Connect with us

Uncategorized

Battery companies are the latest SPAC target as EVs get a huge regulatory boost

Published

on

Batteries are the latest landing pad for investors.

In the past week alone, two companies have announced plans to become publicly traded companies by merging with special purpose acquisition companies. European battery manufacturer FREYR said Friday it would become a publicly traded company through a special purpose acquisition vehicle with a valuation at $1.4 billion. Houston area startup Microvast announced Monday its own SPAC, at a $3 billion valuation.

A $4.4 billion combined valuation for two companies with a little over $100 million in revenue (FREYR has yet to manufacture a battery) would seem absurd were it not for the incredible demand for batteries that’s coming.

Legacy automakers like GM and Ford have committed billions of dollars to shifting their portfolios to electric models. GM said last year it will spend $27 billion over the next five years on the development of electric vehicles and automated technology. Meanwhile, a number of newer entrants are either preparing to begin production of their electric vehicles or scaling up. Rivian, for instance, will begin delivering its electric pickup truck this summer. The company has also been tapped by Amazon to build thousands of electric vans.

The U.S. government could end up driving some of that demand.  President Biden announced last week that the U.S. government would replace the entire federal fleet of cars, trucks and SUVs with electric vehicles manufactured in the U.S. That’s 645,047 vehicles. That’s going to mean a lot of new batteries need to be made to supply GM and Ford, but also U.S.-based upstarts like Fisker, Canoo, Rivian, Proterra, Lion Electric and Tesla.

Meanwhile, some of the largest cities in the world are planning their own electrification initiatives. Shanghai is hoping to have electric vehicles represent roughly half of all new vehicle purchases by 2025 and all public buses, taxis, delivery trucks, and government vehicles will be zero-emission by the same period, according to research from the Royal Bank of Canada.

The Chinese market for electric vehicles is one of the world’s largest and one where policy is significantly ahead of the rest of the world.

A potential windfall from China’s EV market is likely one reason for the significant investment into Microvast by investors including the Oshkosh Corp., a 100 year-old industrial vehicles manufacturer; the $8.67 trillion money management firm, BlackRock; Koch Strategic Platforms; and InterPrivate, a private equity fund manager. That’s because Microvast’s previous backers include CDH Investments and CITIC Securities, two of the most well-connected private equity and financial services firms in China.

So is the company’s focus on commercial and industrial vehicles. Microvast believes that the market for commercial electric vehicles could be $30 billion in the near term. Currently, commercial EV sales represent just 1.5% of the market, but that penetration is supposed to climb to 9% by 2025, according to the company.

“In 2008, we set out to power a mobility revolution by building disruptive battery technologies that would allow electric vehicles to compete with internal combustion engine vehicles,” said Microvast chief executive Yang Wu, in a statement. “Since that time we have launched three generations of battery technologies that have provided our customers with battery performance far superior to our competitors and that successfully satisfy, over many years of operation, the stringent requirements of commercial vehicle operators.”

Roughly 30,000 vehicles are using Microvast’s batteries and the investment in Microvast includes about $822 million in cash that will finance the expansion of its manufacturing capacity to hit 9 gigawatt hours by 2022. The money should help Microvast meet its contractual obligations which account for about $1.5 billion in total value, according to the company.

If Chinese investors stand to win big in the upcoming Microvast public offering, a clutch of American investors and one giant Japanese corporation are waiting expectantly for FREYR’s public offering. Northbridge Venture Partners, CRV, and Itochu Corp. are all going to see gains from FREYR’s exit — even if they’re not backers of the European company.

Those three firms, along with the International Finance Corp. are investors in 24m, the Boston-based startup licensing its technology to FREYR to make its batteries.

FREYR’s public offering will also be another win for Yet-Ming Chiang, a serial entrepreneur and professor who has a long and storied history of developing innovations in the battery and materials science industry.

The MIT professor has been working on sustainable technologies for the last two decades, first at the now-defunct battery startup A123 Systems and then with a slew of startups like the 3D printing company Desktop Metal; lithium-ion battery technology developer, 24m; the energy storage system designer, Form Energy; and Baseload Renewables, another early-stage energy storage startup.

