MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Sitemap


Articles from 2015 In January


10 Outsourcing Pitfalls You Should Address ASAP

10 Outsourcing Pitfalls You Should Address ASAPUpdated February 25, 2016Medtech companies can reap plenty of benefits when it comes to going the contract manufacturing route, but jump into it without asking too many questions, and there’s a chance you might wish you went skinny dipping with piranhas instead.The issue is more important than ever. Large medical device manufacturers, seeking to save money by shrinking their supply chains, are requiring more from contract manufacturers. And on the flipside, a majority of startups are virtual companies, relying on outsourcing firms to do the grunt work of design, production, or both.But contract manufacturing only works well when well managed. To help you accomplish that objective, Qmed editors last year went onto the Medical Devices Group to ask about potential contract manufacturing snags. We received about two dozen responses, with plenty of insightful comments.Here are 10 important pitfalls to avoid in order to guarantee a positive contract manufacturing process.Continue>>Don't miss the MD&M Minneapolis conference and expo, September 21–22, 2016.Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.Like what you’re reading? Subscribe to our daily e-newsletter.

10 Outsourcing Pitfalls You Should Address ASAP

Updated February 25, 2016

Medtech companies can reap plenty of benefits when it comes to going the contract manufacturing route, but jump into it without asking too many questions, and there’s a chance you might wish you went skinny dipping with piranhas instead.

The issue is more important than ever. Large medical device manufacturers, seeking to save money by shrinking their supply chains, are requiring more from contract manufacturers. And on the flipside, a majority of startups are virtual companies, relying on outsourcing firms to do the grunt work of design, production, or both.

But contract manufacturing only works well when well managed. To help you accomplish that objective, Qmed editors last year went onto the Medical Devices Group to ask about potential contract manufacturing snags. We received about two dozen responses, with plenty of insightful comments.

Here are 10 important pitfalls to avoid in order to guarantee a positive contract manufacturing process.

Continue>>

Don't miss the MD&M Minneapolis conference and expo, September 21–22, 2016.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

Like what you’re reading? Subscribe to our daily e-newsletter.

A Coating That Could Thwart Infection in Medical Implants

Researchers believe they may have found a potential game changer when it comes to medical implants, with the development of a bacteria-repelling coating that could help increase the success of implanted devices.

In a study from A*STAR (Agency for Science, Technology and Research), researchers reported encouraging results from a material composed of polyelectrolyte multilayers, onto which a number of specific bonding molecules, known as ligands, were attached to create a unique biomedical coating for medical implants, according to a news release from the IOP. The results indicated that the material not only repelled bacteria, but actually attracted healthy cells as well.

The failure of medical implants remains a consistent struggle for doctors and patients, as many medical implants attract bacteria, sometimes leading to eventual rejection of the implant. The failure rate for many medical implants remains alarmingly high -- around 40% for hip implants for example -- owing to the formation of biofilms upon initial insertion of the implant into the body.

This thin film is comprised of a group of microorganisms stuck together, and can be initiated by bacteria sticking to the implant. This eventually prevents healthy cells from attaching, and results in the body rejecting the implant, which often leads the patient down a path laced with complications and subsequent implants.

The key was finding the right concentration of ligand, a solution that came after testing various concentrations before researchers found that RGD peptide was particularly effective at inhibiting the attachment of bacterial cells, while still attracting healthy cells. The concentration was tested on cultures of healthy fibroblast cells and cultures of bacterial cells with two specific strains used--E. coli and C. aureus. Vincent Chan, lead author on the research from Nanyang Technological University in Singapore, spoke to the IOP about how the biomaterial works.

"The method we developed helped the host cells win the so called 'race-for-surface' battle, forming a confluent layer on the implant device which protects it from possible bacterial adhesion and colonization," he said.

Most medical implants come with an antibacterial coating incorporated into the device, Chan said, but the amount of silver used must be carefully calculated in order to ensure the concentrations aren't too high and become toxic to the human body. The biomaterial created by Chan and his group avoids this issue because the materials used are completely nontoxic, and the preparation process uses water as a solvent.

