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2 Undercover Ways Medtech is Using 3-D Printing

2 Undercover Ways Medtech is Using 3-D Printing

While 3-D printed implants and bioprinted organs might grab the headlines, behind-the-scenes applications for 3-D printing are equally as exciting.

Jamie Hartford

Three-dimensional printing is generating a lot of buzz in medtech these days—most of it centered on 3-D printed implantable devices and prosthetics, as well as bioprinted organs. But those aren’t the only applications for which the industry is embracing the technology.

Some equally exciting uses for additive manufacturing are taking place behind the scenes, says Eric Utley, applications specialist with Minneapolis-based Proto Labs.

“There’s a lot of discussion about 3-D printing and how it’s going to grow and what impact it’s going to have,” says Utley, who will speak on a panel about 3-D printing trends and opportunities at the MD&M Philadelphia conference on October 7.

While many people hyperbolically claim 3-D printing will someday be the primary way we produce goods, has a more realistic view of the future.

“Twenty or 30 years from now, we’ll still be manufacturing traditionally,” he says. “But 3-D printing is going to play a stronger role on the product development side of things.”

In some cases, that’s already happening. As an example, Utley cites Invisalign dental devices, an alternative to traditional braces for patients who want to straighten their teeth.

“They use 3-D printing in the manufacturing of those,” Utley says. “They scan people’s teeth, then use a 3-D printed mold [of the person’s teeth] to produce the parts.”

Another lesser-known use of 3-D printing is for making labs on a chip.

“The traditional way to build it was to hand-make molds, pour in a PDMS material, and then mold the devices,” Utley says.

Now, stereolithography (SLA) is used to either print the mold for the microfluidic device or even fabricate the device itself—although the latter is typically used only in a lab environment to evaluate a proof of concept.

“I think that’ll improve in the future, as the resolution gets better and better,” Utley says. “Photopolymers are leading the edge on that. With SLA or similar technologies, you can get small channel sizes, and as the technology marches forward, it may open up more and more possibilities.”

For his part, Utley says he’s most excited about 3-D printing’s potential to level the playing field when it comes to bringing innovations to life.

“What I’m most excited about is more so the accessibility of the technology and what that’ll do for people,” he says.

A decade ago, 3-D printing was only accessible to big companies, but today it has trickled down into the hands of startups and hobbyists.

“Now more than ever, someone with an idea can really pursue it,” Utley says. “That’s the mark 3-D printing is going to leave on things.”

Jamie Hartford is MD+DI's editor-in-chief. Reach her at jamie.hartford@ubm.com or on Twitter @MedTechJamie

[Photo Credit: iStockphoto.com user mailfor]

New FDA Commissioner Could Redefine the Agency

As FDA commissioner, Robert Califf could usher in a new era for the Food and Drug Administration after the departure of Margaret Hamburg, MD.

Qmed Staff

Robert Califf
Robert Califf, MD

President Obama is poised to nominate Robert Califf to head up the FDA, potentially clearing the way for the agency to be more flexible in its dealings with the medtech industry. Formerly a cardiologist at Duke University, Califf has served as deputy commissioner for medical products and tobacco, which is the second most senior position of the agency.   

Califf differs from the former FDA commissioner in that he has extensive experience running clinical trials and he is in fact one of the most frequently cited medical authors. He also would like to remake how they are performed. Earlier this year, Califf was quoted as saying that clinical trials are "too slow, too expensive, not reliable, and not designed to answer the important questions."

Although many of Obama's nominations for senior government posts have been delayed by slow congressional approval, many media reports predict that Califf could sail through his congressional approval. Some observers such as Forbes' Matthew Herper, however, point out that his ties to the pharma industry may be a liability for him.

Still, Califf seems like a pretty safe pick. As Forbes' describes in nearly glowing terms: "[Califf] worked closely with drug companies in the best possible way: convincing them to do large, expensive, and, for Duke, profitable clinical trials that helped prove the effectiveness of major medicines like Sanofi's Plavix, Merck's Vytorin, and Johnson & Johnson's Xarelto." The Forbes article goes on to state that Califf "has not been a pushover" and that he "has not always been easy on industry."

