Preparing for Medical Device Product Launch While Awaiting a Patent

Posted on June 29, 2011 by derekrudnak

What do you think takes more time: product development cycle for a medical device; or, obtaining a patent for that same device? The answer used to be that the product development took far more time and money than acquiring a patent. But today the U.S. Patent and Trademark Office have a huge backlog, making the wait for patent approval in excess of a year, and sometimes 3 years. In this blog, I will discuss how to take advantage of this backlog (or blackout) period. The moment you submit a patent application you are in cue for patent processing and you can put patent pending on your product. This period can be frustrating as it is definitely a waiting game and there is literally nothing you can do to expedite the process. However, the patent pending period can work to your advantage. Patent pending effectively warns your competitor that a patent application is in process. During this period, your competition may know that you have applied for a patent but they are not able to obtain information about the details of your product and therefore cannot react to it. In other words, you have proprietary information that no one else knows…so why not benefit from it? DeviceLab, a full-service medical device development company, has experience in using the blackout period to their client’s advantage. The most effective way of utilizing the long patent wait is to prepare feverishly and thoroughly for the launch of your product. Remember, you have over 1 year to march ahead with your marketing strategies, product upgrades, etc. without your competition knocking on your door.

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Competitive Research and Analysis, the First Step to Product Success

Posted on June 20, 2011 by derekrudnak

“Today I’d like to focus on the importance of market research and competitive analysis, when it should be conducted, and why.  These are important initial steps in deciding how well a new product will compete in today’s marketplace.”

Dac Vu, general manager at DeviceLab Inc., offers this advice “A client recently approached DeviceLab with what he thought was a unique iPad accessory.  The client was so enthused about their idea that they wanted to bypass the competitive research and analysis phase and surge ahead with product development. We recommended that a thorough research and analysis be done to help determine if the product had a place in the market.  In the case of this particular iPad accessory, we performed a thorough research project and found that there were similar products already in existence.  As a result, the client decided to hold off on developing this product, and concentrate efforts and money on something different.  In this example, Competitive research and analysis saved the client time, money and wasted effort.

“We see this all the time…clients want to rush to the development phase because they have convinced themselves, beyond all doubt, that they have the next fool-proof idea.  A company like DeviceLab, whose job is to produce a viable product for our clients, can conduct the necessary research and put you on a profitable path.

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Octane’s Venture Capital Event in Orange County Brings Investors and Start-up Companies Together

Posted on June 16, 2011 by derekrudnak

In May 2011, Octane sponsored a major funding/venture capital event at the Hyatt Regency in Irvine, CA called VC in the OC.  It was a huge success and brought together investors and start-up companies from Orange County and surrounding areas.  The forum involved keynote speakers, discussion panels, and booths.  Don Kloos of DeviceLab, Orange County, attended the event and had the following to say:  “The event is an ideal way for small business and start-up companies with innovative ideas to make presentations to venture capital groups.  In all, there were about 15 companies presenting.  Products and services were primarily in the high-tech or medical device industries.  Booths showcased service providers as well as technology products and innovations.”

Keynote speakers at the event included:

  • William Wang, Founder and Chief Executive of VIZIO, Inc.  The company was founded in 2002 by Mr. Wang, Laynie Newsome, and Ken Lowe with the idea that everyone deserves to own the latest technology. Eight years later, these three founders are still hard at work, and taking entertainment freedom by storm!  By providing a myriad of high definition entertainment options and unmatchable value, VIZIO has grown to over 160 employees and remains the first American brand in over a decade to lead in U.S. LCD HDTV sales.
  • Mark Stevens, a venture capitalist at Sequoia Capital in Menlo Park, CA.  In 1989 Stevens joined the firm and began to concentrate his talents on semiconductor, software, and systems-related investments.  Over the years, he became a rising star on Forbes magazine’s Midas List of top 100 venture capitalists, climbing as high as 10th place in the ranking. Along with the firm’s voting partners, Stevens is responsible for some of the high tech industry’s most successful investments: Google, Yahoo!, NVIDIA, YouTube, and others. In 2004, he donated 22 million dollars to USC and to help found the USC Stevens Institute for Innovation to develop a new model for innovation at a major research university.

