About Specialty Biomaterials Development...
Successful development requires the innovative design of a biomaterial which meets the specific performance requirements of your device. That process demands the ability to accurately measure and test the physical and mechanical properties of the biomaterial under development. Lastly, successful development requires experience working in a regulated environment. All three are found at Aspire, and the proof is found in our loyal and growing client base.
- Ongoing relationship with a multi-million-dollar European medical device development company since 2001
- Ongoing relationship with a Midwestern allograft and orthopedic device company since 2001
- Ongoing relationship with a major Colorado gastrointestinal medical device development company since 2002
- Ongoing development relationship with a Fortune 500 Company since 2004
- Ongoing development relationship with a Colorado cardiovascular medical device company since 2005
- Ongoing relationship with a multi-million dollar wound-care medical device development company in the Northwest since 2007
Our Biomaterials Development Experience ...
Aspire has extensive experience developing biomaterials which include the following:
| Polyurethanes | Hydrocolloids |
| Opacifiers | Acrylates |
| Pressure-Sensitive Adhesives | Silicones |
| Hyrogels | Solvents |
Innovation...
The President of Aspire Biotech, Inc., Dr. Ian N. Askill, is the author of over 20 issued US patents. His career has been devoted to the development of improved biomaterials and medical devices. Those devices include heart valves, vascular grafts, bone cement, drug delivery systems, wound care and closure systems, dental restorative composites, and tissue adhesives.
Testing...
The scientific staff at Aspire is also innovative and experienced. Our team has developed a myriad of unique testing protocols to better understand and measure the chemical makeup, mechanical performance, and physical properties of biomaterials under development.
Regulatory Experience...
The Aspire team has significant experience working within a regulated environment. We are registered with the FDA and conduct business under QSR (21 CFR Part 820). We have experience with PMA and 510(k) applications and have been a chief testing facility on record for several submissions before the FDA.
Prototyping...
Aspire Biotech, Inc. combined with our strategic manufacturing and packaging partners enable us to offer prototype development and pilot manufacturing for your medical device. Take advantage of our experience designing application systems which maximize the performance of your device. You can also rely on Aspire Biotech, Inc. to provide you with the manufacture of specialty biomaterials with lot sizes up to 100 kg.
