On July 3^rd Stryker Corporation – the Kalamazoo-based orthopedic device manufacturer – announced that the FDA had approved their Cormet Hip Resurfacing System for marketing in the U.S.   On the surface (not the hip surface, that is), it would appear that this was yet another straightforward device approval albeit a very important one as nearly 300,000 patients receive hip replacement procedures each year in the U.S.  Indeed, the announcement was important enough to have been written up over the holiday by Barnaby Feder in the New York Times where he points out that up to 15% of these patients may receive a hip resurfacing procedure instead of the more invasive and more definitive hip replacement operation.

Below the surface, however, this approval and the accompanying press release are extremely revealing and substantiate many of the important trends that have been covered in this blog and that are certain to continue in the future.  So, for perhaps the first time this world has ever seen, we are going to embark on a surgical dissection (or call it a literary analysis) of a press release.  Believe me, I’d rather be analyzing the intricacies of Milan Kundera (a literary critique of literary critique would be a nice start) but since this blog is about the business & investment world of life sciences and that’s why you’re reading this, let’s suspend our disbelief (if not our boredom) and cut away. 

Scalpel please …

Initial Incision: The growing importance of partnerships

“Stryker Corporation (NYSE: SYK) announced that it will begin marketing Corin Group PLC's (LSE: CRG) Cormet Hip Resurfacing System as early as the third quarter of this year ...”

The first thing to note is that this is about two companies – Stryer and Corin – coming together to jointly develop and market a product.  In fact, in parallel with the Stryer release, the Corin Group also issued their own announcement. As my previous posting “A Time to Make Friends: More Partnerships in Biotech, Med Tech” pointed out partnerships are increasingly going to be a key mechanism behind value creation in the life sciences.  As I wrote then:

The future of medical technology will be dominated less by huge behemoths taking a single idea linearly from concept to market but rather by fluid partnerships that take technologies at different stages of development and bring them together. In the 1960s and 1970s, research was king (hence the prominence of Merck as a leading pharmaceutical firm). In the 1980s and 1990s, marketing became increasingly ascendant (hence Pfizer was able to take over the title for the biggest pharmaceutical). As we move further along in the 21st century, the ability to partner will be a key advantage.

Also interesting to note is the global nature of the partnership with Stryker being based in the U.S. and Corin in the U.K.  It is certainly a world of Partnerships Without Borders.

Subcutaneous dissection: Device companies playing a greater role in patient selection

“This follows today's FDA approval of Cormet and is predicated on a comprehensive surgeon education protocol developed by Stryker and Corin, in cooperation with the FDA, emphasizing patient selection criteria to promote successful outcomes.”

One of the most important concepts in surgery is that of patient selection.  For many emergency operations, patient selection plays a relatively minor role, as in these cases there may be no other choice.  However, for most elective procedures and hip replacement/hip resurfacing certainly falls in this category, patient selection is critical.  Of all the skills required for a surgeon, patient selection may, in fact, be one of the hardest as it integrates not only a rational decision-making process based on a balancing of risks and benefits but also involves a professional ethics component as well.  Fortunately most patient selection decisions are not based on whether the surgeon has a boat payment to be paid although at least one blogger has commented on this phenomenon.

Back to the press release.  The statement above tells us that the manufacturer (namely Stryer and Corin) will be integrally involved in the patient selection process.  Of course, this is nothing new but clearly as technology changes ever more rapidly, surgeons absolutely depend upon the guidance of manufacturers in selecting their own patients for operation.  It will be interesting to see how this plays out.  It is one thing for a surgeon to completely dissociate their past due boat payment from a decision to operate; it’s entirely another thing for a publicly traded company to balance its accountability to shareholders with its responsibility to patients.

Incising the fascia: Quality-of-Life measures have a higher expectation for safety

“Interest in hip resurfacing procedures is on the rise globally due to the bone conserving nature of the procedure and anticipated potential benefits related to post-operative activities and range of motion.”

Drug-eluting stents, Viagra, Hip resurfacing.  The common theme for all three is that they fundamentally are measures that improve quality-of-life – especially when compared to the therapies they replace.  Drug-eluting stents do not save any more lives beyond that of bare metal stents.  Viagra doesn’t save lives … although it may be responsible for a few new ones.  And likewise, hip resurfacing is positioned mainly as a quality-of-life benefit.  One of the major reasons for the increased clamor around drug/device safety is that quality-of-life measures have a very different safety expectation than treatments that are directly life-saving.  The all-important topic of drug/device safety was addressed in my previous posting “Drug /Device Safety Debate to Yield Big Changes, Grow More Controversial.” Again, patient selection will be critical for optimizing the safety outcomes for the procedure.

