440-871-0600

Telephone: 440-871-0600  for Design Interface Inc. Facebook link to Design Interface Inc. LinkedIn link to Design Interface Inc. Twitter link to Design Interface Inc. Design Interface Inc. Logo

Login

Blog Archive

What’s the Difference Between Logo Design and Branding?

April 04, 2018
logo_vs_brand_artwork_blog.jpg
Category: Graphic Design

A logo is an easily recognizable, reproducible design element, often including a name, symbol, specified colors or trademark. It’s that shape companies use to represent their company; like Nike’s swoosh or McDonald’s golden arches. A well designed logo should evoke some memory or emotion from the viewer depending upon their relationship with the brand. 


But what’s branding? Branding is how your customers experience your company. While a logo is only a small simple mark, a brand encompasses the positioning, the messaging and communications, the visual design, the target market, the presence, and the experience any individual has with the business, product or service.


A logo all by itself is just a graphic element with a name. A brand is the communications strategy that helps you communicate your passion and expertise. When combined, a well-planned logo and a brand strategy help you effectively and efficiently reach your audience, communicate your message, your value, and benefits, and visually attract more attention.


Do you have a logo, or do you have a brand? We can help bring your brand to life. Visit our Brand Identity or Contact Us page.

Tags: Graphic Design Brand Branding Branding identity packaging product design logo symbol trademark

The Hidden Message in the Olympic Medals

March 14, 2018
medal-min.jpg
Category: Product Design

Did you know? The Winter Olympic Medals change every two years when the International Olympic Committee selects an individual or team from the host country to create a new design. This year they chose Sukwoo Lee, an industrial designer working in Seoul and he came up with five ideas that attempted to combine the Olympic spirit with Korea’s heritage. The winning design cleverly uses the Korean alphabet, called Hangeul, to represent “the seed" of Korea's culture. The seeds are symbolically planted, grown, and finally harvested, and what’s left are the “stems” of culture bunched together and cut into the circular medal shape. You can clearly see these stems depicted on the front. However, turning the medal sideways reveals that the stems are actually extruded letterforms of the PyeongChang games. 

Tags: PyeongChang Olympics Medals Industrial Design

CIA Women In Design

March 01, 2018
CIA-Women-In-Design_1.jpg
Category: News

It was a proud moment for me at the Cleveland Institute of Art when six former industrial design students came together to demonstrate skills and talk about their careers. They were part of the exhibit— X Perspective: CIA Women in Design - Growing Influence. It showcased women who have graduated over the past decade, in addition to two current students. The graduates work across the U.S. in different industries, including automotive, toys, consumer electronics, furniture, housewares and medical products. The show was designed and curated by Rebecca Bible-Churavy, a 2009 CIA graduate, with the support of Dan Cuffaro, Department Chair, Industrial Design. 

~ Carla

Tags: Cleveland Institute of Art Industrial Design careers

Digital Fireworks with Drones at the 2018 Olympics

February 12, 2018
Category: Likes

 

Intel has broken a world record by creating a lightshow comprised of over 1,200 illuminated drones at the opening ceremonies of the 2018 Olympics in PyeongChang, South Korea. The flying points of light are synchronized via computers to create stunning animated 3D figures in the night sky. The audience was awed by images of a snowboarder, a flying dove, and the Olympic Rings flying overhead. Watch the video from ABC News to see how it was done.

Tags: Winter Olympics drones

Cinemagraphs—A Graphic Design Trend For 2018

January 23, 2018
Category: Graphic Design

There are new graphic design trends every year and this year one of the more interesting trends is the use of cinemagraphs. Cinemagraphs are “living” photographs: It is a mix of an image and a video together, where only part of the image is animated, and the rest remains static. It loops seamlessly without any visible breaks or edits. 


The term “cinemagraph” was coined by photographers Kevin Burg and Jamie Beck in 2011. They were the first photographers to really put cinemagraphs on the map through their stunningly beautiful fashion photography.


By defining which elements in a cinemagraph move within the frame and which are static, the cinemagrapher can emphasize certain details, tell stories, or create a unique atmosphere.


To learn more about cinemagraphs and how to create one go to the following websites:

http://cinemagraphs.com

https://flixel.com/cinemagraphs/fresh/

https://blog.hubspot.com/marketing/how-to-create-a-cinemagraph-in-7-easy-steps


Tags: graphic design cinemagraphs photography design video

Ellen's Giving Away Panwaffles!

