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How Google and Novartis Might Revolutionize Contact Lenses

Google's founders may have recently downplayed the high tech giant's healthcare plans. But a new partnership with Novartis, announced Tuesday, shows that Google is pretty serious when it comes to one medical device technology: contact lenses.

When the news came out in January that Google planned to develop a contact lens that could help diabetics keep track of their blood glucose levels, company officials said they were looking for partners with expertise in bringing such products to market.

That seems to be exactly what Google has found in the Swiss multinational Novartis and its Alcon eye care division, which has agreed to in-license Google's "smart lens" technology for all ocular medical uses. Novartis' goal is to have a prototype ready for research and development reviews by early next year, according to The Wall Street Journal.

Google Contact lens

Google's smart contact lens may include camera, glucose meter, or both (Courtesy Google Inc.)

The smart lens technology includes noninvasive sensors, microchips and other miniaturized electronics embedded within contact lenses, according to the companies' news release.

"By combining Alcon's leadership in eye care and expertise in contact lenses and intraocular lenses with Google's innovative 'smart lens' technology and groundbreaking speed in research, we aim to unlock a new frontier to jointly address the unmet medical needs of millions of eye care patients around the world," says Jeff George, division head of Alcon.

The deal between Google and Novartis should serve as an indication that contact lenses are a serious innovation platform for health sensors and more--and other device designers may want to consider whether they are missing out.

In announcing the partnership, the two companies already had an additional potential use for Google's smart lens tech: an autofocusing contact lens for people living with presbyopia who can no longer read without glasses.

"This is a key step for us to go beyond the confines of traditional disease management, starting with the eye," said Novartis CEO Joseph Jimenez.

A patent released earlier this year also shows Google embedding a tiny camera in a contact lens--a scenario that raises the question of whether Google Glass might eventually morph into Google Lens.

It is worth noting that Novartis' Alcon has already proved itself innovative with contact lenses, including the decade-plus work its engineers spent on developing the Dailies Total water gradient contact lenses.

The Dailies Total lenses boast more comfort through a "unique water-gradient material, which allows for a measurable change in water content throughout the lens," according to Alcon's website. The core of the lens features a highly breathable, silicone hydrogel material with a low water content of 33%--allowing more oxygen through the lens to promote healthy looking eyes--while the ultra-soft surface gel layer made up of more than 80% water, nearly the same as the surface of the eye.

The 80% water surface of the Dailies Total lens minimizes friction with the delicate tissues of the eye, according to Alcon's website. One has to wonder a surface with so much liquid might also aid, say, a Google sensor measuring glucose in tears.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

It is worth noting that Google and Novartis are not the only companies interested in contact lenses as a medtech innovation platform.

Contact lens  technology was on display in January at the International CES, where Bellevue, WA-based Innovega showed off its iOptik platform that combines a contract lens paired with a glass-pointed projector.

Other advances include telescopic contact lenses, which NewScientist reports are being developed by researchers in Switzerland and California.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

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With Novartis Deal, Google Shows Its “Science Project” Has Legs

With Novartis Deal, Google Shows Its “Science Project” Has Legs

Diabetes drugmaker Novartis announced Tuesday that it is licensing Google’s smart lens technology through its Alcon eye care division.

The agreement allows Novartis to commercialize the work of the Google X team, which announced only six months ago that the technology would one day be able to sense glucose through tears. Commercialization, Google noted, would take five years.

At the time, executives in the glucose monitoring business were rather disparaging of this effort. A Dexcom executive told MobiHealthNews that it is a “science project” saying that he wasn’t sure how the technology would continuously monitor and report glucose levels in real time. MDDI also wrote an article where experts were skeptical of Google taking on noninvasive glucose monitoring.

But now, Novartis has taken up the challenge of commercializing Google's smart lens technology at least temporarily silencing critics.

“We are looking forward to working with Google to bring together their advanced technology and our extensive knowledge of biology to meet unmet medical needs,” said Novartis CEO Joseph Jimenez in the news release. “This is a key step for us to go beyond the confines of traditional disease management, starting with the eye.”

The news release also specifies how Novartis envisions a future product: a smart contact lens will measure glucose noninvasively and wirelessly connect with a mobile device.

What's more, the Swiss company is specifying another use beyond glucose-sensing. Company researchers want to work with the Google X team to help in developing a corrective lens. Here's what the press release states:

For people living with presbyopia who can no longer read without glasses, the “smart lens” has the potential to provide accommodative vision correction to help restore the eye’s natural autofocus on near objects in the form of an accommodative contact lens or intraocular lens as part of the refractive cataract treatment.

Corrective lens is one thing, but noninvasive glucose monitoring that frees millions of people from the daily pin pricks of lancets is one of the Holy Grails (the other is an artificial pancreas) of diabetics. Both companies have a lot to prove in this regard. 

But with this agreement, the technology leaves Google's idea factory to enter into the world of clinical R&D at a well-known healthcare company. Makers of glucose meters are probably paying closer attention now.

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com


 

Developing Polyisoprene Materials that Meet USP Guidelines


By Saman Nanayakkara, Shu Peng, and Gino G. Banco

A new grade of polyisoprene compounds complies with USP <381> guidelines for both Type I and Type II elastomeric closures.

Natural rubber has been utilized in a variety of general industrial and commercial applications since the mid-1800s. In select applications, it has also found favor in the medical industry. Derived from the latex of the Pará tree, it is composed of long chains of isoprene monomers. However, the recognition that certain proteins in the raw material can elicit allergic reactions has posed a significant hurdle for medical device developers interested in exploiting the material's mechanical and physical properties in medical device applications, compelling them to search for alternatives.

