5 Medical Devices Keeping Us Cool This Summer

Posted on Mon, Aug 08, 2016

The summer sun is beating down, the air conditioning is blasting, and people everywhere are trying to beat the heat. But what about when you're dealing with more than a little bit of discomfort? Fevers and heatstroke can be serious, and medical device technology has come a long way in monitoring body temperature. Here are some of our favorite new medical devices to help you better keep an eye on yourself and your loved ones so you can track fevers and help prevent heatstroke.

Kinsa Smart Thermometer

This Indiegogo-funded thermometer not only takes your temperature, but it can also provide medical guidance. The Kinsa keeps individual records for each member of your family, tracking fever, symptoms, and medications through their app. Using this information, the Kinsa will give advice on how best to proceed, giving you a nudge to see a doctor when the time is right. Since the app saves data for every family member, it can be extremely helpful when you go in to see a healthcare provider, because it will give them a whole picture of your symptoms, an accurate time frame, and the medications that you've been taking.


You've seen wearables before, but have you seen one you actually put in your mouth? The SMRT MOUTH device is specially designed for athletes interested in monitoring performance and making sure they don't exceed their limits. Heat-related injuries are common in sports and can occasionally be fatal--in football alone, there have been 53 deaths since 1995 simply from over-heating. The SMRT MOUTH mouth guard delivers real-time biometric data and tracks circulation, respiration, exertion, hydration, and more to allow coaches to keep an eye on their player's health and prevent heatstroke.

Fever Scout

If you have little ones, you've dealt with the struggle of caring for them when they get sick. In keeping an eye on their fever, you're forced to take their temperature by using thermometers that have to go in their ears, under their tongue, or across their forehead, which can just exacerbate their discomfort. The Fever Scout device eliminates this need. The soft wearable device provides constant temperature monitoring that you can view from your smartphone or tablet, allowing you to monitor their temperature from anywhere without using an invasive thermometer. That way, they can get maximum rest, and you can take comfort in the fact that you have a constant, accurate reading of their temperature.

Spree Wearables

Another device for those of us who like to get active, the Spree Wearables line provides biometric tracking in a unique way. Using data provided from the forehead--the most accurate place on the body to determine temperature--the Spree Smartcap and Headband use medical-grade technology to let you keep an eye on your body. Using the app, you can view real-time information about your fitness progress including heart rate, speed, and of course, body temperature. Before Spree, you would need to wear multiple devices to obtain this much data about your workout, but now a simple headband can tell you everything you need to know so you can push yourself to your limits without exceeding them.

Fever Smart

The Fever Smart patch has many uses. First and foremost, it's a wearable device that constantly monitors your body temperature, allowing you to keep an eye on your fever. Additionally, it can be useful for women planning to get pregnant so they can more closely monitor their basal body temperature. When it comes to illness, the Fever Smart is unique because it will actually alert you when temperatures rise or reach unsafe levels. It has been used in hospitals to allow nurses to have a constant stream of data about their multiple patients so they can better use their time to attend to those that need it most. Their incredible technology is changing lives, and Fever Smart is currently looking to work with government officials to distribute their product to countries with a high Ebola risk to assist in early detection to reduce the spread of the disease.

Tags: wearables, medical devices, summer, thermostat

Product Lifecycle Management (PLM) of Medical Devices

Posted on Mon, Aug 01, 2016

Product lifecycle management (PLM) is a systematic approach to managing the series of changes a product goes through, from its design and development to its eventual disposal.

When it comes to PLM of medical devices, particular vigilance has become necessary in recent years. This is because of high-profile incidents of counterfeit parts unearthed by the FDA and superbug outbreaks that have come about because of the use of unsanitary duodenoscopies as reported by the CDC. Such incidents have a negative impact on patient safety.

To this end, Radio-Frequency Identification (RFID) tracking has been introduced as part of PLM of medical devices. It is very useful for device manufacturers who can use it to prevent counterfeiting and to ensure that the required cleaning and sterilization protocols are observed.