December 11, 2017
panwaffle-on-ellen-2017.jpg
Category: Product Design

Christmas is just around the corner and Ellen is promoting her 12 Days of Giveaways where she features unique and interesting gifts. One that caught our attention is called the PanWaffle that we designed earlier this year. It's a griddle that makes a pancake and waffle in one. In this fun video you can watch Ellen introduce the Panwaffle to her studio audience. You can learn more about the Panwaffle at https://panwaffle.com.


Tags: panwaffle ellen 12 days of giveaways product design christmas

How to Solve Problems Like a Designer

November 29, 2017
design_process.jpg
Category: Product Design

Design is a constantly changing and rapidly evolving field, from product design, graphic design, transportation design, visual design and then to system design. No matter how design changes and evolves, all designs share the same problem-solving methods. The four main steps are: 1) observation, 2) ideation, 3) prototyping and 4) testing. Check out this 5 minute video by TED+Vox+IDEO: https://www.youtube.com/watch?v=wOrmr5kT-48


Like IDEO President, Tim Brown says “everyone is a designer.” Knowing how to solve problems can make you and your communities’ lives better and more enjoyable.

Tags: Vox video product design human centered design IDEO

Flexi~Bling - Handmade Jewelry

November 17, 2017
Flexi-bling-home_1.jpg
Category: Graphic Design

Flexi-bling — flexible jewelry launched their website today! The Design Interface team created the brand identity for founders Linda Jones and Alenna Smith. We started with the foundation of a descriptive logo, then worked on labels, packaging and signage. The website needed a few days of intensive photography and video production done in our photo studio at Design Interface Inc. We worked with outside modeling talent and used our own art direction expertise to create the look and feel. The responsive e-commerce website was developed in WordPress along with the other elements. Visit their website today!


Team Members: Anita Morselli-Zakrajsek, Carla Blackman, Tim Safranek, Doug Halley and Matt Moss

Tags: Logos packaging brand identity photography art direction website design and development

Packaging for Pet-owners

October 26, 2017
crochet_kitty_800.jpg
Category: Graphic Design

Recently we had the opportunity to create this whimsical custom die-cut package and hang tags for Crochet Kitty™, a Cleveland company specializing in handmade cat & dog accessories. The plush toys are attached to a cat-shaped card and the paw folds across to hold them. If you’re a cat lover then be sure to check out the Etsy store.

Tags: Package design Crochet Kitty cats

Pantone’s Top Ten Colors For Fall/Winter 2017

October 11, 2017
Fall-2017-colors_blog.jpg
Category: Graphic Design

The Pantone Color Institute released their color report and I am excited to share this season’s Top 10 Colors for Fall 2017! “The color palette for Fall 2017 leans more to warmth,“ says Leatruce Eiseman, Executive Director of the Pantone Color Institute. Both Autumn Maple and Butterum have a warm and comforting seasonal feel to them. There are also other unique shades such as light pink Ballet Slipper, an eye-catching Golden Lime and a bright Marina blue.“ These hues add a striking touch when paired with the classic autumnal shades of Navy Peony, Neutral Gray, Butterrum and Tawny Port,” said Eiseman. 


Here is a description of the Top Ten colors at a glance.


PANTONE 17-1558 Grenadine-A powerful, evocative, dynamic red, Grenadine is a confident and self-assured attention-getter.


PANTONE 19-1725 Tawny Port-Taking the Red family to new depths, Tawny Port is elegant, sophisticated, and tasteful.


PANTONE 13-2808 Ballet Slipper-Descended from the Red family but with a softer touch, Ballet Slipper is always flattering and reminiscent of the rosy glow of health.


PANTONE 16-1341 Butterum-This snug, warming, and toasty shade is evocative of drinking a glass of Butterrum by a roaring fire on a cool autumn evening.


PANTONE 19-4029 Navy Peony-A mainstay for the season for both palettes, Navy Peony is a dependable and an anchoring shade. Solid and stable, the hue takes some of the load off of black as a go-to neutral.


PANTONE 17-4402 Neutral Gray-The standard bearer of all neutrals, Neutral Gray shares the anchoring role with Navy Peony in this palette. It can be used as an accent or a head-to-toe statement shade.


PANTONE 19-4524 Shaded Spruce-This is a green you might see in the forest – sheltering and protective as evergreen trees.


