10/7/2022
If you clicked on this article and thought, “Haven’t I already read a similar article?” You would be correct. We have posted an article on the top 10 questions to ask when choosing a R&D company, along with a part two. This article is dedicated to answering the remaining questions from the past two parts. So, let’s start with a recap. Here are the 10 questions we suggest inventors consider when evaluating R&D groups for their projects.
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What are the specialties of the R&D group and do they align with the project goals?
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What career disciplines are employed by the R&D group?
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What are the predicted turnaround times for device commercialization?
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Does the R&D group offer financial funding assistance or shares of equity?
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Does the R&D group provide regulatory guidance?
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Does the R&D group maintain manufacturing connections internationally and domestically?
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Does the R&D group outsource prototyping? Can they prototype real prototypes in color? Do they use over-mold prototyping?
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Does the R&D group charge at cost or do they charge a margin for development work?
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Do the engineers test the device hands-on, in dry-lab or wet-lab surgery environments?
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Does the R&D group offer marketing, distribution, and/or sales solutions for product launch?
So, now that you know the most important questions to contemplate before signing up with a R&D company, we’d respond with a few key services Vita Group provides to our investors that are crucial to the quick, affordable, and quality development of medical device products.
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Do the engineers test the device hands-on, in dry-lab or wet-lab surgery environments?
It’s important for engineers to get hands-on experience with their devices in labs. Unfortunately, R/D companies usually hire lab testing services for their prototypes, and engineers don’t get to interact with their device in the lab setting. Instead, they receive notes on the testing through a secondhand source. At Vita Group, our engineers are in the OR/Dry Labs/Wet Labs/ Cadavers Labs weekly, sometimes even 3 to 4 times a week. Our engineers get firsthand experience with healthcare settings and know the surgical environment intimately. There is no need to spend massive amounts of time explaining the surgical or healthcare environment to our engineers, because Vita Group has a front row seat to the show.
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Does the R/D group provide regulatory guidance?
The regulatory process is a vital step to getting your project to the market. It’s also confusing, overwhelming, and a long road to travel, which is why so many inventors get stuck at this part. There are many layers to gaining FDA approval to make sure the device in question is safe and effective to be legally marketed. For submission, you must include the following:
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Device classification
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Predicate device(s)
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Proposed labeling
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Description of the device and specifications, including engineering drawings, photos, etc.
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Performance data such as clinical testing
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Sterilization information (if applicable)
Yes, we know it’s a lot. This is why Vita Group provides you with a regulatory pathway plan. We guide you through the approval process and take care of the hard part so you don’t have to. So when you’re looking into partnering with a R/D company, make sure they provide regulatory guidance like Vita Group does.
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Does the R&D group maintain manufacturing connections internationally and domestically?
Having good manufacturing connections is important to getting your project on the market. Manufacturing is a technical process, as it is really dependent on the requirements of your device and its intended medical use. It includes all aspects of the fabrication of a medical device, from designing a manufacturing process, sterilization, and packaging of a device for shipment. The manufacturing design should produce a visual aesthetic and function that aligns with the client’s expectations. Fortunately, when working with Vita Group you don’t have to worry about finding manufacturing, as it is already integrated into our contract. We have manufacturing connections both internationally and domestically, allowing for access to both markets and so you don’t have to search for an outsourced manufacturer.
It can be overwhelming to choose a R&D company that is right for your project. There are a lot of different factors to consider, but we hope you’ve found some valuable advice in this article.
Are you ready to learn more about developing your innovative medical device ideas?
Book a call with Vita Group’s COO, Jason Scherer, to learn more.