Desktop Metal went public last year after it was acquired by a Special Purpose Acquisition Company, and now 24m is getting a potential boost from a big cash infusion into one of its European manufacturing partners, FREYR.

The Norwegian company, which has plans to build five modular battery manufacturing facilities around a site in its home country intends to develop up to 43 gigawatt hours of clean batteries over the next four years.

For FREYR chief executive Tom Jensen there were two main draws for the 24m technology. “It’s the production process itself,” said Jensen. “What they basically do is they mix the electrolyte with the active material, which allows them to make thicker electrodes and reduce the inactive materials in the battery. Beyond that, when you actually do that you remove the need fo a number of traditional production steps… Compared to conventional lithium battery production it reduces production from 15 steps to 5 steps.”

Those process efficiencies combined with the higher volumes of energy bearing material in the cell leads to a fundamental disruption in the battery production process.

Jensen said the company would need $2.5 billion to fully realize its plans, but that the float should get FREYR there. The company is merging with Alussa Energy Acquisition Corp. in a SPAC backed by investors including Koch Strategic Platforms, Glencore, Fidelity Management & Research Company LLC, Franklin Templeton, Sylebra Capital and Van Eck Associates.

All of these investments are necessary if the world is to meet targets for vehicle electrification on the timelines that have been established.

As the Royal Bank of Canada noted in a December report on the electric vehicle industry. “We estimate that globally, battery electric vehicles (BEVs) will represent ~3% of 2020 global demand, while plug-in hybrid-electric vehicles (PHEVs) will represent another ~1.3%,” according to RBC’s figures. “But we see robust growth off these low figures. By 2025, when growth is still primarily regulatory driven, we see ~11% BEV global penetration of new demand representing a ~40% CAGR from 2020’s levels and ~5% PHEV penetration representing a ~35% CAGR. By 2025, we see BEV penetration in Western Europe at ~20%, China at ~17.5%, and the US at 7%. Comparatively, we expect internal combustion engine (ICE) vehicles to grow (cyclically) at a 2% CAGR through 2025. On a pure unit basis, we see “peak ICE” in 2024.”

Lyron Foster is a Hawaii based African American Musician, Author, Actor, Blogger, Filmmaker, Philanthropist and Multinational Serial Tech Entrepreneur.

Continue Reading
Comments

Uncategorized

How and when to hire your first product manager

Published

on

In the world of early-stage startups, job titles are often a formality. In reality, each employee may handle a dozen responsibilities outside their job description. The choose-your-own-adventure type of work style is part of the magic of startups and often why generalists thrive here.

However, as a company progresses and the team grows, there comes a time when a founder needs to carve out dedicated roles. Of these positions, product management might be one of the most elusive — and key — roles to fill.

Product management might be one of the most elusive — and key — roles to fill.

We spoke to startup founders and operators to get their thoughts about how and when they hired their first product manager. Some of the things we talked about were:

  •  Which traits to look for.
  •  Why it’s important to define the role before you look for your best fit.
  •  Whether your new hire needs to have a technical background.
  •  The best questions to ask in an interview.
  •  How to time your first hire and avoid overhiring.

Don’t hire for the CEO of a product

Let’s start by working backward. Product managers often graduate into a CEO role or leave a company to become a founder. Like founders, talented product managers have innate leadership skills and are able to effectively and clearly communicate. Similarly, both roles require a person who is a visionary when it comes to the product and execution.

David Blake was a product manager before he became a serial edtech founder who created Degreed, Learn In, and most recently, BookClub. He says that experience helped him launch the first prototype of Degreed and attract first clients.

“The must-have skill is the ability to put the team’s best wisdom in check and inform the product decisions with users and potential clients to inform what you are building,” he said. The person “must also be able to take the team’s mission and develop and sell that narrative to users and potential clients. That is how you blaze a new trail, balance risk, while avoiding building a ‘faster horse.”

The overlapping synergies between PMs and founders is part of the reason why the role is so confusing to define and hire for. Ken Norton, former director of product at Figma who recently left to solo advise and coach product managers, says companies can start by defining what PMs are not: The CEO of the product.

