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Things You Should Consider When Preparing for RoHS

Things You Should Consider When Preparing for RoHS

The looming July 2014 deadline to comply with RoHS legislation will require medical device OEMs to remove a number of hazardous substances from the electronic components they use if they wish to ship and sell their products in Europe. This directive, which aims to reduce the environmental impact of electrical and electronic equipment, has already come into effect for manufacturers of consumer devices. Similar legislation appears to be on the way in North America.

With less than two years left to comply with the law, engineers and operations managers need to assess their organization’s RoHS readiness. More importantly, senior management needs to demonstrate their commitment and empower their teams to move the transition plan along and support the initiative with an appropriate budget.

In addition to senior executive commitment, a single dedicated owner responsible for the processes and infrastructure needed to ensure RoHS compliance is also essential. RoHS planning cannot take place in silos. Simply asking the supply chain team or operations team to take over the compliance program without a single point of contact is not advisable.

RoHS planning also needs to take into account the product development pipeline. Organizations need to develop a documented process to help not only assess the current compliance status of each medical device product, but also to ensure compliance to future products. This duty would probably fall to an organization’s dedicated RoHS owner, who needs to act as a subject matter expert who can monitor any future changes to RoHS legislation.

For example, device manufacturers will have to be aware of new additions or exemptions to the prohibited hazardous substances list.

For manufacturers that have just started, or plan to start, their RoHS compliance program, the good news is that it’s not too late to accomplish these key goals and meet the July 2014 deadline.

“For manufacturers that have just started, or plan to start, their RoHS compliance program, the good news is that it’s not too late to accomplish these key goals and meet the July 2014 deadline.

But they may not be able to do this alone.

From our conversations with industry experts, we’ve found that many organizations that have decided to implement RoHS without a strategic partner have spent several years working on only the initial data collection stage.

Even if an organization is not inclined to outsource, the new challenges RoHS bring to the medical device industry require manufacturers to play catch-up. If a medical device maker wants to stay focused on innovating and building next-gen healthcare products, it is crucial they find a strategic partner that can quickly get them up to speed and help them develop a new process.

A strategic partner that has cross-industry expertise in implementing RoHS processes and infrastructure across a variety of OEMs can be invaluable to medical device manufacturers looking to build up their RoHS knowledge base. Many of the lessons learned from other industries, such as the consumer electronics sector, can in fact be applied to the medical device manufacturing.

Of course, the medical device industry has unique challenges and risks when compared to consumer electronics manufacturing. The inclusion of medical devices to RoHS was delayed because of the strict requirements for high levels of performance and safety in the healthcare industry. For instance, the lifecycle of a typical hospital-grade medical device might be 15 to 20 years compared to the one to three year lifecycle on a consumer smartphone.

More from Celestica:

Factors such as reliability under extreme temperatures and constant mechanical stress mean products have to be extremely dependable. And the mere fact that a manufacturer is RoHS compliant does not mean the product will be reliable.

Without an experienced strategic partner, medical device makers risk changing their manufacturing practices so drastically to meet RoHS that their products might suffer the unintended consequences, such as battling with tin whiskers.

The industry is especially at risk today because many of the components used to make medical devices are now coming from the same pool of RoHS-ready components used by consumer electronics manufacturers. As those components have changed, the challenges associated with using them to assemble these crucial healthcare tools have changed along with them.

The impact of non-compliance may not only lead to a major financial loss, but may also open up a manufacturing organization to serious liability risks.

This is a risk that no medical device manufacturer can afford.

Simin BagheriSimin Bagheri, M.A.Sc., P.Eng. is the customer engagement lead for the engineering services division at Celestica Healthtech. She will be presenting this topic and the RoHS implications for materials selection in depth at MD&M West 2013 Conference, Feb. 11 – 14 in Anaheim, CA.

