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Big Ideas Winner Starts Her Own Company

May 2, 2011 By Leave a Comment

As Big Ideas rolls around again this year, we thought we would update you on some of the winners from last year.  Jennifer Blankenship, our second place winner, was inspired to start her own company.  Here is an excerpt from her marketing flyer:

“In the competitive market of rural nonprofit social services and nonprofits engaging in effective development, grant writing, and program delivering can be exhausting.  MAE is here to help!  We can deliver the FAMILY EFFECTIVENESS TRAINING program, GED tutoring, and Self-sufficiency skills building (including employability skills building) that your clients need.  For help with time consuming development projects we are able to offer proven and experienced contracting to get the job done and bring in the dollars to keep your great programs on track.”

When asked about her experiences with Big Ideas and her impressions of the contest, Jennifer stated, “The contest gives people the support from the community that makes a big difference in taking a risk in business.  Knowing that people are hoping that there will be businesses started up and supporting that with dollars is a big incentive to overcome the fear of the mountain of work that can come with making an idea a reality.”

Way to go Jennifer!  What a great example of the entrepreneurial spirit that Big Ideas is attempting to encourage.

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September 22, 2010 – Your Medical Device Software May Be at Risk

September 20, 2010 By Leave a Comment

Complying with the IEC 62304 standard for medical device software requires an established software lifecycle process that includes strong support for risk management and safety assessment. However, IEC 62304 compliance does not need to slow down your medical device software development.

By applying best practices guidance and process automation, medical device companies can reap the benefits:

  • Get through regulatory approvals faster
  • Lower costs
  • Deliver safer devices

Join Dr. David Vogel, founder and president of Intertech Engineering Associates Inc., and Martin Bakal, Market Manager, IBM, at this Webcast to gain a better understanding of this standard and how best of breed tools help tie IEC 62304 into the development process.

Web event: How to Achieve Compliance with IEC 62304 for Medical Device Software Development
Date: September 22, 2010
Time: 10:00 AM PDT
Duration: 60-minutes

Panelists for the Webcast include:

Dr. David Vogel, Founder and President, Intertech Engineering Associates Inc

Martin Bakal, Market Manager, IBM

REGISTER TODAY!

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Do You Understand Your Sales Process?

September 10, 2010 By Leave a Comment

Understanding my sales process has been a long and difficult process. Okay, maybe I still don’t understand it, but I know more today than when I started Creo Quality a few years ago. Here are some things I’ve learned:

  • The sales cycle for Creo Quality services is way longer than I would like. The cycle is at least 6 months and in most cases 12+ months. This means I needed to meet prospects 12 – 18 months ago for business today.
  • It’s worth the risk to approach medical device start-ups who don’t have funding today for the chance that they get funding down the road.
  • Don’t sell services that don’t fit the Creo Quality niche. And I have almost committed this mistake several times in the past 18 months, as recently as last week.
  • Find the pain of the prospect / customer as quickly as possible. And realize what the customer / prospect identifies as their pain is seldom the true source.
  • Sometimes it is better to walk away, even if the customer needs fit our niche.
  • The relationship with the customer almost always peaks at the beginning of the relationship.

So many businesses truly understand their sales process. Most don’t have a process either. Do you understand your sales process?

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INpact Virtual Approach to Daraza Project

August 23, 2010 By Leave a Comment

Daraza process January 2007 – December 2008:

Daraza launches the process be developing the FluoreCam proof-of-concept prototype.

January – April 2009:

Daraza has a functional prototype in hand and recruits Priio to develop additional features to make device more usable. Lebanon-based Online Resources, Inc. assisted Priio in this.

April – October 2009:

Daraza works with RND Group, Inc. to develop the software application for FluoreCam.

October – November 2009:

Daraza brings in Creo Quality, LLC to do the FDA submission work on the project.

April 2010:

Daraza received FDA approval and set launch for device for October 2010. The device will be marketed to dentists for about $5000.

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June 14-15, 2010 – Overview Of FDA Regulatory Compliance For Med Devices

May 14, 2010 By Leave a Comment

Overview Of FDA Regulatory Compliance For Medical Devices

Who Should Attend
This course was developed for those who are involved with ensuring regulatory compliance for medical devices.  Typical attendees include those in:

  • Manufacturing
  • Regulatory Affairs
  • Product Design
  • Research and Development
  • Quality Assurance & Control
  • Development and Preparation of Submission Material
  • Laboratory Operations

This course is designed for individuals who require in-depth knowledge of regulatory affairs and compliance issues.  The course content is continually updated by our expert Course Directors.  When delivered as an in-house program, this course is fully customizable to meet the specific needs of an organization, department or employees functional responsibility.

Learning Objectives

This course is specifically focused on the law, regulations and policies set down by the FDA for the manufacture of medical devices.  It will provide each attendee with the background and knowledge necessary to understand the organization, structure and role of the FDA as it relates to pre-marketing approval processes and compliance issues for medical devices.  The course content is designed to provide an in-depth understanding of the paths to obtaining agency approval, how the FDA performs inspections, the type of information they are looking to see in place and the variety of outcomes from each inspection.  The course also covers the remedies available to satisfy inspectors that manufacturing processes are fully in compliance with quality system requirements.

