A new sen­sory sys­tem

Next gen­er­a­tions of wire­less mon­i­tor­ing tech­nolo­gies—some still years off—prom­ise to trans­form health­care

Modern Healthcare - - SPECIAL REPORT - Jaimy Lee

It’s not hard to imag­ine that a sen­sor as small as the size of a Band-Aid could col­lect in­for­ma­tion about your heart rate or tem­per­a­ture and then trans­mit that data us­ing a wire­less sig­nal to a smart­phone or an­other de­vice. What might be hard to grasp is how large and trans­for­ma­tive the mar­ket for so-called med­i­cal body area net­works could be in the years ahead.

The net­works col­lect data from sen­sors that can be placed at dif­fer­ent lo­ca­tions on the body. The sen­sors wire­lessly con­vey a wide-rang­ing ar­ray of phys­i­o­log­i­cal data to nearby hub de­vices, cre­at­ing op­por­tu­ni­ties for health­care providers to change the way they mon­i­tor pa­tients at home and in the hos­pi­tal.

Some tech­nolo­gies tap into al­lo­cated spec­trum bands set aside by the Fed­eral Com­mu­ni­ca­tions Com­mis­sion for med­i­cal use, or use de­vice-spe­cific net­works built by hos­pi­tals. Those tech­nolo­gies usu­ally re­quire over­sight from the Food and Drug Ad­min­is­tra­tion. Other de­vices, some of which are reg­u­lated by the FDA, rely on un­li­censed Wi-Fi to aid con­sumers as they track any­thing from phys­i­cal ac­tiv­ity and blood glu­cose lev­els to when they take their med­i­ca­tions.

How­ever, the FCC last year al­lo­cated spec­trum specif­i­cally for med­i­cal body area net­works, or MBANs, which are ex­pected to re­duce or to­tally re­move the need for the wires teth­er­ing a pa­tient to a hos­pi­tal bed (May 19, 2012, p. 6). A sliver of that spec­trum has also been set aside for mon­i­tor­ing pa­tients at home.

“That’s a good thing for safety,” says Dr. Eric Topol di­rec­tor of the Scripps Trans­la­tional Sci- ence In­sti­tute in San Diego. “Nor­mally, in a hos­pi­tal, pa­tients are only get­ting checked once a shift. To have con­tin­u­ous mon­i­tor­ing–which is why a lot of peo­ple are in the in­ten­sive-care unit—that’s a big plus. That could lead to lower costs and less uti­liza­tion of the in­ten­sive-care unit fa­cil­ity. Ul­ti­mately, the big­ger op­por­tu­nity is just get­ting peo­ple out of the hos­pi­tal and then do­ing re­mote mon­i­tor­ing.”

It could be sev­eral years be­fore the first MBANs de­vel­oped to use that spec­trum come to mar­ket, but the lag is not likely to limit the de­vel­op­ment and con­tin­ued adop­tion of wire­less re­mote tech­nolo­gies that can be used to mon­i­tor and col­lect phys­i­o­log­i­cal data from pa­tients, re­gard­less of the care set­ting. Sup­port­ers say the tech­nolo­gies could help de­liver higher qual­ity of care and in the long term even lower costs.

Many com­pa­nies have de­vel­oped sen­sor-based tech­nolo­gies that are al­ready be­ing used in clin­i­cal set­tings, but pro­po­nents of the MBAN spec­trum al­lo­ca­tion say it’s needed to en­sure safety and pre­vent in­ter­fer­ence for the life-crit­i­cal med­i­cal de­vices that mon­i­tor and track a pa­tient’s vi­tal signs. The tech­nolo­gies will likely track data such as blood pres­sure, glu­cose lev­els and heart rhythms. How­ever, down the line, the de­vices may be able to bet­ter mon­i­tor car­diac out­put, which may help keep heart-fail­ure pa­tients out of the hos­pi­tal, Topol says. Other pos­si­ble ca­pa­bil­i­ties in­clude fe­tal teleme­try and pre­dic­tive and early-warn­ing sys­tems that track changes in a pa­tient’s con­di­tion.

