CURBELL 

MEDICAL 

September 13, 2018 

Office of U.S. Trade Representative for Monitoring and Enforcement 

Chair, Section 301 Committee 

Office of the U.S. Trade Representative 

600 17th Street NW 

Washington, DC 20510 

Re: Request for Exclusion of Particular Products from the Determination of Action Pursuant to Section 

301: China Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and 

Innovation, 83 Fed. Reg. 32,181 (July 11, 2018). 

We are submitting this petition for an exemption from the tariffs on Patient Monitoring Parts and 

Accessories under HTSUS 9018.19.5500 which were put into effect on 06 July 2018. 

In the matter of initial introduction, Curbell has been manufacturing medical products and distributing 

plastics for over 75 years from our home in Western New York. It will always be our preference to 

manufacture product at or as close to our facility in Orchard Park, NY as economically feasible. 

It is equally important to note that Curbell owns the design and holds the 510(k) for the manufacture of 

the entire product referenced in this communication and is now subject to the 25% tariff. 

We hope that the summary below explains the insurmountable challenges this tariff imposes upon 

Curbell. We further hope that the importance of the cables and leadwire product category to our 

business, along with the limited impact of tariff on our larger competitors, the negative impact to our 

profitability and our long term viability in this market segment are all clearly communicated in this 

document. 

The Challenge to Curbell 

The product implicated in this tariff action (Reference #1) represents a significant and growing 

percentage of the Curbell product portfolio at 14% of total Curbell Medical sales. 

• The market for ECG accessories is highly competitive with larger global market players keeping 

profit margins low in this category. We are a much smaller player than our typical competitors; 

a 25% duty is an unsustainable strain on Curbell profitability and cash flow. 

• We have limited domestic options; known US manufacturers do not appear to have the capacity 

to take on Curbell volumes. In 2014, Curbell engaged in an exhaustive resourcing initiative that 
CURBELL 

MEDICAL 

included reviewing 37 potential U.S. based manufacturers. While a US partner would be 

preferable, we were unable to identify a US source capable and sufficiently qualified to meet 

our requirements. (Refer to Reference #2). 

• Current product is custom designed. All custom tooling used to manufacture the product was 

funded by Curbell and is held by our manufacturing partner in China. 

• Curbell has limited resources relative to our competitors and shifting our contract 

manufacturing outside of our current location would take significant time and effort to 

complete. 

• Curbell competitors in this category are OEMs — they are much larger and have global presence 

with multiple manufacturing options at their disposal. If our competitors moved production to 

other facilities located in low cost regions, Curbell would not be able to compete with their base 

cost. 

• Curbell chooses to stay in WNY — we have a very strong desire to be a good corporate citizen. 

Why we moved manufacturing to a partner in China 

• Competitive pricing — Curbell could not compete when we produced product in the US. We 

researched where our competitors are manufacturing their product to understand market 

pricing. Most competitive product in manufactured in China, we found that moving 

manufacturing to China was our only viable option to remain competitive. 

• China has a number of highly qualified manufacturing companies in this product category with 

many years of experience and expertise. 

• Many of the components, especially electronic components are manufactured in China; 

manufacturing in China lowers the logistics costs on raw materials. 

• Chinese manufacturers have been working with US customers for many years and have 

developed their quality management systems to comply with strict FDA requirements. 

Challenges to moving production back out of China 

• Cost — we have substantial investment in custom tooling that resides with our Chinese partners; 

re-tooling would be required and would be very costly. The custom tooling is specific to the 

machines present in China and the tooling might not be compatible with the machines available 

in the US. 
CURBEIICIAT 

Timing — it would take a minimum of 18 months to locate, qualify and transition production to a 

new supplier, regardless of location. It could potentially be much longer than 18 months as we 

have experienced: 

Recently completed a production move from the US to China 

• Initial supplier search and contact began in Jan 2014 

• Potential partner visits and site audits began in Apr 2014 

• Partner was chosen, approval status was granted Jan 2015 

✓ First tooling orders were placed Jan 2015 

• First production stock was received at Curbell in Jul 2016 

• Final tooling was completed June 2018 

• Effort — if production is moved to another Contract Manufacturing partner, Curbell would need 

to invest substantial resources into requalification, validation and verification of supplier, parts 

and manufacturing processes. 