PANTONE 16-0543 Golden Lime-Earthy tones with a twist, the golden undertones of Golden Lime makes this yellow-green shade a refreshing complement to fall classics.


PANTONE 17-4041 Marina-Cool with an enhanced vitality, Marina is the only truly cool color in the fall palette that brings with it freshness and brightness.


PANTONE 17-1145 Autumn Maple-A quintessential autumn color, Autumn Maple is tawny and russet, introducing warmth into the palette.


Learn more about Pantone, Color of the Year, Trends, Color Trends, and Fall 2017 at www.pantone.com.


Photos courtesy of Pintrest and DiscoverStyle.ru.

Tags: Graphic Design Product Design Package Design Fashion Design Interior Design Graphics Pantone

EcoClone Plant System Showcased at CIA Faculty Show

September 29, 2017
Ecoclone-PosterCIA-show.jpg
Category: Product Design

Each year the CIA faculty show provides an opportunity for students to see the creative work their teachers undertake outside the CIA environment. This year Adrian Slattery showcased his design and engineering skills by presenting the successful Humboldt EcoClone Plant Propagation System. This disruptive technology uses ultrasonic fog to encourage root growth from plant cuttings. Benefits include:

• Ideal root growth - Ultrasonic fog ensures that capillary roots flourish quickly and lessen transplant shock.

• No disease transfer - Non-recirculated water prevents the transfer of diseases between cuttings.

• Water & Energy efficient - Uses about half the water and a third the energy of traditional systems.


The design process used Solidworks engineering software to create the 3D digital parts and assemblies and design validation was performed with an in-house 3D printer. The product was taken from inventor’s idea to final manufacturing. Adrian has taught materials and manufacturing processes at the Cleveland Institute of Art to Industrial Design students for thirteen years. For more information visit: http://humboldt-ecoclone.com.

Tags: Humboldt EcoClone Plant System Cleveland Institute of Art Faculty Show Adrian Slattery Design Interface Inc.

New Designer at Design Interface

September 18, 2017
li_1.jpg
Category: Product Design

Hello, my name is Zhongyang Li (I go by Li). Having recently graduated from the Cleveland Institute of Art, I am starting my career as a cross-disciplinary industrial designer and biomedical artist. My design passion is for medical, healthcare, and UX/UI related product designs. Also, I am a problem solver who lives and breathes design; I enjoy helping others address their concerns and challenges. After graduating from CIA, Design Interface was very interested in my skills and passion, and willing to accept me as part of their team as an industrial designer (independent design contractor). I am truly glad to become part of the team and work with intelligent design professionals.

Tags: Industrial Design Li Design Interface Cleveland Institute of Art Designer

Humanscale Reissue

August 21, 2017
Humanscale-project1_1.jpg
Category: Product Design

Exciting news…Humanscale, featuring data selectors, is being reissued. It’s been out of print for decades and is an invaluable tool for product designers. I’ve been using my personal set with my Ergonomics + Design class for the past 25 years. At the Cleveland Insitute of Art, the sophomore industrial design class collects primary data on hand measurements for their human factors project. Here’s what we do:

• Students measure their hand width and length 

• With the Humanscale selectors, they find their own percentile for each

• Remembering that length and width percentiles aren’t usually the same

• Students make a spreadsheet of the results and post it for the class 

• They test prototypes of their designs on select members of the class to get feedback on fit and feel.


Read more about this gold standard of human engineering statistics below. ~ Carla


To play the Kickstarter video click here: http://tinyurl.com/ya5hxt6s


Reprinted from the IDSA.org website:


"MASTERPIECE OF INFORMATION DESIGN" MAKES A COMEBACK


“In the golden age of American industrial design, Henry Dreyfuss Associates (HDA) knew that there was more to design than just looking good. Products had to be good, crafted to work with the people who use them.”


With this in mind, Niels Diffrient and Alvin R. Tilley of HDA—which was founded of course, by Henry Dreyfuss, an IDSA Fellow and the Society's first president—created Humanscale. It featured data selectors, providing access to more than 60,000 human factors data points in a user-friendly “portfolio of information.”


“Humanscale has long been out of print. Now we're bringing it back,” say Luke Westra, design engineering director and former IDSA International Design Excellence Award Gold winner, and Nathan Ritter, design researcher and strategist, of Chicago-based IA Collaborative (link is external). In Humanscale Reissue (link is external), three booklets and nine, two-sided, interactive data selectors will allow designers, engineers, architects and inventors to reference data that serves as a starting point to design products for people. “Never before or since has there been such a complete and usable compendium of human factors data. Each page is a master class in information design; and this was before computer layouts!”


