When Technology Meets Medicine: 5 Regulatory Items to Look Out For

Posted on Wed, Feb 10, 2016

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When Technology Meets Medicine: 5 Regulatory Items to Look Out For

Many medical and digital health companies are moving into the realm of medical devices. Medical devices are an exciting, lucrative field with plenty of potential for new research and product development. It's no wonder companies like Samsung and Misfit (recently acquired by Fossil) are moving into the market.

There are many medical device regulations to protect consumers, especially in the United States. Some of these are on the state level, but most are handed down by the Food and Drug Administration (FDA). It's important to educate yourself extensively about regulatory requirements before entering the initial phases of your product's creation.

Remember that regulations are very complicated and can change quickly, and this is just an overview of some of the important items. You should always check to make sure your products conform to up-to-date FDA and state-level standards, and if you have questions, you should consult with a regulatory expert.

Why Regulate Medical Devices?

Many medical items diagnose medical conditions or provide other useful medical information to physicians or consumers. Consumers need accurate access to information, both to know about potentially serious medical problems and to avoid health scares or unnecessary treatments.

Medical devices that treat diseases are particularly important to regulate. They may, for instance, help doctors, nurses or patients administer doses of a medicine or another substance. That substance needs to be administered safely and at the proper dosage.

Finally, keep in mind that some things that may seem like medical devices don't actually qualify as medical devices in the eyes of the FDA. In this case, they're free of regulatory requirements. If you're uncertain if your product qualifies as a device, it's always best to contact the FDA for an official ruling.

Five Important Regulatory Items

There's a multitude of requirements put in place by the FDA, all of which medical device designers and manufacturers should keep in mind. Here are five of the important ones:

  • If your device is what the FDA defines as a medical device, then it, as well as your company, needs to be properly registered by the FDA. They need to know about it so they can regulate it appropriately, and you need to know exactly how your device is classified by the FDA in order to effectively maintain a regulated quality system.
  • The rules surrounding the labeling of medical devices are strict and extensive. As an example, you should always make sure that a medical device comes with documentation, including instructions for use, that's clear enough that a layperson should be able to operate it. (The final determination of what that means is up to the FDA.) You should also be sure that all labels are large and easily readable.
  • Device Tracking. For certain classes of medical devices, manufacturers must implement a tracking system that allows them to promptly locate commercially distributed devices in order to facilitate notifications and recalls ordered by the FDA. This is particularly important if the failure of the device could have lethal consequences, if the device is to be implanted in a body for longer than a year, or if the device is life-sustaining and used outside of a medical facility.
  • Device Reporting. In order to detect and correct problems in a timely manner, medical device manufacturers, importers, and use facilities must submit reports to FDA of any adverse reactions or deaths that occur in association with the product.
  • Design History File. One of the most important parts of a comprehensive FDA regulated quality system is a Design History File, which compiles all records that describe the design history of a finished medical device. A device’s DHF includes documentation of verification activities, design reviews and change orders, and all other records of design control that cover the entire life of a device, including any changes that may occur long after a product has been introduced to market.

Conclusion

The rules surrounding the regulation of medical devices may seem confusing or even arbitrary to many industry professionals. However, FDA regulations are of vital importance to protect consumers.

Business owners and product designers should make sure to educate themselves extensively about the FDA's regulatory requirements, as well as any state-level regulations for manufacturers and distributors. By doing this, you'll avoid potentially expensive lawsuits down the line, as well as damaging bad press.

 

Contact Us! We'd love to chat about how we can help get your Medical Device  from conception to market. 

