Five tips for medical device makers seeking FDA approval –

Medical-deviceby Frank Vinluan

Millions of people use a 510(k) cleared medical device daily without even realizing the product has been evaluated by the U.S. Food and Drug Administration.

It’s the toothbrush.

The toothbrush is a class I medical device, said Tammy Carrea, vice president of quality and regulatory affairs for Durham, North Carolina medical technology company TransEnterix. Carrea uses the example to make a point. Medical devices fall within a broad range and it’s important for companies to understand their devices and the products they are equivalent to in order to successfully navigate the regulatory process.

Carrea spoke at a workshop during the medtech11 conference in Chapel Hill, North Carolina. TransEnterix has 510(k) clearance on a product used for laparoscopic surgery. She noted three common missteps companies make in interacting with the FDA: Not talking with the FDA early and often enough; not having a well-thought-out plan before meeting with the FDA; and not having representation to interact with the FDA. She also offered some solutions.

Get regulatory staff involved early. The FDA is a science-based body tasked with making sure that devices are safe. That’s a higher standard than European regulations. What that means for companies is that the FDA expects to see data. And companies need to be thinking about the regulatory part of the process sooner than they might expect. “The bottom line is the FDA is a science-based organization and they want data,” Carrea said.

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Helix Consulting Group

30386_469429916433618_1931028205_nKaren is the President of Helix Consulting Group, a quality assurance company offering businesses a comprehensive range of services to ensure regulatory requirement compliance and assist with approvals and licensing for new product development.

With dual Bachelors Degrees in Science and Education from Memorial University, Karen continued to launch her career as an entrepreneur with the founding of Helix Consulting Group. For nearly two decades, Karen has delivered expert Quality Assurance services to a broad spectrum of clientele in Vancouver and internationally.

Utilizing her foundation of knowledge and experience, Karen not only provides compliance services, but also extends her talents to assist clients in earning FDA, FAA and TCCA approvals, as well as HC licenses and CE Marking.

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Happy New Year!


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American Society for Quality

asqI’m a member of the American Society for Quality, check them out at:

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6 Tips for Maintaining FDA Compliance –

fda-logo#1:  See what is causing FDA Compliance issues with other firms.  Keep on top of FDA observations given to other firms.  Evaluate them for comparison to similar operations in your firm.

#2:  Seek outside help.  Don’t go it alone to be educated or evaluate your FDA Compliance.  Get experts with hands-on experience and knowledge of your particular operations.  Having an outside set of eyes to evaluate your compliance levels or provide training can go a long, long way to improve your quality.

#3:  Think systemically.  Don’t just look at one issue to resolve it – what caused the problem, find the root cause, keep looking and resolve it systemically.    If you don’t heed this valuable tip, then your firm is on a pathway to FDA Non-Compliance.

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5 Ways to Build Your Brand in Short Chunks of Time

By Jayson Demers

5 Ways to Build Your Brand in Short Chunks of Time

Your brand embodies everything that you do and stand for as a business. At a tangible level, your business name, tagline, the colors you use and the content you publish encode your brand and present it visually and conceptually.

Building a solid brand requires a big investment of time. Yet it’s important not to overlook the power of small steps and single interactions that can solidify and share your brand with others. Here’s a closer look at five ways you can spend small chunks of free time to help build your brand.

1. Align your visuals. The visual elements of your brand are a powerful reinforcement of what you’re trying to achieve. Customers recognize your logo. Fans know your brand’s colors.

Are you using your logo in all the places you should? Is it part of your social-media profiles, in your email signature and on your presentations? Do your Twitter and Facebook presences reflect your company’s color scheme? If the answer is no, take a moment to change one thing that’ll bring you closer to a unified visual brand presence such as adding your logo to your email or changing the background color of your Twitter account.

2. Respond to your fans, followers and friends. An accessible brand is one that people want to do business with. One way to help cultivate this image is by being responsive to questions, comments and customer reviews. Spend a minute replying to the latest messages left on your social-media pages, customer reviews on sites such as Yelp and Google, and touching base with new connections on major networking sites.

You’ll strengthen your relationship to a specific customer, while also enhancing your image as a conscientious and responsive business owner.

3. Use a social monitoring tool to listen to social trends. Tools such as Hootsuite and Tweetdeck let you follow brand mentions and hashtags in one place, and are a great way to focus your social-listening efforts. Measure sentiment about your brand, spot and deal with any problems being discussed publically about your business, and track discussion around high-value keywords to keep your pulse on your industry.

Monitor the conversation, learn more about what’s happening and strategically jump into the discussion when you have something to add.

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8 Step Process Perfects New Product Development

By Robert F. Brands

8 Step Process Perfects New Product Development Every entrepreneur knows that productivity is one of the key ingredients for successful product development. One of the two key processes in Robert’s Rules of Innovation is the NEW PRODUCT DEVELOPMENT PROCESS. A formalized, NPD process – also referred to and best practice: the Stage Gate® Process – is a must, from simple to sophisticated.

The New Product Development process is often referred to as The Stage-Gate innovation process, developed by Dr. Robert G. Cooper as a result of comprehensive research on reasons why products succeed and why they fail.

When teams collaborate in developing new innovations, having the following eight ingredients mixed into your team’s new product developmental repertoire will ensure that it’s overall marketability will happen relatively quick, and accurately – making everyone productive across the board.

Step 1: Generating

Utilizing basic internal and external SWOT analyses, as well as current marketing trends, one can distance themselves from the competition by generating ideologies which take affordability, ROI, and widespread distribution costs into account.

Lean, mean and scalable are the key points to keep in mind. During the NPD process, keep the system nimble and use flexible discretion over which activities are executed. You may want to develop multiple versions of your road map scaled to suit different types and risk levels of projects.

Step 2: Screening The Idea

Wichita, possessing more aviation industry than most other states, is seeing many new innovations stop with Step 2 – screening.  Do you go/no go? Set specific criteria for ideas that should be continued or dropped. Stick to the agreed upon criteria so poor projects can be sent back to the idea-hopper early on.

Because product development costs are being cut in areas like Wichita, “prescreening product ideas,” means taking your Top 3 competitors’ new innovations into account, how much market share they’re chomping up, what benefits end consumers could expect etc.  An interesting industry fact: Aviation industrialists will often compare growth with metals markets; therefore, when Boeing is idle, never assume that all airplanes are grounded, per se.

Step 3: Testing The Concept

As Gaurav Akrani has said, “Concept testing is done after idea screening.” And it is important to note, it is different from test marketing.

Aside from patent research, design due diligence, and other legalities involved with new product development; knowing where the marketing messages will work best is often the biggest part of testing the concept.  Does the consumer understand, need, or want the product or service?

Step 4: Business Analytics

During the New Product Development process, build a system of metrics to monitor progress. Include input metrics, such as average time in each stage, as well as output metrics that measure the value of launched products, percentage of new product sales and other figures that provide valuable feedback. It is important for an organization to be in agreement for these criteria and metrics.

Even if an idea doesn’t turn into product, keep it in the hopper because it can prove to be a valuable asset for future products and a basis for learning and growth.

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