Published between 1974 and 1981, the original materials command top dollar on the used market. After finding so much value using Humanscale during the prototyping process in its own design work, IA Collaborative wanted to make a new version available at a reasonable cost to people everywhere. 

As part of IA Collaborative’s ventures program and in collaboration with the creators and US printers of Humanscale, the entire collection is being offered on Kickstarter (link is external). 

Humanscale was published as three separate sets––Humanscale 1/2/3, Humanscale 4/5/6, and Humanscale 7/8/9. Each set includes one booklet and three two-sided selectors. Each of the two-sided selectors contains a circular disc that the designer rotates to dial in user data across attributes like age, height, strength and ability level.


As the designer rotates the disc, distinct measurements corresponding to the chosen data parameter emerge throughout the selector. For instance, a designer working on children’s desks might rotate the disc on Selector 2b to “Age 5” and then “Age 12” to find the appropriate range of “Leg Room” measurements for the product. This toolkit offers data on body dimensions, ergonomic seating standards, wheelchair access guidelines, legibility principles, etc. 


Dan Kraemer, founder and CDO of IA Collaborative, is ventures program sponsor. Kraemer spoke at IDSA's International Design Conference last year and is a past IDSA IDEA winner.


So what's ahead? "We’re currently focused on delivering a faithful and high-quality reissue to our backers. We have a variety of exciting ideas about extending the Humanscale platform, which we plan to explore after the successful completion of the reissue project," says Ritter.


“Humanscale was a masterpiece of information design, and arguably one of the first interactive data visualizations,” reports Elizabeth Stinson in Wired (link is external). “It’s a relic, but it's also regarded among industrial designers as the gold standard of human engineering statistics. Meg Miller of Fast Company (link is external). posts, “In the decades since Humanscale’s publication, this type of data has been digitized, but since gathering the data is such an arduous task, most of it is privately held by the companies that undertook the research.”



Tags: Humanscale ergonomics human factors industrial design Cleveland Institute of Art

2017 IDEA Awards

July 17, 2017
idea-awards-2017.jpg
Category: Product Design

It’s that time of year again! The 2017 IDEA awards have been announced and are available to see at http://www.idsa.org/awards/idea/gallery Some interesting designs include:


HUBB Lifetime Oil Filter

Just as its name implies, the stainless steel filter replaces an ordinary paper filter and is expected to last up to 50 years. Every 10,0000 miles the HUBB is removed, cleaned and inserted back into the vehicle.


Hammerhead One

This device attaches to your bicycle’s handlebars and helps you navigate the safest routes via a system of lights to indicate changes in direction. A cyclist chooses a destination using the smartphone app which communicates with the device using Bluetooth.


Samsung’s SERIF TV

The trend in television design has been to achieve ultimate slimness, but the SERIF stands out by surrounding the thin screen with an elegant frame. This allows it to stand on its own and also offers a surface above the screen to place decorative items if desired.

Tags: IDEA Awards Product Design

How a CIA design student found her dream job in San Francisco

June 19, 2017
anna-cormack-interview-800.jpg
Category: Product Design

Anna Cormack is a recent product design alumni from The Cleveland Institute of Art. She will be starting the intimidating new chapter of her life, being in the real world. She will be a fellow at Chronicle Books in San Francisco, California for a year. For a student designer being in the realm of San Francisco, it is a dream come true. Learn what it’s like to move to San Francisco and how school projects and internships helped get her a design job.

 

Q: Did the projects in school help you more or your internships? 

Anna said that school helped her portfolio a lot because in internships you can’t show what you do. During her summer internship with Munchkin she worked on company projects and learned how to be in a professional environment. At Munchkin she learned how to talk to manufacturers in China, ask for help from professional designers, and talk to people in marketing. She acquired real world skills from her internship that she could not get from a school environment.

  

Q: Are you worried about the cost of living? 

Anna commented that she was somewhat worried but feels better now that she found a cheap apartment in Oakland. At Chronicle Books she commented that they pay enough to survive in San Francisco for a year and she knew she wasn’t going to save a lot of money. She noted that she would, "rather take that jump and risk and have fun in the city I want to live in then taking a well paying job somewhere in Ohio and be sad. It’s year long so I can find a job that can pay me better afterwards. I’m not ready to move into the real adult world so I think this is a good baby step. “

  

So you’re not scared to start? 