GE Health­care first pe­ti­tioned the FCC in 2007 to al­low the spec­trum to be set aside. Two other com­pa­nies, Philips Health­care and Texas In­stru­ments, as well as the Amer­i­can So­ci­ety for Health­care En­gi­neer­ing, later joined the ef­fort.

GE and Philips, both of which al­ready sell pa­tient mon­i­tor­ing de­vices that are used in care set­tings, say they have tech­nolo­gies in de­vel­op­ment that will use the MBAN spec­trum. No MBAN tech­nolo­gies us­ing the al­lo­cated spec­trum have been brought to mar­ket yet.

How­ever, the FDA in April granted 510(k) clear­ance—which does not re­quire clin­i­cal test­ing—to a ca­ble­less res­pi­ra­tion sen­sor that Philips de­vel­oped. The chip for the tech­nol­ogy, which will be in­tro­duced to the U.S. mar­ket later this sum­mer, was de­vel­oped to also op­er­ate in the MBAN spec­trum. The com­pany ex­pects the tech­nol­ogy to re­quire ad­di­tional 510(k) clear­ance to op­er­ate in that spec­trum.

“By open­ing up the new spec­trum, we should be able to ex­pand who gets mon­i­tored (and) bring the price point down,” says An­thony Jones, chief mar­ket­ing of­fi­cer for Philips Health­care’s pa­tient-care and clin­i­cal in­for­mat­ics unit. “Now it’s just a mat­ter of see­ing which de­vices get to mar­ket and how peo­ple im­ple­ment them.”

He says the com­pany will de­velop prod­ucts for the hos­pi­tal and home mar­kets, but sees a dis­tinct new mar­ket op­por­tu­nity for mon­i­tor-

ing pa­tients within their home.

“One of the things we’re putting a lot of ef­fort into is the whole hos­pi­tal-to-home con­cept of mon­i­tor­ing,” Jones says. “As you get more into the home and out of the more in­va­sive ar­eas of mon­i­tor­ing, as you get farther and farther away from the hos­pi­tal, the value of the MBAN tech­nol­ogy starts to have a larger im­pact.”

Ex­ec­u­tives at GE and Philips de­clined to spec­ify when they ex­pect their first MBAN prod­ucts to come to mar­ket.

Charles Gior­dano, GE Health­care’s chief tech­nol­ogy of­fi­cer, says it may oc­cur within a few years. The com­pany is plan­ning to fo­cus de­vel­op­ment of MBANs in the hos­pi­tal set­ting, in­clud­ing the mon­i­tor­ing of heart and breath­ing rates, tem­per­a­ture and pulse oxime­try.

“We’re not talk­ing about a 10-year de­vel­op­ment here,” Gior­dano says.

The reg­u­la­tory path­way to bring th­ese tech­nolo­gies to mar­ket re­mains in­com­plete. Al­though the FCC pub­lished the fi­nal rule in Septem­ber, it has yet to name a fre­quency co­or­di­na­tor. The Amer­i­can So­ci­ety for Health­care En­gi­neer­ing cur­rently serves as the fre­quency co­or­di­na­tor for the wire­less med­i­cal teleme­try ser­vice band, or WMTS, which was al­lo­cated in 2000. The or­ga­ni­za­tion has said it would take on the same role for MBANs.

In ad­di­tion, a task force con­vened by the com­mis­sion rec­om­mended last year that the FCC work with its coun­ter­parts in other coun­tries on in­ter­na­tional har­mo­niza­tion for MBAN prod­ucts. So far, how­ever, the U.S. is the only coun­try to have set aside spec­trum for MBANs.

