Yet in clinics across the country, talented medical professionals are spending hours each day buried in administrative work: updating records, managing appointments manually, writing prescriptions by hand, and sorting through files.

It’s not just inefficient — it’s exhausting.

But what if that could change?

What if you could spend more time caring for patients, and less time wrestling with paperwork?

The Admin Burden Is Real

For every patient seen, there are dozens of backend tasks:

• Scheduling and rescheduling appointments
• Recording and storing patient histories
• Writing and tracking prescriptions
• Managing invoices and receipts
• Following up on missed visits
• Handling compliance and documentation

This creates a double burden:
Time lost on admin tasks
Risk increased due to manual errors and inefficiencies

And let’s not forget — when doctors are distracted by admin, patient care suffers.

GoWello: Turning Chaos Into Care

GoWello is not just a software—it’s a digital ally for the modern healthcare provider.

This AI-powered, all-in-one platform was built to transform how clinics operate, starting with one clear goal: less paperwork, more care.

Here’s how GoWello helps:

Digital Patient Records at Your Fingertips

No more sifting through paper files. With GoWello, every patient’s history, lab results, prescriptions, and follow-ups are stored securely and accessed instantly.

E-Prescriptions Done Right

Say goodbye to handwritten slips and confusion at the pharmacy. Generate, share, and track digital prescriptions in seconds.

Smart Scheduling & Reminders

Automated appointment bookings, follow-up reminders, and real-time availability — no human intervention needed.

Integrated Billing & Invoicing

Create and manage bills directly within the platform, reducing paperwork and speeding up collections.

Time-Saving Templates & Notes

Use reusable consultation templates and AI-suggested notes to record visits faster and more accurately.

The Real Impact

Clinics using GoWello have reported:

• A 60–80% reduction in manual paperwork
• Up to 6 hours saved per week per doctor
• Significant drop in errors and redundancies
• A more relaxed, focused, and productive environment

But the biggest win? More meaningful time with patients.

Go Paperless. GoWello.

By cutting down on paperwork, doctors regain the time and mental space to do what they’re best at: providing quality care.

And in a world that’s moving toward connected, efficient, and digital-first healthcare — GoWello puts you ahead of the curve.

Whether you run a solo practice or a multi-specialty clinic, GoWello adapts to your needs and scales with your growth.

Because when you care less about the files, you care more about the people.

Let’s be honest — even the most skilled doctors and clinic administrators can feel buried under admin work.

But what if there was a way to simplify it all? One platform. Zero hassle. Welcome to GoWello.

Why Patient Management Feels Broken

Most clinics still rely on a mix of disconnected tools — paper forms, Excel sheets, WhatsApp, or outdated software that doesn’t “talk” to each other. This leads to:

• Missed appointments
• Scattered patient records
• Prescription errors
• Delayed follow-ups
• Frustrated staff and unhappy patients

It’s not just inefficient — it’s risky. In today’s digital-first world, patients expect speed, transparency, and continuity. A fractured backend means a fractured experience.

The Case for a Unified Platform

Effective patient management requires integration. Every step — from scheduling to consultation to follow-up — should flow seamlessly. That’s where a modern, all-in-one solution becomes a game-changer.

Enter GoWello: The Future of Patient Management

GoWello is an AI-powered, B2B2C digital healthcare platform designed to bring simplicity, speed, and structure to your clinic operations — with a special focus on streamlining patient care.

Here’s how it works:

Appointment Scheduling Made Effortless

Patients can book online. You get a real-time view of your calendar, automated reminders, and zero no-shows.

Smart, Centralized Patient Records

Access a patient’s full history — prescriptions, consultations, diagnostics — in just a click. No paper. No guesswork.

E-Consulting + In-Clinic = One Unified Workflow

Whether the patient walks in or logs in, their experience remains smooth. GoWello bridges the gap between online and offline seamlessly.

