Insiders' Guide To Winning In the Drug Delivery Device Market — Part 2: Regulatory Compliance
By Doug Roe, Chief Editor
This Q&A is the second in a five-part series that will examine industry opportunities in the drug delivery device space. Part 1 explored the overall market opportunity and some product design-related challenges. Subsequent installments will look at quality systems, mHealth and the Internet of Things (IoT), and vertical integration of product development.
Whether you are an original device manufacturer, an outsourced service provider, or a component/material supplier, the opportunity for growth over the next 10 years in drug delivery devices is enticing. The proliferation of biologics will lead to a large demand for new devices in an industry that lacks the needed expertise.
Navigating two different regulatory landscapes, one for drug and one for device, is the current reality. The FDA’s Center for Drug Evaluation and Research (CDER), which governs drugs, and its Center for Device and Radiological Health (CDRH), which governs devices, have different and often conflicting guidance. Many pharmaceutical companies lack experience in dealing with CDRH requirements, and so they often turn to medical device experts for assistance.
I recently sat down with one such expert, David Amor, managing partner at MEDgineering, Inc., to discuss the challenges associated with bringing drug delivery devices to market, as well as emerging therapeutic areas and technologies. David’s background is in mechanical and biomedical engineering, with expertise in regulatory systems and compliance. He has worked with Boston Scientific, St Jude Medical, and Medtronic on medical and combination device projects.
What therapeutic areas represent the biggest opportunity for drug delivery devices in 2016-17?
David Amor: Since the FDA approved Afrezza, an inhaled form of insulin, in June 2014, inhalation devices have been at the forefront of drug delivery innovation, to the extent that they are drawing funding from the unlikeliest of sources. For example, Israel’s Syqe Medical is attempting to fill an unmet need by developing an inhaler that precisely controls the dosage of medical marijuana and eliminates the associated high. Last week, smoking giant Phillip Morris provided two-thirds of a $30 million investment in the company. And, in November, the FDA cleared a nitric oxide inhalation device for MRI procedures. It is a sure bet that similar drug via inhalation options will continue to emerge in 2016 for management of diabetes and other chronic conditions.
Which drug delivery device platforms do you expect to have the most growth in 2016?
Amor: Inhalers are an area seeing significant disruption, as intranasal administration routes are gaining popularity. Device makers are integrating wireless capability, since connectivity could lead to improved patient monitoring and adherence tracking. Likewise, drug manufacturers are trying to figure out how to safely use drugs with an inhaler platform for faster and more efficacious delivery.
Teva recently purchased Gecko Health, whose smart inhaler has a sensor that enables data analytics for chronic disease management on a mobile application. I expect that pharma will continue the acquisition trend of targeting mobile health products and technologies to enhance their current delivery device portfolios.
What will be some of the key challenges facing companies that are expanding competencies into these delivery device platforms?
Amor: The key challenges are less about the technology itself and more about the integration of two distinct worlds — pharma and medical device. A lot of my work involves trying to teach pharma companies about the medical device world and vice versa. Quality and regulatory requirements in each industry are slightly different, and often the biggest challenges emerge when companies aren’t aware that the constituent products of a combination product are also governed slightly differently.
Although the FDA’s cGMP rule for combo products (21 CFR Part 4) was released recently, companies are still struggling to apply it to their new drug-delivery submissions. Companies that are committed to drug delivery device products must also invest in a robust regulatory/quality system that streamlines submissions and ensures compliance with new regulations and standards.
How will drug companies drive delivery device design innovation in 2016 and beyond?
Amor: Human factors engineering (HFE) ensures that adoption of novel delivery platforms will be successful. Users and caregivers in many therapeutic areas are used to a drug-based treatment regime; introducing a new “toy” that changes administration can be a scary proposition.
Usability studies and HFE work should aim to allay these anxieties and understand use cases, not to mention the FDA is requesting HFE work in combo product submissions. Out of the last four combo product submissions I have directly worked on, three of them contained HFE questions in the first round of review. Long story short: Having a robust HFE / usability program ensures that the innovations within the company actually make it to market.
Lastly, drug delivery companies need to remain up-to-date on regulatory requirements and standards. Knowing which ISO standards govern injection pens, for example, may reduce the head-scratching and hustle around test method development if you’re an injection pen manufacturer.
Following the guidance in 21 CFR Part 4 and the FDA draft guidance Current Good Manufacturing Practice Requirements for Combination Products ensures that your organization is compliant to existing and emerging requirements. I will often create compliance checklists or revise product development procedures for companies seeking to build a robust combination product-adherent design and development process.
What development challenges have you encountered with drug delivery devices and other combination products? Let us know in the comments, Also, for more on this topic, read Insiders' Guide To Winning In the Drug Delivery Device Market — Part 1: Design.