Attending events like VC in the OC is important for a number of reasons:

  • Motivates the inventor to continually pursue new technologies/products/ideas
  • Encourages healthy exchange of ideas
  • Provides opportunities to present products and services to potential investors
  • Establish contacts in a particular marketplace/industry

“Of particular interest to DeviceLab were the companies presenting medical devices.  We were able to provide these entrepreneurs with helpful advice on product development, patents, marketing, and so on,” said Vu.  “For the small business, an event like this might be the stepping stone needed to bring their idea to development, and eventually to market.”

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Product Verification and Validation…Important Steps to Consider When Bringing Your Medical Device to Market

Posted on June 14, 2011 by derekrudnak

In a recent blog, Dac Vu of DeviceLab focused on the research and analysis phase of medical product development and how pivotal this first step is.  This phase is an accurate way of assessing the marketability and viability of a product, prior to investing time and money in its development. Today, Vu is going to comment on another crucial step in product development:  product verification and validation.  This step is sometimes overlooked in the planning phase thus can cause budget overrun and launch delays.   Vu states, “Basically, your product cannot be placed on the market without FDA approval, certification and validation.  This process may take 3 months or longer and can add to the overall cost of product development.

“An example of the validation segment of developing a product is sterilization and packaging.   These processes require about 3 months of laboratory work.  Essentially, testing is needed to verify that the sterilization process required for the product is effective and all potential bacteria are eliminated.  Unfortunately some clients overlook this crucial back-end process and ultimately a release date is not achievable on schedule.  It is much more advantageous to account for the back-end tasks in the planning phase so that the duration and budget for these processes are accounted for.  Therefore there should be no surprises at the end.

“DeviceLab has expertise in all aspects of product development, including assessing the certification and validation phases.  We are a contract medical device design and product development firm and have successfully worked on over 100 products from concept phase to market commercialization.  We can help you with all of your design and product development needs, and take into account every crucial step.

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Pitfalls of Selecting Overseas Molding Companies

Posted on June 8, 2011 by derekrudnak

In today’s challenging economic environment, businesses are exploring all of their options regarding production costs.  DeviceLab Inc., a contract medical device design and product development firm has extensive experience in dealing with overseas molding companies and offers some useful advice.  Dac Vu, general manager at DeviceLab Inc., offers these comments:  “We receive solicitations from oversea molders and tool makers, primarily from China, almost every day.  These companies are seeking to develop business relationships with medical device firms such as DeviceLab Inc.  At first glance, their offers appear to be legitimate and a good way to save money on production costs.  Some of the companies have websites and have staff with ISO certification.  But, there are risks involved in hiring overseas molding companies.

“The advantages of overseas production are twofold.  First, the cost of small tool molds can be as low as 1/3 to ¼ the cost of tools molded in the United States.  Second, the promised completion time at overseas tooling and molds can be much shorter (4 to 6 weeks) than that of U.S. companies (6 to 8 weeks).  A decrease in production time can also lower the overall production cost to 1/5 the cost of a product made in the U.S.  But the fact is, some of these offers are scams or simply not legitimate.  Just recently, one of our engineers flew to China and called on one of the overseas molders who had given us what appeared to be an attractive bid.  The engineer discovered that the company existed only as a store front, and was not a qualified, legitimate production facility.  If we had not researched this, and had hired this company to make a mold for our client, we could certainly have wasted time and money, and more importantly lost client trust.

“Do your homework.  Thoroughly research the companies you conduct business with, whether they are overseas or in the U.S.  If you still have questions, or would like our assistance, contact DeviceLab.  We have engineers who are fluent in Mandarin and frequently travel to China for on-site work with suppliers.  We can help you with your outsourcing, molding and tooling needs.

About DeviceLab (www.devicelab.com) – DeviceLab is a contract medical device design and product development firm. They are a full service company for mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services. Experience includes User Interface (UI) Design, custom and cart development, medical device, industrial design, hospital equipment and lab instrument development. Since its inception in 1998, DeviceLab has successfully helped medical device manufacturers bring over 100 products from the concept phase to market.  Based in Orange County, CA, they serve Southern California (San Diego, Orange, and Los Angeles Counties) and medical device firms nationwide.