Biofelt Nonwoven Biomedical Textile for Implantable Devices

A specialist in the design, development, and manufacture of advanced biomedical textiles has released a new version of its absorbable scaffold for implantable devices used in orthopedic, cardiology, general surgery, and other in vivo applications. The 3-D nonwoven, fibrous-matrix structure of the Biofelt scaffold provides a platform that, with its large surface area and void volume, enables natural tissue in-growth in surgical applications. Produced from polyglycolic acid, poly-L lactic acid, and copolymers such as copolylactic acid–glycolic acid, the textile can serve as a bioabsorbable component of medical devices or surgical systems. It is custom-engineered to suit individual device requirements and offered with various densities and thicknesses. The scaffold material can be produced in flat sheets, disks, tubes, and other geometric shapes, with an absorption profile ranging from less than 30 days to one year.
 
Warwick, RI
 

A220-ADM16 Acrylic In-Line Check Valve by NP Medical

A company that developes and produces drug and fluid access devices and components for the OEM healthcare market has developed an in-line check valve suited for medical device applications such as infusion therapy and enteral feeding. The A220-ADM16 acrylic valve features a preloaded, normally closed latex-free silicone diaphragm that allows flow in one direction while preventing flow in the opposite direction. Composed of a sonically bonded, DEHP-free, thermoplastic body and an elastomeric diaphragm, the valve provides an opening pressure of 0.05 bar with consistent flow characteristics. Fully tested for back pressure and cracking pressure, it withstands a minimum internal air pressure of 3.1 bar with no visible signs of leakage. Manufactured in a Class 100,000 cleanroom in ISO 13485–certified facilities under CGMP guidelines, the valve is made from USP Class VI–approved materials and fits 3.4-mm-OD tubing.

NP Medical
Clinton, MA

 

Evonik Cyro Manufacturers Antimicrobial Polymer for Medical Devices

A specialty chemical company manufactures an acrylic-polycarbonate alloy for medical device construction. Designed to be tough, strong, and opaque, the Cyrex Protect features antimicrobial properties that are built into the material during manufacturing. Thus, devices made from this polymer deliver reliable protection against a variety of microorganisms found in healthcare facilities. In addition, they require no active surface coating that could scratch or wear off and consequently diminish antimicrobial effectiveness. Designed for the manufacture of such Class I and Class II medical devices as luer connectors, spikes, y-sites, check valves, and filter housings, the material offers a notched Izod impact test value of 12 ft-lb/in. It has demonstrated efficacy greater than 4 when tested according to the JIS Z 2801 protocol against Staphylococcus aureus, Pseudomonas aeruginosa, Staphylococcus epidermidis, and Klebsiella pneumoniae after both 24 hours and 96 hours of exposure, according to the company. The polymer is also resistant to plasticizers found in flexible PVC and can be sterilized by means of gamma, E-beam, and EtO techniques.

Evonik Cryo LLC
Parsippany, NJ

 

Microchips Get Bent Out of Shape

A new method for manufacturing flexible electronics starts with standard microchips and relies on conventional fabrication techniques.

Researchers have been busily developing bendable electronics for potential use in a range of medical device applications, from sensors that map and treat neurological disorders to balloon catheter components that perform diagnostic and surgical functions. However, while flexible electronic components commonly consist of circuits embedded in an elastic material that are connected using stretchable interconnects, a new method for manufacturing such components starts with standard microchips and relies on conventional fabrication techniques. This process could eventually facilitate the mass production of flexible electronics.

The new fabrication method combines reliable stretchable interconnections with commercial, off-the-shelf chips, explains Jan Vanfleteren, an electrical engineer at the Interuniversity Micro Electronics Centre at the University of Ghent (Belgium). The first step in the fabrication process involves the thinning of a conventional, unpackaged integrated circuit (IC), according to Vanfleteren. Next, the die is packaged by embedding it between two thin layers of polyimide and providing metallic conductors. After the circuit has been structured to make it stretchable, the component is embedded in polydimethylsiloxane, an elastomer material.

Because thinned dies often suffer from warpage as a result of residual stress caused by the surface films, the researchers must ensure that the dies lie flatly on the base polyimide film to prevent voids between the die and the adhesive. This care is required to avoid breaking the die and to minimize dimensional errors during subsequent photolithography steps.