Follow-Up Automation

Get notified when a follow-up is due, send reminders automatically, and never miss a patient touchpoint again.

Integrated Billing & Prescriptions

Generate e-prescriptions and invoices instantly, while reducing manual errors and saving admin time.

AI-Driven Insights

Track metrics like patient retention, appointment trends, and feedback to continually optimize your care delivery.

Real Results from Real Clinics

Clinics using GoWello have reported:

• A 40% increase in patient retention
• A 70% reduction in no-shows
• Admin time savings of 6–8 hours per week
• Happier patients and more relaxed staff

Why It Matters Now More Than Ever

Patients don’t just want medical care anymore — they want a smart experience. From appointment to aftercare, they expect clarity, convenience, and continuity.

GoWello helps you deliver exactly that — without the chaos.

Final Word

Streamlining patient management doesn’t require a tech overhaul — it just needs a smarter solution. With GoWello, you get one platform that does it all, so you can stop juggling tools and start focusing on what truly matters: your patients.

No hassle. No friction. Just seamless care delivery.

It’s clear that the old ways of running a clinic are no longer sustainable. The real question is: what’s the smarter way forward?

The Rise of Integrated Healthcare Platforms

While digital health has seen massive adoption through teleconsultations, most clinics still run on disconnected systems. One tool for video consultations, another for scheduling, another for prescriptions, and yet another for billing.

This patchwork approach leads to data silos, duplicate work, and missed opportunities to deliver seamless care.

That’s where integration becomes a game-changer.

By bringing e-consulting and clinic management onto a single platform, healthcare providers can achieve:

• Streamlined operations with fewer touchpoints and reduced manual work
• Better patient experiences through connected care journeys
• Smarter decision-making using real-time insights and AI-driven tools
• Higher revenue potential due to improved efficiency and reduced leakages

But not all solutions are created equal. That’s where GoWello steps in.

Meet GoWello: Your All-in-One Digital Healthcare Command Center

GoWello is an AI-powered digital healthcare platform built for modern medical practitioners. Unlike standalone tools, GoWello combines e-consulting, e-prescriptions, and clinic management into one unified ecosystem.

Here’s how it’s changing the game:

Seamless E-Consulting
 Conduct virtual consultations effortlessly, with secure patient data access, real-time notes, and instant e-prescriptions — all in one window.

Clinic Management, Simplified
 Automate scheduling, maintain digital patient records, manage billing, and streamline communication without toggling across platforms.

Paperless, Error-Free Prescriptions
 Say goodbye to illegible handwriting and prescription mistakes. With GoWello, AI-assisted e-prescriptions are fast, safe, and fully compliant.

Reduced Admin Load, More Time for Patients
 Doctors using GoWello report saving hours each week on non-clinical tasks — time they now spend on what truly matters: healing.

Affordable, Scalable & Ready for Tomorrow
 Whether you’re a solo practitioner or managing a multi-specialty clinic, GoWello grows with your practice.

Real Results, Real Impact

With GoWello:

• Clinics reduce operational costs by up to 30%
• Physicians save 5–7 hours a week in admin time
• Patient follow-up rates increase by 40% thanks to better engagement tools

It’s not just a platform. It’s a partner in building the future of your practice.

The Bottom Line

Integrating e-consulting and clinic management isn’t a “nice-to-have” anymore — it’s a must-have for forward-thinking healthcare providers. The future is digital, connected, and intelligent. Platforms like GoWello are making that future accessible today.

If you’re still juggling multiple tools and feeling overwhelmed by paperwork, maybe it’s time to let GoWello do the heavy lifting — so you can focus on your patients.

The aim is to provide guidance, says the project brief, “to improve the consistency of local medical devices formularies reflecting the importance of the patient voice in decision making and wider principles of value-based procurement”.

But, fearing that spending reductions are at least part of the reason behind the project, some in industry aren’t convinced, arguing that local formularies (short lists of products and devices recommended as options for prescribers in the local area) risk compromising the right of clinicians to prescribe, and of patients to receive, whichever product on Part IX they consider best meets the needs of the individual patient.