Sources:

http://mobihealthnews.com/48796/time-is-ripe-for-big-consumer-brands-to-move-into-regulated-medical-apps-devices

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051521.htm

http://www.emergogroup.com/sites/default/files/file/usa-fda-labeling-21-cfr-part-801.pdf

http://www.emergogroup.com/sites/default/files/file/usa-food-drug-cosmetic-act-chap5-subaande.pdf

http://www.emergogroup.com/sites/default/files/usa-fda-medical-device-reporting-21-cfr-part-803.pdf

http://www.emergogroup.com/sites/default/files/file/usa-fda-establishment-registration-device-listing-21-cfr-part-807.pdf

 

 

 

 

Tags: medical device design, FDA, mobile health, Technology, digital health

Last Chance to Enter This Year's Medical Device Excellence Awards

Posted on Wed, Jan 20, 2016

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The deadline to enter the 2016 Medical Design Excellence awards is near! The Medical Design Excellence Awards (MDEA) program recognizes achievements in the design and development of medical products. Medical product manufacturers, suppliers, engineers, scientists, designers, and clinicians are celebrated each year for their contribution in creating the groundbreaking products that are improving outcomes, saving lives and changing the face of MedTech.

Fallbrook Engineering's President/CEO Richard Meyst has previously served two three-year terms as a juror at these awards and encourages any company that has an innovative medical device to enter the competition.

The standard rate entry deadline for the 2016 Medical Design Excellence Awards is Sunday, January 24. Please see the MDEA Program Overview for all entry criteria and fees. MDEA finalists will be announced in May on www.mddionline.com and in the print issue of Medical Device and Diagnostic Industry (MD+DI), and awards will be presented at a live ceremony at MD&M East in New York on June 14, 2016.

 

Tags: MD&M East, MDEA, MDDI

Top 8 Industrial Design Products You Should Buy in 2016

Posted on Wed, Dec 30, 2015

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Top 8 Industrial Design Products You Should Buy in 2016

2016 is here! It's time to look at new trends in design and new and updated products that are coming on the market in the new year. If you are a fan of industrial design, the following products are must-haves for the coming year.

  1. Skully Helmets AR-1: The AR-1 by Skully Helmets takes motorcycle safety to the next level. This SmartHelmet combines head protection with Bluetooth capability, GPS navigation, a Heads-Up Display and a rearview camera. Riders can't afford not to switch to the AR-1.
  2. Indus Outdoors: This startup company is combining industrial design with upcycled products. Indus Outdoors is soon to release a product line of walking sticks made from upcycled materials. Get out and enjoy nature while helping preserve the planet.
  3. Whirlpool Ventless Heat-Pump Dryer: Clothes dryers consume more energy each year in the United States than any other appliance. The Whirlpool Ventless Heat-Pump Dryer combines industrial design with energy conservation to give consumers a more energy efficient appliance that is easier to install in any home.
  4. DeviceLab Futuristic IoT Hospital Bed: This bed promises to revolutionize patient care in hospitals and clinics. The bed is an ergonomic design, giving the patient more comfort, and allowing medical providers to give better care. In addition, all of the electronics, monitors and other needed systems are integrated into the bed. No more wheeling heavy diagnostic equipment from room to room to care for patients.
  5. DuoGard Bike Racks and Shelters: For those who want to conserve energy and increase physical health, riding a bicycle to work is a great option. However, no one wants to come out after a hard day at the office to find their bike stolen. DuoGard has created a wide line of industrial bike racks and shelters to safeguard bicycles and create products out of recycled materials.
  6. iHearty Biomedical Device: This device uses an acccompanying smartphone app to allow users to take an accurate physiological monitor with them anywhere. This device is all you need; it is no longer necessary to carry multiple devices around to collect the data you want. iHearty allows everyone to record baseline measurements any time, anywhere. These measurements can be used to build a database that could enable improved detection of diseases and illnesses.
  7. Phillips HF3520 Wakeup Light With Simulated Sunrise: Before you can even think about your morning commute, you have to wake up and leave your bed. And let's face it - that can be difficult. The Phillips HF3520 Wakeup Light will wake you up with a gradual, colored sunrise. This will give you more energy and an improved outlook on the world.
  8. CareView 1500C Digital Flat Panel Detector: This flat-panel detector is made of extremely lightweight aluminum alloy, and can be folded for increased portability. The industrial design is attractive and simple. The device contains a highly-sensitive image sensor, and can be used to take X-rays without the need for patients to be transported to an X-ray lab.