Get more info.

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Pitching Your Start-Up

May 6, 2010 By Leave a Comment

Here are five rules, according to Bill Bartman, for pitching your start-up to investors:

  1. Respect time – be on time and keep your pitch to the allotted time.
  2. Don’t tell them how your product will revolutionize their business – let them decide.
  3. Stick to the facts in your pitch.
  4. Take notes – don’t make the investors repeat themselves.
  5. Anticipate their needs – leave-behind a well-organized document summarizing your presentation.

Keep these tips in mind next time you plan on presenting your ideas to investors. And if you need more help preparing or finding VCs to work with, we can help.

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May 26-28, 2010 – Process Validation for Medical Devices

April 26, 2010 By Leave a Comment

Process Validation for Medical Devices

Who Should Attend

This course is targeted to professionals directly involved in meeting the FDA’s Quality System validation requirements such as those in regulatory affairs, quality assurance, process development or manufacturing. To maximize the peer learning opportunity, this course is recommended for those who may have a basic understanding of the Quality System Regulation (QSR), including direct work experience.

This course provides regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA’s Quality System Regulation while offering information on how to implement an effective validation program.  The course is also intended for Medical Device professionals who are responsible for performing process validation studies and ensuring compliance with regulatory requirements for validation documentation.

Learning Objectives

The purpose of this course is to provide an introduction to the fundamentals of process validation, explaining how, when, where and why you should validate. Learn how to comply with FDA regulations for validation protocols and determine the format and function of such protocols. Addressed is how to maintain adequate validation documentation systems and perform equipment qualifications, process and software validations, and evaluate the need for re-validations.

Register here.

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May 24-26, 2010 – 16th MDMA Annual Meeting

April 24, 2010 By Leave a Comment

16th MDMA Annual Meeting

Mon, 05/24/2010 – 6:00pm to Wed, 05/26/2010 – 2:00pm

Register Now

Park Hyatt
Washington, DC
May 24-26, 2010

The Medical Device Manufacturers Association (MDMA) is the consistent voice representing the entrepreneurial, innovative medical technology industry. The 16th MDMA Annual Meeting will provide an opportunity for members and non members to hear and discuss some of the most critical issues of concern to device manufacturers within the current legislative and regulatory environment.

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May 24-25, 2010 – Overview of FDA Regulatory Compliance For Med Devices

April 24, 2010 By Leave a Comment

Overview Of FDA Regulatory Compliance For Medical Devices

Who Should Attend
This course was developed for those who are involved with ensuring regulatory compliance for medical devices.  Typical attendees include those in:

  • Manufacturing
  • Regulatory Affairs
  • Product Design
  • Research and Development
  • Quality Assurance & Control
  • Development and Preparation of Submission Material
  • Laboratory Operations

This course is designed for individuals who require in-depth knowledge of regulatory affairs and compliance issues.  The course content is continually updated by our expert Course Directors.  When delivered as an in-house program, this course is fully customizable to meet the specific needs of an organization, department or employees functional responsibility.

Learning Objectives

This course is specifically focused on the law, regulations and policies set down by the FDA for the manufacture of medical devices.  It will provide each attendee with the background and knowledge necessary to understand the organization, structure and role of the FDA as it relates to pre-marketing approval processes and compliance issues for medical devices.  The course content is designed to provide an in-depth understanding of the paths to obtaining agency approval, how the FDA performs inspections, the type of information they are looking to see in place and the variety of outcomes from each inspection.  The course also covers the remedies available to satisfy inspectors that manufacturing processes are fully in compliance with quality system requirements.

Get more info.

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April 29, 2010 – Advertising & Promoting Medical Devices in Today’s Regulatory Environment

April 20, 2010 By Leave a Comment

Advertising & Promoting Medical Devices in Today’s Regulatory Environment

Thu Apr 29, 2010 11:30 AM
Location: Montage, Indianapolis
Fees: $85 members / $105 non-members
CLE Hours have been requested
Presented by: Bradley Merrill Thompson, Shareholder, Epstein Becker & Green P.C.

Sponsorship Available

Overview:

Advertising and promotion can be one of the most daunting areas of medical device regulation, and having a firm grasp on these issues arguably is more important than ever before.  Whether you’re a device promotion guru or novice, this program will bring you up to speed on current issues in device advertising and promotion and will provide a comprehensive overview of the legal requirements.

The program will kick off with a discussion from a device promotion expert, who will cover the fundamental rules of the game, practical suggestions for device promotion, and today’s pressing topics.  Building on that discussion, a panel of industry experts will dissect case studies involving complex device promotional issues.  Audience participation and questions will be strongly encouraged.