This quest has led to the creation of synthetic rubber materials, including polyisoprene. However, while polyisoprene compounds are viable alternatives to natural rubber, traditional grades of this synthetic material do not meet all the requirements of U.S. Pharmacopeia's USP <381>, "Elastomeric Closures for Injections.1 This dilemma has created the need for a new polyisoprene compound that can meet the 2009 USP <381> Type I requirements. Such a material would lessen the regulatory burden facing medical device developers while providing superior resealability and other functional characteristics not typically achieved using other elastomeric materials

Why Polyisoprene?

In the mid-1950s, scientists discovered new types of catalyst systems that allowed for the development of synthetic polyisoprene rubber. Commonly referred to as polyisoprene, synthetic polyisoprene rubber is a cleaner, more consistent analog to its natural cousin. It does not contain proteins, eliminating the allergen issue that has limited the use of natural rubber in the medical device industry. Additionally, polyisoprene has a similar set of desirable mechanical, physical, and chemical characteristics as its natural counterpart, providing advantages for medical device applications.

Excellent material properties such as tear resistance, rebound resilience, elastic modulus, compression set, and stress relaxation can be achieved by compounding polyisoprene with carefully selected reinforcing fillers, plasticizers, cure systems, and other specialty ingredients. If formulated properly, polyisoprene compounds can meet USP Class VI and ISO 10993 biocompatibility guidelines.

Additionally, the material has the unique ability to reseal itself after being punctured, making it suitable for septa, or closures for injection fluid-transfer applications. When a needle pierces an elastomeric septum such as a vial cap closure or an IV bag port, it passes through the seal that protects the inner sterile environment from the outer environment. A properly designed elastomeric septum must allow easy needle penetration while maintaining the integrity of the seal at all times. It must also resist fragmenting, coring, or crumbling to prevent contamination and occlusions while exhibiting the ability to reestablish the seal when the needle is removed.

USP <381>-Compliant Polyisoprene

Despite polyisoprene's many beneficial properties, it is challenging to use traditional polyisoprene materials to manufacture medical injection closures because of stringent guidelines implemented by various standards organizations.2-4 For example, in "Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics," FDA states that the requirements presented in "USP Elastomeric Closures for Injection" are typically a baseline for demonstrating the safety of such components.5 Hence, any injection closure application submitted to FDA after May 2009 is expected to comply with the updated USP <381> guidelines.

The guidelines classify elastomeric closures into Type I closures for aqueous preparations and Type II closures for typically nonaqueous preparations. Type I closure requirements are more stringent than Type II requirements, especially for ultravoilet radiation absorbance and reducing substances. While certain traditional polyisoprene compounds meet Type II requirements, they have had difficulty meeting the updated physiochemical requirements for Type I closures.

After undergoing extensive biological, physicochemical, and functional testing, a new polyisoprene compound, designated RJ651-30, has been shown to comply with USP <381> guidelines for both Type I and Type II closures. The requirements for each test are presented in Table 1.

Table 1: USP <381> testing requirements.

Table 2 compares the physical and mechanical properties of RJ651-30 with those of two traditional polyisoprene compounds that have historically been used in injection applications: RJ614-30 and RJ649-40. While these traditional compounds are USP <381> Type II compliant, they can no longer be used to manufacture closures for aqueous preparations because they cannot meet Type I physiochemical requirements. Since compound RJ651-30 is Type I compliant, it is by definition Type II compliant as well, rendering it suitable for use in both aqueous and nonaqueous preparations.

Table 2: Physical and mechanical properties of RJ614-30, RJ649-40, and RJ651-30 polyisoprene compounds.

Ranging from 30 to 40 Shore A durometer, the hardness of the three compounds is typical for such materials. RJ614-30 and RJ651-30 both exhibit excellent tensile strength, high elongation, and very good tear strength. Compound RJ649-40, which exhibits the best compression set resistance, has slightly lower tensile properties and tear strength than the other two materials. All three compounds demonstrate comparable mechanical and physical properties and perform especially well in compression set resistance tests at 70°C.

Table 3 presents selected results of physiochemical testing. In particular, the absorbance testing highlights the difference between the traditional compounds and the newly developed material. While the traditional compounds satisfy Type II guidelines for absorbance, they fail to meet Type I absorbance guidelines. In contrast, the newly developed compound meets Type I absorbance guidelines, with UV absorbance of 0.1 (50% of the limit).

Table 3: Physiochemical properties of RJ614-30, RJ649-40, and RJ651-30 polyisoprene compounds.

Table 4 shows the results of functionality testing for RJ651-30, indicating that the material performs exceptionally well according to the functionality guidelines described in USP <381>. The penetrability, fragmentation, and self-sealing capacity tests were conducted using 21-gauge needles, as mandated in the guidelines.

Table 4: Functionality tests for RJ651-30 using a 21-gauge needle, per USP <381> guidelines.

Since RJ651-30's self-sealing capacity performance exceeded the level required in USP <381>, this test test was extended to further examine the material's limits. First, the material was tested using needles measuring up to 16 gauge, the cross-sectional area of which is four times larger than that of a 21-gauge needle. The results of the self-sealing capacity tests performed using larger needles are presented in Table 5.

Table 5: Self-sealing capacity tests for RJ651-30 using 16- to 20-gauge needles.