These are just a few of the innovative products on the market in the industrial design field. There are hundreds, if not thousands of new products that will be available in 2016. Design has a huge impact on user experience and can be the defining factor between a customer choosing your product over the competitor.

 

For more information on product development, give us a call! 

Tags: Project Engineer, design engineering, product development, industrial design

5 Common Mistakes in Developing New Products

Posted on Mon, Dec 28, 2015

Getting a new product idea can be thrilling and exciting, though it is certainly far from being a walk in the park. Finishing the prototype is only half the battle won, and there are many challenges that you will encounter on the way to actual product development that might make your product fail.

 

In fact, according to the Product Development and Management Association, the healthcare industry has a 35 percent failure rate in developing new products. It may not seem much, but the FDA's Center for Devices and  Radiological Health said that 82 percent of all the medical devices it reviewed contained some quality-related deficiencies.

 

No one wants to fall into that failure margin, especially since being 'just good enough' is not an option in developing medical devices. In this field, reliability is the name of the game, and there is no room for the following five common mistakes in new product development:

 

Mistake #1: You did not conduct proper market research.

 

It might seem like a good product idea at first, but it will not thrive unless it answers the demand of your consumers. The lack of research development may not be able to predict unforeseeable market circumstances like recession and global economic downturns, but at least it will enable you to know what your target market really wants, not merely what you want.

 

How to make it right: New product development is not solely the turf of product managers and engineers. The product development team should also involve marketing people, who should already be present right from the very beginning. It is their job to understand the target market and its needs and relay this information to the product developers.

 

Mistake #2: You jumped right into product development without strategizing and conceptualizing.

 

According to M3 Design, product development can be reduced to three phases: strategy, concept, and development. Due to lack of resources like time and finances, most small companies tend to jump right into the development phase, skipping the critical steps that involve identifying the target market's needs, defining product specifications and system-level architecture, and selecting the product concept. This makes product development a lot riskier than usual, substantially increasing unnecessary costs and resulting in schedule delays.

 

How to make it right: Slow things down and build the product the right way. The strategy phase will help you discover your strategy in creating and delivering your product to your target market while the concept phase takes the results of the strategy phase and helps you determine the optimal form that your product should take. Only then can you develop the product, validate the design, and manufacture it.

 

Mistake #3: You focused on the features rather than the benefits.

It is very easy to simply focus on the product and its myriad of features, especially in the case of technical or highly complex products. This makes you lose sight of the fact that you are creating this product for your consumers, resulting in a complicated mess of an item that only gives marginal benefits to your users for a hefty price tag.

 

How to make it right: Keep things simple. Your product's value proposition should speak to the benefits, not the features. Remember, your product is trying to solve a problem that your customers have, so always go back to that basic notion to make sure that you are delivering a useful product to your target market.

 

Mistake #4: You underestimated the costs and timeframe.

 

You might overlook the manufacturing costs during the creation of the prototype, but a majority of product costs should be determined by design decisions early in the development phase. Not doing so can significantly reduce quality, provide you with the wrong materials, and balloon up costs. Similarly, the back end of the development phase can be a lengthy process that can create major schedule delays.

 

How to make it right: Do not wait until the design is complete to engage with suppliers. Get design feedback from your production supply chain early on in order to reduce manufacturing costs, improve product quality, and reduce development time. Similarly, allot six months or longer for back-end activities to prevent them from affecting your overall schedule.

 

Mistake #5: You misunderstood the regulatory requirements.

 

Not following regulatory affairs can be very costly due to possible insufficient design, uncertified components, and incorrect test methods. Product certification is also a complex process that requires a great deal of preparation to ensure that the product passes rigorous regulatory requirements.

 

How to make it right: Research all the regulations for your product early on in the development phase. If necessary, speak with a consultant from a product development firm to make sure that you are on the right path. You should also pay careful attention to potential changes in standards since these may change mid-project.


Mistakes in product development are part of the process, but they can be avoided with foresight and proper planning. This will ensure that your schedule, budget, and quality needs are met, and the product ends up successful in the market.