Coming up with such biocompatible materials has been an area of increased focus, as researchers continue to look to improve the reception of implantable devices. Lately, fashioning implantables that are biodegradable has been all the rage. From crafting surgical pins from magnesium, to suture anchors made from iron-tricalcium phosphate, doctors continue to look for ways to enhance implantable devices in an effort to avoid the body rejecting them.

While crafting implants that can be absorbed naturally into the body would be ideal, many implantables, like hip and joint replacements, require a much longer shelf life. Researchers like Chan understand the significance of improving the quality of implantable devices to be able to work in harmony with the body, and not be seen by the body's defense mechanisms as a malicious intruder. This includes preparing the devices to fight off bacteria once they enter the body.

While Chan's development is still more of a proof-of-concept, he and his team remain hopeful that this coating will hold up in a clinical trial setting. As for the future, Chan hopes to continue to test the material and improve the long-term stability of the coating, in the hopes of preparing it for clinical use.

Refresh your medical device industry knowledge at MD&M West, in Anaheim, CA, February 10-12, 2015.

Kristopher Sturgis is a contributor to Qmed and MPMN.

Like what you're reading? Subscribe to our daily e-newsletter.
 

More Google Medtech News: They Want to Tackle MS

Why would two women who visit the doctor with identical early symptoms of multiple sclerosis have vastly different outcomes 10 years later?

That's what pharmaceutical maker Biogen Idec Inc. wants to know. The drug company, which makes five MS drugs, has begun working with Google X Life Sciences to study outside factors that affect MS patients over time, according to a report by Bloomberg.

The Cambridge, MA, company and Google will use novel sensor platforms, advanced laboratory science, and bio-analytical tools to study the drivers of MS progression, Biogen announced in its statement of fourth-quarter results. Both companies remained mum on most details of the deal, but a Google exec said it would likely last for years.

See Babak Parviz, former Google X director and now a vice president at Amazon, deliver a keynote address at MD&M West, in Anaheim, CA, February 10-12, 2015.

MS interrupts the flow of information within the brain and between the brain and the rest of the body. Symptoms range from reduced or lost mobility to numbness and tingling to blindness and paralysis, according to the Multiple Sclerosis Society.

The disease affects more than 2.3 million worldwide, most of whom are diagnosed between the ages of 20 and 50, the nonprofit organization's website says.

Biogen has already run a Fitbit study to determine if the fitness wearable might reliably gather data, and is developing an iPad app with Cleveland Clinic to help physicians assess the progress of patients' disease, the Bloomberg report said. Rick Rudick, Biogen's vice president of development sciences previously directed Cleveland Clinic's MS program.

The iPad app measures cognitive speed using video game-style tests, and graphic-based tests that assess a patient's vision, according to an earlier Bloomberg report. The Cleveland Clinic will begin testing the app this spring, the report said.

Andrew Conrad, head of Google X's Life Sciences division, told Bloomberg that he wants Google X to "be an R&D partner for pharma."

The secretive long-term research arm of Google broke into medical device wearables for chronic diseases in January 2014 when it announced it was developing glucose-reading contact lenses for diabetics. In September 2014, Google acquired Lift Labs, a company that makes a tremor-cancelling cutlery device to help Parkinson's patients eat.

Nancy Crotti is a contributor to Qmed and MPMN.

Like what you're reading? Subscribe to our daily e-newsletter.

Welcome to the Wild Wireless Frontier

Welcome to the Wild Wireless Frontier

The settling of the American West has a lot in common with medtech's move to incorporate wireless technology. 

By Dr. Liam Pender

Wireless connectivity in the medical device industry has introduced turmoil in a market used to predictability. Companies are positioning themselves to make the most of this new opportunity by embracing the new technical challenges, the evolving regulatory climate, and uncertainty about the market.