Next, the self-sealing capacity test was performed by piercing the vials 10 times using 20-gauge needles and then placing them under vacuum. Subsequently, the vials were stressed further by piercing them once, placing them immediately under vacuum, piercing them again, and placing them immediately under vacuum again. By repeating these steps with each vial until a failure was observed, more vial-to-vial resolution was achieved in the data, enabling the researchers to understand how many times the septa could be punctured and resealed before failure occurs. All but one of the 10 vials tested in this manner survived 20 cycles, while the failed vial succumbed at five cycles.

Conclusion

Polyisoprene compounds are well suited for use in medical septa because of their superior resealability and desirable mechanical, physical, and chemical characteristics. However, stringent USP guidelines have made it difficult to use traditional polyisoprene materials in elastomeric closures used for aqueous preparations. While traditional compounds can be formulated to meet Type II guidelines for nonaqueous preparations, they do not pass the absorbance requirements during physiochemical testing.

In contrast to traditional polyisoprene materials, a new polyisoprene compound provides proper mechanical and physical properties while complying with USP <381> Type I guidelines. The new material exhibits such good properties as low needle penetration resistance, unlikelihood of fragmenting or coring, and high resealability, making it suitable for injection septa applications. Because of its ability to comply with USP <381>, its excellent mechanical and physical properties, and its ability to incorporate properties from other polyisoprene compounds such as self-lubrication and antimicrobial agents, this compound shows that polyisoprene can still be used in injection septa.

References

  1. USP <381>, "Elastomeric Closures for Injections" (Rockville, MD: U.S. Pharmacopeia, 2009).
  2. EP 3.2.9, "Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders, and for Freeze-Dried Powders," European Pharmacopeia 5.0 (Strasbourg, France: European Pharmacopeia, 2005).
  3. JP 7.03, "Test for Rubber Closure for Aqueous Infusions," Japanese Pharmacopeia, XV General Tests (Tokyo: Pharmaceuticals and Medical Devices Agency, 2006).
  4. ISO 8871, "Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use" (Geneva: International Organization for Standardization, 2005). 
  5. "Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics" (Silver Spring, MD: U.S. Food and Drug Administration, 1999).

Saman Nanayakkara is a laboratory manager and senior chemist at Parker Hannifin Corp.,'s Medical Systems Div. (Anaheim, CA). He joined the company in 2009. A polymer engineer, he has more than 25 years of experience in elastomer compounding, characterization, testing, and processing. Contact him at saman.nanayakkara@parker.com.

Shu Peng is engineering manager at Parker Hannifin Corp.'s Medical Systems Div. He joined the company as a senior development engineer in 1992. He specializes in polymer engineering, rubber elasticity, and finite element analysis. Contact him at speng@parker.com.

Gino G. Banco serves as principal R&D engineer in Parker Hannifin Corp.'s Engineered Materials Group. He joined the company in 2010. His focus is on the development of products and technologies for the life sciences market. In this capacity, Banco works with the Engineered Materials Group's 14 divisions, including the Medical Systems Div., leading global teams in new materials development, manufacturing, and medical device initiatives. Contact him at gino.banco@parker.com.

How FDA’s Culture Beats the ‘Least Burdensome’ Law

How FDA’s Culture Beats the ‘Least Burdensome’ Law

Most medical device companies try hard to be good citizens and do their best to comply with FDA’s Byzantine regulations and policies. To varying degrees, they employ ex-FDA staff to help them do the right thing, and if they don’t outright employ them, they consult them.

Stay up to date on the goings-on at FDA by attending the MD&M Minneapolis conference October 29–30, 2014.

Many on the fringes, however, do neither.

But whether companies do or don’t seek out former FDA employees for help, there’s a universal enemy at the agency that they can do nothing to overcome: the FDA culture.

An object but obscure lesson in how much harm this seemingly unbeatable foe can cause surfaced briefly this past June in a Federal Register notice that, astonishly, withdrew a three-year-old proposed rule and proposed order to require the filing of a PMA for cranial electrotherapy stimulator (CES) devices—proposals CDRH has been pursuing relentlessly, on and off, for more than 20 years.

This document is simultaneously a remarkably opaque and unforeseen FDA capitulation to the legal reality that these devices have little to no risk and actually have been embraced by the U.S. military as boon in the treatment of post traumatic stress disorder, and a tacit admission that FDA’s culture obstructed a public health benefit.

Notwithstanding a clear congressional directive in the 1997 FDA Modernization Act—reinforced in subsequent legislation— that its reviews of medical devices must follow least burdensome requirements and procedures, CDRH repeatedly, for all those 20-plus years, imposed the opposite on the small cadre of manufacturers making CES devices.

Notable among these was Mineral Wells, TX-based Electromedical Products International Inc. (EPI), the 21-employee maker of the Alpha-Stim CES product for insomnia, depression, and anxiety. The company retained CDRH attorney Larry R. Pilot to battle the center’s “most burdensome” approach, established in 1978, to placing all such devises in Class III simply because “satisfactory effectiveness has not been demonstrated.”

That was a portal to regulatory burdensomeness wide enough to drive an army division through. According to a 1978 FDA classification: 

it is not possible to establish an adequate performance standard for this device because the characteristics of the electrical current necessary for effectiveness are not known. The panel believes that general controls will not provide sufficient control over these characteristics.

The classification went on to opine that the devices present “a potential unreasonable risk of illness or injury to the patient if the practitioner relies on the device, and it is ineffective in treating the patient’s illness.”