 

Tags: risk management, startups, product development

Biocom Presents "Insights into Medical Device Selection in Hospitals: How they Evaluate and Select Products" - December 1, 2015

Posted on Tue, Nov 24, 2015

Join Fallbrook Engineering at the next Biocom Medical Device Breakfast, which will focus on new technology assessment in the hospital market.

On December 1 from 8 am to 10 am at Biocom in San Diego, Biocom's Medical Device Comittee will host speakers Bruce A. Rainey of Scripps Health and Anne Marie Watkins of Kaiser Permanente. CEOs/COOs, Chief Commercial Officers/Marketing Heads, Entrepreneurs, Investors, and any companies developing and commercializing new medical devices, diagnostics, and equipment are encouraged to attend the breakfast and discover the ins and outs of a hospital's process for evaluating and choosing new medical technology. 

For more information and to register, please visit BIOCOM's event page.

Biocom is a member driven organization that offers companies meaningful access to the influential drivers propelling the industry forward across all major life science sectors, including biotechnology, pharmaceutical, diagnostic, medical device, connected health, agriculture, and bio-renewable energy.

Tags: biotech, events, San Diego, BIOCOM

Associate Spotlight: Principal Design Engineer

Posted on Tue, Nov 17, 2015

Fallbrook Engineering's newest Principal Design Engineer, Mr. Ken Bloch, brings his extensive background in Global New Product Development, Design, Mechanical Engineering and Graphics to Fallbrook Engineering's portfolio of expert associates and Outsourcing Services.

For over 30 years Ken has led a diverse career in military, mainframe computer systems, satellite communications, cellular communications, biotech, medical and consumer product development. He has facilitated and been an innovative participant in product brainstorming meetings with his ability to sketch, draw and rapidly visualize conceptual ideas. He has been granted nine U.S. design and mechanical utility patents and several of the products he designed and developed have been featured in design and trade magazines. 

Ken graduated with honors in Product Design from Santa Barbara Art Institute, after receiving his associate degree in art and art history from Riverside City College. He has excellent machine shop and model shop skills and is an experienced prototype developer. Ken is familiar with most metals and fabrication methods including forgings, castings, extruding and all sheet metal processes. He has extensive background using polymers used with injection molding, pressure forming and vacuum forming. Ken also has more than 20 years using 3D CAD and knowledge of many 3D printing and rapid prototyping methods. 

Fallbrook Engineering President and CEO Richard Meyst said, “We are very pleased to have Ken on our team as we are able to share with our clients Ken’s great creative skills and broad technical expertise that are based on years of successful product development. Ken brings a lot to the table.” Please join us in welcoming Ken to the Fallbrook Team.

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Portable Nanogen Biochip Unit -
design to prototypes

Biochip Cartridge - design through to production
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Next Generation Nanogen Instrument -
industrial design
Blood Analysis Cartridge
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Medium Computer System -
chassis design, cooling & illustration
Lab on a Chip Interfaces -
mechanical, optic, fluidic, electronic, chemical, thermal

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Stroller - design & prototype Baby Carriage - design

 

 

Tags: medical device design, associates, design engineering

Upcoming Essential Events for Medical Device and Biotech Startups

Posted on Fri, Feb 06, 2015
MD&M West 2015

Fallbrook Engineering recognizes the importance of supporting startup companies in the healthcare industry, and we're excited to participate in this year's 30th anniversary MD&M West Conferences in Anaheim on February 10, 11 & 12. This is the largest Med-Device event of the year and not something to miss.

This year's conference agenda includes a Financing, Funding and Startups session track that will provide resources and information for companies of all sizes looking to develop a valuable new product. The session will start on Wednesday, February 11, at 10 a.m. with "Startup Shark Tank California," followed by "How to secure funding from a Financier's perspective." The session will wrap up with an expert panel where Fallbrook's Richard Meyst will discuss the "Secrets to a Successful Startup" with David Mills of Dallen Medical and David J. Cuccia of Modulated Imaging. In anticipation of this expert panel, MDDI magazine has published an editorial from each speaker outlining the elements of a successful startup. Read Richard's "5 Practical Tips on Developing a Successful Startup" at MDDI online.

