Intellectual property is valuable and something everyone wants to protect. Losing intellectual property to competitors through theft has serious economic consequences and can damage your brand reputation. CUBE Medical Innovations understands exactly how important your intellectual property is despite medical device design vulnerability. We not only have the experiences, but we have the resources to explain how to patent a medical device to ensure your intellectual property doesn’t fall into the wrong hands.

Keeping Your Intellectual Property Secure

Ideas for new products, services, and product concepts are precious. You have big plans for those ideas and don’t want them to fall into the hands of your competitors. At CUBE Medical Innovations, we understand intellectual property laws and work hard to make sure safeguards are in place to keep all your ideas secure.  Our medical device intellectual property and patents services include IP protection.

Protecting Intellectual Property Means Less Medical Device Vulnerability

Timing is everything when you’re creating a new medical device.  You need to get it designed, created, and on the market before your competition does, which means keeping it a secret from the competition.When you utilize CUBE Medical Innovations’ medical device patent service, you will be set up in such a way that you don’t have to worry about your latest medical device getting leaked to the competition.  We do everything in our power to keep the entire project under wraps.

Our medical device patent and cybersecurity services include:

• Copyright Protection
• Design Protection
• Trademark Protection
• Trade Secret Protection
• Utility Protection

We’re set up to protect new medical devices from the moment you dream up the concept until the day you unveil it.

Learn How You Benefit from CUBE Medical Innovations’ Medical Device Patent and Cybersecurity Service 

Medical device patent and cybersecurity is only one of the medical device development services CUBE Medical Innovations provides. Contact our medical product management team to learn exactly what we do to protect your ideas!

Taking a Dream and Making it a Reality

It takes a village to create a new medical device. Even if the device is the idea of a single person, taking that device from the concept stage to the full production stage takes several people who hold diverse areas of expertise. Finding the perfect team to aid in medical device invention development isn’t easy.

If you’re an inventor who isn’t sure how to turn your dream medical device into a reality, contact CUBE Medical Innovations. We assist inventors in this process by offering our own experience and expertise, but also by pairing our own knowledge with industry resources and esteemed partners.

We have a great deal of experience working with talented inventors and love matching them up with a team of equally talented people that includes designers, project managers, engineers, and experts in patents and cybersecurity.

Unlike other companies that assist with medical device invention and development, we don’t simply help with the design and manufacturing of the product, we also run market analyses and generate reports that help you decide if the medical device justifies the cost of creating, manufacturing, and eventually marketing.

CUBE Medical Innovations’ medical device inventions service include:

• Running an assortment of simulations to identify undesirable traits, features, and outcomes
• Exploring the financial future of the proposed medical device
• Identifying malfunctions or potential malfunctions in the prototypes

Pairing you with a creative, hardworking team that aids with the design and development of your medical device is just one aspect of our medical device invention development service. We have the tools and resources available to protect the intellectual property and patents that go hand-in-hand with creating a brand-new medical device. Our cybersecurity efforts ensure that you’re able to get your device through the development and early manufacturing stages without having to worry about competition or a breach of client health information.

Beginning in 2014, CUBE Medical Innovations started working on the development of medical devices, quickly establishing themselves as a reliable and creative resource for medical device product development. Contact our medical invention management team today to learn how we can turn the medical device you’ve been dreaming of into a reality.

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What Are the FDA Requirements for 510(K) Submissions for Medical Devices?

Most manufacturers of medical devices must submit a 510(K) premarket notification or a premarket application (PMA) before commercializing in the United States. What is a 510(K) or a PMA? Who is required to submit a 510(k) or a PMA? When are they required?

Defining 510(K) for Medical Devices

The United States Food and Drug Administration (FDA) determines the rules on medical device regulatory submissions and compliance. Devices that fall under premarket notification requirements are Class  II, and Class III devices require PMAs.   Without completing the required testing and documentation of the testing, device manufacturers will not be able to legally sell their products in the United States.

The purpose of the 510(K) submission and approval is to attest to the fact that the product in question is not harmful. It also provides official testimony that the device can do what the manufacturer claims it can accomplish. Submitting 510(K) documents to the FDA is a declaration that the new medical device is substantially equivalent to an existing product previously cleared. This means that the device is similar enough in design, purpose, and use of an existing product that it can be considered safe by default.

Manufacturers meet with FDA in a pre-submission meeting to mutually agree upon the regulatory strategy. Once this is agreed upon, and a clinical trial is not required, the medical device manufacturer, once all requirements are met, may submit the 510(k) premarket notification to FDA. Once cleared, the device may be marketed for commercial use.

There are 3 categories of 510(K) notifications:

• Traditional 510(k) premarket notifications are used for new devices. These manufacturers must complete all verification steps to achieve market clearance.
• Special 510(k) premarket notifications are reserved for devices that do not need conformance data.
• Abbreviated 510(k) premarket notifications manufacturers are able to provide summary reports on the use of guidance documents and/or special controls, or declarations of conformity to recognized standards, to expedite the review of a submission.

