Full-Service Medical Device Development and FDA Consulting for Innovators
How Does in2being Help Medical Device Companies?
in2being provides consulting services to propel innovations in the medical device industry out to the market. With a team of highly knowledgeable consultants, in2being can help innovators with any step in the process. We utilize a holistic consulting method that is focused on communication, expertise, and creativity.
in2being is the industry leader for navigating challenging medical device regulation language and agencies, adhering to product-code-specific requirements for marketing and manufacturing, and bolstering confidence for a product launch.
Regulatory requirements can put disproportionate pressure on product development teams within the medical device industry. At in2being, we understand risk management and can expertly parse necessary regulatory elements and circumvent project-blocking distractions, to maximize resources and maintain development momentum. We aim to reduce project chaos and provide a straightforward path through development hurdles.
Experience Our Customized Holistic Medical Device Development Process
Because of our breadth of experience bringing medical devices to market, we understand the parameters necessary for a seamless transition from product inception through design to manufacturing and commerce. Thanks to this strong knowledge base, in2being has a solution and connection for every need and hurdle you may experience bringing your medical device to market.
Our holistic approach guides our communication, allowing us to highlight the areas our team can directly help and what external connections are needed to meet your goals. By focusing on product potential and stakeholder objectives, in2being engagement is flexible and efficient. We offer immediate benefits at any medical device development and clearance stage. Whether your needs are technical or regulatory, our team knows how and where to find the answers to help you get unstuck.
We have innovators ready to advise on design and development issues and various testing systems, with the primary goal of creating a product ready for market launch.
Additionally, the experts at in2being can join in the process when your product is being prepared for launch and help steer product developers through confusing regulatory clearances.
in2being can assist with full-scale project leadership or regulatory advice. With such a flexible and skilled team, we provide excellent value and experience at every stage.
It is important to consider the regulations and testing required for a new medical device to be cleared for use. Medical devices are given a medical device classification which drives the accompanying rules regarding manufacturing and marketing. in2being is comfortable with assisting with prototyping, design control, and product management by drawing on our years of expertise and experience.
Understanding how and where to implement required regulations can be confusing. Setting unnecessary regulations on development may disrupt the natural design methodology. in2being has deep technical and regulatory expertise in the medical device industry. Therefore, we can deliver mechanical and electronic design directions and software development that follow regulations and are appropriate for a product’s specific conditions.
As we connect our clients to manufacturers and distributors, we ensure Food and Drug Administration Current Good Manufacturing Practices (FDA CGMP) are in place. Our developers can solve your design difficulties and ensure your product meets all requirements.
Finding this balance can be complicated without expert help, and medical devices can be forced into more testing and backfilling to meet product regulation guidelines. Or in worst-case scenarios, a device can be recalled.
in2being’s team of innovators can develop intellectual property for you to safeguard your design process and product development. We offer assistance throughout the maturing of your ideas and the development of your intellectual property.
By providing invention disclosures and IP assignments, we bolster our clients’ interests.
An essential piece of the product development process is designing a comprehensive prototype advanced enough to display the indications and abilities of the medical device — all without exhausting resources. At in2being, we make things a little easier for our clients by providing equipment and guidance throughout the prototyping process.
We house a 3D printing lab, machine shop, electronics assembly area, and soft-casting capabilities to turn your innovative medical device idea into a feasible prototype. Our team is also ready to implement only the necessary and appropriate design controls to ensure a regulatory-ready device that’s prepared for a seamless launch.
Knowing when to implement controls can be tricky, especially if a project has an upcoming deadline or is running low on resources. in2being can help you better understand regulatory affairs to ensure you’re making the right decisions for your product.
The FDA has varying regulations on marketing launch and manufacturing practices for new medical devices. in2being can help you find the classification that is right for your device and meet the corresponding regulations.
Calling on our wide breadth of consulting experience and our robust manufacturing chain, our team works with clients to locate trusted medical device manufacturers and prepare a design that will be FDA-compliant.
We know that product development and launch aren’t always easy or straightforward, and that’s why we provide project rescue services. Plain and simple, when product development or design runs off schedule and issues occur, we are ready to step in and problem-solve. Our clients rest easy knowing that their project’s schedule is being monitored and maintained by our team of experts.
Our Regulatory Consultants Will Help You Bring Your Medical Device to Market
One of the main obstacles in the way of new medical device products is the need to compile all of the necessary data for FDA clearance. Depending on your class of medical device, numerous tests, forms, and verifications are required before a device can be cleared for use.
Our FDA-compliance consultants will communicate the importance of implementing some of the FDA regulations and controls in the early development stages. This increases the likelihood of project feasibility downstream. in2being equips clients with knowledge regarding material selection and supplier capabilities so that developers can make informed decisions when conceptualizing the product.
Leaving FDA regulations for a later point in the process because of fewer resources or lack of perceived significance can hinder the product’s ability and function. Considerations made early on will yield great benefits down the line when the product is ready for launch.
For clients looking to expand globally, in2being specializes in International Organization for Standardization (ISO) medical device standards and compliance to help your product get approved for use worldwide.
Understanding the specifics of FDA regulations can feel redundant, cyclical, and at times even unnecessary. in2being is an excellent resource for analyzing the significant controls that can be implemented during design and product marketing.
Developing a thorough regulatory package is imperative to a medical device application submission. Accurately capturing and demonstrating the device’s intended use through an application depends on knowledgeable and clear regulatory package writing. Familiarity with FDA regulations is crucial in ensuring that the necessary guidelines have been followed to achieve compliance. in2being offers regulatory package writing to ensure that the required materials including testing data are present throughout the application and that all claims made are supported.
In addition to writing expertise, in2being can guide clients through their regulatory submissions with clear communication and knowledge based on our years of experience. Submissions are a daunting and lengthy process, so let in2being ensure your submission is completed correctly the first time.
Get Access to in2being’s Trusted Partners
By providing our clients with connections across our wide network of partners, no question goes unanswered. We are committed to finding a solution that works for every need, even solutions that in2being might not offer in-house.
Reach Out to in2being for Reliable Medical Device Development and FDA Consulting
There’s no competitor that can offer the immediate value an in2being consultant brings to a medical device development project. Let us make navigating regulatory affairs and design discrepancies easy and concise, thus allowing project personnel to focus on making the best product possible.
With in2being, innovative medical devices are being approved and activated in medical fields across the nation. We encourage you to explore more about in2being or listen to our MedTech Crossroads webinar and learn how we simplify FDA compliance and approval.
Let us get you there.
We're ready to lead you from concept, to prototype, to FDA clearance. Let us show you how to push your project forward with a free project analysis. Are you ready to bring your medical device to market?
Contact us to request your free analysis today.