Anna commented that she wasn’t scared to start because she knows someone at Chronicle Books. The contact is an alumni, Lauren, she was friendly with when she was a sophomore in the studios. There was an email sent out through Dan (Director ID Program) forwarding Lauren’s search for a fellow and she applied within half an hour. She knew that Lauren was the type of designer that would take a non-traditional job and she also had similar taste so she was interested and applied.

  

So to all the design students wanting a design job in a cool hip city, learning through Anna, making connections with the upperclassman at your school is a notable way to be successful. She also had a quality relationship with her professors and the people around her. Her learning experience at her internship was also a great skill builder and background to have. She didn’t want to miss this opportunity and now she gets to explore the dream city of many undergraduate students. At Chronicle Books she will design desk and home accessories as well as book packaging, trade show design and many other products.

 

Go out there and design great things, readers!


 

Tags: Product Design Cleveland Institute of Art Internship San Francisco Chronicle Books

Inspirational Graphic Designer—Paula Scher

May 17, 2017
Paula-S.jpg
Category: Graphic Design

Paula Scher is a Graphic Designer who’s work I am impressed by and I think you will be too. She began her career creating album covers for both Atlantic and CBS records. She later formed her own design company, and after only a few years there she joined Pentagram. During her career she has created memorable identities and other work for clients such as Citi Bank, Coca-Cola, the Metropolitan Opera, New Your City Ballet and the Museum of Modern Art, among others. 


Paula’s style of design communicates with audiences through the use of pop culture and fine art. Her work has been published internationally and her contributions to the field of design are numerous. As a partner of Pentagram, her work continues to inspire the new generation of designers. Scher is featured in “Abstract: The Art of Design,” the Netflix documentary series about leading figures in design and architecture. For a preview of this documentary go to: http://www.pentagram.com/#/blog/136687


For more about Scher and her work visit: http://thegreatdiscontent.com/interview/paula-scher


Tags: Design Interface Inc. Anita Morselli-Zakrajsek Graphic Design design graphic illustration logos

Cleveland Institute of Art student Dominic Montante big winner in Housewares and IDSA

April 14, 2017
IDSA-student-group-2017_1.jpg
Category: News

Riding on the success of student Dominic Montante, a contingent of students and faculty went to Cincinnati to support him as the IDSA Student Merit winner. He was chosen to represent the Cleveland Insitute of Art at the Central District IDSA conference on March 31.  


Earlier in the year he won the trifecta of awards at the International Housewares Competition. For the first time in the 24-year history of the International Housewares Association Student Design Competition, an industrial design student has won first, second and third place prizes for three different designs!


And that’s prompted the creation of an Outstanding Achievement Award for Dominic Montante, S/IDSA—a senior from the Cleveland Institute of Art. "Winning all three prizes still doesn't seem real," Montante tells IDSA. "It's a real honor. My school has a tradition of winners who are still remembered today, so it's a special feeling to be among their ranks. I'm also hoping the recognition will help to launch my career since I will be graduating this semester."


The annual competition, judged blindly, challenges students to redesign a current housewares product to meet the needs of the future or create a concept for a new product. Winning projects are selected for their innovation; understanding of production and marketing principles; and quality of entry materials.  ~ Carla


Tags: Design Interface Inc. Carla J. Blackman Adrian Slattery Dominic Montante Cleveland Institute of Art IDSA

Giving The World A “Helping Hand”

March 17, 2017
Category: Product Design


Here is an inspirational video about a company that creates free 3D printed hands for children worldwide who need one. The hands are predominantly made of plastic with string to activate the fingers, driven from the wrist or elbow depending on the design. The 3D print files are available on their website  for download and fabrication by anybody who had access to a 3D printer. (enablingthefuture.org) It's exciting to see this technology positively impact the lives of kids.

Tags: 3d printing product design anthropometrics

Affect Your Customer With Effective Packaging Color

February 28, 2017
color-purchases-blog2.jpg
Category: Graphic Design

Tap into the emotional side of color to really drive your product messaging! 


