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Electronics and IP: Part VI—The Hard Facts About Software

A company’s best-kept secret may in fact be someone else’s.

Note: This is the final segment in a six-part series that explores the legality, methodology, and application of reverse engineering as it pertains to the IP life cycle to help companies moving into the market for consumer-grade medical devices understand how and why they must protect their intellectual property rights.
There was once a company that attempted to patent a process for the precise measurement of the knee joint prior to surgery without resorting to expensive CT scans. The process was ingenious in its simplicity, combining low-tech hardware with a custom software solution to build a 3-D image from a few standard 2-D x-rays.
Clever? Yes. Innovative? Yes. Original? No.
It turned out that a method for converting 2-D images into 3-D images had been developed and patented decades earlier for a completely different application. What’s notable about this example is that this company didn’t set out to rip off another’s invention—it had unknowingly recreated a previous invention in another field.
This example illustrates the thin ice upon which many companies can inadvertently find themselves as the partition between hardware and software continues to shift in favor of the latter. A software algorithm that can perform a desired function in place of a hardware component can yield significant cost savings and dramatically shorten time to market. For companies eager to compete in a market as cost-sensitive as consumer electronics, achieving desired functionality and device efficacy with a software solution in lieu of hardware can be a Holy Grail.
Software, of course, can have a relatively high upfront development expense. But once it’s in production, the on-going maintenance is far less costly than continuing to churn out in high volume an expensive hardware component which it can replace.
Take, for example, a sophisticated sensor that’s costly to produce, fragile, and required in large volumes. This could be anything from a sensor in a weigh scale to one in a steam iron that reads heat and pressure to adjust the temperature setting. That same sensor can be replaced with one that’s far more economical, robust, and easier to manufacture, if combined with a software algorithm.

Cirque and Ocular Partner for Display Screens

Cirque Corp. (Salt Lake City) has announced a strategic partnership with Ocular Inc. (Richardson, TX) to develop advanced touch display screens. To start, Ocular has incorporated Cirque’s capacitive touch controller into its Crystal TouchT line of capacitive touch screens. Ocular says that the alliance strengthens its market position. And as the company tries to aggressively advance capacitive touch screen technology by adding gesturing user interface capabilities, Cirque’s technology has been instrumental in its quest, Ocular says. The glass featured on these touch screens is immune to scratching as well as contaminants in the environment. The screens, which are used in medical systems, can be cleaned with caustic chemicals.

Safe-sleep guidelines can reduce number of infant deaths

As with any living thing, a child's breathing can become obstructed, but when a child is very young, an infant can't move away from the problem.

One death here occurred during a father's short military leave from Afghanistan to see his newborn. The days-old infant suffocated in bed with a sibling and the parents, said John Penkitis, an investigator with the Rochester Police Department.

In another case, an 8-month-old was found tangled in blankets. A 6-month-old, who had been sleeping with a mother and brother, was wedged between the mattress and footboard. A 1-month-old was face down on a mattress with sheets and blankets.

"We know these children are dying as a result of being in a bad position or compressed," said Dr. Caroline Dignan, Monroe County medical examiner.

In November, the federal Consumer Product Safety Commission issued its Nursery Product Report, which said that the 60 baby deaths nationwide per year in baby furniture such as cribs, bassinets and play yards were more often happened because of added pillows and comforters than to a failure of the baby furniture.

The report studied 2005 through 2007; the number of deaths is a yearly average for that period. The commission is now reviewing the safety of crib bumpers.

Various issues get in the way of safe sleep, according to the Baby Safe Sleep Coalition here. Many parents and grandparents haven't heard about the risks and share outdated information.

Dr. Joanne Cordaro, a Webster, N.Y., pediatrician on the local coalition, says some parents worry whether a baby will be warm enough without a blanket. She recommends a baby sleep sack that zips down and has either arm holes or sleeves.