“It’s about not handing off the product responsibilities to somebody,” he said. “You want the founder and the CEO to continue to be the evangelist and visionary.” Instead, the role is more about day to day “blocking and tackling.” Norton wrote a piece more than 15 years ago about how to hire a product manager, and it’s still an essential read for anyone interested in the field.

Define the role and set your expectations

Product managers help translate all the jugglers within a startup to each other; connecting the engineer with marketing, design with business development and sales with all the above. The role at its core is hard to define, but at the same time is the necessary plumbing for any startup that wants to be high-growth and ambitious.

While a successful product manager is a strong generalist, they have to have the ability to understand and humanize technical processes. The best candidates, then, have some sort of technical experience as an engineer or otherwise.

Continue Reading

Uncategorized

Dan Siroker’s new startup Scribe automates Zoom note-taking

Published

on

Optimizely co-founder Dan Siroker said the idea for his new startup Scribe goes back to a couple of personal experiences — and although Scribe’s first product is focused on Zoom, those experiences weren’t Zoom-related at all.

Instead, Siroker recalled starting to go deaf and then having an “epiphany” the first time he put in a hearing aid, as he recovered a sense he thought he’d lost.

“That really was the spark that got me thinking about other opportunities to augment things your body naturally fails at,” he said.

Siroker added that memory was an obvious candidate, particularly since he also has aphantasia — the inability to visualize mental images, which made it “hard to remember certain things.”

It may jog your own memory if I note that Siroker founded Optimizely with Pete Koomen in 2010, then stepped down from the CEO role in 2017, with the testing and personalization startup acquired by Episerver last year. (And now Episerver itself is rebranding as Optimizely.)

Fast-forward to the present day and Siroker is now CEO at Scribe, which is taking signups for its first product. That product integrates into Zoom meetings and transforms them into searchable, shareable transcripts.

Siroker demonstrated it for me during our Zoom call. Scribe appears in the meeting as an additional participant, recording video and audio while creating a real-time transcript. During or after the meeting, users can edit the transcript, watch or listen to the associated moment in the recording and highlight important points.

From a technological perspective, none of this feels like a huge breakthrough, but I was impressed by the seamlessness of the experience — just by adding an additional participant, I had a full recording and searchable transcript of our conversation that I could consult later, including while I was writing this story.

Scribe screenshot

Image Credits: Scribe

Although Scribe is recording the meeting, Siroker said he wants this to be more like a note-taking replacement than a tape recorder.

“Let’s say you and I were meeting and I came to that meeting with a pen and paper and I’m writing down what you’re saying,” he said. “That’s totally socially acceptable — in some ways, it’s flattering … If instead, I brought a tape recorder and plopped in front of you and hit record — you might actually have this experience — with some folks, that feels very different.”

The key, he argued, is that Scribe recordings and transcripts can be edited, and you can also turn individual components on and off at any time.

“This is not a permanent record,” he said. “This is a shared artifact that we all create as we have a meeting that — just like a Google Doc — you can go back and make changes.”

Scribe screenshot

Image Credits: Scribe

That said, it’s still possible that Scribe could record some embarrassing comments, and the recordings could eventually get meeting participants in trouble. (After all, leaked company meeting recordings have already prompted a number of news stories.) Siroker said he hopes that’s “not common,” but he also argued that it could create an increased sense of transparency and accountability if it happens occasionally.

Scribe has raised around $5 million in funding, across a round led by OpenAI CEO Sam Altman and another led by First Round Capital.

Siroker told me he sees Zoom as just the “beachhead” for Scribe’s ambitions. Next up, the company will be adding support for products like Google Meet and Microsoft Teams. Eventually, he hopes to build a new “hive mind” for organizations, where everyone is “smarter and better” because so many of their conversations and knowledge are now searchable.

“Where we go after that really depends on where we think we can have the biggest positive impact on people’s lives,” he said. “It’s harder to make a case for personal conversations you have with a spouse but … I think if you strike the right balance between value and privacy and control, you could really get people to adopt this in a way that actually is a win-win.”

