The Legend of the Too Tall Lasers

Ed "Too Tall" Jones

For the past several years, every Candela employee has heard the story of the too tall lasers. It goes like this: All Candela US sales reps have company vans, to carry demo lasers as part of the sales process. Several years ago, after more than a year of development, a project team wheeled their latest greatest device out to the local rep’s van. You can imagine everyone’s surprise when the product just wouldn’t fit. For the next couple of months, the launch team fumed while the engineering group shaved a few inches from the design.

How could this happen? And what should the company have done differently? Continue reading “The Legend of the Too Tall Lasers”


Ethics and Options in Clinical Trial Design

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You can’t help but be moved by the plight of the patients in Saturday’s NY Times article “New Drugs Stir Debate on Rules of Clinical Trials.” The article caused me to reflect on my role, as a medical device executive, in the design of clinical trials.  The story presents the ethical challenges of a randomized controlled clinical trial (RCT) of a new drug, through the story of two patients in the trial.  The same challenges faced by drug trials also apply to medical device trials.   What are some of the issues and what are some of the options?

Continue reading “Ethics and Options in Clinical Trial Design”

Physician Disclosure – Device CEO’s Should Take Action

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In case you missed it, on Monday 13 September 2010, the Archives of Internal Medicine reported that highly-paid physician-consultants to medical device companies did not disclose device company relationships in peer-reviewed journal articles.  In New York Times coverage,”Representatives from Stryker, Zimmer and DePuy had no immediate comment on Monday.”

That’s the wrong answer.  Here’s what medical device companies should do instead. Continue reading “Physician Disclosure – Device CEO’s Should Take Action”

Coronary Artery Bypass Graft Surgery Report Puts Registries in the Spotlight

Yesterday, Consumers Union published quality rankings of 221 of 1,100 cardiac surgery programs in the US.  If you haven’t already, I encourage you to read the New England Journal of Medicine and New York Times coverage.  The underlying data come from a clinical registry developed by the Society of Thoracic Surgeons, and managed by Duke Clinical Research Institute.  I expect to see registries used more commonly  for the clinical, regulatory and market development of new medical devices.

Continue reading “Coronary Artery Bypass Graft Surgery Report Puts Registries in the Spotlight”

Medical device companies are different

Medical device companies are different.

Most people in the medical device industry believe that regulation by the FDA (and similar entities around the world) sets the industry apart.  While medical device companies are indeed overseen by the FDA, this is not really the primary cause of differentiation.  Many industries, such as wireless communications, are highly regulated.  Quality and reliability requirements in many industries are controlled by tight industry standards (Telecordia), ISO standards, military requirements, and customer demands.

So, what really sets medical device companies apart from other high-tech companies?

The four-part customer: patient, physician, provider and payor.

Medical device companies sell products and services to an incredibly complex four-part customer – the patient, the caregiver (usually a physician), the care provider (typically a hospital, outpatient center, or physician office), and the payor (aka the insurance company).  Successful medical device businesses address the needs of all four constituencies.

It’s common that the needs of these four constituencies are not aligned.  A powered contrast injector saves the interventional cardiologist time and x-ray exposure, but adds expense to the hospital.  So hospitals push back on use.  A better-but-slightly-more-expensive pap smear (ThinPrep) took years to gain market adoption, as insurers needed to be convinced that the improved performance was worth the extra cost.  Robotic tools for prostate cancer have been adopted with relatively little clinical evidence, as hospitals found the device to be useful in their marketing to patients.  Drug-eluting coronary stents achieved rapid adoption because Medicare decided to pay for these devices even before FDA approval.

This four-part customer sets the bar for business success at a much higher level than just FDA clearance or approval.  While some pre-clinical and clinical data are often needed to obtain regulatory clearance, rarely will this provide sufficient evidence to drive significant product adoption.  Economic data is not required for regulatory approval, but physicians, providers and payors all want to save costs or increase income.  As a population, we get sicker as we get older.  So the US Center for Medicare Services (CMS) must be convinced that new medical devices and new procedures will benefit their patients, at a reasonable cost.

The four-part medical device customer impacts every aspect of a medical device business plan, including technology/product, clinical/regulatory, market, and financing strategies.  Failure to master the four-part customer may be the most common cause of medical device business failure.  How does your business address each of these constituencies?