You Have Options!

Our Hybrid Model

Distribution & Direct Sell = Faster Revenue

MDD Options has developed a hybrid sales model for MedTech that merges the strengths of a distributor with those of a 3rd-party logistics provider. This innovative approach can significantly accelerate revenue streams for manufacturers.

Maintaining Direct Customer Contact
In our model, manufacturers retain control of the sales process, sales teams, resources, and messaging, while MDD Options manages the business processes that facilitate sales transactions. Having developed valuable relationships with Key Opinion Leaders and clinical teams, you can retain that intimate relationship, gaining valuable feedback and insights while you do.Domestic & Foreign Manufacturers
This unique model solves many of the frustrations that start-ups encounter when deciding whether or not to use distributors, and while this is highly effective for US domestic manufacturers, there are even more advantages to foreign manufacturers.Establishment Listing, Initial Importer, U.S. Agent
Upon receiving their 510(k), PMA, or qualifying for exemption, foreign MedTechs must appoint a US Agent and an Initial Importer. The US Agent acts as a communication facilitator, whereas the Initial Importer ensures the QMS is fully functional, and all safety regulations are met. MDD Options fulfills these responsibilities similarly to a distributor.Basic Business Needs
We can also assist with setting up a US entity, and making introductions to experienced accountants, attorneys, risk managers, recruiters, employers of record, advisory board meeting planners and public relations experts who know MedTech.State Regulators
Manufacturers must register with up to 26 state regulators before selling their products in those states for prescription medical devices. MDD Options takes title of the product and, being registered with all state regulators, usually only needs to update the product listing.State-by-State Sales Tax Registrations
Manufacturers must register for sales tax in 46 states upon reaching nexus (a type of legal qualification), which can be triggered by transaction value, quantity, hiring staff, or acquiring premises. MDD Options handles sales tax registration, collection, exemptions, payment and reporting.Supplier Registration, Approval & Credentialing
We provide access to healthcare systems, hospitals and other facilities by managing the supplier qualifications and credentialing process.Your Customers, Your Data
We provide real-time access to every customer interaction, full disclosure of all reports and sales data, and data availability for PMCF and other product assessments.

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Options

OP·TION·AL·I·TYn.
The quality of being available to be chosen but not obligatory

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Speed Dial

Some things should just happen. Quickly.

Don't spend unnecessary time trying to find the right resources to get things done. We know the MedTech Community, and we know it well. For a surprisingly low one-time fixed fee, we offer you Speed Dial. (With or without Corporate Entity Services)

Who manages the sales process?

You do! You keep those very important relationships with key opinion leaders and other stakeholders, while we manage the back-end processes in support of your hard work.

Do you have access to every healthcare system and provider?

Yes, potentially. With more than 6,000 hospitals, 800 general buying organizations, 10,000 ambulatory surgical centers and tens of thousands of medical practices, it is impossible to be set-up for all of them. As we grow, we add these customers to our systems, and we add your products to our registrations.

Can you assist with credentialling?

We work hand-in-hand with you to ensure that your sales team has access to the facilities they need to visit.

Do you provide field clinical engineers?

We do not, but we can help you get your own FCEs on a contract or full-time basis through partnerships with providers, professional employer's organizations and specialist recruiters.

Do you provide technical and patient support?

We have a variety of US-based contact center support options, including direct to patient.

How much storage space do you have?

We use a combination of our own space and sub-contracted 3rd-party logistics providers. Collectively, that means we have an almost unlimited capacity, but currently around 1 million sq ft.

Can you support direct to consumer/patient models?

Yes, we have innovative solutions for direct-to-consumer requirements, including prescription only requirements. We are unable to support Durable Medical Equipment (DME) models in some states due to the geographic location requirements.

Can you support Durable Medical Equipment (DME) requirements?

Yes, we can support DME needs for medical devices going to hospitals and healthcare providers. Some states require local distribution of DME directly to patients which we cannot support.

I'm negotiating a distribution contract with a strategic. Why would I work with you?

There are a number of reasons to work with us. While your negotiations continue, you can be generating early revenue and learning more about the marketplace. You can get early patient feedback, sales trends, adoption and health economics data.

Do we have access to our product data?

Yes, you have near real-time access to your delivery data and all customer feedback - be it adverse events, product quality complaints or high-fives! You can use this data tin your PMCF processes.

Can you support us with loading software onto wearables and tablets?

Yes, we can support this requirement, as long as it does not constitute manufacturing of a medical device.

How do your prices compare to distribution & 3PL models?

We offer competitive pricing comparable to other models. By hastening your market entry, we save you money by reducing your pre-revenue cash burn.

How can I get detailed pricing information?

Please contact us using the Contact Form below. We'll get back to you within one business day.

Can you support pay-per-click and use-based pricing models?

Yes, we know that there are many different sales models. We will tailor our model to fit your unique needs.

How flexible are your contracts?

Our contracts are very flexible - only limited by regulatory compliance considerations.

Will we need to register for sales tax in all 46 states that charge sales tax in the USA?

With our model, you don't have to worry about sales tax management at all - we take care of everything.

Will we need to manage sales tax returns for all 46 states that charge sales tax in the USA?

With our model, you don't have to worry about sales tax management at all - we take care of everything.

My customers will be exempt from sales tax. Do I need to register with all 46 states that charge sales tax in the USA?

Even if every customer you have is exempt, you need to register for sales tax so that you don't pay tax twice. It is as important to register with exempt customers as it is with tax paying customers. With our model, you don't have to worry about sales tax management at all - we take care of everything.

My product is software. Do I need to charge sales tax?

Most states have put in place requirements for charging sales tax on software. With our model, you don't have to worry about sales tax management at all - we take care of everything.

If I am doing business in every state, do I have to file state income tax returns every year?

When working with us, you can avoid submitting tax returns in most of the 41 states and DC that you would have to for direct sales.

How many states do we have to register with to sell our medical device products?

This does depend on the exact nature of your medical device, but around 22 states require registration, and some states require registration with multiple departments.

Do we need to register our medical devices state-by-state?

With our model, we manage all the registrations that are required. As manufacturer, there are several states that require your registration along with ours, but we will help and support you through this. We then add your products onto our state listing.

I will sell my SaMD remotely. Do I need to register state by state?

There are specific rules that apply to SaMD and Clinical Decision Support Software. We can add your products onto our state listing and manage this process.

FDA Requirements & Approvals

Can you help with getting my PMA, De Novo or regular 510(k) approvals/clearances?

No, this is not something we do. We have a great network of experts and will be happy to make appropriate recommendations.

Can you act as my Initial Importer only?

As the Initial Importer, we must adhere to some significant responsibilities. While we can offer this as a standalone service, it may not be the most efficient model for your needs

Can you act as my U.S. Agent?

Yes, we can act as your U.S. Agent, as long as we are also acting as your Initial Importer.

My product is cloud-based software. Do I need an Initial Importer?

If you are a foreign manufacturer, yes, all software that is a medical device - i.e. has either a 510(k), a PMA or is exempt, is treated like a physical device by the FDA.

My product is software. Do I need a U.S. Agent?

If you are a foreign manufacturer, yes, all software that is a medical device - i.e. has either a 510(k), a PMA or is exempt, is treated like a physical device by the FDA.

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