March 28, 2024

Businesses, Too, Have Eyes for iPads and iPhones

SAN FRANCISCO — Steven P. Jobs never cared much for selling Apple products to big businesses.

The late Apple chief executive so disliked the process of catering to the needs of business, rather than those of consumers, that he called chief information officers in corporations “orifices” at a conference in 2005. “There are 500 men and women in the Fortune 500 — C.I.O.’s — that you have to go through,” Mr. Jobs said then.

A funny thing happened, though, in the last few years. Big companies started buying Apple products — a lot of them — for their employees. The iPad and iPhone have given the Apple symbol a presence in workplaces that Apple never enjoyed when it was strictly focused on selling Macintosh computers.

While corporate technology buyers say Apple does not try to hide the fact that consumers are still its top priority, they note that the company has gotten easier to work with in recent years, adding features to its devices that make them more palatable to business. It also doesn’t hurt that Apple’s new chief executive, Timothy D. Cook, is known to be far more at ease meeting with the C.I.O.’s Mr. Jobs once so memorably disparaged.

“What they’ve done in the past few years is really started thinking in a deeper way what the enterprise needs,” said Rich Adduci, chief information officer of Boston Scientific, a medical device manufacturer that has distributed about 3,000 iPads to its field sales people, and expects to buy 1,500 more by the end of the year.

Apple, which declined to comment for this article, has begun to drop hints that it sees the corporate market as a big growth opportunity. During recent earnings calls with Wall Street analysts, Apple executives have boasted about the portion of Fortune 500 companies testing or deploying iPads and iPhones — 92 percent and 93 percent, respectively, Apple said last month.

“You never heard those stats before,” said Gene Munster, an analyst at Piper Jaffray. “The reason why is they struggled for decades, and finally they have a story to tell in the enterprise.”

Among the big customers Apple has won recently is the home improvement retailer Lowe’s, which says it bought about 42,000 iPhones to be used by employees on store floors. Instead of having to find a computer, the employees can use the devices in store aisles to check inventory, pull up how-to videos and help customers estimate costs for painting, flooring and other projects.

Airlines have begun to use iPads to replace the printed aircraft flight manuals, navigation charts and other material that pilots are required to bring on board. The binders holding those manuals typically had to be popped open every few weeks by pilots so they could replace pages with updated information. With iPads, the updating occurs electronically.

All of Alaska Airlines’ more than 1,400 pilots now have iPads, and United and Continental Airlines, which have merged, started giving iPads to all 11,000 of its pilots in August.

“We’ve shown we can retrieve an electronic page faster than we can retrieve a printed manual,” said Captain Joe Burns, a United pilot and managing director of technology and flight tests for the airline.

The iPad, in some cases, is proving to be an attractive substitute for laptops in situations where portability and speedy access to information matters. Technicians for Siemens Energy, for example, routinely have to scale 300-foot towers to service wind turbines, sometimes in blistering heat in places like West Texas. Some of the technicians have been using laptops to read manuals and run through checklists when they’re doing this work, but the devices are too bulky and take too long to boot up, said Tim Holt, chief executive of Service Renewables for Siemens Energy.

Now the company is outfitting its wind service technicians with iPads, which are light, start instantly and have cameras that let workers send pictures to a technical support department if they need help troubleshooting an issue. About 350 technicians have the device already; within five years, about 5,000 should have it, Mr. Holt said.

Information technology departments, though, may find working with Apple a challenge. Historically among I.T. managers, Apple Macs were largely shunned as too expensive, and the company was viewed as not serious about making the computers blend well in corporate environments.

Mr. Holt said there was “pushback” initially from the central I.T. department of Siemens in Germany about the prospect of using iPads as part of its technology arsenal.

Also, although Apple’s secrecy about where its products are headed may help it make a big marketing splash in the consumer market, corporate I.T. departments like to know more so they can budget for big new technology investments.

Article source: http://feeds.nytimes.com/click.phdo?i=ed08e3c395cbe503229b5a54820e4d6b

Study Faults Approval Process for Medical Devices

In a report, released Friday, a panel of the Institute of Medicine found that the existing rules were never intended to provide safeguards for screening out dangerous or ineffective products. The panel urged the Food and Drug Administration to devise a new regulatory system for the so-called moderate risk devices — a category that now includes artificial hips, external heart defibrillators and hospital pumps — because the current system was not fixable.