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DeviceLab Rapid Prototyping and Stereolithography

Posted on June 2, 2011 by derekrudnak

Rapid Prototyping is the automatic construction of physical objects using additive manufacturing technology.  The use of additive manufacturing for rapid prototyping takes virtual design from computer aided design or animation modeling software, transforms them into thin, virtual, horizontal cross-sections, and then creates successive layers until the model is complete.  It is a process whereby the virtual and physical models are almost identical.  DeviceLab, a full-service consumer and medical product company,  provides rapid prototyping and stereolithography (SLA) for their clients.

The Prototyping Process

Dac Vu of DeviceLab recently had this to say about the rapid Prototyping process of product development: “Think of it as a softer plastic molded over a harder plastic.  The inner hard plastic part is formed in a mold, then the softer plastic is poured over it.  The softer plastic over-mold has a better grip and a softer feel.  It is useful for hand-held devices such as cell phones and hand-held apparatus such as kitchen tools.”

Over the last couple of years, a new machine has been developed which prints the first mold and subsequently prints the second mold on top of the first.  This has revolutionized the prototyping process by decreasing the turn-around time to overnight.  Dac Vu states: “you can set up the process, push the start button, and the end product is ready the next morning.  It saves time and money and achieves the same result.”

Large Panel Prototyping

DeviceLab is a leader in large panel techniques.  “We work on medical carts requiring enclosures up to 4 ft. by 5 ft. by 12 in.”, comments Vu.  There are many options for prototyping techniques but only four options for large panels.  These include SLS, VFM, SLA, and CMC.  Of these, the most common and effective large panel prototyping methods are SLA and CMC.  SLA parts are as large as 22 in. by 30 in. by 60 in. and cover a wide range of materials, including transparent mediums.  The accuracy is high, surface finish is smooth, and fine details can be recorded.  CMC parts can be 2 ft. by 5 ft. by 10 ft., making them suitable for large MRIs.

Some companies take smaller panels and glue them together however this may compromise the integrity of the piece and there are apparent cosmetic flaws.  It is much better to construct in one piece, as in DeviceLab’s SLA process.  “It makes for a more robust unit and a better surface.  The majority of our medical carts are made with the SLA process”, says Vu.

About DeviceLab (www.devicelab.com) – DeviceLab is a contract medical device design and product development firm.  They are a full service company for mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services.  Experience includes User Interface (UI) Design, custom and cart development, medical device, industrial design, hospital equipment and lab instrument development.  Based in Orange County, CA, they serve Southern California (San Diego, Orange, and Los Angeles Counties) and medical device firms nationwide.

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DeviceLab Discusses Medical Device Marketing and FDA Approval in the U.S.

Posted on June 1, 2011 by derekrudnak

Developing a medical device is one accomplishment; bringing it to market is quite another. DeviceLab is a contract medical device design and product development firm with specialties in marketing.  Since its inception in 1998, DeviceLab has successfully helped medical device manufacturers bring over 100 products from the concept phase to market   Dac Vu, an engineer with DeviceLab, states “marketing a medical device in the United States requires passing a strict evaluation process by the FDA.  Domestic and foreign manufacturers must undergo one of two evaluation processes: a Pre-Market Notification 510(k), unless exempt; or, a Pre-Market Approval (PMA).

Details of 510(k) and PMA

In general, products requiring 510(k) approval are less risky/less hazardous to humans than products requiring PMA approval.  According to Vu, “the 510(k) process involves less time (taking about 2 to 3 months on average) and therefore costs much less than the PMA process. Products requiring PMA evaluation tend to have a higher risk factor, or have not been proven safe.  These products are looked at with closer scrutiny and must withstand lengthy clinical testing and data analysis (over a period of 1 to 4 years on average).  Plus it can cost millions of dollars.”