The settling of the Western frontier in America was a historic saga that has been blown up with heroic tales of romance and violence, but the reality was less glamorous. Western pioneers faced a high level of toil on their journeys, during which nothing was guaranteed except hardship and uncertainty.

There are many aspects of that story that resonate with the evolving story of wireless technology in medical devices, our new wild wireless frontier.

The first analogy between our frontier stories is the new necessity to use shared resources. Wireless medical devices share their over-the-air communication channels with other licensed radios.

Devices like cellphones, computers, tablets, networking equipment, and other radio transmitters all share the same medium: free space. There are some wireless medical devices that use the relatively uncluttered and exclusive MICS or WMTS bands. However, most of the new generation of mHealth products has WiFi, Bluetooth LE, cellular, and ISM band radios. Using these busy airways while ensuring reliable, secure, and timely data transfer is a new requirement for medical device designers.

Another shared resource challenge experienced by medical mobile apps is having nonexclusive use of the hardware and operating system of the hosting Smartphone. Other “critters” sharing this platform are music players, cameras, navigation aids, Facebook and Mindcraft apps, and pretty much any unknown program.

Both of these shared resource requirements put an onus on medical device engineers to anticipate the behavior of the others. In the radiofrequency domain, implementing extremely robust radio protocols with security to mitigate interferers is a design requirement.

On the smartphone, anticipating other applications’ memory, power, and hardware needs are new design considerations. Anticipating smartphone obsolescence or replacement is now among the concerns of a mobile medical device manufacturer.

A second similarity with the frontier world of old is the need for new relevant laws and policing. FDA recognized that the ground was moving in the medical device world. As far back as 2010, a joint FDA-FCC meeting informed industry that the agencies desired to promote innovation while ensuring patient safety. The 2013 FDA documents on mobile medical apps (MMA) guidance and radiofrequency wireless technology in medical devices have helped set expectations for how the regulatory body will view devices incorporating these new technologies.

Enforcement discretion based on patient risk is also alluded to by FDA in its communications. This has been welcomed by innovators. As recently as last week, FDA decided to down-classify a Dexcom mobile app from a Class III device accessory, removing the need for premarket approval for similar smartphone applications. These new rules and policies are welcome and needed in the new wild wireless frontier.

Finally, a third similarity with the untamed frontier is the appearance of unexpected travelers. While Johnson & Johnson expects to encounter Medtronic and Baxter at industry trade shows, until recently the company likely didn’t expect to see Qualcomm and AT&T along their aisle. The world of medical devices is being entered by many unconventional players who see market opportunity as consumer behavior changes in tandem with technology innovation. At the upcoming MD&M West Conference, there will be keynote addresses by executives from Amazon and Google—Silicon Valley techies rather than medtech experts from Minneapolis or Boston.

This is the journey we’re traveling. Our welcome to the wild wireless frontier is fraught with technical challenges; it requires a changing of old mindsets. But the medical device industry has its wagon firmly hitched to this mobile and wireless wave, and there’s no getting off. Whether in dealing with shared resources, coping with changing regulation, or competing with new players, those medical device companies that can thrive on the journey stand to reap the great rewards.

Dr. Liam Pender, president and CEO of Egret Technologies, will lead the discussions on this topic as he chairs the track "The New Wireless Frontier : Innovations in Wireless Capabilities, Interoperability and Sensor Technologies in Medical Devices" on Tuesday February 10, 2015, at MD&M West in Anaheim, CA.

[image courtesy of WITTHAYA PHONSAWAT/FREEDIGITALPHOTOS.NET]

Pirates Also Needed Medical Devices

blackbeard

Antique medical devices provide a glimpse into how medicine was performed in past centuries. But few people have taken a look at how medical care was administered on a pirate ship until the discovery of a shipwreck known as Queen Anne's Revenge, which was helmed by none other than Blackbeard--the most famous pirate in history. The ship was captured in 1717. 

"Because his passion for piracy, I think he cared very much about keeping it going, and to keep it going, he had to have a healthy, functioning crew," Linda Carnes-McNaughton, an archeologist working on the project told The Washington Post.