“If you want to make sure that a product is safe and effective, you have to start by asking the question whether it is safe and effective,” said William Vodra, a member of the 12-person panel assembled by Institute of Medicine and a lawyer who has worked closely with device producers.

The report, which was commissioned by the F.D.A., follows a number of recalls of medical devices, like one involving so-called metal-on-metal artificial hips that have failed in thousands of patients, crippling some of them. Those implants received little, if any, testing in patients prior to being implanted in tens of thousands of people.

It is not immediately clear what impact, if any, the new report will have. But it is likely to set off a high-powered lobbying battle in coming months over the possible future shape of F.D.A. rules.

Even before the report’s release, allies of the industry had waged an aggressive campaign to discredit it, and had taken legal steps intended to bar the F.D.A. from adopting its recommendations.

On Friday, a trade group, the Advanced Medical Technology Association, which represents device industry giants like Medtronic, Boston Scientific and Johnson Johnson, unequivocally rejected the report, saying it did not deserve “serious consideration” from Congress or the Obama administration.

Patient advocacy groups, however, seized on the study as an affirmation that current rules allow dangerous or ineffective devices onto the market with scant review. For their part, F.D.A. officials, who had anticipated recommendations on how to improve the existing system, appeared taken back by the panel’s finding that it was unfixable.

Dr. Jeffrey E. Shuren, the director of the F.D.A.’s Center for Devices and Radiological Health, said in a statement that he did not believe the existing regulatory system should be scrapped, adding that any significant changes would have to be approved by Congress. Dr. David R. Challoner, who served as the panel’s chairman, said that members of the group were stunned when they realized that the current system could not be salvaged. “We surprised ourselves,” Dr. Challoner said.

The Institute of Medicine review covered the approval system for a wide range of moderate-risk products, known as the 510(k) clearance process. It did not examine devices that carry the highest risk to patients if they fail, like implanted heart defibrillators. Those products go through a separate regulatory pathway that requires extensive testing before sale.

The big problem, the study found, is that the Congressional law that created the 510(k) pathway, the Medical Device Amendments of 1976, required producers of such products only to show that they were “substantially equivalent,” or similar, to one already on the market.

The committee’s report emphasized that its members believed most medical devices in use were safe and beneficial. But the panel concluded that existing rules had created a daisy-chain system of regulation, in which new devices simply piggy-back on earlier ones, without any examination of their safety or their value to patients.

“The committee concludes that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of moderate-risk devices, the report concluded, adding, “Furthermore, that it cannot be transformed into one.” The panel also concluded that the F.D.A. should act quickly to determine whether artificial joints, such as hips, which are currently approved through the 510(k) process, should have to undergo the type of rigorous scrutiny that high-risk devices now go through prior to sale.

Another industry trade group, the Medical Device Manufacturers Association, said Friday that it was “concerned about efforts to overhaul a regulatory pathway that would create additional uncertainties and slow patient access to medical therapies.”

Among other recommendations, the report also urged the F.D.A. to quickly tighten the way it tracked the performance of devices once they are on the market, and said the agency needed to move more quickly to stop the sales of harmful ones. It also said that the agency should better monitor software used in diagnostic tools because of the growing use of such technology.In many ways, the report is a rebuke to the medical device industry and its allies, who have been waging a campaign over the last year to dispute the need for any new regulations.

Last month, the Washington Legal Foundation, a pro-business group, filed a petition with the F.D.A. arguing that the agency was statutorily barred from adopting any of the report’s recommendations because of what it claimed was the panel’s bias.

The legal foundation argued that the Institute of Medicine, which is part of the National Academy of Sciences, had failed to balance the panel by including officials from the device industry, the investment community or patients who had benefited from devices. An F.D.A. official said the agency was happy with the panel’s composition, which included doctors, academics and three lawyers, included two who worked closely with the industry.

The report on Friday addressed several other complaints by the industry on possible new regulation, including the claim that toughened rules would slow the introduction of innovative products that could benefit patients.

The panel said there was no way of assessing, based on a review of available evidence, whether current regulations were having either a positive or a negative effect on innovation. The group, however, recommended that the F.D.A. assemble a group to review the issue.

Article source: http://feeds.nytimes.com/click.phdo?i=b5b327694b445fde6348fe928f4ffb80