"Any material becomes flexible if it is sufficiently thin," Vanfleteren says. "Although conventional, unpackaged ICs are brittle, thinned versions measuring 20 to 30 µm in thickness are flexible." This phenomenon, Vanfleteren adds, is explained by the fact that when a material is bent, strains are introduced along the material's cross-section, which varies linearly with the thickness. Decreasing the material's thickness therefore decreases the strain magnitudes and improves its mechanical flexibility.

"It is not specifically the chip, but rather the whole technology platform combining ultrathin bendable chips and compliant, elastic electrical interconnections, that makes our technology of interest for medical implantable devices or wearable sensing systems," Vanfleteren states. "These applications typically benefit from compact and lightweight systems that fully conform or dynamically adapt to irregularly shaped surfaces, such as the human body."

The Ghent researchers have found that the introduction of a polyimide support around the interconnections increases the components' reliability greatly. Hence, the new stretchable electrical interconnections have been shown to offer stable resistance when stretched up to 100%, although the electronics will not commonly undergo such severe stretching in target applications, Vanfleteren remarks. The components have also withstood cyclic stretching at lower strain levels, such as 500,000 cycles at 10%.

In theory, any IC can be thinned and embedded using the technology developed at the University of Ghent, Vanfleteren comments. This technology therefore opens the door to producing bendable electronic components for a variety of applications in which conformability and miniaturization are key requirements. "For example, to achieve further miniaturization, we are currently investigating the 3-D stacking of several thin dies in a polyimide package," Vanfleteren adds. "This design could be of interest for manufacturers of such implantable devices as cochlear implants or such wearable devices as hearing aids."

Sorin Purchases Minority Share in Highlife SAS

The Sorin Group, an Italian medical device manufacturer, announced that it had invested $5.4 million in Highlife SAS. Highlife SAS is an early-stage company working on the development of transcatheter mitral valve replacement technologies. The minority investment by the Sorin Group includes an option to buy the cardiovascular technology company. Georg Bortlein is one of the prominent founders of Highlife SAS. His history includes co-founding CoreValve, a company that specialized in aortic valve implantation technology. CoreValve was later purchased by Medtronic. Sorin's investment in Highlife SAS also includes an exclusive option for acquisition. The investment will help fund the company's ongoing clinical testing and product development. In prepared remarks, CEO Andre-Michel Ballester said, "The HighLife investment is an important step forward in our long-term plan to build a significant new growth platform in percutaneous mitral valve therapies." He continued, "This is consistent with Sorin's Strategic Plan to accelerate top-line growth through investments in innovation." Sorin has also made minority investments in other cardiovascular technology companies. Sorin Group recently made an $8 million investment in CardioSolutions. CardioSolutions is a heart access device manufacturer. The company also develops repair systems for the treatment of mitral valve diseases. References www.sorin.com/press-release/sorin-group-invests-highlife-development-stage-company-focused-percutaneous-mitral-valve-replacement

ISO 13485 Registrars List

ABS Quality Evaluations Inc.
Contact: Dominic Townsend
16855 Northchase Dr.
Houston, TX 77060
201/287-8353
fax: 201/342-0173
dtownsend@abs-qe.com

American Management Technology Inc.
Contact: Brian Barch
1106 Kathy Ct.
Fontana, WI 53125
262/275-5468
fax: 262/275-1418
brian@amtecregistrar.com

American Systems Registrar (ASR)
Contact: Richelle Kinzie
5281 Clyde Park Ave., S.W.
Wyoming, MI 49509
888/891-9002, 616/942-6273
fax: 616/942-6409
richelle@asrworldwide.com

BSI Group America Inc.
Contact: Shereen Abuzobaa
12110 Sunset Hills Rd., Ste. 200
Reston, VA 20190-5852
703/464-1931
fax: 703/437-9001
shereen.abuzobaa@bsigroup.com

Bureau Veritas Certification
Contact: Chris Carson
390 Benmar Drive, Ste. 100
Houston, TX 77060
651/423-2162
Fax: 281/310-3101
chris.carson@us.bureauveritas.com

DEKRA Certification Inc.
Contact: H. Pierre Sallé
4377 County Line Rd.
Chalfont, PA 18914
215/997-4519 ext. 41305
fax: 215/997-3810
pierre.salle@dekra.com

