1. Identifying the unmet clinical need.
Today the #1 preventive causes of death is Obesity. US spends over $150 Billion in direct and indirect cost to treat obesity and obesity related problems. There are no therapies to provide durable weight loss. Diet and exercise alone cannot help the patients. Many patients who have comorbidities and need to lose more than 50lbs are looking at bariatric surgery. Today, there are surgical procedures that are effective than drugs. US gov needs to support companies that are focused on providing treatment for obesity. 90 Mil people are obese in US, of which 50% need some kind of medical intervention, 14 Mil people are medicare approved to get a surgical intervention and assume a medical device cost $8000 to $10,000 it is a $140 Billion market in US alone. At the recent JP Morgan Health Care Conference 2012, there was a renewed interest in Obesity interventions. VCs and companies are looking at new technologies to fund. It is predicted that Obesity will be the biggest medical device market in this decade. There is opportunity for 50 more companies in this space.
2. The US FDA and the industry need to work together.
The US medical device, drug and biologics innovation is in danger because the regulations are too strict, stringent and one sided. The industry has recommended the FDA to create methods where the companies can provide ample data to show safety of the product and get provisional approval, to enable the innovation to reach the needy patients in the US. The industry has also suggested that post marketing studies can define effectiveness. This way the industry can bring innovations to the health care providers and patients. This is a simple and reasonable solution for both the FDA and the industry, and someone in the US FDA and the White House must pay attention to the above suggestions.
FDA has taken the role of playing “Dr” was the sentiment at the recent JP Morgan health care conference in Jan 2012. “FDA needs to soften its approach and industry will stop complaining” said a young medical device manufacturer.
FDA has taken the role of playing “Dr” was the sentiment at the recent JP Morgan health care conference in Jan 2012. “FDA needs to soften its approach and industry will stop complaining” said a young medical device manufacturer.
The above suggestions were brought to the notice of the speakers representing the FDA at the Jan 2012 JP Morgan Health Care Conference. The response was “FDA is not going to imitate EU regulations”
Today, there is a real threat of innovation moving outside US soil, if that happens, US will no longer be using cutting edge medical technology to treat patients. Emerging countries will dominate in medicine and technology.
2012 is an election year. Medical, investment and pharma community is huge and is waiting to see actions before the elections so they can decide who to vote for.
3. Practicing Social & Preventative Health.
Public needs to pay more attention to their social and personal health practices. Have a small budget for buying vitamins and healthy foods. Make sure that the immunization shots are taken regularly, diet and exercise is part of the daily conversation. Kids are exposed to vegetables and good nutrition, exposed to sunlight, good personal hygiene, just washing hands can prevent infections.
4. Opportunity to open patient portals:
Consumers should be able to connect with health care providers and check appointments, see lab results, renew prescriptions, and communicate with doctors and nurses. The HIPAA regulation needs to be reviewed to make sure it does not cost us more because the health information was not available on time to treat the patient.
Privacy of health care info is a good thing, but if people are openly discussing everything on facebook, what is the point of HIPAA? Is this not making health care expensive?
5. Reform HIPAA: Health Insurance Portability & Accountability Act
If everyone, is chatting about everything on Facebook and twitter and other social media. Why are we worried about privacy of health records? The access to these records is so difficult that, in a medical emergency the patients have to go through a whole battery of test, because his or her recent records were not available in time. The cost burden is on the subscribers.
Is this not adding to the health care cost America? This is more expensive and think about it, very risky! If important history is not available, it can result in sad or unnecessary outcomes. Reach out to the White House or your local representative.
Or one day affording health care will be a dream. Privacy is needed but within reason.
No comments:
Post a Comment