And if Scribe actually achieves its mission of helping us to record and recall information in a wide variety of contexts, could that have an impact on our natural ability to remember things?

“Yes is the answer, and I think that’s okay,” he responded. “Your brain has limited energy … Remembering the things somebody said a few weeks ago is something a computer can do amazingly. Why waste your precious brain cycles doing that?”

Continue Reading

Uncategorized

UK’s MHRA says it has ‘concerns’ about Babylon Health — and flags legal gap around triage chatbots

Published

on

The UK’s medical device regulator has admitted it has concerns about VC-backed AI chatbot maker Babylon Health. It made the admission in a letter sent to a clinician who’s been raising the alarm about Babylon’s approach toward patient safety and corporate governance since 2017.

The HSJ reported on the MHRA’s letter to Dr David Watkins yesterday. TechCrunch has reviewed the letter (see below), which is dated December 4, 2020. We’ve also seen additional context about what was discussed in a meeting referenced in the letter, as well as reviewing other correspondence between Watkins and the regulator in which he details a number of wide-ranging concerns.

In an interview he emphasized that the concerns the regulator shares are “far broader” than the (important but) single issue of chatbot safety.

“The issues relate to the corporate governance of the company — how they approach safety concerns. How they approach people who raise safety concerns,” Watkins told TechCrunch. “That’s the concern. And some of the ethics around the mis-promoting of medical devices.

“The overall story is they did promote something that was dangerously flawed. They made misleading claims with regards to how [the chatbot] should be used — its intended use — with [Babylon CEO] Ali Parsa promoting it as a ‘diagnostic’ system — which was never the case. The chatbot was never approved for ‘diagnosis’.”

“In my opinion, in 2018 the MHRA should have taken a much firmer stance with Babylon and made it clear to the public that the claims that were being made were false — and that the technology was not approved for use in the way that Babylon were promoting it,” he went on. “That should have happened and it didn’t happen because the regulations at that time were not fit for purpose.”

“In reality there is no regulatory ‘approval’ process for these technologies and the legislation doesn’t require a company to act ethically,” Watkins also told us. “We’re reliant on the healthtech sector behaving responsibly.”

The consultant oncologist began raising red flags about Babylon with UK healthcare regulators (CQC/MHRA) as early as February 2017 — initially over the “apparent absence of any robust clinical testing or validation”, as he puts it in correspondence to regulators. However with Babylon opting to deny problems and go on the attack against critics his concerns mounted.

An admission by the medical devices regulator that all Watkins’ concerns are “valid” and are “ones that we share” blows Babylon’s deflective PR tactics out of the water.

“Babylon cannot say that they have always adhered to the regulatory requirements — at times they have not adhered to the regulatory requirements. At different points throughout the development of their system,” Watkins also told us, adding: “Babylon never took the safety concerns as seriously as they should have. Hence this issue has dragged on over a more than three year period.”

During this time the company has been steaming ahead inking wide-ranging ‘digitization’ deals with healthcare providers around the world — including a 10-year deal agreed with the UK city of Wolverhampton last year to provide an integrated app that’s intended to have a reach of 300,000 people.

It also has a 10 year agreement with the government of Rwanda to support digitization of its health system, including via digitally enabled triage. Other markets it’s rolled into include the US, Canada and Saudi Arabia.

Babylon says it now covers more than 20 million patients and has done 8 million consultations and “AI interactions” globally. But is it operating to the high standards people would expect of a medical device company?

Safety, ethical and governance concerns

In a written summary, dated October 22, of a video call which took place between Watkins and the UK medical devices regulator on September 24 last year, he summarizes what was discussed in the following way: “I talked through and expanded on each of the points outlined in the document, specifically; the misleading claims, the dangerous flaws and Babylon’s attempts to deny/suppress the safety issues.”

In his account of this meeting, Watkins goes on to report: “There appeared to be general agreement that Babylon’s corporate behaviour and governance fell below the standards expected of a medical device/healthcare provider.”