Eagle Registrations Inc.
Contact: Brian Payne
123 Webster St., Ste. 300
Dayton, OH 45402
800/795-3641
fax: 937/293-0220
brian.payne@eagleregistrations.com

HSB Registration Services
Contact: Janet Kowalski
595 E. Swedesford Rd.
Wayne, PA 19087
484/582-1419
fax: 484/582-1802
janet_kowalski@hsbct.com

Intertek
Contact: Lauren Reidy
70 Codman Hill Rd.
Boxborough, MA 01719
800/810-1195
fax: 978/263-7086
business.assurance@intertek.com

ISOQAR Inc.
Contact: Andy Smith
24840 Burnt Pine Dr., Ste. 5
Bonita Springs, FL 34134
866/947-6727 or 239/947-6980
fax: 239/947-4251
andy.smith@isoqarinc.com

Lloyd’s Register Quality Assurance Inc.
Contact: Kunden Dhillon
1330 Enclave Pky., Ste. 200
Houston, TX 77077
407/384-1257
fax: 407/492-8656
kunden.dillon@lrqa.com

National Quality Assurance USA
Contact: Arlen Chapman
4 Post Office Square
Acton, MA 01720
978/635-9256
fax: 978/263-0785
achapman@nqa-usa.com

National Standards Authority of Ireland
Contact: Chris Morrell
402 Amherst St.
Nashua, NH 03063
603/882-4412
fax: 603/882-1985
chris.morrell@nsaiinc.com

NSF International Strategic Registrations (NSF-ISR)
Contact: Tony Giles
789 N. Dixboro Rd.
Ann Arbor, MI 48105
734/827-6881
fax: 734/827-7829
information@nsf-isr.org

Orion Registrar Inc.
Contact: Lori Correia
7850 Vance Dr., Ste. 210
Arvada, CO 80003
303/456-6010
fax: 303/456-6681
info@orion4value.com

Perry Johnson Registrars Inc.
Contact: Terry Boboige
755 W. Big Beaver Rd., Ste. 1340
Troy, MI 48084
800/800-7910
fax: 248/358-0882
tboboige@pjr.com

SAI Global Certification Services Pty. Ltd.
Contact: Guillaume Gignac
2 Summit Park Dr., Ste. 425
416/401-8653
fax: 416/401-8650
guillaume.gignac@saiglobal.com

SGS
Contact: Don Castle
Meadows Office Complex
201 Rt. 17 N.
Rutherford, NJ 07070
201/508-3000
fax: 201/508-3191
don.castle@sgs.com

Smithers Quality Assessments, Inc.
Contact: Drew Markley
425 West Market St.
Akron, OH 44303-2099
330/762-4231 ext. 1440
fax: 330/762-7447
dmarkley@smithersmail.com

SRI Quality System Registrar
Contact: Christopher Lake
300 Northpointe Circle, Ste. 304
Seven Fields, PA 16046
724/934-9000
fax: 724/935-6825
clake@sriregistrar.com

TÜV Rheinland of North America Inc.
Contact: Brian Ludovico
1300 Massachusetts Ave., Ste. 103
Boxborough, MA 01719
978/266-9500, ext. 234
fax 978/266-9992
bludovico@us.tuv.com

TÜV SÜD America Inc.
Contact: Robert Dostert
10 Centennial Dr. 
Peabody, MN 01960
978/530-7986
rdostert@tuvam.com

TUV USA Inc.
Contact: Mike Hopkins
215 Main St., Ste. 3
Salem, NH 03079
603/870-8023
fax: 603/870-8026
request@tuv-usa.com

UL DQS Inc.
Contact: Richard Burgess
1130 W. Lake Cook Rd., Ste. 340
Buffalo Grove, IL 60089
847-279-3300
fax: 631/439-6022
richard.burgess@us.dqs-ul.com

ISO 13485 Registrars List

ABS Quality Evaluations Inc.
Contact: Dominic Townsend
16855 Northchase Dr.
Houston, TX 77060
201/287-8353
fax: 201/342-0173
dtownsend@abs-qe.com

American Management Technology Inc.
Contact: Brian Barch
1106 Kathy Ct.
Fontana, WI 53125
262/275-5468
fax: 262/275-1418
brian@amtecregistrar.com

