With the FDA's approval of Medtronic's Melody Transcatheter Pulmonary Valve and Ensemble Delivery System (see link), another step has been made toward eliminating traditional surgery — at least that's the idea. The ability to implant a valve via a percutaneous procedure advances the art of less invasive intervention in ways akin to laparoscopic surgery, albeit at lower volume.
Percutaneous, NOTES (natural orifice transluminal endoscopic surgery) and laparoscopic surgery are progressively removing the need for invasive traditional surgery.
It is precisely due to percutaneous procedures that coronary stents have been able to present such a clinical challenge to coronary artery bypass. Although minimally invasive approaches to CABG are an attempt to pull back some surgical caseload, they are technically complex, expensive and, therefore, are not likely to stem the tide toward the dominance of percutaneous procedures. Ironically, the one procedure that may save bypass is the transcatheter route. With the approval of the Melody approach, it is clear that that is not impossible.
Looking at the course of developments — in the healthcare reform "debate" (as it were) and medical technology — it is not a huge leap of judgment to make the following predictions for the ups and downs of healthcare overall and for specific medical technologies.
Predictions for the healthcare market
A healthcare reform package will pass this year, but it will fall short of what anyone wants or fears (the U.S. will not have a government takeover of healthcare nor become a socialist state despite the outrageous hyperbole flying around and the constrained legislation will do little to address the problems in healthcare).
Through 4Q 2009, startup and early stage medtech company failures will begin to abate, while new company formations will ramp up.
Investment and manufacturing will pick up in healthcare. Mid-size and larger companies’ hiring will lag the hiring rate (and relative amounts) of startup and early stage hiring. By year-end 2009, investment will see a BIG uptick at startups, early stage and later medtech companies.
Regulatory, liability and other adverse scrutiny of medical device, pharma and biotech will reach a fever pitch into late 2009, early 2010.
Despite the investment and hiring constraints at mid-size and larger medtech companies, stock prices will steadily rise through year-end and into 2010.
In terms of specific technology forecasts…
Stem cell therapy developments and advances will begin to appear at a startling rate in late 2009.
The coronary stent market will become increasingly fragmented as new DES products reach the market.
Traditional general surgical technologies (e.g., "open" procedures") will become rare, eclipsed by single port or incisionless laparoscopy and NOTES procedures. Robotic surgery will continue to draw more headlines than sales.
Obesity devices and drugs will be one of the most active areas of medical technology developments through 2010 and beyond.
Despite the intuitive appeal of diagnostic technologies (especially imaging technologies) for preventive medicine, there will be considerable pressure to restrict their use due to their contribution to healthcare costs.