“I was informed that Babylon Health would not be shown leniency (given their relationship with [UK health secretary] Matt Hancock),” he also notes in the summary — a reference to Hancock being a publicly enthusiastic user of Babylon’s ‘GP at hand’ app (for which he was accused in 2018 of breaking the ministerial code).

In a separate document, which Watkins compiled and sent to the regulator last year, he details 14 areas of concern — covering issues including the safety of the Babylon chatbot’s triage; “misleading and conflicting” T&Cs — which he says contradict promotional claims it has made to hype the product; as well as what he describes as a “multitude of ethical and governance concerns” — including its aggressive response to anyone who raises concerns about the safety and efficacy of its technology.

This has included a public attack campaign against Watkins himself, which we reported on last year; as well as what he lists in the document as “legal threats to avoid scrutiny & adverse media coverage”.

Here he notes that Babylon’s response to safety concerns he had raised back in 2018 — which had been reported on by the HSJ — was also to go on the attack, with the company claiming then that “vested interest” were spreading “false allegations” in an attempt to “see us fail”.

The allegations were not false and it is clear that Babylon chose to mislead the HSJ readership, opting to place patients at risk of harm, in order to protect their own reputation,” writes Watkins in associated commentary to the regulator.

He goes on to point out that, in May 2018, the MHRA had itself independently notified Babylon Health of two incidents related to the safety of its chatbot (one involving missed symptoms of a heart attack, another missed symptoms of DVT) — yet the company still went on to publicly rubbish the HSJ’s report the following month (which was entitled: ‘Safety regulators investigating concerns about Babylon’s ‘chatbot”).

Wider governance and operational concerns Watkins raises in the document include Babylon’s use of staff NDAs — which he argues leads to a culture inside the company where staff feel unable to speak out about any safety concerns they may have; and what he calls “inadequate medical device vigilance” (whereby he says the Babylon bot doesn’t routinely request feedback on the patient outcome post triage, arguing that: “The absence of any robust feedback system significant impairs the ability to identify adverse outcomes”).

Re: unvarnished staff opinions, it’s interesting to note that Babylon’s Glassdoor rating at the time of writing is just 2.9 stars — with only a minority of reviewers saying they would recommend the company to a friend and where Parsa’s approval rating as CEO is also only 45% on aggregate. (“The technology is outdated and flawed,” writes one Glassdoor reviewer who is listed as a current Babylon Health employee working as a clinical ops associate in Vancouver, Canada — where privacy regulators have an open investigation into its app. Among the listed cons in the one-star review is the claim that: “The well-being of patients is not seen as a priority. A real joke to healthcare. Best to avoid.”)

Per Watkins’ report of his online meeting with the MHRA, he says the regulator agreed NDAs are “problematic” and impact on the ability of employees to speak up on safety issues.

He also writes that it was acknowledged that Babylon employees may fear speaking up because of legal threats. His minutes further record that: “Comment was made that the MHRA are able to look into concerns that are raised anonymously.”

In the summary of his concerns about Babylon, Watkins also flags an event in 2018 which the company held in London to promote its chatbot — during which he writes that it made a number of “misleading claims”, such as that its AI generates health advice that is “on-par with top-rated practicing clinicians”.

The flashy claims led to a blitz of hyperbolic headlines about the bot’s capabilities — helping Babylon to generate hype at a time when it was likely to have been pitching investors to raise more funding.

The London-based startup was valued at $2BN+ in 2019 when it raised a massive $550M Series C round, from investors including Saudi Arabia’s Public Investment Fund and a large (unnamed) U.S.-based health insurance company, as well as insurance giant Munich Re’s ERGO Fund — trumpeting the raise at the time as the largest-ever in Europe or U.S. for digital health delivery.

“It should be noted that Babylon Health have never withdrawn or attempted to correct the misleading claims made at the AI Test Event [which generated press coverage it’s still using as a promotional tool on its website in certain jurisdictions],” Watkins writes to the regulator. “Hence, there remains an ongoing risk that the public will put undue faith in Babylon’s unvalidated medical device.”

