The Future of the Medical Device Industry and the Role of Quality Assurance
By: Debjani Goswami
Tags: Medical Device Market, Software Testing, Quality Assurance, AI, Medical Devices

The medical device industry is about to see significant changes with the evolution in the quality assurance trends of medical device software effective from 2020 onwards. There is an increase in the number of industry experts with each passing day.

The principal aim of these experts is the betterment of quality production and enhancement of efficiency in medical devices. The great leap that the entire medical device industry has been taking in embracing advanced and future technology is quite evident. Experts are gradually discarding obsolete approaches to target prevalent challenges that medical device software technology faces.

As far as market statistics are concerned, there is an estimated upsurge in the sales of global medical devices globally. International Trade Administration reports, from 2016 to 2020, there will be an annual sales increase of 6.4%, which is approximately $440 billion. Although the Americas region is estimated to be the largest medical device market globally, the markets in Asia/Pacific and other Western European regions are also likely to grow faster in the coming years.

Let us look at some of the latest developments in the medical device industry and the role of medical device quality assurance in backing-up those trends:

· The U.S Food and Drug Administration’s (FDA) technology up-gradation plan

The plan aims to digitally catch-up with how the agency conducts its quality and dealings with several companies. With vast data-driven devices flooding the market, the administration will soon manage highly secure data transfers digitally. Modernization of technology will also ensure better interaction, reduced errors, and partnership with several companies.

The FDA in 2020 is planning to adopt the ISO Standards, upon which many of the MDSAP requirements are based. The Medical Device Single Audit Program (MDSAP) is a regulatory approval process that allows an organization who deal with medical devices to undergo a single audit by a third party.

It ensures quality regulations in associated countries like Canada, Australia, U.S.A, Japan, Brazil, etc. The program has several benefits for device makers like fewer audits, lesser business disruption, etc.

Therefore, you must ensure that your medical device software clears every upcoming FDA audit and has impeccable quality.

So, you should not overlook the role of medical device software testing to test whether your medical device conforms with the FDA compliance standards.

· An increased reliance on Contract Manufacturing Organizations (CMO)

The current global medical circumstances see a considerable hike in demand for medical devices. Such organizations will continue to grow at a rate of 8.5% between 2019–2030.

High manufacturing costs and the technical nature of complicated devices are leading to more medical device companies turning to outsource their business processes, which include medical device quality assurance.

The market for global medical device outsourcing is expected to grow from an estimated 104.5 billion in 2019 to a compound annual growth rate of 10.4% in the upcoming years.

There are few factors like increasing diseases, globalization of medical device manufacturers, the growing complexity of medical devices contributing to the market growth in 2020, and the future.

Organizations can save many expenses required in setting up an in-house infrastructure for medical device quality assurance, by outsourcing their software testing requirements to quality assurance organization, who possess a robust global delivery model. This model in QA establishments, help medical device companies by providing in-house, offshore, and nearshore QA services.

· The popularity of the genomic medicine trend

Recent developments in the medical device industry show that using the genomic data of a patient helps make better healthcare decisions. The fields of oncology and pharmacology have seen great results by utilizing genomic medicine. Genomic medicine is driven by future technologies like machine learning and artificial intelligence, which have helped in its advancement. AI/ML increases the accuracy of devices in analyzing genes and their mutations.

A report by the National Institute of Health shows, the Human Genome Project through which the human genome was decoded, has steered this field towards reaching its zenith. This innovative technology is evolving rapidly, and every professional dealing with medical devices should be conscious about it.

· Rise of future technologies like Artificial Intelligence and Robotics

Some of the most overwhelming shifts brought about in medical devices is the incorporation of artificial intelligence and robotics. This technology helps in diagnosing conditions, identifying diseases, targeted treatments, etc. relying on algorithms.

The da Vinci surgical robot and similar micro-bots that use the collaborative robotics technology are already supporting surgeons with several complex surgical procedures. Treatment and rehabilitation of patients, automation of research laboratories and even hospital room disinfection processes are being carried out by doctors with the aid of robots.

Keeping the above technological advancements in mind, medical device companies must check whether the software testing company possesses AI testing and RPA capabilities when outsourcing their software testing requirements to QA organizations. Software testing organizations that leverage the power of AI in medical device software testing can provide faster results that are precise as well.

The above facts have introduced us with some insightful knowledge about the emerging trends in the future of the medical device industry. However, each of these technological advancements also indicates the significance of quality assurance and software testing procedures in successful medical device deployment.