Parents desire bonding time with their baby, and some cultural and family traditions promote co-sleeping or the "family bed." Families with a safe crib or bassinet may not always use it because it's easier and cozy to fall asleep together.

Parents often believe they would never roll against their baby. But Dignan said parents of young babies are typically sleep deprived. Some are on pain medication after childbirth or drink alcohol.

Melisa Vazquez, a senior case manager for Unity Health System's Healthy Start Center here, admits she liked to cuddle in bed with her son after breastfeeding him as a baby. After the baby's concerned father took photos of mom and baby together on the edge of the bed, Vazquez said she realized the risks and put their son in a playpen in her room after nighttime feedings.

Sheila Darling, a lactation consultant and child development specialist for Lifetime Health Medical Group's Wilson Center, said her message to parents changed once she joined the coalition and learned more.

Now when parents talk about co-sleeping, "my response is there's no 100% safe way," Darling said. One of her patients had a baby die in bed with her last fall.

USDA: Eggs' cholesterol level better than cracked up to be

Eggs have taken a beating for years because they are high in dietary cholesterol, but a new study shows that eggs today contain a lot less cholesterol than they did a decade ago.

A large egg has about 185 milligrams of cholesterol, down from 215 milligrams, according to new research from the U.S. Department of Agriculture.

Researchers collected large eggs from 12 locations around the country and sent them to a laboratory for testing. These latest cholesterol findings, published on the website of the Agricultural Research Service, update numbers from 2002. The agency regularly does nutrient checks on popular foods.

The drop in cholesterol may be because of changes in hens' diets, the way the animals are bred or other factors, said Mitch Kanter, executive director of the Egg Nutrition Center, the research arm of the American Egg Board, which represents egg farmers.

Meanwhile, the government's latest dietary guidelines indicate that eating one egg a day is OK.

"Evidence suggests that one egg (i.e. egg yolk) per day does not result in increased blood cholesterol levels, nor does it increase the risk of cardiovascular disease in healthy people," according to the government's Dietary Guidelines for Americans.

The guidelines also recommend that most people eat less than 300 milligrams of total dietary cholesterol a day. Consuming less than 200 milligrams a day can help people at a high risk of cardiovascular disease, the government says.

To stay below 300 milligrams, you could eat an egg a day and other cholesterol-containing foods, such as an ounce of cheese, which has about 30 milligrams, and three ounces of fish, which has 60 milligrams, said Dawn Jackson Blatner, a spokeswoman for the American Dietetic Association.

The USDA research also showed that an egg has 41 international units (IUs) of vitamin D, up from 25 IUs measured several years ago.

There aren't many food sources of vitamin D, which is important for bone health, so it's good that eggs contain some, Blatner says. Even so, one egg still provides only about 7% of the 600 IUs recommended for one day, she says.

Kanter says egg producers are trying to increase the vitamin D in eggs by giving chickens feed enriched with vitamin D.

Some people try to avoid the dietary cholesterol by eating just the egg whites, but Kanter points out that the yolk contains most of an egg's vitamins and minerals and much of the protein.

New shingles vaccine in short supply

Zostavax, made by Merck, reduced risk of getting shingles by 55% in clinical trials, the CDC says.

But Merck spokeswoman Pamela Eisele told USA TODAY on Tuesday that the company won't be able to fill many orders until April. USA TODAY contacted the company after several readers said they couldn't get the vaccine.

Nearly one out of three people in the USA will develop shingles, a painful and potentially serious condition also known as herpes zoster. Adults who had chickenpox as a child are at risk. Both Zostavax and chickenpox vaccine Varivax are made with varicella, the virus that causes both diseases.

Merck must "prioritize" which vaccine to make, because of a limited supply of varicella, Eisele said. "Merck's first priority is the childhood vaccine."

A Jan. 11 report in the Journal of the American Medical Association, by the CDC and Kaiser Permanente recommended most Americans 60 and up get the one-time vaccine. Not all insurance or Medicare covers the $150-$300 cost.

