Regulations for Medical Devices in a Digital world

In the Spotlight: Digitization of Medical Devices

The influence of the digitization wave on our well-being is evident. We no longer rely on clinicians and hospitals to evaluate our heart rate, blood pressure, or sugar levels. Today, we measure these vital parameters from the comfort of our homes, thanks to valuable digital medical devices. Applications on our smartphones tell us how many minutes of exercise we need, how many calories we have to burn, and what our daily diet should be. What’s more, wearable sensors can identify stress levels and even ask us to take deep breaths if they ‘sense’ that our body has exerted itself a bit too much!

As the digital revolution makes headway in healthcare, manufacturers of medical devices are further leveraging digital technologies to improve our well-being. Having said that, digitization is no mean feat. Medical device manufacturers have to overcome numerous challenges associated with cyber security and interoperability to innovate effective devices. This is where the U.S. Food and Drug Administration (FDA) is trying to streamline processes and provide greater transparency to consumers.

FDA pre-certification: raising the bar for product digitization

In September 2017, the FDA selected nine companies out of over 100 applicants to join in the development of the Software Pre-Certification Pilot program, as outlined in the FDA's Digital Health Innovation Action Plan. The program will establish a regulatory model to assess the safety and effectiveness of software technologies in healthcare. Today, it is making rapid progress, and its first version is slated to be released in 2019. When the pre-certification program goes live, it will enable manufacturers of medical equipment to enhance their credibility, address known and emerging risks better, ensure timely availability of solutions to patients, and achieve compliance.

The primary benefits of FDA pre-certification to a healthcare original equipment manufacturer (OEM) are that it can drastically shrink time to market and enhance brand credibility. Pre-certified organizations can do away with premarket reviews for lower risk software as a medical device (SaMD). They also have to adhere to strict guidelines of excellence and safety, enabling them to develop high-quality software products consistently. These guidelines also enable organizations to iterate products easily.

That’s not all! Pre-certification will also provide access to post-market data about products from a wide array of sources. This data will further enable quick decisions on product performance/issues and drive reactive or pro-active actions.

Getting it right through collaboration

As the FDA pre-certification pilot program takes shape, manufacturers of medical devices must simultaneously take measures to achieve high levels of digital product excellence and safety. These measures involve creating a culture of accountability to enhance product quality, using technology to mitigate cyber threats, adopting data-driven solutions to optimize product safety, complying with diverse regulations to enhance credibility, and a lot more.

Achieving this tall order implies that organizations will have to invest significantly in people, processes, and products. Alternatively, they can also collaborate with technology service providers that have proven expertise in the healthcare domain to fast-track processes.

We, at Wipro, have a strong portfolio of regulatory services and established capabilities in mobility, cloud, and Internet of Things. By collaborating with us, a wide range of companies in the healthcare sector — from medical device and pharmaceutical manufacturers to healthcare providers, can comply with upcoming regulations across US and EU (SaMD, EU MDR, MDSAP)

As a first step in the collaboration, we assess the product excellence levels of an organization by analyzing software design, testing capabilities, clinical practices, and monitoring real-world performance. Based on our analysis, we further identify digital assets as SaMD, categorize risks, provide pre- and post-market support, and implement product maintenance, support, and upgrades.

If you are a manufacturer of medical devices, it’s the right time to prepare your organization for upcoming SaMD guidelines and upcoming regulations

About the Author

Phani, in his current role, leads R&D innovation, engineering applications and compliance activities for PES Health. He has held various leadership positions across healthcare business and has worked extensively with clinicians and IT departments at Mayo Clinic, MSK, Hartford, Indiana Heart, UPMC, Stanford and hospitals in Japan and China. He has led teams across multiple global locations and incubated multiple products for emerging markets.

Phani holds an Executive MBA from Marquette and MS in Computer Science from University of Wisconsin. He is GE Six Sigma black belt certified, a graduate of multiple GE Crotonville courses and holds 3 patents and 5 disclosures.

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