Such restrictions could adversely impact upon patient experiences and outcomes, proving to be a false economy if the move leads to otherwise avoidable complications and/or episodes of treatment.

The project is being driven forward with an unusual air of urgency, kicking off with a call for evidence in early July, and completing with the publication of the new guidance in April 2026, and production, by all local NHS systems (ICSs) in England, of the new formularies by April 2027.

The range of products set to be caught in this new project is very wide, including continence, stoma and wound care; gastrointestinal and urological care; respiratory and airway management; lymphoedema, support and therapeutics; sexual, reproductive and pelvic health; diabetes, glucose monitoring and insulin delivery; oral, dental, ear, eye and nasal care.

Anticipating concerns about the need to avoid unintended consequences for clinicians and patients, the initial project brief does identify a series of issues that will need to be considered.

Those issues include: clinical effectiveness; availability of/access to “real world” evidence; supporting self-care; supporting system savings; reducing health inequalities; supporting patients in living life to the full; appearance, comfort, fit of medical devices; patient choice; diversity of users (including skin colour, those with physical or mental health restrictions, allergies etc.); quality/accessibility of information to help patients choose a device; impact of patient’s personal circumstances; adherence to use of medical devices by patients; accessibility/availability of medical devices; inclusion of medical devices characteristics [learning curve, incremental innovation, dynamic pricing, and organisational impact]in Health Technology Assessments; influence of sex and gender in clinical trials of medical devices; software as a medical device; medical devices used for patient self-testing; medical devices safety.

Industry must proactively engage with this process, as should clinicians, patients and their advocates, and those with expertise in assessing whole system costs when comparing one product with another in the same category. Real world evidence and case studies must be part of the process if patients are not to be adversely affected by an over-reliance on randomised control trials, which are simply not available or feasible for many product categories. The principle that clinicians may prescribe any device listed on Part IX, that they consider most appropriate for their patient, should be highlighted in every formulary and must not be compromised. Med-Tech Insights

These address a critical gap in treating two common fractures. Designed to improve stability, enhance performance, expand surgical options and increase efficiency^4†, both systems feature the same precision threaded locking technology introduced with the original VOLT Platform in 2024.

Little more than a conversation starter a few months ago, value-based procurement is now one step nearer to making a practical difference to patients and practitioners.

Since I last wrote about value-based procurement back in September, there has been considerable momentum, and I am heartened to see the issue gaining greater exposure across both the government and the health system.

Eight months on from Lord Hunt’s influential written question committing government ministers to the delivery of “value-based procurement” (VBP) across the NHS, and it’s safe to say that the government has not only heeded the call but is also taking major steps toward revolutionising the procurement approach in the health sector.

The DHSC’s MedTech Strategy, launched in February last year, recognises the need for procurement to deliver value for money across the NHS. The strategy acknowledges that “the value of medtech products should not be considered in isolation but across the whole patient pathway” and that “lowest price does not always translate to best value.”

Up until now it was unclear whether those promises would translate into action. At the end of last year, I was invited to attend a meeting with Lord Hunt (a long-standing campaigner and advocate for VBP) and DHSC officials to represent the voice of industry and brief Government on the importance of VBP. This meeting concluded with a commitment from the government to move forward with the concept, marking a significant step toward its proper implementation in NHS purchasing decisions.

The MedTech Directorate, led by its director David Lawson, is imminently to launch a value-based procurement (VBP) methodology. The methodology contains a new approach to VBP that would put patient experience and outcomes at the heart of purchasing decisions, taking fully into account whole system costs. Placing a renewed focus on the patient, it has the potential to deliver a paradigm shift in approaches and attitudes to purchasing, moving away from item price to true value.

