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| related topics |
| {product, liability, claim} |
| {cost, regulation, environmental} |
| {customer, product, revenue} |
| {property, intellectual, protect} |
| {competitive, industry, competition} |
| {stock, price, operating} |
| {regulation, government, change} |
| {condition, economic, financial} |
|
|
The Company participates in a highly competitive environment.
Decreased availability or increased costs of raw materials could increase the company s costs of producing its products.
Changes in third party reimbursement could negatively impact the Company s revenues and profitability.
Our success depends upon the development of new products and product enhancements, which entails considerable time and expense.
We are dependent on adequate protection of our patent and proprietary rights.
Our business of the manufacturing, marketing, and sale of medical devices involves the risk of liability claims and such claims could seriously harm our business, particularly if our insurance coverage is inadequate.
The Company is subject to substantial domestic and international government regulation, including regulatory quality standards applicable to its manufacturing and quality processes. Failure by the Company to comply with these standards could have an adverse effect on the Company s business, financial condition or results of operations.
Our products may be subject to product recalls even after receiving FDA clearance or approval, which would harm our reputation and our business.
The Company is exposed to certain credit risks, resulting primarily from customer sales.
The market price of our common stock may fluctuate widely.
If a natural or man-made disaster strikes our manufacturing facilities, we may be unable to manufacture certain products for a substantial amount of time and our revenue could decline.
Full 10-K form ▸
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