Combination Medical Devices

The Term Combination Product Includes:

(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
(2) Two or more separate products packaged together.

Combination Medical Devices

Current Coated Combination Products

A considerable number of coated combination products that are regulated as devices by CDRH have been successfully introduced to the marketplace. The products include : * heparinized intravascular catheters * and cardiopulmonary bypass circuits * antimicrobial bone cements * intravascular and urinary catheters * cardiac pacing leads with steroid-coated tips.

The potential benefit of coating an existing product with a drug or biologic to improve efficacy and increase profits is significant.

Minimally Invasive Surgical Devices

Potential Niche Applications

Clinical specialties such as prostate resection, nephrectomy, ureteric surgery (urology), lap. ablation, endometriosis, fibroids (gynaecology), carpal tunnelling, shoulder and knee surgery, mandibles surgery (orthopaedics), gastric bypass, splenectomy, bowel surgery as well as gastrectomy (general surgery) are included in the potential niche applications that MIS device manufacturers can target.

Orthopedic Prosthetic Implant Devices

The annual growth rate for revision implant products during the past several years has been estimated at nearly twelve per cent to 15 per cent - more than double the growth rate for primary implants over the same time frame.

Technological advances in materials, operative procedures, product design and manufacturing processes are also providing impetus to market development. Novel manufacturing techniques such as CAD/CAM, new materials technology such as bone substitutes, bio-absorbable products and specialised alloys and innovative joint replacement product designs, which support improved performance characteristics and/or multiple applicability, are contributing to overall market value.

Medical robotics, computer-assisted surgery including image-guided technologies, minimally invasive joint replacement surgery and bio-engineered technologies also represent notable technological progress. Although currently in use, their further advance is projected to significantly influence the development and design of new innovative products.