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FAQ

Medical Device Frequently Asked Questions

In case you have some questions about our medical device development services, you can directly contact us via our contact form. However you might want to take a look at our FAQ list below.

Business/Sales Financial General Quality Regulatory
How can I realize financial benefit with a patent?

While obtaining a patent is potentially a costly undertaking, there can be significant financial benefits that derive from the ability to assert the patent to block competitors. Sometimes this translates to domination of a market opportunity with high financial value. And sometimes this translates to more limited scope that may be of lesser financial value. Patents can be important, but other factors can and do influence the competitive advantage of an idea/product.

I have a product I’m looking acquire/buy/sell. Can you help?

Absolutely. We have a strong network to connect your needs with other parties. Give us a call at (704) 843-7852 or an email at info@kapstonemedical.com.

What kind of post-market support do you offer?

We provide services such as on-going quality support and logistics & distribution support. For non-US companies, we can act as your FDA US Agent.

How developed does my idea need to be before I bring it to you?

Your idea doesn’t have to be developed; in fact, you can come to us with just a “napkin sketch”. As mentioned in the previous question, the earlier you bring an idea to us, the easier it is and the more likely we can help you achieve the best design for success.

What are some things that I can do for my device to be successful?

Engaging early with a turnkey provider such as Kapstone will help the development of your idea be a smooth and complete process. We want to make sure you don’t sacrifice the best idea for the first idea. Allowing us to assist you early in the design will help save time and money later on.

How and when can I introduce my medical device idea to potential buyers?

It’s best to be active early in the process. Being engaged in the business development process is a benefit that Kapstone can offer. We have strong relationships with a number of companies and OEMs.

Do you have your own Quality Management System (QMS) system or can you use ours?

You may not need a quality system. If you do need a quality system developed, we can help build one for you. If you already have an established quality system, we can work under yours.

What is a Design History File versus a Device Master Record?

A Design History File (DHF) is a complete record of development of the device. A Device Master Record (DMR) is a recipe for designing, producing, labeling, packaging, servicing, and storing the device. Both have requirements mandated from the FDA.

What are the benefits of a Quality Management System (QMS) and design controls?

A sound design process will minimize the chance of failure later in the development process. Good design controls ensure you consider alternatives early in the process. The cost of changes become exponentially greater as the product becomes closer to commercialization.

What are the requirements for safe and legal use of a new device in humans?

Device makers must have effective methods and procedures for each device they design and manufacture to comply with basic requirements as part of current good manufacturing practices (CGMP).

More information can be found on FDA guidance Click  here

Have you received CE markings on a product before?

Yes, Kapstone often works with our European partner (Baat Medical) in compiling a technical file for submission to a Notified Body (NB).

How much time is required to gain 510(k) clearance once I have a firm design concept?

After a “concept freeze”, your idea will need to be further developed before gaining regulatory clearance. This will include fulfilling all quality system and testing requirements. Once the 510(k) submission is created and sent, the FDA has 90 calendar days to reach a decision.

Can I begin selling my new device after the FDA issues a 510(k) clearance letter?

Yes (in the U.S.); however, this assumes that all other requirements of a medical device company are met.

For a complete list of the requirements, please visit this FDA page. Click Here

Do you have experience with 510(k) premarket notification?

Yes, Kapstone has successfully assisted in compiling and submitting numerous 510(k)’s, also known as premarket notifications.

Do I need a 510(k) for my device?

Many devices do require a 510(k) clearance before they can be distributed in US commerce, especially implants and some instruments. Typically, the requirement for clearance is dependent on how the FDA would classify the device. Most Class II devices require a 510(k).

For more information on classification, see the FDA website. Click here

What is a 510(k)?

Briefly stated, a 510(k), also known as a premarket notification, is a submission made to the FDA that demonstrates your device is at least as safe and effective a a previously marketed and 510(k) cleared device (typically referred to as a predicate).

More information can be found on the FDA guidance website Click Here

How much does a 510(k) cost?

Official fees charged by the FDA can be found In addition, there are costs associated with assembling all of the proper documentation in support of a 510(k) submission, which will vary depending upon how much work has been done prior to bringing your idea to Kapstone.

How much does a typical project cost? What is your fee structure?

The costs of projects vary depending on the extent of services needed and the complexity of the project. Please visit our Business Model page for more information.

I am a non-US company looking to expand into the US market, can you help me?

Refer to our International Expansion page.

I am a US company looking to expand my sales overseas, can you help me?

Refer to our International Expansion page.

What are the benefits of outsourcing my project to Kapstone?

Simply put, the main benefits to outsourcing include one or all of the following, depending upon the specific project and your position in the market: 1) access to specific knowledge; 2) access to key resources; 3) reduced risk; and 4) speed to market

Do I need a patent before I can share my idea with you?

No, you do not need an issued patent or even a patent application before you come to us. We use confidentiality agreements to ensure that the information you share with Kapstone is afforded protection, particularly from risk that could impact your options to pursue patent protection. And, of course, you do not give up any rights in your idea by disclosing to us.

Do you have medical devices in the marketplace?

No, we do not. We serve the needs of those who sell or license the rights to sell medical device products.

What does your company do?

We provide medical device development services from the point of concept to FDA filing to commercialization – end-to-end and anywhere in between. Our mission is to guide, equip and inspire innovators to bring their ideas to life.

Can’t find the answer on the list?

If you can’t find your answer on the list, you can directly contact us.
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