Early bird rates for the conferences are not available this close to the event date, but online registration is still discounted from at-the-door pricing. Visit the MD&M website to register now for your expo and conference passes.

Fallbrook Engineering's interest in supporting and mentoring medical device startups continues with announcement of the continuation of our Product Development for Medical Technology Startups Series of seminars and expert panels. Once again we will be collaborating with Molecular Diagnostics Consulting to bring insightful, valuable information and advice to Med-Device startups of all kinds. So stay tuned, more information on the next event in the series will be available shortly.

Tags: Workshop Series 2014, MD&M West, startups, MDDI

Join Fallbrook Engineering at MD&M's 30th anniversary event

Posted on Fri, Jan 09, 2015
MDM West 2015

Register now to join Fallbrook Engineering at America's largest medtech event.

Fallbrook Engineering will continue their focus on successful practices for medical device and biotech startups by participating in this year's 30th anniversary MD&M West conference. Along with representatives from Dallen Medical and Somersault Orthopedics, Fallbrook President/CEO Richard Meyst will participate in the panel discussion "Learn the Secrets to a Successful Startup" on Wednesday, February 11.

Feb. 11 Conference Agenda - MD&M West 2015

Early bird rates end January 16 and conference sessions fill up fast, so sign up soon. We hope to see you there!

To view the full conference schedule and register to attend, please visit the MD&M West 2015 website.

Tags: events, MD&M West, startups

Fallbrook Associate Spotlight: Medical Device Executive

Posted on Thu, Dec 11, 2014

Fallbrook Engineering is pleased to announce that Ed Boarini has joined our team as Senior Associate.

Mr. Boarini is a successful global business executive with over 35 years of experience in medical device commercialization spanning the product life cycle from concept to commodity. He is familiar with FDA Class I/II/III and his hands-on experience ranges from high-volume disposable products to long-term implant devices in a wide variety of diverse medical specialties. He has devised strategies that drove growth through operational efficiencies, market insight and tactical implementation.

In his various leadership roles Mr. Boarini set the direction and scope of strategic planning, business development and acquisition activities and led key R&D and marketing initiatives driving innovation and leading-edge capabilities across various technology platforms. His technical expertise ranges from custom extrusions, catheters, performance fibers, injection molding and metal fabrication through numerous end-user products ranging from urological catheters to interventional GI products.

In one of his most recent roles Boarini led Teleflex Medical OEM as SVP/GM from 2007-2012. Prior to Teleflex Medical OEM, Boarini accumulated over twenty-five years of executive management experience with several large medical device corporations including Baxter Healthcare, Boston Scientific, and CR Bard.

Mr. Boarini is a successful senior executive with an extensive background in design development and commercialization of medical devices.  He is a proven contributor to corporate growth, profitability and intellectual property estate.  Mr. Boarini earned a Bachelor of Science in Biology from the University of Illinois and a Master of Science in Technology Management from Pepperdine University.

Tags: medical device design, associates

Another Successful Evening Discussing Product Development for MedTech Startups

Posted on Fri, Nov 07, 2014

 

Panel Discussion: Product Development StrategiesFallbrook Engineering was excited to once again collaborate with Molecular Diagnostics Consulting in the second event in a series outlining Product Development for Medical Technology Startups. Last night's event featured a panel of industry experts familiar with every stage of product development, from funding and marketing to process control and intellectual property. All in all it was a successful evening filled with great networking opportunities and valuable information.

Thank you to all who participated!

 

Featured exhibitors:

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Westpak, Lab Fellows, Hera Labs, GattaCo, Bartz Consulting

Featured expert panelists:
Marliese Bartz, Bartz Consulting
Iryna Clark, InceptPoint
Madhushree Ghosh, AltheaDx
Susan Gorman, Gorman IP Law
Martin Kleckner, TriTech SBDC
Mark Sarno, Vision Biotechnology Consulting

 

Information for the next event in early December will be available shortly. 

Tags: molecular diagnostics, Workshop Series 2014, events