There followed an erratic regulatory follow-through, including decades of slumbering, until in 1993 CDRH proposed a rule requiring a PMA for the devices. Why did this take so long? Nobody has offered an explanation.

The rule was finalized in 1995 and revoked two years later after EPI sued the agency, causing it to briefly convert to full flexibility and admit in the Federal Register that it had “become aware of additional information relevant to the possible reclassification of the CES device from Class III to Class II or Class I.”

FDA then announced that it believed it was “more appropriate” to invoke the procedures under section 515(i) of the Food Drug & Cosmetic Act and issue an order requiring manufacturers of CES devices to submit information on their devices’ safety and effectiveness.

It took CDRH another 14 years to get serious about that. In April 2009 it published a 515(i) notice that applied to all of the 25 remaining devices, including EPI’s Alpha-Stim, that still held Class III preamendments status “as the first step in the process of final rule-making.” Letters went out giving their makers four months to respond.

The center then slumbered on the issue for another four years, until August 8, 2011, when it snapped back to its original 1978 position, proposing to require PMAs for the CES devices. That’s when EPI and two other CES manufacturers petitioned CDRH for Class II status.

In February 2012, CDRH took the matter to its Neurological Devices Panel (NDP). None of the members disclosed “qualified expert status” in CES devices, but they were provided with what EPI called a biased 83-page CDRH executive summary that argued for Class III status on the same vague grounds the center had used in 1993. As it customarily does, CDRH ambushed the company with this voluminous “data dump” in less than 48 hours before the meeting, depriving it of an effective response before the panel.

As intended by CDRH, the panel voted to keep CES in Class III because there was no showing of effectiveness. Neither, it failed to admit, was there any showing of risk beyond a few reports of skin irritation, headaches, and two cases of dizziness.
As in too many other episodes in this most dysfunctional of FDA centers over the years (e.g., Myo-Tronics, Utah Medical Products, TMJ Implants, Laerdal, et al), here appears another instance of CDRH serial malfeasance against a small company with a successful product that has somehow fallen from bureaucratic favor.

Fast-forward to June 12, 2014, and FDA’s one-page, smiley-faced complete reversal in the Federal Register, signed by assistant commissioner for policy Leslie Kux.

What happened? The notice doesn’t say, but it hints that instead of finding no evidence of effectiveness over 20 years of on-again, off-again searching, it finally found no evidence of risk sufficient to justify continuing to impose maximally burdensome requirements on this industry.

That discovery came more than 20 years later than it should have, and was doubtless brought about by the inevitable turnover in key decision-makers over such a long interval, and by the center’s latter-day tendency to put lawyers into key regulatory management positions. One of these lawyers must have recognized the festering CES mess CDRH had accumulated and, armed by the daunting fact that 300 public comments overwhelmingly favored down-classification in Class II, shoved the center out the nearest exit.

This poses the obvious question: Why does CDRH continually behave in such a way?

Pilot and an allied warrior in the trenches, ex-CDER engineer Leroy Hamilton—who, like Pilot, has the rare distinction of besting CDRH in combat (revising CDRH’s flawed device classification questionnaire last year)—blame the CDRH culture.

In their diagnosis, the culture has two dominant traits: a crudely expressed cover-your-butt syndrome and a reflexive command-and-control syndrome that compels it to retain power wherever it can, regardless of need.

In the view of both Pilot and Hamilton, these two syndromes are perversely encouraged by industry’s broad reluctance to push back when FDA demands become unreasonable.

The combined effect of these syndromes —not unique to CDRH but widely manifested across government in all agencies with police powers—almost always works to industry’s detriment, which in the case of the medical device industry, also means to the detriment of public health.

That might explain why, 17 years after its passage into law, “least burdensome” FDA regulation has been so hollow.

Stay up to date on the goings-on at FDA by attending the MD&M Minneapolis conference October 29–30, 2014.

—Jim Dickinson is MD+DI's contributing editor.

[image courtesy of KIBSRI/FREEDIGITALPHOTOS.NET] 

Medtronic, Thermo Fisher Making Largest Medtech Buys

Whether it involves Medtronic buying Covidien for $43 billion or Thermo Fisher Scientific acquiring Life Technologies Corp. for $13.6 billion, the medical device industry has seen some major mergers and acquisitions deals in 2014. The 10 largest deals Qmed has covered this year are worth about $83 billion. And the year is only a little over halfway done. Reasons for the deals include the need for larger companies with more economies of scale needed to compete amid a trend toward reduced healtcare spending in the United States, Europe and other developed countries. For U.S.-based multinationals, the chance to move the headquarters overseas also has tax benefits. Here are 10 of the largest medtech M&A deals so far this year:

1. Medtronic to Buy Covidien

Price: $43 Billion

Medtronic announced in June that it has agreed to acquire Irish medtech firm Covidien for $42.9 billion in cash and stock. The purchase is the largest acquisition of a foreign firm by a U.S. company, based on Standard & Poor's Capital IQ data. The move stands to make Medtronic, which was already the fourth largest medical device firm, even more competitive. With total revenue of $14.3 billion, Covidien is a heavyweight in its own right, ranking as the eighth largest device company. In the same time period, Medtronic's total revenue was $16.7 billion. For the sake of comparison, diversified healthcare behemoth Johnson & Johnson had total revenue of $28.6 billion in that same time period. The merger will give the firm 87,000 employees based throughout more than 150 countries. Executives at the company have indicated that strategic cost-cutting could follow, with approximately $850 million in potential cost savings earmarked over the course of the next two to three years. The merged entity will be known as Medtronic plc. Medtronic's current CEO Omar Ishrak will be put at the helm of the combined company, who incidentally denied that the merger was motivated by a desire to lower its tax rate. While the company will be officially headquartered in Ireland, it will still retain operational headquarters in Minneapolis. The merger is expected to pass regulatory hurdles by the end of the year or by the early 2015. Read Qmed's story about the deal.