• Competitors are very large OEMs who typically have manufacturing operations in multiple 

locations around the globe; production moves to tariff-free trade zones would be much less 

difficult for the larger companies. This would prove to be a serious if not insurmountable 

competitive disadvantage for Curbell. 

• In addition to the time and effort required, if we were forced to move production to remain 

competitive, Curbell would need to invest in duplicate tooling to keep current supply active 

during the entire transition period. 

Unique challenges to moving production to a US source 

• There are a relatively small number of manufacturers doing this type of production in the US. 

• Known US manufacturers do not currently have the capability and/or capacity to handle the 

additional Curbell volumes. 

• Curbell could not compete with the OEMs on pricing if manufacturing was US based. 

• Curbell could not survive the cost or time required to transition. 

Challenges to moving production to another low cost region 

• Curbell has been unable to identify manufacturers with acceptable quality and process controls 

in other low cost regions. 

• Learning curve for a new contract manufacturer in a low cost region would likely be longer that 

in China as China manufacturers have been active in this commodity group for many years. 
CURBELIAT 

Implications to Made in China 2015: 

We do not believe there are direct implications to the "Made in China 2015" initiative (Refer to 

Reference #3). This product is neither strategically important nor related to "Made in China 2025. 

Based on our review of the initiative, it is our belief that there is no link to the products that we are 

seeking exemption for; 

,f Product does not contain or rely on software; 

✓ Product is not implicated by the initiative's electrical objectives that focus on large scale thermal 

power, hydropower and nuclear power; and 

./ Product is not implicated in the initiative's stated objectives focusing on drug quality standards 

and systems. 

The product meets industry standards, is produced by a number of manufacturers, and would not 

commonly be defined as Mid or High Level Medical Equipment. 

Curbell is a privately held U.S. company; we have not received any subsidies from the Chinese 

government for assembling the parts in China and we have not been forced to transfer technology by 

the Chinese Government policies. We also have contractual provisions and relationships with our 

contract manufacturers that tightly protect our valuable intellectual property and have not experienced 

any of the IP issues described in the Section 301 investigation. 

Identification of Product and ability of CPB to administer the Exclusion 

• As noted on Reference #1 attached, Curbell has been cleared to sell and distribute the Products 

in the United States through the FDNs Premarket Notification program, more commonly known 

as the 510(k) pathway. 

• Curbell could instruct our Chinese manufacturers and our Customs Brokers reference our 510(k) 

number on all commercial documents submitted to CBP. 

• Curbell proposes that it would be relatively easy for the U.S. Customs and Border Protection 

(CBP) to administer this exemption by allowing any item under HTSUS code 9018.19.5500 with a 

510(k) number of K081762 to be allowed entry into the United States without payment of the 

Section 301 tariff. 
CURBELL 

MEDICAL 

For the reasons explained above, we are requesting that the USTR grant an Exemption for products 

entering the United States under HTSUS 9018.19.5500 and Premarket Submission K081762 from the 

Section 301 tariffs. 

It is our sincere hope that we have clearly demonstrated how a failure to grant such an Exemption 

would result in grave economic consequences for Curbell. 

We hope that we can be granted the exclusion. 

Thank you in advance and kindest regards, 

Curbell Medical Products, Inc. 

