Tag Archives: Winifred Wu

Some talk about nanotechnology-enabled medical devices and regulatory requirements

Jim Butschli suggests a ‘new-to-me’ question in regard to nanotechnology-enabled devices and regulatory frameworks in his Feb. 12, 2013 article for Packaging World,

The projected worldwide market for nanotech-enabled products could range between $500 billion and $3 trillion by 2015, according to “Nanotechnology and nanomaterials medical devices—The regulatory frontier,” a presentation by Mary Gray, manager of regulatory affairs with DePuy Synthes—Johnson & Johnson, during MD&M West.

Gray said that medical devices and multiple industrial sectors could be improved through nanotech applications. She pointed to nano-based coatings that could be applied to medical device surfaces to optimize and improve health outcomes. Nanotechnology applications involve medical devices and consumer products, as well as their packaging.

Why would a company want to introduce combination products given their potentially onerous regulatory challenges? A key reason: enhanced therapeutic results and better patient outcomes.

That was an important takeaway from another presentation at MDM West given by Winifred Wu, president of Strategic Regulatory Partners LLC, entitled, “Strategies for the combination product pathway: Submission and approval.”

Wu cited a Research & Markets report that said the drug-device combination product market was growing 11.8% annually between 2010 and 2014.

Wu spent time discussing the U.S. Food and Drug Administration’s Office of Combination Products, noting that OCP tends to work closely with other FDA centers. She noted that there is still considerable debate around what products are combination products. [emphasis mine] The definition and scope continues to evolve as more therapies are developed.

Further investigation about combination products yielded this definition from the US Food and Drug Administration (FDA),

Combination products are defined in 21 CFR 3.2(e).  The term combination product includes:

(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;

(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or

(4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

I wish there was a bit more detail about the area of debate regarding what constitutes a combination product but Butschli seemed a little more interested in regulatory strategies,

Morton’s [Michael Morton, senior director of global regulatory affairs with Medtronic] speech, “Regulatory strategies for 2013: The art of framing a successful submission,” touched on some familiar observations, including the following:

• Determining the intended use of the product seems obvious, but uses can become difficult to define clearly among multiple stakeholders.

• Understand the indicated patient population and be clear about a product’s benefit claims. …

There’s more about nanotechnology and regulatory strategies in Butschli’s article.

The MD&M (medical devices and manufacturing) West 2013 conference where these talks were presented ended on Feb. 14, 2013.