Instead of lowering regulatory standards, as frequent industry critic Diana Zuckerman, president, suggested in the WSJ, Califf appears to be interested in finding more efficient ways to show that medical products are safe and effective. In his work on clinical trials, he has endeavored to collect more-targeted patient data, for instance.  

As Califf put it Time earlier this year, the "greatest progress almost certainly will be made by breaking out of insular knowledge bases and collaborating across the different sectors." There is "a tension which cannot be avoided between regulating an industry and creating the conditions where the industry can thrive, and the FDA's got to do both."

Since prevision commission Hamburg's departure, former FDA chief scientist Stephen Ostroff has served as acting commissioner.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

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One Chart Shows the Waning Influence of Docs in Value-Based Environment

One Chart Shows the Waning Influence of Docs in Value-Based Environment

Medtech companies have thrived by developing very close relationships with doctors. One chart shows the reality is rapidly changing.

Arundhati Parmar

You've heard this before. Medtech companies need to develop relationships with hospital administrators and not just physicians because the days of the doc as the only customer that counts is pretty much gone.

Now, one chart captures the waning influence of doctors and the rising influence of hospital executives and purchasing managers in stark terms. 

The chart below is taken from a recent McKinsey study and is based on the consulting firm's survey of 249 hospital staff comprising C-suite, purchasing managers, and department heads. 

To deal with the move to value-based care and the pressures wrought by reduced Medicare reimbursement, hospitals are rapidly consolidating and cost concerns are front and center.

And at these consolidated systems, "the C-suite and purchasing managers are using new approaches to align disparate physicians, even on high-physician- preference items, and wielding greater influence over purchasing decisions. And as these larger systems strive to manage larger pools of dollars, cost and reimbursement will be major decision factors, in several cases trumping physician preference," the report declares.

All the more reason that small and large medtech companies come armed with data that shows clear clinical and economic benefit of their products. Only that can convince those cost-conscious influencers and decision makers within hospitals and health systems.

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb 

 [Photo Credit: iStockphoto.com user marvinh]

To learn more about medical devices and trends in the marketplace, attend the two-day MD&M Minneapolis conference, Nov. 4 and 5 at the Minneapolis Convention Center. 

How Metrology Is Solving Its Shadow Puppet Problem

For decades, many engineers have measured the accuracy of manufactured parts using a method bearing a certain resemblance to the method kids use to make shadow puppets appear on a wall.

Brian Buntz

Micro-Vu
The Micro-Vu Vertex vision system with a four-station touch probe kit is shown here testing a medical device component. 

For a substantial part of the twentieth century, the way the tolerances of manufactured objects was measured remained essentially unchanged. Invented in 1920, the optical comparator used for this purpose are similar to a complex overhead projector, which project a magnified image onto a screen--whether it be a projector slide or a mischievous student twisting his hands into the shape of a dog's head in front of the light when the teacher isn't looking.

In the case of an optical comparator, a part is put on a lit stage, which magnifies and projects a silhouette of it onto a screen using a series of lenses and mirrors. A screen overlay can help show how much the part being tested falls inside or outside of the shadow of the engineer's specs.

A central problem with the optical-comparator method is its less-than-stellar repeatability. "If you give three guys an assignment to measure a part with optical comparators, you might get three different answers," says Greg Chatfield, sales and support manager at Micro-Vu Corp. (Windsor, CA).

"One of the big changes we see in the medical device industry is that they are starting to retire their aging manual optical comparators," Chatfield says. "The optical comparators are not as accurate or reliable as some of the newer technologies out there, which also offer better repeatability."

The introduction of video overlays is another reason that a growing number of medical device companies, as well as electronics and plastic suppliers serving the medtech industry are turning to vision machines instead of optical comparators. Video overlays can essentially do what an optical comparator did with an optical-comparator overlay did, but can provide more data about how well the part meets prescribed tolerances. "You can get discrete data that gives real answers. You can know that one side of a part is, say, 15 microns too big," Chatfield says. "You can also get information on variables such as the max- and mid-point."

