Dalla progettazione allo sviluppo e commercializzazione di medical device; un caso pratico Controcyst
Time: 2:50 pm - 3:10 pm
Date: 18 September 2019
From the design to development and marketing of Medical Devices; a practical case Controcyst Unmet medical need may seem an obvious concept, but there are a lot of factors and thoughts that go into determining this element; many scientists emphasized that starting talks with the FDA as early in the clinical process as possible… Read more »Making pharmaceuticals Italy
From the design to development and marketing of Medical Devices; a practical case Controcyst
Unmet medical need may seem an obvious concept, but there are a lot of factors and thoughts that go into determining this element; many scientists emphasized that starting talks with the FDA as early in the clinical process as possible is the best way to determine how to meet the needs of patients.
While all scientists had similar advice for how to hit on the next big thing, they had a variety of opinions on exactly what that area might be. They often take advantage of smart, biotech or artificial intelligence or machine learning advances. They look to improve quality, safety and reduce costs. But by far the factor that defines exceptional medicinal products is their ability to pinpoint an unmet need in the healthcare chain and respond with a solution that makes sense.
Interstitial cystitis is a chronic condition causing bladder pressure, bladder pain and sometimes pelvic pain. The pain ranges from mild discomfort to severe pain. The condition is a part of a spectrum of diseases known as painful bladder syndrome. Interstitial cystitis most often affects women and can have a long-lasting impact on quality of life. The exact cause of interstitial cystitis isn’t known, but it’s likely that many factors contribute. For instance, people with interstitial cystitis may also have a defect in the protective lining (epithelium) of the bladder. A leak in the epithelium may allow toxic substances in urine to irritate your bladder wall.
Although there’s no cure, medications and other therapies may offer relief. Controcyst is a medical device consisting in a sterile solution for intra-bladder instillation this presentation describes how the product for this disease with unmet treatment has been projected and developed, trying to approach these activities in view of the new European regulation for medical devices.
- Dr. Angelo Colombo Consulente - Giellepi pharmaceuticals srl