What Are the Requirements for 510(K) Submissions?

There are four criteria that qualify a medical device for 510(K) premarket notifications.

• For domestic manufacturers who plan to market their goods in the United States, medical compliance, as your regulatory affairs consultant will explain, requires proof of the safety and efficacy of finished products. This does not apply to manufacturers of components used in the construction of finished products.
• Specification developers outline the product’s final form but outsource the actual construction to another party. In this case, the specification developer is responsible for the premarket notification.
• Repackagers who make significant changes to package instructions or information may be required to submit paperwork.
• Foreign manufacturers or exporters who wish to market their goods in the United States often need to submit proof of efficacy and safety before putting their products up for sale.

When Is a 510(K) Required?

510(k) premarket notifications are required for all new Class II products unless they are exempt. The FDA guidelines require 510(K) submissions when a new device is being introduced for commercial distribution. Paperwork must be submitted at least 90 days before commercialization and the device manufacturer must receive a 510(k) clearance letter.

Existing devices that are modified in a way that could affect efficacy and safety may also be required to submit documents. In these cases, the FDA lets the marketer decide if paperwork is necessary. However, all modifications must follow current Quality System Regulations. This also applies when an existing device is to be marketed for use beyond its originally stated purpose.

Premarket notifications are not required for products made for testing purposes, when unfinished devices are sold to another party for further processing, if the product was already in distribution before May 28, 1976, or other exempt parties.

Is a 510(K) premarket notification in your future? Rely on the expertise of CUBE Medical Innovations and our regulatory affairs consultants and partners at Eminence Clinical Research to guide you through the process. We can help you design, build, test, and manufacture your commercial 510(K) medical device. We also walk you through the maze of regulatory affairs and requirements to get your device approved and ready for purchase. Contact our device development experts to learn how CUBE Medical Innovations can make your 510(K) submission process easier.

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Why Not Give Us a Call?

Physician inventors find themselves in a fiercely competitive field. In the United States spending on healthcare grows faster than the total gross domestic product of the nation. That impact creates a huge interest in medical device innovation and how those innovations can drive the growth of wealth across the full economic spectrum.

Have you looked at your practice and thought of an alternate tool or device that would improve methods, techniques and practices? That type of thinking drives innovation in healthcare by creating new inventions in the medical field. Don’t you owe it to yourself, your colleagues and your patients to explore the viability of your ideas? There is absolutely no risk to exploring how those potential medical device innovations can be shared with the world.

CUBE Medical Innovations provides physician inventors with the tools and support needed to navigate the complicated healthcare market through the development of their new inventions for the medical field. Physician inventors and other innovators are learning the value of joining their strengths with the skills and experience of design experts. How does CUBE Medical Innovations assist in the creation and implementation of innovative medical products?

1. Expertise in the process of Ideation 

Ideation focuses on finding the right questions and emphasizing the needs of users and insights about users. Ideation steps beyond the obvious solutions to increase the potential for greater medical device innovation. By using ideation, you surpass obvious solutions and move into the realm of the creative. CUBE Medical Innovations assists inventors in the identification of design risks and sourcing, new technology manufacturing, and intellectual property guarantees. Together we will analyze key performance indicators, determine costs, and specifications. We will help you to evaluate the full cycle of your product through all the stages of development.

2. Security during development

Unfortunately, we live in an age where competition of ideas from local and international entities can be very real threats. In addition to intellectual property risks, there is also a high level of vulnerability in new technological inventions in the medical field. CUBE Medical Innovations works to address every possible threat vector across the cyber landscape to protect your idea, your product, your facility, and your future patients.

3. Prototyping

Prototyping validates and tests the design. The goal is to generate less-expensive, scaled down versions of a product to investigate the solutions developed during ideation. At CUBE Medical Innovations, we design fully functional prototypes and use Failure Mode Effects Analysis to create an effective risk management plan. Our prototyping process uses iterative design and promotes product viability and agility.

4. Testing and Validation

Testing is the final stage of design, and new inventions in the medical field require rigorous testing for validation. We use advanced engineering to validate the product and manufacturing process and ensure that manufacturing facilities can complete a finished product that meets efficiency and quality controls. At CUBE Medical Innovations, we partner with ISO 9001 and ISO 13485 suppliers to produce the products that you require.

5. Dealing with regulatory requirements

The regulatory process — especially for medical devices — can feel like traveling through a maze. Medical device innovation requires taking risks, but those risks are mitigated by a thorough understanding of regulations and the agencies that enforce them. CUBE Medical Innovations is your guide to successfully navigating the maze of regulatory approval. We will help you in consulting with the FDA and other agencies involved in the process.

6. Assistance with scaling-up to full production

Managing cost, quality and delivery targets are challenging and are an area that most physician inventors are not familiar with. CUBE Medical Innovations maintains transparent supply chains, facilitating sustainable and efficient volume in manufacturing. We negotiate with contractors and suppliers to provide truly scalable manufacturing.