A Medical device classification is needed to determine which, if any, pre-market approval submission is needed.  Class I devices present minimal risk to the user.  They are simple in design and have been proven safe and effective.  Examples of Class I include tongue depressors and arm slings.  Most Class I devices are exempt from 510(k) and pre-market approval submission. Most Class II devices cannot assure safety and effectiveness with General Controls (as defined by the FDA) and typically require pre-market approval by 510(k) submission.  Examples of Class II devices include x-ray systems, pumps, and surgical drapes.  Class III medical devices have the most controls due to the level of risk they present to the user.  These products generally lack sufficient information to assure their safety and effectiveness.  Class III devices are usually involved in supporting or sustaining human life, or present an unreasonable risk of injury or illness (i.e. a replacement heart valve).  A PMA submission is almost always required for Class III medical devices.

You can go to www.fda.gov to view a list of devices similar to the one you are trying to bring to market.  This process is detailed and often requires a working knowledge in the field of medical device classification.  DeviceLab has experienced FDA consultants who can classify your device and assist you with the FDA approval submission process.

Visit www.devicelab.com to learn more.

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DeviceLabs Explains the Need to Patent Your Idea

Posted on May 25, 2011 by derekrudnak

We have all come up with a great idea, superb invention, or one-of-a-kind product and thought “…wow, I could make a million bucks if I just started selling now”. DeviceLab, a full-service consumer and medical product company in Orange County, California, has successfully brought to market over dozen of successful products.
Dac Vu, President and Founder of DeviceLab, has this to say about the patent process: “Inventors call me each week to present ideas and ask if they should obtain a patent. I tell them they can surge ahead without one but there are risks; or we can take them through the patent process and protect their idea.”

Should You Obtain a Patent?
Vu states, “Obtaining a patent is like creating a security fence around your invention or idea. You are making it more difficult for others to enter your market and infringe on your territory. In the course of researching a patent, you may find that a product like the one you want to bring to market is already patented. In this case, you might be infringing on someone else’s product. If you still want to proceed with your idea, you might find it necessary to make revisions so your ideas does not infringe.”
If you understand your marketplace and there are no major competitors present, it is possible to successfully launch your product without obtaining a patent. You would need to work quickly, though, as there is a small window of opportunity for being the sole product in any given marketplace. Soon, if your idea is successful and no patent was obtained, you will have many competitors offering bigger, better, and cheaper products just like yours. Additionally, if there is a large existing players in a market and you enter the same market with another type of product but do not obtain a patent, you are at substantial risk. Vu gives an example of how this works: “Let’s say you design a new widget better than an existing widget, but you don’t get a patent. The old widget, although inferior, has distribution and sales/marketing networks in place and can easily copy your design, market it, and outsell your product. In fact, the company who owned the patent to the old widget would most likely wait for the new widget to be successful and then they would improve upon your own unpatented design and bring it to market.”
“I recommend doing a preliminary search to find out if your product is already patented and determine if the market is crowded. The website for doing the search is www.uspto.gov . If there are too many competitors, you can abandon the idea before investing a lot of time and money. On the other hand, if your search is encouraging I would suggest hiring a patent attorney to assist you in the patenting process.”

About DeviceLab (www.devicelab.com) – DeviceLab is a contract medical device design and product development firm. They are a full service company for mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services. Experience includes User Interface (UI) Design, custom and cart development, medical device, industrial design, hospital equipment and lab instrument development. Based in Orange County, CA, they serve Southern California (San Diego, Orange, and Los Angeles Counties) and medical device firms nationwide.

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DeviceLab Completes Design Work on the Loewe™ On-Wheel Pump

Posted on February 17, 2011 by derekrudnak

DeviceLab, a full-service, product development company based in Orange County, California has recently completed design and development work on the Loewe™ on-wheel pump for Wheelpump Corporation. The patented device, integrated into typical passenger car wheels, is designed to offer improved safety, increased mileage and optimized tire performance.

Unlike the tire pressure monitoring systems (TPMS) that are federally mandated on all new light passenger vehicles in the United States, the Loewe on-wheel pump actually compensates for the under-inflation, maintaining proper tire pressure as the vehicle is driven under normal usage. This on-wheel pump weighs less than one ounce and takes up less than two thirds of a cubic inch of space. It is expected that automobile manufacturers and their suppliers will adapt the on-wheel pump designs to fit specific vehicles.