RFID tracking is also helpful in tracking products when they are recalled. Manufacturers can significantly improve their PLM capabilities from the design and development phases right through to the purchase of medical devices, their use, and disposal. This has a positive ripple effect for everyone in the chain from the manufacturer to the user of the medical device.

The PLM process has three stages;

  1. The Beginning of Life which is the stage of new product development and design.
  2. The Middle of Life which is the stage of collaborating with suppliers, taking care of product information management and management of warranties.
  3. End of Life which is the disposal of products or their discontinuation or recycling.

The FDA regulatory process for medical devices is generally significantly shorter and less strict and costly than the process of drug approval. It takes between three and seven years from idea conception of a medical device to getting it out in the market.

The PLM process for medical devices is done following the Medical Device Amendments of 1976 to the Federal Food Drug and Cosmetic Act. Within the framework of the current FDA policies on medical device approval, a lot of new regulated devices fall under Class III. This is the class of devices that support or sustain human life or that are significantly important in preventing the impairment of human health. These are also devices that pose a potential, unreasonable risk of injury or illness.

Manufacturers are allowed to request that their devices are put in Class I, which is the category of low-risk devices, or Class II, which is for moderate risk devices. The petition can be made if a device has only minor differences from devices that have been approved.

Class III devices are subject to FDA premarket approval (PMA) requirements. Those in Class I and II are also subject to these requirements, but they are less stringent. PMA is the strictest type of device marketing application that the FDA requires. It is required for new devices that have no existing equivalent or pre-existing predicate. PMA approval can only be granted if the FDA determines that a new device can be supported by enough scientific proof of its safety and effectiveness.

PMA is followed by a Premarketing Notification. This is a fast-track process where a device has to be demonstrated as  significantly equivalent to a similar device that is already in the market in terms of safety and effectiveness. The pre-existing device or predicate has to have PMA or a Premarketing Notification. A Premarketing Notification -which is also known as 510 (k) application - needs to be submitted at least 90 days prior to the device being marketed.

The last stage specifies how a medical device should be maintained while it is in use. FDA also has laws on when a medical device is no longer considered safe. This may be after it has been used for a specific period of time or when certain signs of wear and tear appear. A device is then declared dead and is required to be disposed of in accordance with the FDA rules for disposal of medical devices.


Patient safety is the FDA’s top priority with the PLM process. It should be the first concern of manufacturers as well. With RFID technology and adherence to FDA PLM regulations, it is a goal that is within reach.

The use of PLM software can also help a manufacturer and health care provider to manage the lifecycles of their products. This is done through a data warehouse that has all the information about a product.

Tags: medical device design, FDA, medical device, product lifecycle

8 Surprising Ways Medical Devices are Hacked

Posted on Tue, Jul 12, 2016
From implantable cardiac defibrillators to CT scanners, thousands of medical devices are at risk of a security breach, something that could put providers and patients at serious risk. Here are eight ways a medical device can be hacked and what manufacturers need to know before building a device.

1. Hardware

A lack of hardware-based encryption in a medical device — which can lead to devices like digital radiography panels and acute ventilators being exposed to a cyber attack — has caused security concerns. British company Accutronics has developed a series of smart batteries and chargers that utilize SHA-1 hardware encryption, a technology used by the NSA to detect whether a piece of hardware is genuine or fake. Also, device manufacturers need an effective risk management strategy that identifies hardware security flaws during the manufacturing process.

2. Software

More than 300,000 Americans are given a wireless implantable medical device (IMD) — such as a pacemaker or drug delivery pump — every year; however, hackers can infiltrate the software that powers these devices, change the default settings and perform remote commands. The Food and Drug Administration (FDA) has implemented a software security blueprint — the Infusion Pump Improvement Initiative — for manufacturers. The federal agency hopes the initiative increases user awareness of possible security breaches and facilitates design improvements that prevent devices from being hacked.

3. Medical Device Design Phase

Hundreds of medical devices are at risk of firmware security flaws, many of which are exposed during the device design phase. The FDA has issued guidance on how manufacturers should overcome these obstacles from the onset: “Manufacturers should consider cyber security during the design phase of the medical device as this can result in more robust and efficient mitigation of cybersecurity risks,” the agency says. Programmers should also perform source code analysis to catch firmware errors before a device is submitted for FDA approval.