This is a most welcome but long overdue step, and it is refreshing to see government truly consider industry concerns. It demonstrates the importance of government-industry engagement to ensure that policies are rooted in practical realities, drawing on the invaluable insights, experiences, and knowledge of those directly involved within the health sector.

The methodology is expected to be shared with key industry stakeholders imminently, with it being promoted to the procurement sector in March. We can then expect a wider soft launch of the toolkit in the Autumn to coincide with other regulations on procurement expected around the same time. The intention would be to make the guidance mandatory from Autumn 2025.

While this development is undoubtedly positive, the challenge now turns to those on the ground, and promoting the new approach to the individuals in charge of making budget purchasing decisions at local level. There is simply not enough understanding or a standardised uptake of VBP, and the lack of a joined-up approach across the system means that the value of whole system costs has been greatly under-appreciated for many years.

The absence of central guidance has hindered the adoption of VBP, with a prevailing focus on unit costs rather than overall value. Addressing this gap in understanding and uptake is essential, and the proposed methodology will deliver a much-needed solution to clarifying the roles and responsibilities of all parties within the health system.

A recent National Audit Office (NAO) report on NHS procurement highlights the ambitious savings target of £1 billion by NHS Supply Chain from January 2022 to 2030. It is imperative for the DHSC and the NHS to collaborate to ensure that these savings consider the entire system and do not compromise patient outcomes for immediate cost reductions.

Integrated Care Systems must place patients at the core of their pathways, and the new methodology provides a roadmap for achieving this. Successful implementation will require a concerted effort from all stakeholders involved, turning the idea of VBP into a concrete reality and fulfilling the commitment to prioritise patients in decision-making processes.

As President Donald Trump’s tariff policies continue to evolve, medtech investors will be focused on companies’ plans to manage the impact on supply chains when they tune into first-quarter earnings calls starting this week.

Stock prices for some of the sector’s largest companies, such as GE Healthcare and Intuitive Surgical, have come under pressure amid fears about how Trump’s trade wars will affect manufacturers’ businesses.

The tariff plans have brought concerns across industries about the repercussions for global trade. GE Healthcare and Medtronic were among more than 20 U.S. companies that participated in a roundtable meeting last week with China’s Ministry of Commerce.

Expect tariffs to be “highly topical” on first-quarter calls, where companies could discuss how to rejigger manufacturing to match geographies and reduce exposure to tariffs, Morningstar analyst Debbie Wang said in an email.

On Friday, a GE Healthcare spokesperson told MedTech Dive the company would provide an update on the tariff situation on its next earnings call. In February, the company said its 2025 outlook for earnings before interest and tax incorporates an impact from China tariffs of about 10 basis points.

“Our teams are working on potential mitigation plans as these trade policies evolve,” the spokesperson said via email. “Our top priority is to make sure patient and customer deliveries for products and services are not interrupted under any circumstances, while maintaining the best possible quality and cost. This is a dynamic issue.”

Earlier this month, China’s Ministry of Commerce also began an anti-dumping investigation of X-ray tubes from the U.S. and India used in computed tomography machines. A GE Healthcare spokesperson told MedTech Dive at the time that the company did not think the investigation was a material risk to its business in China.

Medtronic is also monitoring global tariff policies and will “continue to assess potential impacts to the company and implement mitigations if necessary,” a spokesperson wrote in an email.

Confusion on reciprocal tariffs

Trump announced a 90-day pause on most reciprocal tariffs last week, in a turnabout from his “Liberation Day” declaration of hefty tariffs on imported goods from most U.S. trading partners. The president also raised total duties on imports from China to 145%. Countries besides China remain subject to a 10% baseline tariff.

Analysts emphasized that the pause on reciprocal tariffs is temporary.

“Despite this 90-day pause, we wouldn’t be surprised if the administration moves forward with implementing tariffs,” said Wang. “However, it’s not clear that any potential reciprocal tariffs would significantly impact the large medical device makers.”