Color is one of the most crucial decisions you can make for your packaging because, if used properly and intelligibly, it:

• Helps cut through marketplace clutter

• Provides the extra appeal that can solidify a ring at the register

• Enhances other design elements, such as shape, feel, finish, and graphics

• Triggers “sensorial cues” evoking consumer thoughts and perceptions of taste, smell, feel and sometimes even sound.


There are a lot of different factors that influence how and what consumers buy. A large part of every decision is based on visual elements, and one of the strongest and most persuasive is color. Color plays a pivotal role in the customer’s critical decision — to buy or not buy.


Color & Marketing

Research conducted in the United States states the following relationships between color and marketing:

• 92.6 percent said that they put most importance on visual factors when purchasing products.

• Only 5.6 percent said that the physical feel via the sense of touch was most important.

• Hearing and smell each drew 0.9 percent.


However, the effects of color differ among different cultures, so the attitudes and preferences of your target audience should be a consideration when you plan your design of any marketing materials. For example, white is the color of death in Chinese culture, but purple represents death in Brazil. Yellow is sacred to the Chinese, but signified sadness in Greece and jealousy in France. In North America, green is typically associated with jealousy. People from tropical countries respond most favorably to warm colors; people from northern climates prefer the cooler colors.


In the western world, the following colors are associated with certain qualities or emotions:

Red — excitement, strength, sex, passion, speed, danger.

Blue — (listed as the most popular color) trust, reliability, belonging, coolness. Yellow — warmth, sunshine, cheer, happiness Orange — playfulness, warmth, vibrant

Green — nature, fresh, cool, growth, abundance

Purple — royal, spirituality, dignity

Pink — soft, sweet, nurture, security

White — pure, virginal, clean, youthful, mild. Black — sophistication, elegant, seductive, mystery

Gold — prestige, expensive

Silver — prestige, cold, scientific


Color also has the unique ability to attract specific types of shoppers and change shopping behavior. Impulse shoppers respond best to red-orange, black and royal blue. Shoppers who plan and stick to budgets respond best to pink, teal, light blue and navy. Traditionalists respond to pastels — pink, rose, sky blue.


Making the Right Choice for Your Packaging Colors

In making the right choice of colors you need to: 

• Keep the consumer of your product in mind, your target market 

• Put yourself in their shoes to see what motivates them to buy

• What is their age, their gender, their economic status, their education level determine the purpose of your product and what message you want the packaging to send to your buyer 

• Is the message professional, serious and conservative, is it about health and well-being, is it to make the customer feel good, is it to help with a problem, is it about luxury, is it about elegance and sophistication

• Make sure the colors send the right message!


To read more about packaging colors visit the following websites:

https://www.pantone.com/affect-your-customer-with-effective-packaging?from=topNav

https://medium.com/@rodgerdwightbuyvoets/how-color-affects-shopping-habits-36141daf4c49#.ugu51jxgh


Image credit: KISSmetrics.com


Tags: graphic design package design product design graphics package product color

Wondering about Medical Device Approval Terms?

February 10, 2017
FDA_-_flag_doc_scrubs_1.jpg
Category: Medical Device Design

Here at Design Interface, we get many questions about the correct pathways to Medical Device Approval. The Food & Drug Administration (FDA) has regulations and provides guidelines on the design of a safe and effective product. You may have heard some of these key terms:


   • Regulatory Assessment

   • Investigational Device (IDE)

   • Premarket Approval (PMA)

   • Feasibility Clinical Studies

   • Pivotal Clinical Trials 

   • Post-Market Studies

   • Class I, II & III devices

   • FDA pre-submission

   • 510(k) application]

   • Premarket Approval (PMA) Submission

   • de novo pathway


The article, “What are the 10 keys to the U.S. pathway to medical device approval?” by Debra Grodt/Director of Regulatory Affairs/Medical Device and Diagnostics Novella Clinical appeared in the publication, Medical Design & Outsourcing. It gives excellent definitions for all the terms above. ~Adrian


What is a regulatory assessment?

A regulatory assessment is a comprehensive review of Food & Drug Administration (FDA) regulations and similarly marketed devices to establish a framework to design a safe and effective product. Assessments include: 1) a detailed rationale for product classification; 2) applicable regulatory agency consensus standards and guidance documents; 3) laboratory and preclinical testing requirements; 4) clinical study requirements; and 5) submission format, elements and recommended timing. A list of Design History File documents to support FDA-mandated Design Control (21 CFR Part 820.30) should also be included.


What is an Investigational Device Exemption (IDE)?