7. Dealing with launching the product to market

No single physician inventor can find customers for a product and develop training for new users — especially while maintaining a medical practice! CUBE Medical Innovations has partnered with Eminence Clinical Research to assist you in developing customer adoption and acquisition.  Our experts train medical staff in the use of your product and use at their facilities.

 

If you have an idea for new inventions in the medical field, contacting CUBE Medical Innovations can be the first step to making your solution a reality.

Don’t allow uncertainty about engineering, manufacturing or marketing hold you back from medical device innovation. As we said earlier — you owe it to yourself and others to move your ideas into the real world. There is no risk to consulting with experts about issues that may be holding you back.

We have the expertise and experience to help you travel the road from problem to solution to manufactured product in the hands of end users and beyond. Our empathetic design-thinking and real-world solutions for marketing, regulatory approval and beyond will provide you with the help you need for breakthrough medical device innovation. So why not contact us today?

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Moving Health Science and Medicine with Medical Device Invention

Physician inventors create and drive the innovation that cuts costs, alleviates suffering, and ultimately saves lives. Because physicians live on the front line of medical treatment, they recognize the needs of patients and fellow practitioners. They recognize the true value of medical device invention through firsthand experience.

The typical physician inventor focuses on the problem encountered in daily practice, listens to colleagues’ frustrations, and identifies the common problems. These common problems provide fertile ground for new designs and better devices and propel the inventor down the road of the medical pioneer.

Physician Inventors throughout History
A quick search in Google shows the historical significance of the physician inventor:

1. Imhotep
   The earliest physician inventor of record was Imhotep. Ancient Egyptians regarded him as one of their greatest men — so great that he was deified after his death. Imhotep was famed for his innovations in medicine, culture, and architecture.

 

2. Hippocrates
   Of course, Hippocrates developed the Hippocratic oath. But he also developed advanced methods for treatment of many ailments and was a medical pioneer with the invention of many medical devices, like the speculum, that are still in use. Hippocrates is widely considered to be the man who developed naturalistic medical treatment.

 

3. Rene Laennec
   We owe the stethoscope to the French physician Laennoc who, with the invention of the now ubiquitous medical device, promoted its use as a tool to explore the chest cavity.

 

4. Charles Paraz and Alexander Wood
   These two physicians changed the world with their medical device invention of the hypodermic syringe. Paraz lived in France, Wood lived in Scotland. They didn’t work on the invention together, rather each individually invented the syringe at the same time and share credit for its invention.

 

5. Paul Zoll
   Working from earlier inventions Paul Zoll improved and pioneered the use of pacemakers and cardiac defibrillators. Zoll was a practicing physician and a medical pioneer throughout his career and his inventions and refinements were based on his day-to-day experience as a physician.

Moving Forward

It is clear that physician inventors throughout the ages have been the engine of innovation in medicine. Physicians who see opportunities to improve current technology or to create new devices, techniques or treatments should be encouraged and excited to move into the future with their own innovations.

Does the physician inventor need to abandon his practice at this point? No. The best practice is to partner with a specialist, like CUBE Medical Innovations, who can take the innovation and turn it into reality through the work of engineers, manufacturing, testing and marketing specialists. CUBE Medical Innovations provides these specialists to physician inventors to help create and commercialize their medical device inventions while helping the physician concentrate on the creation and of course, their practice. The first step is to contact us for medical device and healthcare product development.

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A new OEM medical device company has chosen CUBE Medical Innovation’s partner Eminence Clinical Research (ECR) to manage their product launch of an exciting new device.  The product launch will be conducted in more than 100 hospitals across the United States.

A healthy and responsive relationship between an OEM company and its medical device contract manufacturing selection is essential for a long-lasting and profitable partnership, and the business’s decision to move forward with ECR speaks to the adaptability and quality focus offered by our partners. The product and manufacturer can’t yet be named, but the width and depth of this launch indicate its importance in the national OEM medical device market.

Medical Device Contract Manufacturing & Product Launches

Over the course of a product launch, new medical products go through a process of acknowledgement, acquisition, and adoption. Some key areas in which ECR assists OEMs include:

• Customer acquisition and adoption of the OEM medical device
• Hospital staff training on device set-up and end-use applications
• Maintaining ideal inventories and forecasting supply and demand
• Development of optimum pricing to maximize customer perceptions of the product

Hospital staff training can be challenging.  ECR’s core competency of training comes into play here.

• Training material development
• Study plan development
• Competency standards development
• On-site training
• On-site testing

About Eminence Clinical Research, Inc.

ECR provides assistance with clinical research from first-in-human trial to outcome registries, Biostatistics – Data Management – EDC, and Regulatory Affairs – Quality Assurance with assistance in meeting US Federal Regulations and Global Standards.

About CUBE Medical Innovations, Inc.

CUBE Medical Innovations, Inc. provides the smart choice for product realization in the medical product market. Our mission is to assist innovators with medical device development from concept through medical device contract manufacturing while utilizing our partner ECR for support in clinical trials and product launches.

 

Contact us with the form below for more information!