During fourth-quarter calls, device makers including Boston Scientific, Edwards Lifesciences and Zimmer Biomet said the potential impact from tariffs was factored into their full-year guidance ranges. “Most management teams seemed to downplay it as modest to immaterial,” noted Wang.

However, some smaller companies, such as Masimo and Enovis, said during fourth-quarter calls that new tariffs, particularly on products sourced from Mexico, had the potential to affect their financial results.

Intuitive Surgical said in January that a “significant portion” of its instruments are manufactured in Mexico, so tariffs implemented there could have a material effect on the company. However, the company has not yet included a tariff impact in its profit forecast.

J.P. Morgan analyst Robbie Marcus, in a note to clients Monday, wrote that Mexico has been left off of the reciprocal tariffs list for now, but the country is subject to a roughly 25% tariff, with the exception of goods compliant with the United States-Mexico-Canada Agreement.

“We think the worst case scenario has so far been avoided for Intuitive,” Marcus wrote.

RBC Capital Markets analyst Shagun Singh, in an April 3 report, said the implementation of tariffs would likely be an “incremental headwind” to most of the medtech companies the firm covers, as device makers find ways to offset their exposure, with potential impacts beginning to show up in the third quarter and beyond.

When first putting together this issue of Med-Tech Innovation News, my Twitter (no Elon, I’m not calling it X) feed in the early days of January lit up with government cabinet members celebrating the great opportunity that awaits businesses in the UK joining the Horizon Programme. Sorry, re-joining.

I had earlier said in a piece on the website that it was a good move from government for the UK to be back in the Horizon Programme – a grown up move following several years of populist, childish squabbling. Yet it stuck in the craw a little when a substantial number of those who advocated for Britain’s withdrawal from the European Union, subsequently shifting the goalposts to claim a mandate to withdraw from any initiative or institution that had any variation of the word “Europe” in the title – were those celebrating this news.

It serves as a reminder of the uncertainty and lost time and talent that has been a signature of recent years because of playground politics. Speaking of which, it is an election year in the UK, with opinion polls suggesting the public will be voting for a change in government. If that is the case, one would hope that an ejection of the incumbents will see a return to sanity, allowing industry, and businesses such as in this sector to have a more certain environment to operate in and make it easier to trade with neighbouring nations.

That’s not to say a change in government will be the silver bullet to all the challenges facing manufacturers and other businesses involved in medical technology. There are challenging economic conditions still being faced, the manufacturing outlook in the UK is not exactly optimistic as one report indicated the sector shrank for the 17^th consecutive month with optimism hitting a 12-month low at the start of January – and on a wider scale, economic statistics suggests the UK economy entered recession towards the end of last year.

On a separate note, this will be the last time I will be adorning these pages, so apologies to those who miss my musings, but after the best part of four years editing this title, and five-and-a-half years at Rapid News, it’s time for a change from writing about all things medical technology in an editorial capacity.

It has been a great pleasure covering this industry. I knew close to absolutely nothing on Day One walking into this job – some of you may suggest I don’t know an awful lot now – but it has been an eye opener covering this industry during one of the most tumultuous times in human history with a pandemic and seeing how much a force for good the sector can be. It’s been, and still is, a really exciting time to be a part of it.

I’m sure the next editor will have loads of fun with you all, and I’m very excited for the journey they will be going on with you.

For those wondering if I’ll still be involved in medical technology. Yes, in a way, on the other side of the fence! You might well see me at Med-Tech Innovation Expo 2024. So, this might not be goodbye, just au revoir.

It was set up as a quango, which means it is funded by taxpayers, but not directly controlled by central government. As the prime minister has said in recent days, the same jobs were being done by similar departments in both NHSE and the Department for Health and Social Care (DHSC), so the plans will aim to streamline functions.

The prime minister has said that abolishing the body would “cut red tape” and bring management of the NHS “back into democratic control”, also adding that it would allow for a refocus on cutting waiting times at hospitals.