And, while the FCC is re­spon­si­ble for li­cens­ing the spec­trum, it is the FDA that reg­u­lates the tech­nolo­gies that op­er­ate on the var­i­ous spec­trums. The agen­cies have in­creas­ingly worked to­gether as a re­sult of an agree­ment in 2010 that aligns their work sup­port­ing de­vel­op­ment of wire­less med­i­cal de­vices.

“Med­i­cal body area net­works is an ex­cit­ing, emerg­ing area of tech­nol­ogy with many med­i­cal de­vice im­pli­ca­tions,” an FDA spokes­woman said in an e-mail. “As it does with all med­i­cal de­vices, the FDA would eval­u­ate de­vices that use MBAN based on the level of risk the tech­nol­ogy might present.” The agency de­clined to comment fur­ther.

“It’s not un­usual for there to be a lag in the tim­ing be­tween when the FCC can make a waiver or grant spec­trum … and the time they take their ac­tion and the time that the mar­ket can re­spond and adapt to it,” says Kerry McDer­mott, se­nior di­rec­tor of health­care tech­nol­ogy pol­icy at the West Health In­sti­tute, a not-for­profit or­ga­ni­za­tion in San Diego that ad­vo­cates for tech­nolo­gies to lower the cost of health­care.

The FCC granted a waiver in 2011 to al­low Sec­ond Sight Med­i­cal Prod­ucts, a Syl­mar, Calif.-based de­vice man­u­fac­turer, to mar­ket its reti­nal im­plant sys­tem that helps restore some func­tional vi­sion to the blind. The tech­nol­ogy con­verts video im­ages taken by a cam­era in the pa­tient’s glasses that are then wire­lessly trans­mit­ted to elec­trodes on the sur­face of the retina.

The sys­tem re­ceived ap­proval from the FDA in Fe­bru­ary, 16 months af­ter the FCC’s waiver.

“It’s still very new,” McDer­mott says about the MBAN spec­trum. “If GE and Philips ac­tu­ally get prod­ucts in the mar­ket and be­gin to drive trac-

“To have con­tin­u­ous mon­i­tor­ing—which is why a lot of peo­ple are in the in­ten­sive­care unit—that’s a big plus.”

—Dr. Eric Topol, di­rec­tor, Scripps Trans­la­tional Science In­sti­tute, San Diego

tion on this, there will be some fast fol­low­ers.”

Not all man­u­fac­tur­ers are in­ter­ested in fo­cus­ing their de­vel­op­ment strat­egy on the MBAN spec­trum. Sotera Wire­less, a San Diego-based start-up de­vel­oper of sen­sor-based wire­less tech­nolo­gies that mon­i­tor vi­tal signs, is one ex­am­ple. The com­pany be­lieves there is more than enough ev­i­dence to re­li­ably and se­curely mon­i­tor pa­tients us­ing a hos­pi­tal’s Wi-Fi net­work.

“We don’t think it’s nec­es­sary to have pro­tected spec­trum,” says Jim Welch, Sotera’s vice pres­i­dent of qual­ity sys­tems, reg­u­la­tory af­fairs and clin­i­cal af­fairs. “The need for ded­i­cated MBAN just con­sti­tutes, in my opin­ion, a land grab.”

Mon­i­tor­ing tech­nolo­gies that use Wi-Fi al­low pa­tients to be more mo­bile be­cause they are not re­quired to stay near a hub de­vice and are less ex­pen­sive, he says. In ad­di­tion, MBAN tech­nol­ogy can be used only in the U.S., which is less than half of the to­tal avail­able mar­ket, he says.

Re­gard­less of the ques­tions about spec­trum, at­ten­tion to re­mote mon­i­tor­ing tech­nolo­gies— in­clud­ing sen­sor-based body area net­works for con­sumers as well as med­i­cal body area net­works that will use the new al­lo­cated spec­trum—is on the rise. A num­ber of mo­bile ap­pli­ca­tions also have been de­vel­oped to track health data.