Dac Vu, President of DeviceLab, stated, “This was an exciting project for our team as we were actively involved in all steps of the process from proof of concept to the final build. We look forward to working with WheelPump on future projects.”

In working with WheelPump, DeviceLab used their LabVIEW expertise to be actively involved in many aspects of the project including electronics, prototype build, testing, proof of concept and mechanical engineering.

Tim Lee-Thorp, vice president of marketing at Wheelpump stated, “DeviceLab was a great partner in getting the on-wheel pump designed and engineered. Their expertise in taking ideas and making them tangible was outstanding.”

DeviceLab is a full-service design and product development firm, offering mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services. DeviceLab’s expertise involves taking a product from concept to market quickly and cost-effectively. Based in Orange County, CA, they serve Southern California (San Diego through Los Angeles) and medical device firms nationwide. More information regarding DeviceLab can be found at http://www.devicelab.com.

Wheelpump Corporation is a specialty engineering and manufacturing company based in Tustin, California. It provides design services, prototype fabrication and production component manufacturing of the Loewe™ on-wheel pump, which eliminates typical tire under-inflation. More information regarding Wheelpump Corporation can be found at http://www.wheelpumpcorp.com.

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DeviceLab Expands Graphical User Interface Development Team for Medical Projects

Posted on February 9, 2011 by derekrudnak

DeviceLab, Inc. has expanded its Graphical User Interface (GUI) and LabVIEW Development Teams to address a wide range of medical and diagnostic projects. The group has a 10-year track record developing medical equipment UIs.

Medical Product UI Developers
Medical Product User Interface

Quote startMedical UI’s involve art and science, a blend of ergonomics, engineering, system control, and graphic design.Quote end

Orange County, CA (Vocus/PRWEB) February 08, 2011

DeviceLab (http://www.devicelab.com) has been developing medical devices for over 10 years. The company has recently completed multiple UI development projects using LabVIEW, Photoshop and Illustrator. The UI development team is growing quickly, with the addition of new designers and engineers (Seehttp://www.devicelab.com/services/electronics-and-software/ui.php).

DeviceLab creates intuitive UI’s to give operators a seamless, natural experience when working with the equipment. Designs account for human factors as varied as the operator skill level, height and viewing distance. DeviceLab’s product development projects often include complex, electro-mechanical systems with feature-rich control software. DeviceLab applies both art and science to create interfaces that are intuitive, easy to use and flexible.

DeviceLab’s medical UI development process involves a close working relationship with the customer. This is illustrated by a UI that DeviceLab is currently developing for a new patient monitoring system. On this project, DeviceLab’s Project Manager first studied the customer’s requirements. Next, a detailed flow chart was created along with three sample screens designed using Photoshop and Illustrator. This was followed by UI development that addressed all system functions while taking into account human factors and appearance.

DeviceLab’s UI development team is growing quickly. The latest addition is Industrial Designer Bob Gibb. Bob brings a mastery of UI experience gained as a GUI designer at PV Powered and other firms. Another DeviceLab leader is Phil Morello, DeviceLab’s Director of Electronics and Software Development, with over 30 years experience in the field. Phil leads many of DeviceLab’s GUI development projects. Prior to DeviceLab, Phil led the engineering team at Newport Medical that developed the e500 Ventilator and its GUI interface. DeviceLab has developed UI’s for a wide range of medical devices. Past projects include surgical tools, diagnostic systems, laboratory equipment and consumer products.

“The UI design side of our business is growing rapidly,” said Dac Vu, President of DeviceLab. “Medical UI’s involve art and science, a blend of ergonomics, engineering, system control, and graphic design. These are all within DeviceLab’s expertise”

About DeviceLab
DeviceLab is a full-service, consumer and medical product development company in Orange County, Southern California. Established in 1998, the company has completed over 100 projects including 19 medical carts, 22 table-top instruments, 20 hand-held devices and 9 single-use, disposable medical devices. Disciplines include mechanical engineering, electronics, software, industrial design, ergonomics/human factors, prototyping, testing, regulatory affairs, patent/intellectual property and production ramp-up (including limited run and contract manufacturing). Clients include fast growing startups as well as Fortune 500 corporations.

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