American Systems Registrar (ASR)
Contact: Richelle Kinzie
5281 Clyde Park Ave., S.W.
Wyoming, MI 49509
888/891-9002, 616/942-6273
fax: 616/942-6409
richelle@asrworldwide.com

BSI Group America Inc.
Contact: Shereen Abuzobaa
12110 Sunset Hills Rd., Ste. 200
Reston, VA 20190-5852
703/464-1931
fax: 703/437-9001
shereen.abuzobaa@bsigroup.com

Bureau Veritas Certification
Contact: Chris Carson
390 Benmar Drive, Ste. 100
Houston, TX 77060
651/423-2162
Fax: 281/310-3101
chris.carson@us.bureauveritas.com

DEKRA Certification Inc.
Contact: H. Pierre Sallé
4377 County Line Rd.
Chalfont, PA 18914
215/997-4519 ext. 41305
fax: 215/997-3810
pierre.salle@dekra.com

Eagle Registrations Inc.
Contact: Brian Payne
123 Webster St., Ste. 300
Dayton, OH 45402
800/795-3641
fax: 937/293-0220
brian.payne@eagleregistrations.com

HSB Registration Services
Contact: Janet Kowalski
595 E. Swedesford Rd.
Wayne, PA 19087
484/582-1419
fax: 484/582-1802
janet_kowalski@hsbct.com

Intertek
Contact: Lauren Reidy
70 Codman Hill Rd.
Boxborough, MA 01719
800/810-1195
fax: 978/263-7086
business.assurance@intertek.com

ISOQAR Inc.
Contact: Andy Smith
24840 Burnt Pine Dr., Ste. 5
Bonita Springs, FL 34134
866/947-6727 or 239/947-6980
fax: 239/947-4251
andy.smith@isoqarinc.com

Lloyd’s Register Quality Assurance Inc.
Contact: Kunden Dhillon
1330 Enclave Pky., Ste. 200
Houston, TX 77077
407/384-1257
fax: 407/492-8656
kunden.dillon@lrqa.com

National Quality Assurance USA
Contact: Arlen Chapman
4 Post Office Square
Acton, MA 01720
978/635-9256
fax: 978/263-0785
achapman@nqa-usa.com

National Standards Authority of Ireland
Contact: Chris Morrell
402 Amherst St.
Nashua, NH 03063
603/882-4412
fax: 603/882-1985
chris.morrell@nsaiinc.com

NSF International Strategic Registrations (NSF-ISR)
Contact: Tony Giles
789 N. Dixboro Rd.
Ann Arbor, MI 48105
734/827-6881
fax: 734/827-7829
information@nsf-isr.org

Orion Registrar Inc.
Contact: Lori Correia
7850 Vance Dr., Ste. 210
Arvada, CO 80003
303/456-6010
fax: 303/456-6681
info@orion4value.com

Perry Johnson Registrars Inc.
Contact: Terry Boboige
755 W. Big Beaver Rd., Ste. 1340
Troy, MI 48084
800/800-7910
fax: 248/358-0882
tboboige@pjr.com

SAI Global Certification Services Pty. Ltd.
Contact: Guillaume Gignac
2 Summit Park Dr., Ste. 425
416/401-8653
fax: 416/401-8650
guillaume.gignac@saiglobal.com

SGS
Contact: Don Castle
Meadows Office Complex
201 Rt. 17 N.
Rutherford, NJ 07070
201/508-3000
fax: 201/508-3191
don.castle@sgs.com

Smithers Quality Assessments, Inc.
Contact: Drew Markley
425 West Market St.
Akron, OH 44303-2099
330/762-4231 ext. 1440
fax: 330/762-7447
dmarkley@smithersmail.com

SRI Quality System Registrar
Contact: Christopher Lake
300 Northpointe Circle, Ste. 304
Seven Fields, PA 16046
724/934-9000
fax: 724/935-6825
clake@sriregistrar.com

TÜV Rheinland of North America Inc.
Contact: Brian Ludovico
1300 Massachusetts Ave., Ste. 103
Boxborough, MA 01719
978/266-9500, ext. 234
fax 978/266-9992
bludovico@us.tuv.com