4. Ransomware

Dubbed the single biggest security concern in 2016, ransomware in medical devices takes control of a wearable, blocks access and demands money — typically the digital currency Bitcoin — from the user. Hackers only need to make small modifications to a device's malware for ransomware to wreak havoc.

5. Hard-Coded Passwords

Researchers Billy Rios and Terry McCorkle of global cyber security company Cylance revealed that hard-coded password vulnerabilities affected 300 medical devices manufactured by 40 different vendors in 2013. Hackers could have exploited these vulnerabilities and changed the firmware and critical settings in a device. The FDA recommended against the use of hard-coded passwords to prevent unauthorized device access.

6. Firmware Updates

Hackers can now alter device readings and drug dosages after a firmware update. There are a number of precautions manufacturers can take to mitigate these problems. They can create devices that require user authentication before an update is downloaded onto a device and restrict updates to authenticated code. Users should be educated on the importance of keeping their device safe, too. Manufacturers can display security guidelines prominently on their web sites in user manuals.

7. Cloud Technology

Many device manufacturers now use cloud-based data repositories. If hacked, valuable data could be exposed. Manufacturers need the right infrastructure to handle major security breaches like this and identify physical and technological threats quickly.

8. Interoperable Devices

Interoperability is another major security concern for device manufacturers. The FDA recently addressed the topic in “Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices,” released in January. The federal agency recommends that manufacturers identify the level of interoperability needed to achieve their goals and ascertain the type of data exchange that is taking place when different devices are connected.

Tags: medical device, medical, telemedicine, hackers, cybersecurity

3 Medical Device Trends to Watch Out For

Posted on Mon, Jun 27, 2016

The medical device industry is booming. A huge $172 billion was spent on medical devices in 2013, up from $34.6 billion in 1989. Digital innovations — borne out of clever design and the latest feats of engineering — are spearheading industry growth, with a treasure trove of new devices expected to hit the market this year and much more in the pipeline. Here are three medical device trends to watch out for in the future.

  1. Telemedicine is Getting Smarter

While telemedicine isn't new, remote monitoring devices have swelled in popularity, with seven million patients predicted to use this technology in 2018. The concept is simple: you can check self-administer medication — for example, insulin if you have diabetes or antihypertensive medication if you have a high blood pressure — and send pools of data about a medical condition to your doctor without leaving your home. Expect this technology to skyrocket in the future. At the recent Consumer Technology Association 2016 Digital Health Summit, a remote diagnostic device called MedWand — which incorporates, among other features, a stethoscope, a three-lead electrocardiogram, and an otoscope — created a massive buzz. Creator Dr. Samir Qamar hopes his device will become commonplace in schools, nursing homes, and workplaces. At $250, the device is competitively priced for the commercial market, too, allowing you to measure your heart rate and blood oxygen level at home. Like all telehealth devices, MedWand benefits the elderly, chronically ill and rural patients who can't access specialty services.

  1. It Will Be Easier to Get Medical Devices to Market

Two recent FDA reforms could revolutionize the way manufacturers get medical devices to market. In March, the agency announced a new "lean management model" that aims to improve consistency and efficiency in combination product review. In April, a new committee — the Combination Products Policy Council — planned to centralize the review process for combination medical devices, a change that will hopefully shorten waiting times and encourage more innovators to submit their products for approval. There are still barriers that businesses need to be aware of when entering the market, such as the FDA's stringent review procedures; however, if these new developments streamline combination product review, you could see a host of game-changing products on the market in the next few years.

  1. The Rise of Big Data

Big data is having an enormous impact on medical device production across the board. One emerging trend is the creation of technology that enables devices like ultrasound and X-ray machines to interpret patient data. In fact, devices could soon analyze masses of data and identify diagnostic patterns without the need for human intervention. A smart device that makes use of big data might draw from sources such as medical records, diagnostic results, weather reports and body-worn sensors. Although this technology is still in its infancy, several manufacturers are creating revolutionary products that you might see in a hospital soon. For example, BATTELLE EluciData, a healthcare data analytics tool, utilizes pattern recognition and provides healthcare professionals with deep insights.