Bill Brennan,Director of Procurement 

Office: 716-667-3377 Ext 7434 Cell: 716-239-0781 

Email: wbrennan@curbellmedical.com 
CURB,Eyz 

Reference #1 — Product details 

Product Information: ECG Cables and Leadwires 

Accessories - aftermarket versions designed as replacement parts for various OEM monitors 

Varying lengths, configurations, connectors and terminations 

"Curbell Medical offers a wide range of high-quality ECG cable configurations, which seamlessly 

interface with the monitors of major Original Equipment Manufacturers. Our cables are compatible with 

GP/Marquette®, Philips®/HP®, Spacelabs®, and Nihon Kohden®, to name a few. Proper fit and function 

are assured, as each connector has been tested with OEM equipment to ensure compatibility and 

optimal performance. 

USFDA Classification Information 

Proprietary Name Curbell Reusable Lead Wires, One Patient Disposable Lead Wires 

Classification Name Cable, Transducer and Electrode, Patient, (Including Connector) 

Product Code DSA 

Device Class II 

Regulation Number 21 CFR 870.2900 

Medical Specialty Cardiovascular 

Premarket Submission Number K081762 

Owner/Operator Number 9033808 

Establishment Operations Manufacturer, Specification Developer 

USHTS Import Classification 

Import Classification HTSUS 

9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences, 

including scintigraphic apparatus, other electro-medical apparatus and sight-testing 

instruments; parts and accessories thereof: 

9018.19.5500 Parts and accessories for Patient Monitoring Systems 
CURBElrclz 

Reference #2 — Cables and Leads 2014 Resourcing Project 

Curbell resourcing project 2014: A total of 102 potential contract manufacturing partners were 

identified and engaged in manufacturing discussion: 

United States 37 identified 30 deemed incapable or uninterested 

5 declined due to conflicts, pricing, capacity or capability 

2 were engaged but neither was ultimately deemed capable 

Canada 5 identified 3 deemed incapable, 2 declined were uninterested 

EU 3 identified None expressed interest in pursuing 

Multi-Nation 14 identified 8 declines to participate, lacked capability 

6 declined after initial engagement, not capable or stopped 

responding 

Taiwan 8 identified 5 deemed incapable or not interested 

1 withdrew before submitting quotation 

1 considered and ranked based on capability and experience 

China 35 identified 25 deemed incapable or not interested 

7 dropped out during discovery, incapable or stopped 

responding 

3 were considered and ranked based on capability and 

experience 

Of the original 102 potential manufacturing partners contacted, the list was narrowed to a final group of 

the five most capable and knowledgeable. After a final ranking process, the decision was made to 

partner with the most the capable manufacturer, who was located in China. 

*Product is available in the US, but after a thorough review, Curbell was unable to identify a domestic 

partner with sufficient expertise, capability or capacity. 

*Product is manufactured in other, third countries, but again Curbell was unable to locate a 

manufacturing partner with acceptable capability, capacity and/or quality controls. 
CURB,97,17 

Reference #3 — Implications to "Made in China 2025" 

Information Source: 

US Chamber of Commerce: 

https://www.uschambercom/sites/default/files/final_made_in_china_2025_report_full.pdf 

"According to the US Chamber of Commerce, the goal of Made in China 2025 is to upgrade industry writ 

large and the plan highlights 10 priority sectors": 

1) New advanced information technology; 

2) Automated machine tools & robotics; 

3) Aerospace and aeronautical equipment; 

4) Maritime equipment and high-tech shipping; 

5) Modern rail transport equipment; 

6) New-energy vehicles and equipment; 

7) Power equipment; 

8) Agricultural equipment; 

9) New materials; and 

10) Biopharma and advanced medical products." 

Based on our review of the initiative, it is our belief that there is no link to the products that we are 

seeking exemption for; 

✓ Product does not contain or rely on software; 

✓ Product is not implicated by the initiative's electrical objectives that focus on large scale thermal 

power, hydropower and nuclear power; 

✓ Product is not implicated in the initiative's stated objectives focusing on drug quality standards 

and systems; and 

✓ Product meets industry standards, commonly produced by a number of manufacturers, and 

would not commonly be defined as Mid or High Level Medical Equipment.