TÜV SÜD America Inc.
Contact: Reiner Krumme
1775 Old Hwy. 8 N.W.,
Ste. 104
New Brighton, MN 55112
651/638-0278
fax: 651/638-0285
rkrumme@tuvam.com

TUV USA Inc.
Contact: Mike Hopkins
215 Main St., Ste. 3
Salem, NH 03079
603/870-8023
fax: 603/870-8026
request@tuv-usa.com

UL DQS Inc.
Contact: Richard Burgess
1130 W. Lake Cook Rd., Ste. 340
Buffalo Grove, IL 60089
847-279-3300
fax: 631/439-6022
richard.burgess@us.dqs-ul.com

This Week in Devices [ Thanksgiving Edition ]: Misfit Wearables Shines; Device Tax Leads to Layoffs at Strkyer; An Innovation for Glaucoma Patients

This Week in Devices [ 11/21/12]:
Misfit Wearables seeks crowdfunding for its new product. FDA doesn't like St. Jude's pacemaker leads. Getting laid off at Strkyer? Blame the device tax. A device that may replace eyedrops for glaucoma patients. Sea creatures inspire a new device for the fight against cancer.
 
 
 
Misfit Wearables Unveils the Shine
Misfit Wearables, a company dedicated to creating the next wave of wearable technology, has announced a crowdfunding campaign for its first product, the Misfit Shine. The tiny, stylish activity monitor can be synced to a smartphone to monitor a variety of user activities. [IndieGogo]
 
FDA tisk-tisks St. Jude Pacemaker Leads
A recent report by the United States Food and Drug Administration showed a significant number of problems with St. Jude Medical’s Datura pacemaker leads. The report spooked investors and led to an 11 percent decrease in stock prices for the company. [Qmed]

Stryker Blames Medical Device Tax for Layoffs
Amidst an announcement that it will be laying off 1000-1200 employees, Stryker has claimed that the staff reduction is necessary in order to keep up with costs associated with the medical device tax. [Qmed]

Ultra-Small Device Promises New Relief for Glaucoma Patients
At the 116th Annual Meeting of the American Academy of Ophthalmology researchers announced the results of clinical trials of the Hydrus Microstent. The device, which is no larger than an eyelash, is used to relieve pressure in glaucoma patients – protecting them from vision loss or blindness. [Ivantis Inc]
 
A Cancer-Fighting Device, Inspired by Marine Life
A new microchip device, inspired by the appendages of the jellyfish and other sea creatures, may have therapeutic use in fighting cancer. The device could potentially be used to detect, bind, and capture cancer cells in a patient. [Medical News Today]
 

Gearing up for RSNA Annual Meeting? So are we.

Andrew Dallas is all charged up to attend RSNA. The editorial advisory board member and frequent contributor has agreed to represent MD+DI on this mission, and will report throughout next week. Check back frequently to get his personal take on this improtant event. To start, here is Dallas' first blog on what he is most looking forward to at the event:  

This year’s Radiological Society of North America (RSNA) annual meeting starts this Sunday and it looks to be a smash. With new technologies in imaging, patient management, and treatment, there is bound to be a feast for the eyes and mind.

As my company has had the privilege of working in this space for some time, I am particularly eager to see the latest product announcements and advancements.

3D reconstruction imaging is a fairly mature industry with some fabulous open-source tools. These allow us to easily integrate visualizations, read DICOM data and quickly deliver products. Performance of the tools is always advancing and leading product manufacturers are finding novel ways of using these technologies all the time. This may be a break-out year for companies adopting higher resolutions, doing more automated structure analysis and providing higher precision in their tools. There are a host of companies that I’m watching here including Hologic, Inc.

On top of these types of technical advancements, I’m also keenly interested in observing trends in workflow. As the treatment room can be a busy place, working to ensure systems are intuitive, efficient and reduce the likelihood of error are key to well designed products. I’ll be interested to see Medicalis’ presentations in this area. LifeImage’s sharing solution is also an interesting play.

I look forward to reporting back on those discussions, technologies and products that stole the show. 

—Andrew Dallas, Full Spectrum Software

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