2. Thermo Fisher's Personalized Medicine Play

Price: $13.6 Billion

Thermo Fisher Scientific in May completed its $13.6 billion acquisition of Life Technologies Corp. (Carlsbad, CA), a move that will provide lab products leader Thermo Fisher with access to the DNA sequencing market. "Our combined offering provides cutting-edge technologies, such as genomics and proteomics, to accelerate life sciences research and improve human health," Thermo Fisher Scientific CEO Marc N. Casper said in a news release. The deal was first announced more than a year ago. That is likely no idle boast. Genomic sequencing is poised to ultimately play an important role in healthcare, helping shift medicine away from a one-size-fits-all methodology to make it increasingly personalized. For now, however, genomic sequencing is a niche technology that has not been tested extensively in the real world. In addition, many of its benefits are often described in the context of an unspecified time in the future. In March, San Francisco Gate published a piece pointing out some of the current-gen technology's alleged shortcomings in a piece titled "Whole-genome sequencing falls short, study says."

3. Zimmer Holdings 'Shakes Warsaw' with Biomet Deal

Price: $13.4 Billion

The Wall Street Journal in April ran the headline, "The Deal That Shook Warsaw, Ind.," when Zimmer Holdings announced its plans for the $13.35 billion acquisition of Biomet, the other big ortho device company headquartered in the Indiana city. The acquisition--expected to close early next year pending customary closing conditions--is expected to solidify Zimmer's position as the second-largest orthopedic company in the world. Zimmer says it expects to realize cost synergies of $270 million annually by the third year after closing, but the operative word in the deal has been integration, not restructuring. Read Qmed's story about the deal.

4. Abbott Labs Sharpens Device Focus with Pharma Sale

Price: $5.3 Billion

Abbott Park, IL-based Abbott Laboratories continues to divest itself of pharmaceutical holdings as it focuses more attention on medical devices and diagnostics, with the latest deal involving the multibillion-dollar sale of its developed markets branded generics pharmaceuticals business to Pittsburgh-based Mylan. Abbott will receive 105 million shares in a "New Mylan" entity that will include Mylan and the former Abbott assets, according to a July 14 news release. Based on Mylan's closing stock price on Friday, Abbott's equity stake would be worth $5.3 billion, and Abbott Labs CEO Miles White says the company does not plan to hold onto the shares long term. The transaction is expected to close during the first quarter of 2015. The generic pharmaceuticals business has had about $2 billion in annual sales generated in Europe, Canada, Japan, Australia, and New Zealand--about two-fifths of Abbott's remaining pharmaceuticals business. Based on 2013 sales, medical devices would make up 38% of Abbott revenue, versus a previous 35%. (Abbott also has a multibillion-dollar nutritional business.) Read Qmed's story about the deal.

5. J&J Sells Blood Testing Equipment Business to Carlyle Group

Price: $4 Billion

Johnson & Johnson in late March announced that had accepted a binding $4 billion offer from The Carlyle Group to buy its Ortho-Clinical Diagnostics business, which provides blood-testing equipment and chemicals. J&J announced sale completion on June 30. One would think a blood testing equipment business would be a gold mine. Getting one's blood drawn is pretty common, after all. But it has not been so for J&J. The company's diagnostics business brought in $1.89 billion in revenue in 2013, a nearly 9 percent decline from 2012. J&J is not alone in this situation. Even with a slight uptick related to the U.S. Affordable Care Act bringing in new patients, the $75 billion lab testing industry will continue to slow down through 2015, according to G2 Intelligence research recounted by American Public Media's Marketplace. Read Qmed's story about the deal.

6. Smith and Nephew Buys ArthroCare

Price: $1.5 Billion

Smith & Nephew announced in February that it had executed an agreement to buy sports medicine company ArthroCare Corp. It announced on May 29 that the purchase was completed, at a price of about $1.5 billion. The news came only weeks after ArthroCare agreed to pay $30 million to settle securities fraud-related charges with the U.S. Department of Justice. Still, Smith & Nephew CEO Olivier Bohuon said: "This is a compelling opportunity to add ArthroCare's technology and highly complementary products to further strengthen our sports medicine business. Together, we will be able to generate significant additional revenue from the more comprehensive portfolio, combined sales force and Smith & Nephew's global footprint."

7. GE Acquires Thermo Fisher Life Sciences Technology

Price: $1.06 Billion

Cell culture and gene modulation technology, as well as magnetic beads used protein analysis and medical diagnostics, are included in GE's $1.06 billion acquisition of life science business lines from Thermo Fisher Scientific, which closed in March. GE announced in January that the product offering additions would allow GE Healthcare to develop "end-to-end" technologies for cell biology research, cell therapy, and the manufacture of innovative medicines and vaccines. Buying Thermo Fisher's Sera-Mag magnetic beads product line enables GE to extend its existing technologies in protein analysis and medical diagnostics. The Sera-Mag beads have a high surface area per unit mass and slow settling rate with good lot-to-lot reproducibility.

