It has been another challenging year for the industry, with cybersecurity issues, tech defects, industry layoffs and supply chain concerns all making headlines. But some exciting breakthroughs and innovations have also made waves. We highlight the top stories of 2023.
GE HealthCare spin-off
Back in January, GE Healthcare made its debut as a stand-alone company, launching at around 8% above its $54.30 starting share price on Nasdaq. The spin-off is part of an overarching restructure for corporate giant General Electric which has split its business into three independent companies – GE Healthcare, GE Aerospace, and the combined operations of GE Digital, Renewable Energy and GE Vernova.
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GE Healthcare is made up of divisions that generated around $18bn while it was part of the parent company. Industry analysts predict the business will focus on R&D spending (including ultrasound, imaging, and pharmaceutical diagnostics), AI enabled devices, and acquisitions of MedTech that complements its existing products.
Cybersecurity
Administration (FDA) issued policy guidance for the industry. Vendors were given until 1st October to prepare submissions meeting the new standards. A study by Ponemon Institute revealed that around 49% of device makers had not been following guidance from the FDA, to mitigate or reduce inherent security risks.
According to GlobalData forecasts, the global cybersecurity market will be worth $334bn by 2030 and software-based cybersecurity products will be the largest market segment, contributing 44% of total revenue.
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AI regulation
GlobalData forecasts that artificial intelligence (AI) platform revenue will reach $52bn by 2024 and that the market value for AI platforms for the healthcare industry will reach $4.3bn. But although AI can optimise many medical devices, its increasing use raises questions surrounding regulation.
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By GlobalDataIn October, the Biden administration released the most comprehensive set of rules and guidelines surrounding AI regulation the US has ever seen. Meanwhile, the European Parliament and Member States are continuing trilogue discussions this month on the draft Artificial Intelligence Regulation (AI Act). The UK Government published its policy paper on A pro-innovation approach to AI regulation earlier this year, which was updated in August. But the question remains, Will AI safeguard the public or stifle innovation?
Illumina challenges European Commission order to give up GRAIL
We reported in October that Illumina was seeking to challenge the European Commission’s (EC) jurisdiction over its acquisition of GRAIL, in the hope of keeping the merger on the table. San Diego-based Illumina had already completed its acquisition of cancer-test provider GRAIL for $8bn in 2020. However, in an unprecedented move, the EC ordered the reversal of the merger, citing that the deal would likely impact consumer choice in the emerging market for blood-based early cancer detection tests.
Previously, in July, the EC fined Illumina €432m for completing the acquisition without its approval. Illumina’s jurisdictional challenge remains pending at the European Court of Justice, along with an additional challenge to the ruling at the US Fifth Circuit Court of Appeals.
ProPublica instigates Philips device recall
In November, online news hub ProPublica declared that Philips Respironics had “received thousands of complaints about a dangerous defect in its breathing machines but kept them secret for years as stock prices soared”. The devices, including the popular DreamStation for sleep apnea, were dispensed to consumers before the global manufacturer announced a massive recall. It was found that Philips knew for over a decade about the defects before issuing the recall in 2021. The FDA was “unsatisfied” with the Philips recall and stated that it would continue to oversee the process.
Industry layoffs
Workforce reductions have been on the increase this year across industries as businesses worldwide face economic pressures. While some companies have remained resilient, others have instigated industry layoffs in the wake of regulatory issues, supply chain challenges, and business restructuring. Companies forced to make workforce reductions this year include Siemens Healthineers, 3M Health Care, Philips, and Johnson and Johnson. GlobalData analysts suggest that MedTech layoffs worldwide may top 18,000 by the end 2023.
ReCor & Medtronic – FDA approval for renal denervation
In November, ReCor Medical announced that the FDA had approved its Paradise Ultrasound Renal Denervation (RDN) system for the treatment of hypertension. Paradise received a positive vote from an FDA advisory committee meeting earlier this year after encouraging results from a six-month follow-up of its RADIANCE trials. The data showed that the ultrasound renal denervation groups had 3mmHg lower daytime ambulatory systolic blood pressure when adjusted for medication differences. A week later, the FDA then approved Medtronic’s Symplicity Spyralrenal denervation (RDN) system to treat hypertension.
Intuitive Surgical struggles to compete with GLP-1 therapies
Intuitive Surgical, the largest company in the robotic surgical systems market, suffered a share price drop of 8% in its Q3 earnings this year. The downturn was linked to concern among investors about the rise of glucagon-like peptide 1 therapies (GLP-1) receptor agonists on the diabetes technology industry. Positive trial results for the GLP-1 drug class, which includes Ozempic and Wegovy, showed improved blood sugar control and weight loss, calling into question the demand for surgical interventions for diabetes-related conditions.
However, while Intuitive Surgical’s recent decline may appear negative, GlobalData predicts an upward trajectory for robotic surgery as an increasingly popular alternative to traditional surgery, with major growth and innovation occurring in the market.
GenAI Revolution begins
In August, we reported on how generative artificial intelligence (GenAI) is expected to change the way life sciences companies are organised. GlobalData estimated the total AI market to be worth $908.7bn in 2023, growing at a compound annual growth rate of 35% from 2022–30. Research from consulting firm Accenture suggests that half the time currently spent in work activities at a biopharma company will be either automated or augmented.
Supply chain challenges
Although the MedTech supply chain has recovered significantly post-pandemic, 2023 has still been a year of disruptions. Inflation, corporate restructuring, difficulties with demand forecasting, and geo-political tensions (particularly the Russia-Ukraine and Taiwan-China conflicts) have all had an impact. Material shortages have also been problematic with 71% of global companies citing raw material costs as their number one supply chain threat this year. (Aluminium and titanium are commonly used in MedTech manufacturing are sourced primarily from Russia and China). Freight prices and port congestion have also been an issue.