Blunt dissection and retraction of underlying muscle: Minimally Invasive Surgery – Surgical Paradigm Shift

“In these procedures, surgeons replace the acetabulum in much the same way as a conventional total hip but the femoral head is resurfaced rather than removed … ‘Hip resurfacing offers the right patient a more conservative, bone preserving procedure than traditional hip replacement … ‘ said, Bernard Stulberg, M.D., Director, Cleveland Center for Joint Reconstruction.

Many hip replacement operations are themselves performed in minimally invasive fashion and the hip resurfacing procedure takes that one step further.  The Academic Medical Center in Gent, Belgium has produced an illuminating video comparison between replacement and resurfacing which you can download here.

MIS is great for patients.  What is not widely appreciated, however, is that minimally invasive surgery is more than just small incisions and rapid patient recovery.  The true promise of minimally invasive surgery (MIS) is this:

Conventional surgery involves fairly significant trauma to the tissues traversed on the way to and surrounding the operative target.  Recovery from the operation results in significant scar tissue formation and while this may not be visible from the outside after a fully healed incision, all surgeons know that a re-operation is infinitely more difficult and in many cases impossible.  Conventional surgery thus requires that the operation be definitive (once-and-for-all) and as comprehensive as possible.  That’s why – in the “old days” – if a patient had to have some abdominal surgery, they would take out the appendix as well as potentially other things just because – as the Mt. Everest mountain climber George Leigh Mallory would say – “it was there!”  With minimally invasive surgery, the trauma is minimal enough so that re-operation is, in fact, possible and hence (1) the surgery doesn’t need to accomplish everything at one sitting (or one “lying” as it were) and (2) surgical treatments can be planned in a staged fashion involving potentially several operations over time.  As the New York Times article wrote: “[Hip resurfacing] makes it easier to replace the original implant with a total hip in the future if necessary, which is often the case for active patients who have their artificial hips for 15 or 20 years. “ MIS fits perfectly with the trends of patients living longer and diseases being more chronic.

Transforming the practice of surgery from a definitive, one-time procedure into a limited, repeatable process represents a complete paradigm shift.  Dr. Kurt Semm – one of the seminal founders of MIS – predicted such a paradigm shift even during his early pioneering studies.

Preparation of femoral head: Patient choice is key

“Bernard Stulberg, M.D., Director, Cleveland Center for Joint Reconstruction …  added, ‘the dialogue between surgeon and patient will be more critical than ever in determining which anatomic option is right for the patient’”.

Patient choice is another increasingly important trend.  There is often no single approach or treatment that is categorically better than any other.  While I believe that our world would be made better by a wider use of evidence-based medicine, that goal is an illusory one.  What is better for one patient may be worse for another.  And even more importantly, what one patient may need and desire may not be the same as that of another. This “primacy of choice” was the main them of my previous posting “What Patients Want: A Story of Choice, Trials, Evidence-Based Medicine.”  The approval of Styker’s hip resurfacing system may not have solved all of mankind’s hip problems but it certainly has offered more choice.

What is the value of choice?  We know that value is very high but we do not quantify that value in conventional evidence-based medicine or clinical trial paradigms.  An interesting question for another time.

So – operatively speaking – we are here at the femoral head and even though the patient evaluation and preoperative scans pretty much define the options, a decision needs to be made.  Will it be hip replacement or hip resurfacing?  If it were your hip what would you prefer?  My apologies for leaving you hanging – as it were – in mid-operation.  The remaining text of the press release is pretty much perfunctory – as most press releases are.  However, at a minimum, I think we have demonstrated that a sentence-by-sentence literary critique of a press release is possible.  Insofar as this blog is about “thinking outside the box” with respect to not only “content” but also “process,” we have experienced here a bit of press release dialectic history. 

In summary, reading more deeply into the Stryker/Corin press release sheds insight into the following important themes:

• The growing importance of partnerships;
  
  
• Device companies are playing a greater role in patient selection;
  
  
• Quality-of-Life measures have a higher expectation for safety;
  
  
• Minimally Invasive Surgery – Surgical Paradigm Shift;
  
  
• Patient choice is key.
  

Your comments are more than welcome and perhaps this will help us get closer (metaphorically speaking) to completing the operation – fixing the hip, restoring the tissues, closing the skin and letting the patient go on their way.

Ogan Gurel, MD MPhil
gurel@aesisgroup.com
http://blog.aesisgroup.com/

httpHip Resurfacing Implants Minimally Invasive Surgery Orthopedics