In fact, Blackbeard orchestrated a blockade of Charleston to procure medicine. The pirate proclaimed that he would take on any attackers and "would murder all their prisoners, send up their heads to the governor, and set the ships they had taken on fire," if the governor of that state did not deliver medical supplies to him, according to Captain Charles Johnson, who published a text on Blackbeard in 1724.

Syringe
This urethral syringe injected mercury to treat Syphilis. Image courtesy of N.C. Department of Cultural Resources. In large doses, mercury can prove fatal.

Archeologists have been excavating the remains of the ship since it was discovered in 1996 and recently found a trove of medical instruments. In fact, the ship likely had more medical gadgets onboard than a normal pirate ship. The Queen Anne's Revenge was formerly a slave vessel that was captured by Blackbeard's crew, who were so weak at the time they couldn't do much to fight back. Three French surgeons were on board and Blackbeard decided to spare their lives and to pay them for their services. He, however, abandoned the ship when it sunk off of the North Carolina coast in 1718.

clyster
A "clyster pump" was used to treat severe cases of dehydration. Image courtesy of N.C. Department of Cultural Resources.

Among the gadgets found in the ship were an urethral syringe used to treat Syphilis and a "clyster pump," an enema device used to treat severe dehydration. A device used for bloodletting was also found. A cast brass mortar and pestle for grinding medications was also onboard. The medical devices were evidently made in France.

The archeological team sorting through the shipwreck remains are working their way from the back of the ship to the front of the hull. They are now about halfway through.

Carnes-McNaughton, the archeologist cited earlier, expects to find more medical instruments as the team continues their work.

The team plans on comparing the medical artifacts they find with those from other wrecks.

Not surprisingly, pirates were generally not a healthy lot. Common ailments suffered by pirates include scurvy and "bloody flux," an outmoded word for amoebic dysentery.

Refresh your medical device industry knowledge at MD&M West, in Anaheim, CA, February 10-12, 2015.

Like what you're reading? Subscribe to our daily e-newsletter.

Top 10 Medical Device Deals of 2014 (MID Labs)

Company: MID Labs

Headquarters: San Leandro, California

Amount Raised: $51 million

Investors: OrbiMed Advisors LLC, Frontline Bioventures, SOFTBANK China Venture Capital, Sungent BioVenture

Products: The company makes several instruments for use in ophthalmic procedures, including the MID Cannula Insertion system pictured below.

   

Top 10 Medical Device Deals of 2014 (AqueSys)

Company: AqueSys

Headquarters: Aliso Viejo, CA

Amount Raised: $43.6 million

Investors: Accuitive Medical Ventures, Carlyle Group, L.P., The Longitude Capital Management Co LLC, Rho Capital Partners Inc, Sv Life Sciences Advisers LLC, Undisclosed Firm

Products: The company makes the Xen System, which implants a permanent gel stent in the eye through an injectable procedure to treat glaucoma. 

glaucoma treatment, xen gel stent

   

Top 10 Medical Device Deals of 2014 (Holaira)

Company: Holaira

Headquarters: Plymouth, MN

Amount Raised: $42 million

Investors: Advanced Technology Ventures, Morgenthaler Ventures, Split Rock Partners LLC, Undisclosed Firm, Versant Ventures, Vertex Venture Holdings Ltd., Windham Venture Partners

Products: The company makes the Holaira Lung Denervation System to treat chronic obstructive pulmonary disorder (COPD).

COPD treatment, Holaira,

    

Top 10 Medical Device Deals of 2014 (Restoration Robotics)

Company: Restoration Robotics

Headquarters: San Jose, CA

Amount Raised: $40.2 million

Investors: Alloy Ventures, Clarus Ventures LLC, InterWest Partners LLC, Sutter Hill Ventures, Undisclosed Firm

Products: The company makes the Artas Robotic System, described as the first and only robotic hair transplant system.

hair transplant, robotic hair transplant,