Speaking about the reported 9,000 jobs that will be lost due to the plans, Health Secretary Wes Streeting told Sky News’ Trevor Phillips: “[It] will be an anxious time for them… there’s no way of sugarcoating it. But we will be treating people with care and respect and the fairness that they are owned through this process.”

Med-Tech Insights heard from experts and members of the MedTech industry with their reaction to the news:

Chris Whitehouse, a political consultant and expert on MedTech policy at Whitehouse Communications said:

“The move is born of the frustration of government ministers that whilst they, in the eyes of the voters, are accountable for long waiting times, poor productivity, plummeting staff morale and poor health outcomes, ministers have not been able to exercise sufficient political control to force through change at the pace that will be necessary for voters to see real improvements delivered at sufficient pace.

“Wes Streeting’s announcement makes it clear that work must begin immediately to return many of NHS England’s current functions to the Government’s Department of Health and Social Care.

“A longer-term programme of work will deliver the changes to bring NHS England back into the department, while maintaining a ‘laser-like focus on the government’s priorities to cut waiting times and responsibly manage finances’. It will also realise the ‘untapped potential of the NHS as a single payer system, using its centralised model to procure cutting-edge technology more rapidly, get a better deal for taxpayers on procurement and work more closely with the life sciences sector to develop the treatments of the future’.

“The devil will be in the detail of future structures and priorities, but given the challenges facing government in terms of waiting lists, patient outcomes, and out of control spending, there’s every chance that the changes bode well for the MedTech sector, provided it continues to engage with government to promote the role it can play in helping the government deliver on its objectives.”

Sarah Woolnough, Chief Executive of The King’s Fund, said:

“The announcement lands on the same day that NHS stats show people continue to wait days in A&E and many patients remain stuck in hospital beds despite being well enough to leave. The most important question is how will the abolition of NHS England make it easier for people to get a GP appointment, shorten waits for planned care, and improve people’s health. That hasn’t yet been set out – ministers will need to explain how the prize will be worth the price.

“It is absolutely right that democratically elected politicians must have clear oversight of how the NHS delivers for patients and spends hundreds of billions of taxpayer money. It is also reasonable to want to deliver better value by reducing duplication and waste between two national bodies where they are performing a similar role. It is true that over its just over a decade of existence, NHS England has been asked to take on a lot more additional power, functions, and therefore staff, than it was originally designed to do.

“Having now made the decision to abolish NHS England, and whilst we still wait for the publication of the NHS 10-year plan, the government must be clear why this significant structural change at this time is necessary, and how its fits into their wider plans. The potential costs savings would be minimal in the context of the entire NHS budget, and so they must ensure that the changes produce the improved effectiveness which is sought by making this change.  As with previous NHS restructures, structural change comes with significant opportunity cost, with staff who would otherwise be spending their time trying to improve productivity, ensure safety, and get the best outcomes for patients, now worrying about whether they will have a job.”

Kate Davies, public procurement associate director in the life sciences and healthcare team at Osborne Clarke: 

“Over the next two years, existing contracts between NHS England and its suppliers will need to be novated to the Department of Health. For new contracts that would have been procured by NHS England under the Procurement Act 2023 (such as for goods and non-healthcare services), the Department of Health can procure those contracts under the same legislation. Suppliers will notice some changes in what and how contracts are procured.

“In particular, we expect to see more centralisation of approach, but fundamentally the same legal principles will apply. However, in relation to healthcare services that would have been procured by NHS England under the NHS Provider Selection Regime, the legislation does not currently allow the Department of Health to award contracts under that legislation. The government will need to amend the legislation to allow the Department of Health to have this power, and until then, we expect NHS England to continue procuring essential contracts under the PSR until the amendments can be effected.”