In his summary he also includes several pieces of anonymous correspondence from a number of people claiming to work (or have worked) at Babylon — which make a number of additional claims. “There is huge pressure from investors to demonstrate a return,” writes one of these. “Anything that slows that down is seen [a]s avoidable.”

“The allegations made against Babylon Health are not false and were raised in good faith in the interests of patient safety,” Watkins goes on to assert in his summary to the regulator. “Babylon’s ‘repeated’ attempts to actively discredit me as an individual raises serious questions regarding their corporate culture and trustworthiness as a healthcare provider.”

In its letter to Watkins (screengrabbed below), the MHRA tells him: “Your concerns are all valid and ones that we share”.

It goes on to thank him for personally and publicly raising issues “at considerable risk to yourself”.

Letter from the MHRA to Dr David Watkins (Screengrab: TechCrunch)

Babylon has been contacted for a response to the MHRA’s validation of Watkins’ concerns. At the time of writing it had not responded to our request for comment.

The startup told the HSJ that it meets all the local requirements of regulatory bodies for the countries it operates in, adding: “Babylon is committed to upholding the highest of standards when it comes to patient safety.”

In one aforementioned aggressive incident last year, Babylon put out a press release attacking Watkins as a ‘troll’ and seeking to discredit the work he was doing to highlight safety issues with the triage performed by its chatbot.

It also claimed its technology had been “NHS validated” as a “safe service 10 times”.

It’s not clear what validation process Babylon was referring to there — and Watkins also flags and queries that claim in his correspondence with the MHRA, writing: “As far as I am aware, the Babylon chatbot has not been validated — in which case, their press release is misleading.”

The MHRA’s letter, meanwhile, makes it clear that the current regulatory regime in the UK for software-based medical device products does not adequately cover software-powered ‘healthtech’ devices, such as Babylon’s chatbot.

Per Watkins there is no approval process, currently. Such devices are merely registered with the MHRA — but there’s no legal requirement that the regulator assess them or even receive documentation related to their development. He says they exist independently — with the MHRA holding a register.

“You have raised a complex set of issues and there are several aspects that fall outside of our existing remit,” the regulator concedes in the letter. “This highlights some issues which we are exploring further, and which may be important as we develop a new regulatory framework for medical devices in the UK.”

An update to pan-EU medical devices regulation — which will bring in new requirements for software-based medical devices, and had been originally intended to be implemented in the UK in May last year — will no longer take place, given the country has left the bloc.

The UK is instead in the process of formulating its own regulatory update for medical device rules. This means there’s still a gap around software-based ‘healthtech’ — which isn’t expected to be fully plugged for several years. (Although Watkins notes there have been some tweaks to the regime, such as a partial lifting of confidentiality requirements last year.)

In a speech last year, health secretary Hancock told parliament that with the government aimed to formulate a regulatory system for medical devices that is “nimble enough” to keep up with tech-fuelled developments such as health wearables and AI while “maintaining and enhancing patient safety”. It will include giving the MHRA “a new power to disclose to members of the public any safety concerns about a device”, he said then.

In the meanwhile the existing (outdated) regulatory regime appears to be continuing to tie the regulator’s hands — at least vis-a-vis what they can say in public about safety concerns. It has taken Watkins making its letter to him public to do that.

In the letter the MHRA writes that “confidentiality unfortunately binds us from saying more on any specific investigation”, although it also tells him: “Please be assured that your concerns are being taken seriously and if there is action to be taken, then we will.”

“Based on the wording of the letter, I think it was clear that they wanted to provide me with a message that we do hear you, that we understand what you’re saying, we acknowledge the concerns which you’re raised, but we are limited by what we can do,” Watkins told us.

He also said he believes the regulator has engaged with Babylon over concerns he’s raised these past three years — noting the company has made a number of changes after he had raised specific queries (such as to its T&Cs which had initially said it’s not a medial device but were subsequently withdrawn and changed to acknowledge it is; or claims it had made that the chatbot is “100% safe” which were withdrawn — after an intervention by the Advertising Standards Authority in that case).

