Friday, August 15, 2014

Handling the Regulatory Challenges of Bringing New Innovative Technology to Market

In our ever changing world, innovation is an imperative for medical industries. We must have effective, safe solutions that are available quickly. Incremental changes used to be enough, but now with the increased needs and through the use of wireless communication, the Internet, and social media, it’s imperative that we find creative ways to get our ideas and solutions to market quickly. In this panel discussion from Medical Technologies 2014: A Frost & Sullivan Executive MindXchange, participants discussed challenges being faced and how companies might overcome them.

Elisabeth George, Vice President of Global Government Affairs, Standards & Regulations, Philips Healthcare

- Laetitia Cousin, Vice President, Clinical Affairs & Quality Assurance, Nuvasive
- Frederick (Rick) A. Curro, Clinical Professor & Director, PEARL Practice Based Translational Network
- Vinu Gurukar, Information Technology Leader, Product Development, Edwards Life Sciences
- Michelle McMurry-Heath, Associate Director of Science, Office of the Center Director (OCD) at the Center for Devices and Radiological Health (CDRH), FDA
- Robert Newman, Vice President, Regulatory Affairs, Apical Instruments


All sides agree that patients need access to innovative medical technologies sooner. In today’s highly globalized medical world, the amount of regulations around technology and products has slowed down the release of potentially life-changing technology. Medical tech companies, along with pharmacology and healthcare organizations, are trying to find the best ways to meet those guidelines without delaying new products.


One key to success for medical technology is to keep up to date with regulations and be heavily involved in learning those requirements.

Speed will be important for products’ success. Companies need to think about how to have devices accepted by the FDA and CMS simultaneously.

That will require thinking about the regulatory process as products are designed. Developers must measure what is beneficial to patients versus which risks are tolerable. It’s also critical to maintain the ability to put in local flexibilities for other markets where the rules may be different.


For every aspect of development, all people involved need to be highly educated and informed on changes in regulations and laws, both nationally and globally. Employees must be trained on those regulations, so when products are moved into the regulatory phase, the process is as quick and efficient as possible.
Education is paramount. Companies must make sure they diversify their knowledge about the different levels of regulation so that people know exactly what needs to be done to meet the needs of the FDA and other agencies.

As advanced healthcare technology becomes accessible across the world, a global standard for approval and quality assurance needs to be set, panelists argued. However, in the meantime, it’s critical to make sure the company is knowledgeable about the regulations in all applicable areas.


Medical technology companies should also work to open communication pathways with regulators and innovators in order to increase the expediency of the regulation process. That will help pull ideas for projects and allow new medical technologies to make it through the FDA regulatory process at a much faster rate.


Consortiums and partnerships should be established to foster dialogue and breed ideas on solid solutions that will make it through the regulatory hurdles.


Panelists offered some of the steps medical technology companies can take to stay on the cutting edge of the regulatory environment and avoid delay in bringing new products to market:

  • Offer training and classes on regulatory issues to all employees involved in developing new products
  • Network and foster relationships with the FDA, as well as other agencies and political figures. That will make sure the company understands the best ways to get approval as well as offer opportunities to educate regulators on the value of the products.
  • Maintain those relationships so the company always has up-to-date information.


One of the three top priorities for the FDA over the next few years will be to shift the balance of pre-market and post-market regulatory requirements. The goal is to make sure that only what is essential is required for pre-market data and allow for additional data to be collected post-market.


In that new environment, panelists encouraged companies to open lines of communication with regulators early on in the process. Pre-submission work will expedite the approval process by allowing companies to engage with review teams and get early feedback.


Companies should be in communication with the FDA and other agencies during the pre-submission phase and engage early on with review teams. Educate the agency on the existing property and which vendors will use the product. Present the product to different reviewers and educate them on the importance of the device.

Fortunately for medical technology companies, the FDA is working to expand its pre-submission base so that more companies can come to the FDA early on for a consultation.


The FDA has developed a tracking system for applications in order to increase transparency. This system allows applicants to monitor the status of their application as it moves through the approval process. There are also new quality assurance measures in place, including more education and training for all new reviewers to make sure they are knowledgeable.

Though the agency is working to streamline processes, there are still major hurdles in making potentially lifesaving technologies available quickly. Technology companies need to find the best ways to navigate the bureaucracy so they can deliver their products quickly to healthcare systems around the world.
It’s important for any business to educate itself on the changing regulation landscape within the United States and internationally. There is also a very important need to maintain and foster relationships with regulators around the world.

Information should be gathered quickly and efficiently when new products are developed in order to pass the information along to reviewers in a timely manner. Partnerships can also help in the expedition of approval for new devices.

For more valuable information, download Frost & Sullivan's Executive MindXchange Chronicles: Medical Technologies 2014, a unique collection of all the key take-aways and best practices discussed at the event.

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