8. Boston Scientific Buys Interventional Division of Bayer AG

Price: $415 Million

This roughly $415 million deal, announced in May, is expected to close in the second half of 2014, subject to customary closing conditions. Boston Scientific said buying Bayer AG's Interventional Division will help it meet its goal of providing a comprehensive portfolio of products and services to treat peripheral vascular disease--which affects more than 27 million people worldwide. Bayer Interventional had about $120 million in sales in 2013, and purchasing it gives Boston Scientific more access to what it described as attractive segments in the peripheral space, including in the atherectomy and thrombectomy categories. "These technologies help physicians save both limbs and lives," Boston Scientific CEO Mike Mahoney said in a news release.
Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

9. St. Jude Buys Heart Failure Tech

Price: $375 Million

St. Jude Medical in May announced that it was paying $375 million to acquire CardioMEMS and its device to help manage heart failure. The purchase came amid U.S. FDA approval of the CardioMEMS HF System. The device is about the size of a dime and is implanted in the pulmonary artery during a minimally invasive procedure. It can transmit information about pulmonary artery pressure from a patient's home to a health provider. Increased pressure in the artery is an early warning of worsening heart failure. Catching a rise in pulmonary artery pressure allows doctors to proactively manage medications and other treatment options, decreasing the likelihood of hospital admission. Odd are, that's an attractive value proposition for U.S. health systems, especially since Obamacare has Medicare increasingly reimbursing based on how overall patient populations are managed. Public relations for St. Jude noted that heart failure costs the United States $31 billion annually, an amount expected to more than double to $70 billion by 2030. The CardioMEMS HF System is also touted as the first FDA-approved implanted device that is a pressure-reading silicon chip, hermetically sealed in glass using a laser. St. Jude has continued big acquisition spending post-CardioMEMS. Just on July 14, it announced an agreement to acquire NeuroTherm, a manufacturer of pain management therapies. The $200-million acquisition will enable St. Jude to enter the market for spinal pain treatment using radiofrequency ablation (RFA) therapy.

10. Cardinal's AccessClosure Takeover

Price: $320 Million

Dublin, OH-based Cardinal Health Inc. announced in May that it has completed its acquisition of privately-held AccessClosure Inc. (Santa Clara, CA), giving it a foothold in the interventional cardiology space. The all-cash $320 million deal, originally announced on April 2, will add AccessClosure's extravascular closure devices and other products to Cardinal's portfolio of solutions. AccessClosure's Mynx family of patient-friendly vascular closure devices helps physicians close the femoral artery using a unique, secure sealant, which dissolves within 30 days and leaves behind nothing but a healed artery. According to the company, Mynx allows patients to safely ambulate more quickly and enables them to return home sooner. At the April announcement, Don Casey, CEO of Cardinal Health's Medical segment, said, "We are excited about this opportunity because it provides a scalable platform - with an outstanding product, strong customer base, cost-effective service model, and seasoned management team. Our goal is to become the partner of choice for solutions that improve patient care while reducing the cost and complexity of procedures for hospital systems." Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

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Abbott Labs Sharpens Device Focus with $5 Billion Sale

Maybe they should change their name to Abbott Engineering. Abbott Park, IL-based Abbott Laboratories continues to divest itself of pharmaceutical holdings as it focuses more attention on medical devices and diagnostics, with the latest deal involving the multibillion-dollar sale of its developed markets branded generics pharmaceuticals business to Pittsburgh-based Mylan. Abbott will receive 105 million shares in a "New Mylan" entity that will include Mylan and the former Abbott assets, according to a Monday news release. Based on Mylan's closing stock price on Friday, Abbott's equity stake would be worth $5.3 billion, and Abbott Labs CEO Miles White says the company does not plan to hold onto the shares longterm. The transaction is expected to close during the first quarter of 2015. The generic pharmaceuticals business has had about $2 billion in annual sales generated in Europe, Canada, Japan, Australia, and New Zealand--about two-fifths of Abbott's remaining pharmaceuticals business. Based on 2013 sales, medical devices would make up 38% of Abbott revenue, versus a previous 35%. (Abbott also has a multibillion-dollar nutritional business.) Abbott's medical device holdings include its medical diagnostics business--which makes a wide variety of blood and other types of testing equipment--and its vascular business--which makes an array of stents, balloon dilation products, guidewires, valve repair devices and other products. Abbott diagnostic sales were up 5.9% in 2013 versus 2012, while vascular sales were down 1.9%, according to the company's annual report for 2013. "I think in an ideal world I'd like to see more in our medical device business. I think our diagnostics business has great breadth and depth, and yet I can see some opportunities there where we could seriously broaden our position or our footprint. ... Medical devices would be a priority for me. But that said, I don't see a very robust group of opportunities out there either," White said in a Monday conference call with investors.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.
As for pharmaceuticals, White still sees opportunities in emerging markets, where Abbott is retaining its generic pharmaceuticals business. But as for the United States, Europe and other developed market, White has seen curtailed healthcare spending. "This has led to an environment for branded generic pharmaceuticals that now, more than ever, requires scale and breadth of product portfolio to be successful in these geographies," White said. The latest sale comes more than a year and a half after Abbott Labs spun out its research-based proprietary pharmaceuticals business as a new publicly traded company, AbbVie, which had $18.8 billion in revenue during its first year.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

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New mHealth Device Aims to Give Clinical Capability To Consumers

New mHealth Device Aims to Give Clinical Capability To Consumers

The consumerization of healthcare, together with the ever-increasing need to know more about our bodies, has given rise to the likes of FitBit, Samsung Gear, Apple's HealthKit, AliveCor's iPhone ECG device in addition to innumerable other apps and devices.