Physician Rafael Harpaz, head of the CDC's division of viral diseases and co-author of the report, said he had not been aware of a shortage until contacted by USA TODAY. But he said a shortage would create "real challenges to our program and cause frustration to physicians and patients alike."

The shortages could lead to unnecessary outbreaks among the elderly and "devastating pain," says physician Sharon Brangman, president of the American Geriatrics Society.

"It's hard to try to raise public awareness about this vaccine and then have the shortage," she says. "It's all about prevention."

Shingles starts as a numbness, tingling or itching and develops into a rash, CDC says. The rash eventually blisters and can sometimes lead to a painful condition known as post-herpetic neuralgia. In severe cases, the virus can also affect the eyes and cause blindness.

• SHINGLES VACCINE: What you need to know

Spreading the word about prevention to the 77 million Baby Boomers — the first of whom turn 65 this year — is crucial, says Juanita Watts, a Kaiser Permanente family-care physician near San Diego.

Kate Gooderham, 60, of Fort Myers, Fla., is one of the readers who contacted USA TODAY. She says after seeing her old brother and several friends suffer from shingles, she called her doctor in December to find out about getting the vaccine, and was put on a waiting list.

"I was told there was a shortage then," she says. "They called me in late January and said they received three doses and wouldn't be getting any more until April."

Merck's website helps people locate pharmacies offering adults vaccines.

The vaccine is not recommended for children, women who are pregnant, those with HIV or AIDS, or people who are allergic to gelatin.

Drug shortages forcing some risky alternatives

 Drug shortages forcing some risky alternatives

 

 

Unprecedented shortages of injectable drugs have forced doctors to resort to medications that are less safe or postpone or cancel procedures, often at the last minute, according to the Food and Drug Administration and health care groups.

Anesthesiology and oncology have been hit particularly hard. Last month, the only U.S. maker of Pentothal, used for 70 years to induce anesthesia, said it had abandoned plans to resume production, which it had halted a year and a half earlier.

"I can say right now it's as bad as it's ever been," says pharmacist Bona Benjamin of the American Society of Health-System Pharmacists, which has tracked shortages since 2001. The number of drugs in short supply has tripled since 2005, Benjamin says. "It's drugs that are potentially lifesaving or critically important in care." The painkiller morphine; amikacin, an antibiotic for serious bacterial infections; and carmustine, a chemotherapy drug, are among about 150 drugs in short supply, her group says.

Hospital pharmacists and doctors report that patients have deteriorated or died because a drug wasn't available, says pharmacist Michael Cohen, president of the Institute for Safe Medication Practices. Others, he says, have been harmed by dosing errors stemming from drug substitutions.

Drugmakers aren't required to alert the FDA to shortages or explain them, but reasons commonly cited include greater demand, a shortage of raw materials and production delays.

Hospira hasn't said why it stopped making Pentothal in North Carolina. Hospira had planned to resume production in Italy, spokesman Dan Rosenberg says, but the supplier of its active ingredient bowed out. He says Italian authorities wanted Hospira to ensure Pentothal wasn't used for lethal injections, as in many states.

The newer drug propofol is used far more often than Pentothal, but they aren't interchangeable, says Jerry Cohen, president-elect of the American Society of Anesthesiologists. In emergency cesarean sections, for example, propofol can complicate matters by anesthetizing babies as well as moms.

Although the FDA had been working with Hospira to bring back Pentothal, the company did not notify the agency it had decided not to, says Valerie Jensen of the FDA's Drug Shortages Office. Because of tip-offs by makers, she says, the FDA was able to avert 38 drug shortages last year. The agency can help locate raw material suppliers and alternative production sites and arrange for foreign manufacturers to step in, she says.

Sen. Amy Klobuchar, D-Minn., is working on a bill to require companies to notify the FDA well in advance of shortages. "No patient should be put at risk simply because a drug happens to not be available on a certain day," she says.