As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to differentiate themselves. Digital leaders are turning to Software as a Medical Device (SaMD) to assist with the diagnosis or treatment of disease.
These next-generation tools create more personalized experiences for patients, more information to guide clinical decision making and plenty of data for biopharma companies to use to continually improve therapies and to make a case for reimbursement. Along with this growth have come several developments in the regulatory space that impact how SaMD products are classified and how they can be used.
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Mark Tarby Mark Tarby is the Vice President, Regulatory Affairs, for BrightInsight. Mark has over 25 years of global quality and regulatory leadership experience at leading digital health and medical device companies. Prior to joining BrightInsight he was head of Quality and Regulatory for Capsule Technologies (formerly Qualcomm Life) where he provided global regulatory and […]
According to the International Medical Device Regulators Forum (IMDRF), Software as a Medical Device is software intended to be used for one or more medical purposes, and is not part of a physical medical device. These purposes vary and can include assisting with the diagnosis or treatment of disease, assisting with symptom management, or as a companion diagnostic software to a drug. There are many other uses as well.
SaMD software must be developed under a Quality Management System, like hardware devices. There are standards and guidance documents that apply specifically to SaMD. For example, IEC 62304 Medical Device Software — Software Life Cycle Processes is an international standard that provides a framework for developing and maintaining SaMD and software within medical devices. There are several other standards and guidance applicable to SaMD products.
Several trends around SaMD development are impacting how these products are classified and regulated, or present challenges to those processes. Here are five of the top trends.
Trend 1: Widening divide between U.S. and European regulations in classifying an SaMD product
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The rapid growth in the SaMD market is driving expanded use of existing digital products in new ways that can change their classification, as well as evolving classifications from regulators.
That makes it challenging for U.S. biopharma companies to market a SaMD product if it doesn’t easily fit in the rules-based classification system of the EU Medical Device Regulations or isn’t substantially equivalent to a predicate device in the U.S. These regulations are focused more on traditional medical devices, so software classifications may be more difficult to determine.
SaMD products may also contain software of unknown pedigree or provenance (SOUP). This is software that IEC 62304 defines as software that has not been developed for the purpose of being incorporated into a medical device, and/or where adequate records of the development process isn’t available. Because of this, additional controls are required to manage the risk of the SOUP.
Trend 2: Certification of companies that develop SaMD, rather than each new SaMD product
Another significant trend is how SaMD products are being handled within the regulatory scheme. FDA is working to pilot some programs that will help here. The idea is for the agency to provide a streamlined and efficient regulatory approach through a pre-certification of the SaMD developer first, rather than primarily on the product.
That would ease the burden of ongoing monitoring of these companies, and could reduce the submission of content, accelerate review, or both. The benefit comes from the fact that changes to software typically happen much more rapidly than they do in traditional hardware products.
Some of these products also use software-as-a-service type models. In these cases, the software may be undergoing continuous change. The challenges become how do you manage those changes, keep the software compliant, and ensure that the changes don’t impact the functionality of a device?
Trend 3: AI and machine learning create a need for a framework that allows for ongoing changes
The increased use of artificial intelligence and machine learning technologies has significant impact on SaMD products. These advanced technologies enable the software to continuously “learn.” That is terrific for patient care, especially in the diagnosis and treatment of cancer. AI and ML are becoming an even larger part of SaMD offerings. But it also means that these products are continuously changing.
Regulations will have to keep up with these learning algorithms. It is important for the algorithms to continue to learn and to do advanced data processing to get their full benefit. The traditional paradigm requires the learning algorithm to be “locked” and would likely require FDA to conduct pre-market review for any changes.
A new regulatory approach could enable a continuous learning environment, where the algorithm can continue to learn and change, but it also has adequate regulatory oversight to assure safety and efficacy are maintained. While being discussed by the FDA, that model does not exist yet.
Trend 4: Taking devices to market that have no predicate examples
A growing experience for many organizations is that a new SaMD product they want to take to market is totally new or unique. If a pharmaceutical company plans to use the traditional FDA 510(k) pathway to get into the market, it generally requires that the firm has a predicate device or a substantial equivalent.
In many cases, there is no predicate device available, so the FDA 510(k) pathway to market clearance cannot be used. The organization must have the device classified through a De Novo classification request, or go through FDA Premarket Approval, which is more rigorous, time consuming and expensive.
Trend 5: An urgent need for successful third-party partnerships
Another growing trend is the need for pharmaceutical companies to have trusted third-party partners that can help build and then take SaMD products to market, as well as to help navigate the complex regulatory route along the way.
The ideal partner is one that knows the current regulatory climate, but also knows what is in the works that will impact future product development. Such a partner can build the products under a medical device Quality Management System, take the product to market, and navigate the regulatory hurdles on the customer’s behalf.
Some third-party vendors may be able to help develop software, but a truly valuable partner is one that can help manage risk during the development cycle and handle any other regulatory questions or concerns that a SaMD product can encounter on its journey from drawing board to market.
Photo: Elena Lukyanova, Getty Images
Mark Tarby is the Vice President, Regulatory Affairs, for BrightInsight. Mark has over 25 years of global quality and regulatory leadership experience at leading digital health and medical device companies.
Prior to joining BrightInsight he was head of Quality and Regulatory for Capsule Technologies (formerly Qualcomm Life) where he provided global regulatory and quality strategic guidance in the digital health and patient monitoring space. He previously held global quality and regulatory leadership positions at St. Jude Medical, Philips Healthcare, CareFusion, Medtronic and Johnson & Johnson. Mark received a BS in Chemistry from the University of Akron, an MBA from Southern Methodist University and a JD degree from Concord Law School.