They tell us how we eat, sleep, exercise, and track heart rate and other metrics, too. They also tell our doctors whether we are gaining weight, whether we are experiencing abnormal heart rhythm, and other clues about our health status.

But so far, they have have been neatly divided into consumer apps and devices meant for educational and self-tracking purposes on the one hand. And on the other, there are clinical apps and devices requiring approval from FDA and, in some cases,a prescription by physicians.

A brand new startup - Cue - based in San Diego aims to change this balance. It launched the Cue deep self tracker in May with the lofty goal of bringing lab-grade diagnostic results to a consumer mHealth device. What's more, instead of skirting FDA, as many mhealth trackers do, Cue founders are working with the agency to do a usability study by which consumers who preorder the device now for $199 automatically become part of an FDA-approved trial. 

The Cue device intends to perform molecular diagnostics at home and is composed of several components - a base charger; the Cue testing unit; five separate cartridges labeled influenza, fertility, testosterone, inflammation, and Vitamin D; and sample wands to collect blood, saliva, or a nasal swab to enable those results. 

One of the five tracking cartridges is entered into the Cue. One of the three companion wands collects the sample - for influenza the wand functions like a nasal swab; for fertility, inflammation, and Vitamin D, the wand collects a drop of blood; and for testosterone, the wand collects saliva. That wand with the relevant sample is then inserted into the cartridge and the Cue device senses that a sample wand has been inserted into the cartridge and the analysis commences. In a few minutes, the results are wirelessly transmitted and displayed on an Android or iOs device enabled by Bluetooth 4.0. 

Here's a video of how Cue works:

The product will begin shipping next spring to consumers who preorder now and they will help Cue executives to understand how the device is being used. A parallel performance validation study will be conducted to see how the device stacks up against the gold standard of lab testing in each of the five health metrics, explained Ayub Khattak, cofounder and CEO in a recent interview.

For consumers, there are obvious advantages no matter who you are - for avid health buffs interested to learn about whether they are getting enough Vitamin D; for men who want to know about testosterone levels; and even women who want to start a family. But the greatest advantage from a healthcare delivery point of view must be the effect of the device on harried parents of young children.

These parents often have to wonder whether their child has the flu during winter months, which requires taking time off from work to take the child to the doctor's office where appointments may not be available immediately. Even at the doctor's office, a rapid flu test may not reveal whether the child has the flu and its accuracy is not without question, according to Clint Sever, cofounder and chief technology officer of Cue. A lab test is the only way to know definitively, and that can even longer.

Cue intends to disrupt this current status quo by providing molecular diagnostic capability in the average home.

"Ultimately we are trying to provide that lab-level accuracy in the home," Khattak said. "We can’t talk about data because of FDA restrictions but we have compared our product with the gold standard lab method and gotten good results."

Cue has competitors like the much-ballyhooed Scanadu, which has ventured into the home medical diagnostics market with its Scanadu Scout vital sign monitor, ScanaFlo urine analysis test and Project ScanaFlu saliva tests. But Server and Khattak said Scanadu and Cue cannot be compared.

"I think their primary competency is being able to collect a level of information related to outside the body - they are using electrical sensors to collect information about heart rate, blood pressure but they are not collecting information at the molecular level, which is our core competency," Khattak said. "We have the technology behind quantifying molecules from inside the body using chemistry."

Assuming the Cue device works as Khattak and Sever hope, it can radically change the level of information people glean about their bodies and also how healthcare is practiced. This is how Khattak describes the company's goals:

"People are more proactive with their health. We are already starting to see that with people collecting information about themselves with their mobile device. We’d like to enable them to take that one step further so they can really see the leverage points in their health - how their diet and exercise is affecting their body and make an adjustment in real time. We really want to enable a new form of healthcare where people don’t have to wait in long lines or have to wait three days for a doctor’s appointment and weeks for a lab result."

And yet Khattak is aware that the challenge of changing healthcare delivery is not small. Getting a device that provides lab grade results at home is one thing. Getting doctors - especially in the case of the flu - to heed the results of a mhealth device and prescribe medication based on that is quite another.

"Overall we are going to be aggressively pursuing to close the loop on actionability of that information," Khattak said. "Our FDA clearance is going to make a big step in that direction. It validates this for the doctor and the consumer."

Khattak expects to get FDA clearance by the end of next year. So far, Cue has raised $1 million from angels. Currently, venture capitalists and corporations are also taking an interest though Khattak declined to name them. The interest may not be misplaced if Cue can ride on current trends and create a meaningful category of molecular diagnostics at home.

"The time is right for that change and there’s some macroforces at play with Obamacare and trends like the mobile device becoming the hub of health information," he said. "And we are an important and powerful layer in that context that can help drive these healthcare models toward the consumer."

[Photo Credit: Cue] 

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com

What's Germany Better at than Soccer? Medtech

Germany has more to brag about than a World Cup championship (thanks to a late-game goal that put the nail in Argentina's coffin in the final). The country is also home to a thriving medical device industry showing impressive strength in all areas ranging from R&D and medtech startups to regulation and market growth. While the eurozone crisis and global recession crippled some countries and brought others to their knees, fiscally conservative Germany has weathered the storm and maintained a growing healthcare sector.
 