The medical device industry — worth $136 billion in the U.S. — is evolving rapidly. In the near future, expect remote monitoring devices to get smarter and big data to transform the diagnostic process. Also, FDA reforms should make it easier for manufacturers to get combination products to market in a quicker time frame, something that will benefit both patients and practitioners.  

Tags: medical device design, medical device, telemedicine

Fallbrook Engineering Welcomes New Expert Associate

Posted on Mon, Jun 20, 2016

Joely_cropped.jpgFallbrook Engineering is pleased to welcome Joely Gardner, PhD, to our team of expert associates.

Dr. Gardner is a highly experienced human factors and usability testing expert who specializes in medical devices, software, and web-based applications. She has done usability testing and voice of customer research projects for companies such as Bespak Injectables in the UK, Mitchell Medical, ThermoFisher, Quest Diagnostics Clinical Trials Division, and Cardinal Health. She also works with technology companies like Sony to bring the voice of the customer into early-stage product development efforts. According to Dr. Gardner, “It’s both a pleasure and an honor to be associated with Richard Meyst and Fallbrook Engineering, a firm with a distinguished history of innovative design and engineering excellence.”

Dr. Gardner is committed to the rigor required for the effective combination of quantitative and qualitative research methodologies and the use of appropriate statistical analyses to document safety and efficacy studies for FDA and other regulatory bodies. “Fallbrook Engineering is excited to have an expert of Dr. Gardner’s experience and expertise available for our clients’ design projects,” said Fallbrook CEO Richard Meyst. “With FDA’s increased focus on human factors and usability as a key element of risk management as outlined in the recently issued Guidance, Applying Human Factors and Usability Engineering to Medical Devices[1], Dr. Gardner’s involvement can ensure products we design are done to the latest standards,” Meyst added.


Usability testing and analysis is critical in medical device design because it helps ensure a product is safe and effective for its intended users, uses, and environments. While FDA stresses the importance of usability engineering mainly to minimize use errors and their resulting harm, human factors research is also key to creating a successful, marketable product that maximizes ease of use and user satisfaction. The benefits of considering human factors in design are evident throughout a product’s entire life cycle, and Fallbrook Engineering is happy to have Dr. Gardner join our team as an invaluable resource for our clients.


Dr. Gardner currently chairs the Education Committee of SDRAN (San Diego Regulatory Affairs Network) and is a part-time faculty member at California State University at Fullerton in the Certificate Program for Customer Experience and User-Centered Design.


[1] Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued February 3, 2016 http://www.fda.gov/downloads/MedicalDevices/.../UCM259760.pdf

Tags: associates

Will Wearable Medical Devices Take Off? Here's What We Think

Posted on Mon, Apr 04, 2016

Will Wearable Medical Devices Take Off? Here's What We Think

From smartwatches that track daily fitness activity to patches that detect blood glucose levels and monitor breast health, wearable medical devices are the latest fad in health care these days. According to a report published by IndustryARC, the wearable medical devices industry is estimated to reach a market value of $41.3 billion by 2020, up from 2015's $15.7 billion. This translates to an annual growth rate of 21.3 percent from 2015 to 2020—proving that the potential of the wearable medical device market is practically infinite.

How Wearable Medical Devices Impact Healthcare

Thanks to these devices, data collection and healthcare management have become easier for all of us. Physicians are provided with a steady stream of data about how their patients are doing despite infrequent checkups. Some wearable technology automatically sends data about organ function and disease markers straight to the physicians, hence giving them access to in-depth information when they are trying to diagnose a disease or monitor a chronic disease like diabetes.

There are even wearables specifically designed to assist doctors with their medical procedures. For example, Google Glass is now being worn by a number of surgeons and medical students during surgeries in order to give them the perfect point of view while doing the procedure.