If you’re already an expert, in addition to being an excellent refresher course, this program will provide you with an opportunity to interact with other experts and ask your most pressing questions.  If you’re a novice, this program will help you understand the complex regulatory framework governing device promotion and bring you up to speed on today’s hot topics.

Click here for more information.

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The Importance of Doing Your Homework

April 10, 2010 By Leave a Comment

We frequently discuss the importance of planning and doing research before jumping in and committing dollars to building a device or even creating a conceptual design. However, from time to time, we are hired to help individuals or companies get their devices to market after they have a design or product created. It’s a simple concept…

IDEA –> STRATEGY & FEASIBILITY –> FDA PATH –> PRODUCT DESIGN –> FINAL PRODUCT

The most successful ideas happen when the inventor/entrepreneur comes to us BEFORE the design phase and those companies that focus on the designing of products advise their clients to approach a company like Creo Quality BEFORE the design phase.

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April 21-23, 2010 – Process Validation for Medical Devices

March 21, 2010 By Leave a Comment

Process Validation for Medical Devices

Who Should Attend

This course is targeted to professionals directly involved in meeting the FDA’s Quality System validation requirements such as those in regulatory affairs, quality assurance, process development or manufacturing. To maximize the peer learning opportunity, this course is recommended for those who may have a basic understanding of the Quality System Regulation (QSR), including direct work experience.

This course provides regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA’s Quality System Regulation while offering information on how to implement an effective validation program.  The course is also intended for Medical Device professionals who are responsible for performing process validation studies and ensuring compliance with regulatory requirements for validation documentation.

Learning Objectives

The purpose of this course is to provide an introduction to the fundamentals of process validation, explaining how, when, where and why you should validate. Learn how to comply with FDA regulations for validation protocols and determine the format and function of such protocols. Addressed is how to maintain adequate validation documentation systems and perform equipment qualifications, process and software validations, and evaluate the need for re-validations.

Register here.

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March 25, 2010 – ASQ Biomedical Midwest discussion group meeting

March 17, 2010 By Leave a Comment

ASQ Biomedical Midwest discussion group meeting

What is the difference?  How do they affect us?  Why do we have them?  Click on the link and get registered today to find out more!!!

NEW REGISTRATION PROCESS: Get registered today!

Come hear Fred McClure, currently Manager, Regulatory Compliance at Roche in Indianapolis, IN and responsible for recalls in the US.

Fred has 12 years of regulatory experience in Medical Devices.  He spent 5 years in orthopedic implant industry and 7 years in the in-vitro diagnostic industry.  He has a breadth of experience in the medical device regulatory field including experience in pre-market regulatory submissions (510(k), PMA and IDE), clinical trials, post market activities (complaint handling, medical device reporting and recalls), quality system management, internal auditing, supplier auditing, FDA 483 and Warning Letter remediation as well as review and approval of advertising and promotional materials.

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March 21-23, 2010 – PMRG Annual National Conference

March 9, 2010 By Leave a Comment

Waves of Change: Preparing Wisely for Healthcare’s Uncertain Future

Our 2010 Annual National Conference will focus on the ever changing healthcare industry. The focus will be on industry trends, challenges in the marketplace and how to adapt to such changes. The conference agenda will offer three dynamic keynote speakers, along with general sessions, break-out sessions and panel discussions which has been selected from submissions for the Call for Papers along with a few invited speakers.

The 2010 Annual National Conference will be held at Disney’s Contemporary Resort on March 21-23, 2010. Registration and consultant fair packages are available now.

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Thank You Angela 407125

December 23, 2009 By Leave a Comment

We had a disaster at our house earlier this week. One of our satellite receivers is not working. We called the customer service number to get this resolved. They really need to change the name of this to “we’ll kinda help you but not fix your problem”. It’s one of those automated systems. You know the kind: “Thank you for calling. Please state the problem you are having.” After several attempts and several minutes, they finally get us connected to a live person.

The customer service representative did her best to help us, but could do no more. She put us on hold for several more minutes and connected us with another department. Another customer service representative (Angela 407125) was very patient and tried to be helpful. I was a bit upset–okay, angry. I took it out on her. Definitely the wrong thing to do. So I asked for her supervisor and told him that Angela did a great job being calm and trying to difuse the situation.

But while talking to the supervisor, the other satellite receiver which was working just fine prior to the call, stopped working. He had to transfer me back to Angela. (Oh, and I did apologize to Angela for my behavior and told her she is doing a good job.)

After several more minutes of troubleshooting, being put on hold, and more troubleshooting, Angela could not help. She is sending the solution (gosh, I hope) overnight. In summary, prior to calling customer service, we had one good and one bad receiver. After the call zero good and two bad.

I don’t blame the representatives. They are doing the best the can to help people like me. I imagine they get to hear a lot of grief and anger from people. But I do blame their customer service process. It’s terrible for customers. The call lasted nearly 40 minutes, solved nothing, and might have created additional technical issues.

Unfortunately, this example is all too common today. I think customer service is a lost art. Is any business out there working on fixing this?

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