As a device part of what some call the healthcare revolution, CardioMEMs HF from St. Jude Medical ticks all the boxes. It is the first permanent diagnostic cardiovascular implant, and a big deal in terms of developing the digital healthcare market.
The device enables mobile monitoring of patients at risk for heart failure. It works wirelessly, and transmits data to healthcare providers to protect patients while they are at home, with the aim at reducing hospitalization. CardioMEMS HF System features a sensor that is implanted in the pulmonary artery (PA) during a non-surgical procedure to directly measure PA pressure. Increased PA pressures appear before weight and blood pressure changes, which are often used as indirect measures of worsening heart failure. Through the system, patients transmit daily sensor readings to health care providers. This level of personalization should anticipate health problems, reducing a patient’s need to be hospitalized.
In the marketplace, however, the device has run up against some challenges, and from the beginning, it’s been a lukewarm reception. In 2013, FDA relied on an advisory panel to assess the product before approval. Most of the Circulatory System Devices panel agreed on the device’s safety, but had continued questions on the product efficacy. Nonetheless, the committee wanted the product to move forward by a narrow vote of 6-4 in favor, saying that the benefits of the product likely outweighed its risks. FDA approved the product in May 2014, noting that it would “continue to learn about the device’s performance when used outside the context of a clinical study.” I accept the nature of FDA and advisory panels to use careful language, particularly with new products, but this seems more like barely passable analysis from the agency.
In the last few months, the product has taken some hits. The company says insurers are objecting the product’s use. CEO Daniel Starks spoke about the challenge during SJM’s in a quarterly earnings call on Oct 21. “There’s a lot of resistance to uptake of new technology in the payer environment,” he said, according to a Seeking Alpha transcript. “Our challenge is to fight through just a natural inertia and resistance to pay for new technology and to educate people fully that this technology is one of the good guys. It’s … not something that adds to the cost of healthcare. It’s something that really reduces the cost of healthcare.”
In September, the Institute for Clinical and Economic Review (ICER) released a draft report concluding that CardioMEMS HF represented a “small net benefit” compared with alternatives to monitoring patients with heart failure risk. The ICER report also skewered the price of the product at $17,750 as “excessive.” SJM had already defended its pricing scheme. In March, medical director and vice president of medical affairs Philip Adamson presented the company’s cost analysis data at the Heart Rhythm Society’s Scientific Sessions. Following the ICER report, Adamson discussed it again in October at AdvaMed’s annual meeting, saying that the price of the system fits within typical healthcare economic evaluations and is “defensible.”
The latest wrinkle for SJM is its Atlanta manufacturing plant, where the CardioMEMS HF products are made. FDA issued a warning to the company about the Atlanta facility, noting nonconformities to good manufacturing practices on September 30. The agency said the plant failed to meet deadlines to address concerns about incorrect serial numbers, device surface coating defects, and validation of the sterilization process. SJM has clarified that these concerns do not involve the performance of CardioMEMS. Nonetheless, it feels like another negative in the CardioMEMS column, and there is no doubt that mass media is making a connection.
The lessons: In the new digital healthcare market, everyone – including FDA – is working to find the best way to navigate. It could be that FDA and insurers are going to be particularly difficult on companies that try to get new technologies on the market. The market success of CardioMEMS rests squarely on its ability to influence and educate the many stakeholders on the value of the technology.
I spoke with Michael Drues, president of Vascular Sciences, for regulatory advice for companies who are also developing digital healthcare products. Drues is a published author and has served as an advisory panel member for FDA on multiple occasions (Drues is also the regulatory consultant for a company developing a product that will directly compete with CardioMEMS).
Here are the pointers he had for companies:
- Don’t think of the regulatory structure for digital products differently than you would for any other medical device. The basic tenets are the same.
- Don’t just get do the regulatory minimum to pass. In fact, don’t even think about the regulatory structure for safety and efficacy. Think about the fact that one day, you, your mother, or your son, might need a device. What would be your acceptable safety and efficacy levels?
- Don’t think of regulation in isolation. You have to make it part of the reimbursement, quality, and manufacturing structures. It is all connected.
- Involve FDA is discussions early on and before you submit your PMA or 510(k). If you send a submission with the expectation of getting questions back, you are moving in the wrong direction and wasting money. Get those questions from FDA and include the answers in your submission.
Most importantly for other companies who are also developing digital products: Don’t move too fast. In the new technology market, maybe it’s best to be second.