Com­pa­nies de­vel­op­ing prod­ucts in the re­mote pa­tient mon­i­tor­ing space re­ceived $42 mil­lion in ven­ture fund­ing in the first quar­ter of 2013, on par with the $44 mil­lion in fund­ing given to com­pa­nies de­vel­op­ing hos­pi­tal ad­min­is­tra­tion tech­nol­ogy, ac­cord­ing to an anal­y­sis by Rock Health, an in­cu­ba­tor for health­care dig­i­tal start-ups. Fund­ing in the re­mote mon­i­tor­ing mar­ket dur­ing the first quar­ter was led by Sotera, which re­ceived $15 mil­lion.

“Re­mote mon­i­tor­ing is of in­tense in­ter­est,” says Malay Gandhi, Rock Health’s chief strat­egy of­fi­cer.

A Deloitte study pub­lished in 2012 es­ti­mates that the mar­ket for all wire­less health mon­i­tor­ing de­vices in the U.S. will hit $22 bil­lion by 2015, com­pared with the cur­rent $7 bil­lion mar­ket. An in­creas­ingly en­gaged pa­tient pop­u­la­tion, an ag­ing baby boomer pop­u­la­tion and the evo­lu­tion of pay­ment mod­els that re­ward bet­ter pa­tient out­comes are ex­pected to drive adop­tion of th­ese tech­nolo­gies.

ABI Re­search pre­dicts that 5 mil­lion dis­pos­able sen­sors will en­ter the mar­ket dur­ing the next five years, ac­cord­ing to a re­port re­leased this month.

GE Health­care and Philips Health­care, as well as the FCC in its reg­u­la­tory doc­u­ments, say that MBAN tech­nol­ogy will be low-cost and will re­duce costs for the broader health­care sys­tem. An FCC of­fi­cial says the agency’s as­sess­ment of cost comes from back­ground pro­vided by the com­pa­nies that ad­vo­cated for the spec­trum al­lo­ca­tion.

“We are also per­suaded that the ready avail­abil­ity of chipsets and tech­nol­ogy that can be ap­plied to this band will pro­mote quick de­vel­op­ment of low-cost MBAN equip­ment,” ac­cord­ing to an FCC re­port re­leased last year. “This, in turn, will re­duce de­vel­op­men­tal ex­penses, en­cour­age mul­ti­ple par­ties to de­velop MBAN ap­pli­ca­tions, and will pro­mote the wide­spread use of ben­e­fi­cial MBAN tech­nolo­gies. Such de­ploy­ment will re­duce health­care ex­penses, im­prove the qual­ity of pa­tient care, and could ul­ti­mately save lives.”

The high vol­ume of the mon­i­tor­ing mar­ket, the dis­pos­able na­ture likely for many prod­ucts and the suc­cess that man­u­fac­tur­ers have al­ready had in de­vel­op­ing low-power, low-cost chips in other sec­tors are ex­pected to keep the costs of the sen­sor-based MBAN tech­nolo­gies low.

“We want to make sure it’s af­ford­able and pro­duc­tive for our cus­tomers to lever­age the tech­nol­ogy be­cause if it doesn’t fit the cost model and it doesn’t fit the work­flow, it still won’t be adopted,” GE’s Gior­dano says.

Topol says that while de­vel­op­ment of sen­sors is con­sid­ered in­ex­pen­sive, the in­tro­duc­tion of new med­i­cal tech­nol­ogy usu­ally comes with a higher price tag. “Ev­ery time there’s been new tech­nol­ogy in medicine, it’s been as­so­ci­ated with higher costs,” he says. “We’re not at a point in our world where that can be tol­er­ated.”

Philips Health­care re­cently re­ceived fed­eral clear­ance for a ca­ble­less res­pi­ra­tion sen­sor (above). De­vices us­ing MBAN spec­trum will of­fer a wide va­ri­ety of mon­i­tor­ing ca­pa­bil­i­ties.

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