Here are some of the must-read stories on the trends and companies that are marking Germany's medical device industry.
 
 
What's Germany's Secret?
 
What can the rest of the world learn from Germany's thriving medtech industry?
In its 2011/2012 industry report, BVMed cites the healthcare industry as the largest employer in Germany with 5.4 million employees. Almost one in seven jobs in Germany can be found in the healthcare industry. 
Read the full article on MD+DI 
 
 
Germany Thrives on Precision
 
How much does Germany's commitment to R&D play into its competitive edge?
Poor in natural resources, the southwestern German region has long relied on the ingenuity and diligence of its people to fuel its economy. 
Read the full article on Qmed
 
 
A Shortcut to Medical Device Reimbursement in Germany
 
How new laws are offering device manufacturers a more-timely road to reimbursement.
During the last seven years, we have provided consulting services to more than 100 different medical device startups. Some of them planned to obtain the CE mark for their product relatively quickly and launch it in Germany. The problem was getting those German Sickness Funds (payers) to provide reimbursement in a timely manner.
Read the full article on EMDT
 
 
Western Europe's Medical Device Market Under Increasing Pressure
 
How Germany's medical device industry stays strong where other countries have struggled
Anticipating the draining effects of an ageing population, Germany has implemented a series of major healthcare reforms over the past 20 years. 
Read the full article on EMDT
 
 
Wow-Worthy Medtech Startups – Germany
 
A German company is transforming smartphones into hearing aids.
The Mimi smart hearing technology is aimed to be a low-cost, effective alternative to traditionally expensive hearing aids
Read the full article on MD+DI
 
 
Wireless Medical Devices to Watch – Moticon OpenGo Sensor Insole
 
German company Moticon’s OpenGo sensor insoles can be placed into any pair of shoes to measure weightbearing, balance, acceleration, and foot temperature. 
OpenGo insoles are currently used to analyze patients after orthopedic surgery, but in the future Moticon hopes to incorporate phone-based audio, visual, or haptic feedback into the device.
Read the full article on MD+DI
 
 
[image via FreeDigitalPhotos.net]
 
-Chris Wiltz, Associate Editor, MD+DI
Christopher.Wiltz@ubm.com
 

ATS Labs Acquires MicroTest Labs

ATS Labs of Eagan, MN, has bought MicroTest Labs of Agawam, MA, as part of its efforts to expand its microbiology and chemistry laboratory services, which are focused on the medical device and biopharmaceutical industries. The combined companies will soon be known as Accuratus Lab Services, according to an ATS news release. ATS officials expect that administrative functions will be consolidated, but the new company will continue to operate at its present locations in Minnesota and Massachusetts. Financial terms of the deal were not immediately disclosed. "The acquisition of MicroTest by ATS has been a long time in the making and I could not be more pleased about the future of the two companies and how they will combine to create the market leader in providing microbiology and analytical chemistry testing services," Steve Richter, PhD, CEO of MicroTest Labs, said in a news release. Tom Burnell, PhD, executive chairman of ATS added, "Like ATS, MicroTest has a strong reputation in the industries it serves, which is supported by long-standing client relationships. Leveraging the strengths of the two companies will only further enhance our ability to continuously exceed our client's expectations."

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.
Ampersand Capital Partners owns a majority of ATS Labs.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

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St. Jude Medical Spends $200 Million on Pain Management Tech

St. Jude Medical has announced an agreement to acquire NeuroTherm, a manufacturer of pain management therapies, according to a company news release. The $200-million acquisition will enable St. Jude to enter the market for spinal pain treatment using radiofrequency ablation (RFA) therapy. St. Jude expects to complete the transaction by the end of the third quarter and predicts that the acquisition will add about $10 million to $15 million to its 2014 sales. This year, the transaction will be neutral to St. Jude's consolidated earnings per share (excluding acquisition-related expenses). NeuroTherm is a privately held company specializing in minimally invasive pain management products, including radiofrequency ablation (RFA) therapies for spinal pain. It is a treatment that has been used for over 25 years. The treatment works by using heat to destroy painful nerves and can be used prior to neurostimulation or surgical intervention. NeuroTherm's flagship technology is the NT2000iX RF generator, which has four independent RF channels. This allows for simultaneous treatment of multiple sites, real-time temperature monitoring, and the elimination of unwanted stimulation. The product also features independent timers, which are designed to ensure a complete treatment of each targeted nerve. The NT2000iX can be used with NeuroTherm's RF needles and electrodes. NeuroTherm also makes epidural catheters and products for intradiscal therapy, vertebroplasty and vertebral augmentation. NeuroTherm's technology will complement St. Jude's chronic pain portfolio and will make the company the only one that offers both RFA and spinal cord stimulation, according to the press release. St. Jude's product line for spinal cord stimulation products include implantable pulse generators, paddle leads, percutaneous leads, steerable paddle leads, lead anchors, and programming platforms. The company's Eon Mini rechargeable pulse generator is said to be one of the smallest on the market.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.
Chronic pain affects more than 1.5 billion people worldwide. In the United States, more people are impacted by chronic pain than heart disease, cancer and diabetes combined. 230 Americans were diagnosed with acute and chronic pain in 2013, but only about 8% received interventional therapy. NeuroTherm's products are available in over 65 countries and the company has registered over 40 patents with the U.S. Patent and Trademark Office. The company was founded in 2005 and is headquartered in Wilmington, MA.

Camilla Andersson is a contributor to Qmed and MPMN.

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