Peter Rudd-Clarke, regulatory and litigation partner in the life sciences and healthcare team at Osborne Clarke:

“Manufacturers of medical devices and pharmaceuticals will want to see how these reforms dovetail with the work the government is doing on its 10-year health plan for the NHS. The government has stated that its focus will be on reforming the current healthcare model by moving from analogue to digital systems, and by putting an emphasis on prevention of sickness.

“NHS England is being scrapped soon after the government’s creation of the Regulatory Innovation Office (RIO). RIO was launched in October 2024 and is intended to support the regulatory system in bringing innovative products and services to market more swiftly, including digital health products, medicines and services.

“Manufacturers will hope that by integrating NHS England’s functions into the DHSC, the healthcare system will be able to provide greater political support, and public money, for the adoption of innovative life sciences products that support the aims of RIO and the government. These aims are expected to receive further impetus when new pre-market medical device regulations, and associated MHRA guidance, is brought in during 2025 and 2026.”

Dr Sonia Szamocki, founder and CEO of 32Co, says:

“As someone who has worked as a front line doctor, delivered healthcare transformation projects as a management consultant, and now building a company in the dental sector – I have seen every angle, and re-organisation on this scale is incredibly challenging. I’d caution anyone who believes this will result in overnight change.”

Matt Skinner, CEO of CareCity said:

“The announcement of the planned abolishment of NHS England to help ‘put health service back into democratic control’ represents a shift in the UK’s healthcare system strategy.

“However, simply ploughing any savings from reducing bureaucracy into our existing frontline will only be a temporary fix to a much more permanent problem. A focus and investment into prevention is required to realise any significant benefit, to both the economy and our population, from these savings. Only by tackling health problems further upstream (and working closely with communities and social care) can we stem the tide which is already overwhelming services and delivering worse outcomes for people.

“This is a once in a generation opportunity to divert significant funds to local, on the ground prevention which can improve health outcomes, reduce healthcare costs, and improve quality of life. It should be an opportunity to embrace and properly fund new integrated ways of working, innovations and design led approaches to health and care that work with and for our communities. I hope we also see investment in meaningful digital and tech approaches to prevention, leveraging the cost effective potential in early detection programs, assistive technologies and remote monitoring.”

The Food and Drug Administration is grappling with a surge in the number of medical devices that contain artificial intelligence or machine learning features. The agency had authorized 882 AI/ML-enabled devices as of March, and many other devices include AI features that don’t require regulatory review.

Currently, AI is most often used in medical devices in the radiology field, although the technology is also used in pathology, for appointment scheduling and in clinical support tools that pull in a variety of metrics.

The influx of AI in medical devices has raised questions from lawmakers and patient safety groups. Medical device industry group Advamed responded to a Congressional request for information on AI in healthcare in May. Advamed said the FDA’s authority is “flexible and robust enough” for AI/ML in medical devices.

On the other hand, patient safety nonprofit ECRI listed insufficient governance of AI in medical technologies among its top health technology hazards for 2024. CEO Marcus Schabacker said AI has the potential to do good, but the technology also can do harm if it provides inaccurate results or magnifies existing inequalities.

MedTech Dive spoke with Schabacker about what developers, regulators and hospital administrators can do to ensure devices that use AI are safe and effective.

This interview has been edited for length and clarity.

MEDTECH DIVE: The FDA finalized guidance in late 2022 on clinical decision support tools, and which ones should be regulated as medical devices. What are your thoughts on that? 

MARCUS SCHABACKER: We think the FDA is taking a much too laissez faire approach here. They should be much more stringent, particularly with decision support tools, and have clear regulations.

If they don’t want to regulate it upfront, they need to put post-market surveillance programs in place at a minimum. But we believe they should be way more forceful in the regulatory pathway and get more evidence from the companies that their tools are truly supportive instead of influencing decisions in a more severe way.

The FDA’s always in a tough spot. On the one hand, they want to make sure that the population stays safe. That’s their mission. That’s our mission too. On the other hand, they want to make sure appropriate innovation can happen and don’t want to be seen as a blocker.