On the other hand, patients are also quickly adapting to the new industry as it allows them to take responsibility for their own health. A decade ago, patients relied on a physician's professional opinion to monitor their treatment and health progress. With wearable medical devices, they can educate themselves and make decisions on their own health issues.

Even portable pain relief devices are being developed in order to eliminate the need for daily pain medication for over 1.5 billion chronic pain sufferers all over the globe. An example of this is the Transcutaneous Electrical Nerve Stimulation (TENS) patch, which delivers low-voltage electrical stimulation to alleviate pain. It is connected via Bluetooth to a smartphone app that allows physicians to track and manage the patient's pain.

It is certainly a win-win situation for both sides of the health care spectrum as these devices enhance doctor- patient interaction.

Security Problems in the Wearable Medical Devices Industry

But like any new industry, the wearable medical device market is also facing a number of challenges. Foremost of these are cyber security and privacy concerns, as hackers can compromise medical devices to gain access not just to a patient's health record but also to complex hospital networks. More often than not, these security and privacy risks are only exposed once hackers have successfully infiltrated the system and created media waves.

In order to solve these security problems, we think that wearable medical device manufacturers should establish a secure hardware and software development process from the very beginning. This should include secure code analysis so that vulnerabilities are quickly identified. There should also be security-related testing before it is released to the market. The deployment process should also include cross-authentication of both the device and the network so that the device does not transmit confidential information to a ghost network.

With proper cyber security, we believe that these wearable devices can deliver better medical services, reduce the cost of healthcare, and improve the overall quality of life for its users. Once this core challenge is solved, then we will probably see the market start to explode with growth and opportunity.

Tags: medical, healthcare, wearables, medical devices

What You Need To Know About HIPAA Compliance

Posted on Mon, Mar 28, 2016


What You Need To Know About HIPAA Compliance

The Health Insurance Portability and Accountability Act of 1996, better known as HIPAA, has been in place for two decades and by now most Americans notice private health information disclosure warnings in familiar places like doctor’s offices and pharmacies. However, you can find yourself in the position to trip up if you encounter an electronic transmission of an individual’s protected health information in practically any business. HIPAA violations come with penalties, and it is worthwhile to learn how to avoid them.

What is HIPAA?

HIPAA contains multiple regulations that mainly fall into two categories. The first category affects how group health insurance plans determine coverage and when new employees can obtain coverage after changing jobs. The second category regulates how health providers, insurance companies, and employers handle private health- related information.

There are a few key concepts any company must understand about HIPAA privacy rules:

  • Protected health information (PHI) is a broad category that includes all individually identifiable information about health care or status - including payments for medical care - that can be linked to a specific person.
  • The HIPAA privacy standards apply to health plans, health care providers, health care processing clearinghouses, and business associates such as claims processors and billing companies.
  • There are specifically permitted uses of PHI for companies that must comply with HIPAA’s privacy standards. For example, they may disclose PHI to the person who is the subject of the information or for purposes of treatment or payment. The disclosure, however, must never be more than necessary.

Violating the act can be costly. Civil violations range from a minimum $100 up to $50,000 penalty per violation, with a maximum fine of $1,500,000 per year. If the violation is wilful, a person who violates the privacy rule can be both fined and sentenced to time in prison.

HIPAA Compliance Roadmap

Like many government compliance issues, businesses can cut down on headaches by adopting strict policies that adhere to the law. To avoid HIPAA privacy violations:

  • Limit access to PHI to only those who absolutely need it.
  • Protect PHI with passwords.
  • Draft a written policy for handling health information and present it to employees.
  • Appoint a security officer to make sure the company complies with the written policy.
  • Apply the written policy to vendors, consultants, and other business associates by requiring them to sign a PHI agreement.

You are wise to put these policies in place at the outset of business rather than try to implement a new plan after non-compliant practices have begun.

Products to Avoid HIPAA Violations

There are number of products now available to help a business avoid the pitfalls of HIPAA.

  • HIPAA training programs can bring an organization into compliance and provide a training regimen for employees and certification for the business.
  • Digital document collections provide HIPAA-compliant customizable templates for offices.
  • Specialized office equipment can protect privacy. Some examples include HIPAA-complaint paper shredders and computer screen filters.

