team members that have received any form of venture capital financing for their Taylor University Business Plan or a likeness thereof may not participate in the competition
  2. Note that teams with seed financing from non-venture capital sources totaling less than $75,000 may compete
  3. Any team that receives seed financing from non-venture capital sources totaling more than $75,000 at any time during the competition will be disqualified
  4. The amount and source of secured capital arrangements should be clearly identified in the executive summary

B. A top three place finisher from the previous year is not eligible to compete.

C.Business operations of  the business concept is preferably intended for implementation along the I-69 corridor generally defined as between northern Indianapolis and southern Ft. Wayne but at a minimum must be committed to the State of Indiana.

D.The proposed business concept should not be in violation of any intellectual property rights

E. Each entrant and/or team member must sign the Agreement of Understanding.

Timeline:

  • 3/5/2012 Overview / Executive Summary Due
  • 3/12/2012 Semi-finalists Announced
  • 4/10/2012 Business Plan Due
  • 4/25/2012 Finalists Announced
  • 5/10/2012 Presentations & Awards
Filed Under: All, start-up Tagged With: , , , , , ,

Camp Out with Your Customers to Get Ideas

February 15, 2012 By Leave a Comment

How do you come up with inspiration when it comes to medical device product development? Robert G. Cooper and Angelika Dreher wrote an interesting article dealing with the concept of Voice of Customer (VoC) Ideas for idea generation.  One of the techniques they discuss is ethnographic research. Ethnography involves “camping out” with customers or observing customers for extended periods, and watching and probing as they use or misuse products.

An example cited in the article is about a company who makes breathalyzer testing devices used by police forces in the U.K.  A team from the company actually accompanied police officers on their night-time roadside spot checks and discovered some interesting leads to new product development that might have been missed otherwise.  For example, it was determined that the two minute wait time for the breathalyzer to process was resulting in officers being overwhelmed when more than one vehicle was pulled over at a time because carfuls of possibly intoxicated people were forced to wait while the breathalyzer was being used on another car. This put the officers in a potentially dangerous situation. So, the company developed a new breathalyzer with only a 10 second wait time. It was also discovered that because of the dials, the current version of the device could only be used with the right-side drivers in the U.K. Thus, when a left-hand-side driver from France or Germany was pulled over in the U.K., the police could not conduct the test quite as quickly. Because of time pressures, the officers had no option but to simply wave the car through. Therefore, an ambidextrous test instrument was developed. These and several other changes based on observations made in the field made for a new device that delighted police forces.

The article states that “Ethnography provides perhaps the greatest insights into users’ unmet and unarticulated needs, applications and problems.”

When trying to come up with new ideas, perhaps you should get down in the trenches with your customer in order to discover what their needs really are.  Maybe you will come across something you never even considered before.

Filed Under: Events, Medical Device - General Tagged With: , , , , ,

Who Needs Human Interaction, Anyway?

February 13, 2012 By Leave a Comment

“Can Texting Keep Teens From Becoming Depressed?”  This title caught my eye.

Researchers at the University of Auckland in New Zealand used these concepts to develop and test an intervention for adolescents focused on preventing depression.  The intervention was designed around 15 key messages derived from cognitive behavior therapy.  These positive and encouraging messages were delivered automatically via mobile phones twice daily for 9 weeks by means of text, video, cartoons, and mobile website.  Two types of controls were used, including a control program with the same number and types of messages on varying topics and a randomized controlled trial performed in surrounding high schools of the Auckland, New Zealand area.

The study concluded that key messages from cognitive behavioral therapy can indeed be effectively delivered by mobile phone, and young people reported that they found this to be helpful.

I’ve blogged about smart phones being capable of inferring user emotion.  Then there were the apps that help you to work through your phobias.  Here is yet another example of how smartphones are replacing basic human interaction when it comes to our emotional issues. Are we that self-absorbed that we don’t want to take the time to interact with our children ourselves and instead would prefer to entrust their well-being to a mechanical device?

Filed Under: All, Medical Device - General Tagged With: ,

Cockroaches Produce Electricity

February 9, 2012 By Leave a Comment

Researchers at Case Western Reserve University managed to generate electricity from naturally occurring chemicals within the abdomen of the false death’s head cockroach. How does this help us, you might ask?  The thought is that if we can learn to harvest energy from within the human body, we may spur the development of a new generation of implantable devices that can work as long as the patient is alive, and therefore producing electricity, without requiring bulky batteries, a typical stumbling block for biomedical engineers.

I’m all for advances in technology, but I can’t seem to wrap my mind around this one.  Part of the problem is probably that I am a cockroachaphobe.  I don’t mind most bugs (except spiders), but I am having troubles getting over the fact that I find cockroaches creepy, ugly, and disgusting. Why couldn’t a cute bug, like a lady bug, have chemicals capable of producing electricity in its belly?

 

Filed Under: All, Medical Device - General Tagged With: , , , ,
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