8 August, 2017 by Alex Butler, Manager Medical Device Solutions, MasterControl
Thanks to constant leaps in scientific and technological innovation in recent years, we’re witnessing a steady (and very promising) trend toward combination products – those that merge two or more different types of regulated drugs, medical devices or biologics into one multi-faceted treatment. As more device and pharma companies join forces to develop combo products, the traditional industry and regulatory boundary lines between the two sectors become blurred, presenting medical product makers with as many opportunities as challenges.
This excerpt from my recent MDDI Device Talk blog post highlights some of the advantages and growing pains to keep in mind if you are considering making the move into the combo product space in 2017.
Opportunity #1: Knowledge Sharing Leads to Increased Innovation
Device, pharma and high-tech companies are highly specialized in their respective areas. But as the combo product market continues to grow, each industry must look beyond its borders to either acquire new manufacturing, scientific and regulatory knowledge, or partner with those who already have it. Collaboration across the healthcare ecosystem affords a range of opportunities for companies to share knowledge, which fosters innovation and pushes the boundaries of medical treatment as we know it. GlaxoSmithKline’s partnership with Google’s Verily to create Galvani Bioelectronics in 2016 is one of many such examples.
Opportunity #2: Personalized Medicine Is Here to Stay
In contrast to a one-size-fits-all approach, personalized medicine allows clinicians to diagnose and treat patients based on a unique subset of individual characteristics, typically with the help of two or more medical products or therapies. The FDA calls it a new era of medical product development and has already begun discussing its role and responsibilities in this area. Extraordinary advances in the fields of genomics, computational biology, medical imaging and generative medicine continue to pave the way for personalized medicine, a movement that promises to be a key driver of the combination product market.
Opportunity #3: Existing Products Can Be Re-purposed
It is often possible for companies to leverage an existing device or drug to create a new combination product. The advantage here is that the bulk of the work is already done; the product has already been tested, documented and cleared by the FDA, thus minimizing cost, time to product registration and likelihood of failure. In this way, a company’s previous product investments allow it to springboard into a new and relatively untapped market.
This article is related to the White Paper:
To get the full details, please view your free White Paper.
Challenge #1: A Lack of Predicate Devices Slows the Registration Process
Given the novelty of drug-device combination products, device makers don’t have the luxury of leaning on predicate devices to demonstrate safety and efficacy. This means that product registrations must be compiled from the ground up, including conducting clinical trials if necessary, which can be time-consuming and daunting for med device firms that often don’t possess the required in-house skills and resources. For these companies, there are a lot of unknowns and not a lot of information to work from. Fortunately, in a drug-device market expected to reach $115 billion by 2019, pharma companies are typically eager to partner with device makers and lend their expertise to help bring a new drug-device product to market.
Challenge #2: Determining a Registration Strategy Can Be Tricky
The rule of thumb for whether to register a combination product as a device or a pharmaceutical is to identify the primary mode of action (PMOA), or the component that has the most effect on a patient. But the FDA leaves this determination much to the discretion of the registrant, which in turn opens plenty of room for error. An inexperienced company that registers a combination product for the first time might find itself down the wrong regulatory pathway, due in large part to a lack of historical data. To get an early indication of how a product will be classified and regulated by the FDA, companies can complete a Pre-Request for Designation (Pre-RFD), an informal inquiry that can be submitted at any point during a product’s development.
Challenge #3: Human Factors and Usability Are Critical to User Adoption
Bioelectronics, interoperables and interconnected devices show great potential in augmenting drug-device combos, but even the most robust tech-assisted health tools will not benefit users if they are not adopted or used properly. In designing combination products, particularly those that are patient-administered or -operated, engineers must consider the skill level and dexterity of users early in the design process to promote user engagement, and human factors must frequently be evaluated throughout the design and development process to improve the user experience and increase the likelihood of adoption and compliance.
As more drug-device partnerships emerge in 2017, expect to see novel approaches and continued collaboration as companies overcome the challenges and reap the rewards of this growing market.
As the manager of medical device solutions at MasterControl, Alex Butler is focused on developing solutions that help medical device companies increase efficiencies, ensure compliance and speed time to market. Before joining MasterControl in 2014, Butler worked as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices, including the Opal Espirit™ Class II Corrector. With more than five years of direct medical device experience, as well as understanding of the FDA’s submission process and audit procedures, Butler is a vital part of the MasterControl product management team.