Ben Franklin is credited with having said, “An ounce of prevention is worth a pound of cure.” HIPAA was still two centuries away from enactment when he made the comment, but the sage could have been talking about the healthcare legislation. You are best served by adopting preventative policies well before trouble arises.


U.S. Department of Health and Human Services, Summary of the HIPAA Privacy Rule: http://www.hhs.gov



Tags: FDA, medical device, medical law, hippa, compliance

10 Basic Legal Tasks You Should Take Care of Before Launching Your Product on the Market

Posted on Mon, Feb 29, 2016

10 Basic Legal Tasks You Should Take Care of Before Launching Your Product on the Market

When introducing a new medical device on the market, you have to take care of many things before launching the product. The healthcare industry poses quite a few challenges for medical device entrepreneurs, but you can overcome them with a little extra work prior to the launch. This will help ensure that your company avoids any legal issues and carries through a successful launch. Following the basic regulatory requirements will streamline development and help you launch a safe, effective product.

1. Properly Classify Your Product

Your healthcare product needs to be properly classified, for example, as a medical device or combination product, so that you know which set of regulations you need to follow. Contact the regulatory body for your product if you aren't sure how to classify your device. Otherwise you run the risk of legal repercussions.

2. Figure Out Your Claim

Your device should have a medical claim that proposes what it will do. This is important to identify before launch, because if your claim changes, you may have to apply a different set of regulatory requirements. Without properly addressing your exact claim, you leave room for misinterpretation and legal issues.

3. Review Marketing Materials

Make sure that all your marketing activities are consistent with your claim and the information you provide on the product label. In order to avoid legal issues, when creating your marketing materials, you have to be careful with wording and include information on associated risks and the correct way to use the device. Even if you have all of your official paperwork accurately filed, the wording of your marketing material can pose legal problems if it doesn't adhere to the guidelines.

4. Complete the Pre-Market Submission

Medical devices require a pre-market submission by the Food and Drug Administration (FDA). It's important to allow time for this paperwork to be filed and approved, because the FDA doesn't have a strict timeline for the process. If you don't take this step you won't be able to legally sell your product.

5. Set Up a Clinical Program

Some devices require a clinical program to support the licensing application. These should be conducted with good clinical practices and should adhere to the requirements of each individual country. Without a clinical program, your licensing application might not get approved.

6. Collect Data

You'll have to collect the data from your design, manufacturing and clinical programs in order to include them in the regulatory submission of your device. This data is crucial to getting your device approved and proving that it is beneficial to consumers.

7. Establish and Maintain Product Development Plans

Your product development plans should be established and maintained, and should describe the design and development activities. These must follow the design control requirements and will serve as a reference to prove you are meeting the U.S. Code of Federal Regulations. If you don't establish these and update them as you make changes, you are at risk of running into legal problems.

8. Ensure Post-Marketing Compliance

You have to meet the manufacturer's regulatory obligations to make sure that your device is compliant going forward. This includes safety reporting, establishment registration, as well as product listing, inspections, licensing renewal and more. Without taking this step, you could fall short of regulations in your industry, which is against the law.

9. File for Intellectual Property

Intellectual property laws are essential for launching a new medical device on the market. You first need to ensure that no one else is claiming your device as intellectual property and then need to file for intellectual property in order to protect your investment. If you don't take care of your intellectual property claims, it can turn into an ugly legal situation.

10. Establish State-of-the-Art Compliance

Manufacturers need to adequately address the state-of-the-art analysis in the clinical evaluation reports. Without doing so, you leave yourself open to legal suits against the quality of your product.

Many companies get sued for not properly filling out and filing regulatory and licensing material prior to launch. Others get sued for not updating information to maintain compliance as changes are made to the device. In order to ensure that you have a successful product launch and avoid litigation surrounding your medical device, it's important to work with a qualified attorney who can review your regulatory submissions.





Tags: legal, medical device, medical law

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

Posted on Wed, Feb 10, 2016


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.


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. 












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


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