Two of the biggest medtech niches driving the uptick in precision measurement systems are the orthopedics and dental-implant industries. "In the orthopedics industry, when you are dealing with bone plates, bone screws, and stuff like that, a lot of it is based on profile tolerances--making sure something fits in an envelope," Chatfield says. "That kind of accuracy is also important for dental implants."

Chatfield also notices a growing interesting from medical device companies in automated metrology systems. "Many companies are finding that the automated systems help them stay competitive with offshore production from a cost perspective. Once you have an automated system up and running, the difference in operation costs in the United States versus someplace else is just a matter of electricity. And then you don't have to pay as much overhead for shipping," he says. "I tell our customers in the U.S. for the difference in cost between an automated and manual, the automated is well worth it. I encourage them to buy automated because it helps keep production in the US and it is just a matter of electricity here versus somewhere else. And you don't have to pay the overhead of shipping."

Micro-Vu practices what it preaches, using automated technology extensively in the production of its machines. "We automate our manufacturing quite a bit so that we can keep our production costs lower. We have some FMS flexible manufacturing systems in house. Our machines keep working and running parts to build our systems all day and night. As a result, we can compete with Chinese companies in terms of cost," Chatfield says. And the company also sells many of its systems in China. Asia is the company's biggest geographical market. "We are fully international. Less than half of our business in the United States."

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

Brian Buntz is the editor-in-chief of Qmed. Follow him on Twitter at @brian_buntz.

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Former St. Jude VP Charged with String of Felonies

LinkedIn Former St. Jude VP Charged with String of Felonies

Bryan Szweda had a history of "bad purchases," according to the criminal complaint in Minnesota.

A former St. Jude Medical vice president has been accused of stealing nearly $142,000 via falsified expense reports and his corporate credit card, spending the money on everything from NBA tickets to multiple strip club visits.

Bryan Szweda has been charged in Ramsey County District Court in Minnesota with five counts of theft by swindle, along with an additional felony charge of theft of trade secrets. If convicted on all counts, Szweda faces up to 70 years in prison and $200,000 in fines.

There is now an arrest warrant out for Szweda in California, where he presently works for Irvine, CA-based Edwards Lifesciences, according to the criminal complaint obtained by Qmed. (The Star Tribune of Minneapolis broke the initial story on Tuesday.)

Szweda's wife mentioned in a Facebook post Tuesday that she was getting her hair done for Las Vegas. The profile has since become unavailable.

As of Wednedsay afternoon, Szweda was still not in custody, said Sgt. John Eastham of the Ramsey County Sheriff's Office. If and when Szweda is arrested, the timeline for getting him back to Minnesota depends on a host of variables, Eastham said.

Szweda did not immediately respond to requests for comment via email and LinkedIn. A St. Jude Medical spokeswoman declined to comment.

"Edwards Lifesciences is learning of this matter as it's been reported in the media today. We take these reports very seriously, and will take urgent action to investigate this matter," Edwards spokeswoman Sarah Huoh said in an email.

St. Jude Medical (Little Canada, MN) hired Szweda in 2009 as a senior director of operations for tissue valves--unaware of "bad purchases" he supposedly made while previously working at Boston Scientific, according to the criminal complaint. In 2013, the company promoted Szweda to vice president of operations of its worldwide structural heart devices manufacturing business.

The thefts at St. Jude allegedly took place from March 2012 to July 2014, two months before St. Jude let Szweda go, according to the criminal complaint. He stole more than $10,000 via his corporate credit card and submitted or approved falsified expense reports worth nearly $130,000.