An Investigational Device Exemption (IDE) allows unapproved devices to be used in a clinical study to collect safety and effectiveness data required to support a Premarket Approval (PMA) or 510(k) application.


What are feasibility clinical studies?

A medical device feasibility study or pilot clinical study is used to validate device design and clinical study design by the intended users. These proof-of-concept studies are generally small, usually between 20 and 60 patients. They should be done in a staged process, measuring training effectiveness, device issues and ease-of-use (human factors and ergonomic testing) before enrolling subjects to define preliminary safety and effectiveness. Data from these pilot studies can help companies modify devices, labeling and training methods to develop better products, as well as to better define endpoints, follow-up requirements and patient populations for subsequent clinical studies.


What are pivotal clinical trials?

Pivotal clinical trials are the equivalent of Phase III drug clinical studies and are intended to collect safety and effectiveness data required to gain regulatory and market approvals. These clinical studies require a significant number of patients to provide adequate statistical power and the design is generally randomized against another device for the same intended use, or against standard-of-care. In addition to meeting FDA requirements, results from these studies can help support public and private coverage determinations for device reimbursement.


What are post-market studies?

Post-market studies may be required by the FDA or may be conducted voluntarily by the manufacturer to collect real-world, long-term performance data. Post-approval studies and post-market surveillance studies are studies mandated by the FDA for novel and/or high-risk devices to define long-term safety and effectiveness. Beyond what is required by the FDA, device manufacturers may choose to conduct post-market studies for the purposes of data collection to bolster market adoption, labeling claims or reimbursement. 


What are Class I, II & III devices?

FDA classifies devices by risk, which governs the design verification, validation and clinical testing required, and therefore, how long it takes to get a device cleared for market. 

Class I are low-risk, e.g. surgical instruments, gloves and visual acuity charts.

Class II are moderate-risk, e.g. contact lenses, urologic catheters, vascular clamps and blood pressure cuffs.

Class III are high-risk devices that support or sustain human life or pose higher risk of illness or injury, e.g. vascular grafts, coronary stents, implantable pacemakers and artificial hearts.


What is an FDA pre-submission?

This voluntary program allows sponsors to obtain FDA feedback to help guide product development and/or application preparation prior to submitting a formal IDE, PMA or 510(k) application.

 

What is a 510(k) application?

A 510(k) is a premarket submission made to the FDA to demonstrate a device is safe and effective and similar in intended use, materials, components, operating principles and method of use (i.e. substantially equivalent) to a legally marketed device. The FDA’s review of the 510(k) application and notification of clearance is required before placing a moderate risk device on the market

.

What is a premarket approval (PMA) submission?

A PMA submission initiates the FDA’s scientific and regulatory review process to evaluate the safety and effectiveness of Class III medical devices. The PMA must be approved prior to marketing the device. FDA generally requires the manufacturer of a first-of-a-kind device to pass an on-site quality audit and attend an Advisory Committee meeting prior to issuing an approvable letter.


What is the de novo pathway?

New devices, regardless of risk, that are not substantially equivalent to an existing cleared device are automatically classified as Class III by the FDA. The de novo or Automatic Class III Designation process allows manufacturers to petition the FDA to reclassify a device as a Class I or II. Submitters will provide justification on why the device should not be considered Class III, highlighting the risks and benefits of the device.


For more information on the FDA visit: http://www.fda.gov/MedicalDevices/default.htm



Tags: Design Interface Inc Adrian Slattery Classifications Clinical Trials FDA Approvals Medical Device Business Regulatory medicaldeviceanddiagnostics novellaclinical

Title of your posts.
By Author's Name

January 1, 2030

Category: Category Name

This is where the post content will show up. The font color, font size, line-height, and other styles related to the font, as well as stroke, corner radius and backgroung color / image can be styled. Simply use the text / color / stroke panel to style any of these elements! You can also change the spacing by clicking on the top right arrow near this field. Again this is a sample text and will be replaced with the content of each post.

Tags: Tag Link

100 Comments

Comments

John Smith

 

January 1, 2030

 

This is the comment text. It can be long and break into several lines.

 

Design Interface Inc.

25125 Detroit Rd Ste 110

Cleveland, Ohio 44145-2500

© 2018 Design Interface Inc. All rights reserved.

 

Facebook link to Design Interface Inc. LinkedIn link to Design Interface Inc. Twitter link to Design Interface Inc.