In my previous post, I discussed the need for healthcare companies to take a more market-focused approach to the healthcare consumer, including a more concentrated effort to segment the market and tailor strategies to different consumer groups.
Today, I’d like to explore the growing power of the healthcare consumer.
Overall, healthcare costs – both on the societal and the individual level – are increasing. Consumers are required, one way or another, to pay a greater share. So they are starting, albeit slowly, to ask questions about value. And they are interested in the value to themselves, individually, not to the population as a whole. How the consumer perceives healthcare value is an area that needs a lot of further exploration.
At Popper and Company, we have observed that an empowered consumer, armed with more information than ever before, is using this information to demand more tailored, customer-centric treatment from practitioners and institutions and from the tools and technology used. This customer demand is starting to move information from large centers accessible only to physicians, researchers or engineers to mobile devices, web sites and social media platforms accessible to nearly everyone.
How might healthcare innovators respond to such changes in customer demand?
- Create new metrics, like the popular Consumers Union of the U.S. rankings, that measure how customers rate a product (high/low acquisition costs, maintenance costs, product lifespan) according to their preferences. This would require healthcare providers and technology developers to consider customer input in their products and services. More significantly, it would require them to be able to describe their products and services in a way that’s comparable to a competitor’s (and in ways that consumers will understand).
- This new “report to consumers” would require the development of information systems that can read customer behavior, wants, and needs. Seeing patients as customers means considering how these customers will react to products or services, and taking those reactions into account when designing a product or service, or when developing a new treatment strategy.
Certainly, this would require quite a paradigm shift in the life sciences industry, but it’s the way our colleagues in the automobile, electronics, and durable goods industries work every day. Now, as in these other industries, consumers can educate themselves and retrieve information easily. Therefore, it’s probably time that our industry joined those other industries in putting consumer perceived needs first or a the very least on a par with what the health care providers think is “good for them.”
Do you think a consumer ranking system is possible broadly in healthcare? How readily are you now able to capture your customer’s ratings and opinions of your company or its products? Are there any other ways those developing healthcare solutions can integrate and embrace the changing role of the customer? Please share your thoughts with us.
Tags: consumer report, empowered consumer, healthcare, healthcare consumers, healthcare marketing, healthcare providers, healthcare solutions
Posted in Our Views | No Comments »
On January 19, the FDA’s Center for Devices and Radiological Health (CDRH) announced its action plan to address deficiencies of the 510(k) program. As the program exists today, some have argued that there’s a lack of clarity, efficiency and speed in the process. With that in mind, there’s been a push by industry, patient advocates and other critical stakeholders for significant change. Needless to say, the FDA has a tough balancing act to perform in this space.
For context, here’s a current definition of the 510(k) program from the FDA website:
“Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.”
In the past, the process associated with this program has created delays for companies to market their devices while at the same time it has protected the public from devices that perhaps were not quite ready to market.
According to a statement made by Jeffrey Shuren, Director of the CDRH, the FDA’s action plan is expected to create a transparent pathway through the 510(k) process to build “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly.”
Some history behind the changes – in 2009, two committees were established to address the concerns expressed by industry, consumers, and healthcare providers about the impediments to the 510(k) program. Namely, some stakeholders criticized the 510(k) program for being unpredictable, inconsistent, and opaque. As a result, some argued, medical device developers have begun to look outside of the U.S. to further develop and market their device in “better” regulatory markets.
The two committees established in 2009 are the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. In addition, the Institute of Medicine is also independently reviewing the 510(k) program and making recommendations.
The general public also had the opportunity to provide input into the recommendations, either in writing or through public meetings. Consumers, healthcare professionals, patient advocates, industry, third party payors, venture capitalists, academicians, legal counsel, and other stakeholders were among the groups that provided comments to the FDA.
After receiving feedback from the public, the working groups made more than 50 recommendations for improvement of the 510(k) program. From the larger list of recommendations, 25 actions were developed into the action plan.
In my opinion, some of the most significant action plan recommendations include:
- Streamlining the de novo process
- Clarifying when to provide clinical data
- Clarifying and consolidating the concepts of “indication for use” and “intended use”
- Providing supplemental guidance on pre-IDE meetings and the 510(k) process
- Creating a network of experts to review new medical device technologies
The agency has a tall order to fill and needs to make changes that will provide a scientifically based, efficient, and expeditious program to bring new devices and tests to market while at the same time assuring consumers and patients who use those devices that they are safe, effective, and economical.
What is your reaction to the FDA’s action plan? Have the right steps been addressed? What is missing? Share your thoughts here.
Update: Yesterday, the FDA announced that it would be reviewing cutting-edge medical devices through its newly proposed “Innovative Pathway,” a program intended to accelerate the time it usually takes to review truly innovative new devices. Only a few devices will be reviewed per year due to limited resources at the FDA. The program is subject to public comment at a meeting set up for March 15, 2011.
However, the Agency is still faced with the fact that the majority of medical devices are innovative but they may not be revolutionizing in terms of changing patient care — a current feature of the proposed pathway. Thus, most devices reviewed by the Agency would not go through the Innovative Pathway as currently defined.
We’ll continue to watch this unfold and to keep you updated!
Tags: 510(k), cdrh, de novo process, FDA, healthcare providers, institute of medicine, jeffrey shuren, medical devices, pmn, premarket notification, task force on the utilization of science, working group
Posted in Our Views | No Comments »