The chatbot itself has also been tweaked to put less emphasis on the diagnosis as an outcome and more emphasis on the triage outcome, per Watkins.

“They’ve taken a piecemeal approach [to addressing safety issues with chatbot triage]. So I would flag an issue [publicly via Twitter] and they would only look at that very specific issue. Patients of that age, undertaking that exact triage assessment — ‘okay, we’ll fix that, we’ll fix that’ — and they would put in place a [specific fix]. But sadly, they never spent time addressing the broader fundamental issues within the system. Hence, safety issues would repeatedly crop up,” he said, citing examples of multiple issues with cardiac triages that he also raised with the regulator.

“When I spoke to the people who work at Babylon they used to have to do these hard fixes… All they’d have to do is just kind of ‘dumb it down’ a bit. So, for example, for anyone with chest pain it would immediately say go to A&E. They would take away any thought process to it,” he added. (It also of course risks wasting healthcare resources — as he also points out in remarks to the regulators.)

“That’s how they over time got around these issues. But it highlights the challenges and difficulties in developing these tools. It’s not easy. And if you try and do it quickly and don’t give it enough attention then you just end up with something which is useless.”

Watkins also suspects the MHRA has been involved in getting Babylon to remove certain pieces of hyperbolic promotional material related to the 2018 AI event from its website.

In one curious episode, also related to the 2018 event, Babylon’s CEO demoed an AI-powered interface that appeared to show real-time transcription of a patient’s words combined with an ’emotion-scanning’ AI — which he said scanned facial expressions in real-time to generate an assessment of how the person was feeling — with Parsa going on to tell the audience: “That’s what we’ve done. That’s what we’ve built. None of this is for show. All of this will be either in the market or already in the market.”

However neither feature has actually been brought to market by Babylon as yet. Asked about this last month, the startup told TechCrunch: “The emotion detection functionality, seen in old versions of our clinical portal demo, was developed and built by Babylon‘s AI team. Babylon conducts extensive user testing, which is why our technology is continually evolving to meet the needs of our patients and clinicians. After undergoing pre-market user-testing with our clinicians, we prioritised other AI-driven features in our clinical portal over the emotion recognition function, with a focus on improving the operational aspects of our service.”

“I certainly found [the MHRA’s letter] very reassuring and I strongly suspect that the MHRA have been engaging with Babylon to address concerns which have been identified over the past three year period,” Watkins also told us today. “The MHRA don’t appear to have been ignoring the issues but Babylon simply deny any problems and can sit behind the confidentiality clauses.”

In a statement on the current regulatory situation for software-based medical devices in the UK, the MHRA told us:

The MHRA ensures that manufacturers of medical devices comply with the Medical Devices Regulations 2002 (as amended). Please refer to existing guidance.

The Medicines and Medical Devices Act 2021 provides the foundation for a new improved regulatory framework that is currently being developed. It will consider all aspects of medical device regulation, including the risk classification rules that apply to Software as a Medical Device (SaMD).

The UK will continue to recognise CE marked devices until 1 July 2023. After this time, requirements for the UKCA Mark must be met. This will include the revised requirements of the new framework that is currently being developed.

The Medicines and Medical Devices Act 2021 allows the MHRA to undertake its regulatory activities with a greater level of transparency and share information where that is in the interests of patient safety.

The regulator declined to be interviewed or response to questions about the concerns it says in the letter to Watkins that it shares about Babylon — telling us: “The MHRA investigates all concerns but does not comment on individual cases.”

“Patient safety is paramount and we will always investigate where there are concerns about safety, including discussing those concerns with individuals that report them,” it added.

Watkins raised one more salient point on the issue of patient safety for ‘cutting edge’ tech tools — asking where is the “real life clinical data”? So far, he says the studies patients have to go on are limited assessments — often made by the chatbot makers themselves.

“It’s one quite telling thing about this sector is the fact that there’s very little real life data out there,” he said. “These chatbots have been around for a good few years now… And there’s been enough time to get real life clinical data and yet it hasn’t appeared and you just wonder if, is that because in the real-life setting they are actually not quite as useful as we think they are?”

Continue Reading

Trending