Szweda's thefts, according to the complaint, included:

  • $11,000 worth of duplicate airfare expenses;
  • More than $50,000 expensed for "team outings" or "meeting room rentals" that the complaint says was actually for season tickets to Minnesota Timberwolves games;
  • More than $2,800 on the company credit card for Minnesota Lynx playoff tickets;
  • More than $10,000 in expense reimbursements for Lady Antebellum, Jason Aldean and Luke Bryan concerts;
  • $1,260 in credit card bills accumulated during six visits to Rick's Cabaret, a Minneapolis strip club;
  • And hundreds of dollars' worth of meals and drinks at Seven, Bacio and Hubert's in Minneapolis, and more than $600 in car rentals for family trips to Buffalo, NY.

On or about Sept. 8, 2014, the day St. Jude Medical placed Szweda on administrative leave, Szweda allegedly copied more than 4600 work files to the hard drive of his work computer, and later to two other devices. The files included the company's "highly sensitive" 2014-2018 Strategic Plan, according to the criminal complaint. Other allegedly copied files included marketing plans, new medical device technology concepts, production costs, sales numbers, and goals, the complaint said.

St. Jude Medical terminated Szweda on Sept. 10, 2014, according to the complaint.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

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

Nancy Crotti is a contributor to Qmed and MPMN.

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How to Get Doctors to Embrace Next-Gen Technology

How to Get Doctors to Embrace Next-Gen Technology

An orthopedic surgeon explains what it will take to get widespread physician adoption of advanced technologies such as computer-assisted surgical navigation and surgical robots.

Jamie Hartford

Companies like Stryker have struggled to sell surgeons on new technologies, such as its RIO surgical robotic system, shown above.

Imagine if you could purchase a software program to make your job easier or, better yet, buy a robot to do your job for you. Sounds like a no-brainer, right?

But orthopedic surgeons haven’t been so easily convinced to embrace technologies such as computer-assisted surgical navigation software and surgical robots. Case in point: Stryker’s struggle to gain traction with its MAKO surgical robotics systems.

Part of the problem for robots, of course, is the fact that they’re expensive, says Neil Sheth, assistant professor of orthopedic surgery at the University of Pennsylvania.

“If the robot costs $1 million, and most guys are doing 20 [surgeries] a year, their hospital isn’t going to buy it for them,” Sheth says. “ And the guys who are doing 600 [surgeries] a year don’t need the robot because this is all they do every day.”

But technological advances also get a bad rap among orthopedic surgeons.

“The concern, in general, with a lot of this technology is that it’s trying to make bad surgeons into good surgeons,” Sheth explains.

It’s a problem not unlike that seen in the aviation industry in the 1970s, when pilots shunned the newly introduced “autopilot” feature in airplanes, he adds. Today, you’d be hard-pressed to find a pilot who doesn’t occasionally hand the controls over to “George,” as autopilot is jokingly referred to by aviators.

So how can medtech companies get orthopedic surgeons to the same place with technologies like computer-assisted navigation and surgical robots? Sheth has a theory: Start them young.

“I think one of the ways to really introduce technology is through education,” he says.

Sheth, a specialist who performs about 450 joint replacement surgeries per year and has a patient-satisfaction rate of 80% to 85%, says using a computer navigation system would likely only add time to his own procedures.

“However, as a teaching tool I think it would be great,” he says. “It’s a tool that we could use to help teach med students and fellows to understand their tendencies are and change them before they become problematic.”

Sheth, who will speak on a panel about what physicians want and need in medical devices at the MD&M Philadelphia conference on October 7, 2015, says it behooves companies with ahead-of-the-curve technology to get their devices into teaching hospitals.

“That way, you’re training the next generation of people coming out of medical school, and they may have that in their contracts that if you want me to do knee replacements at your hospital, I need this system.”

Jamie Hartford is MD+DI’s editor-in-chief. Reach her at Jamie.hartford@ubm.com or on Twitter @MedTechJamie.

[image courtesy of STRYKER]

FBI: Be Wary of Connected Medical Devices

FBI: Be Wary of Connected Medical Devices

Marie Thibault

Patients with insulin pumps or users of mobile health wearables probably don’t realize the FBI is thinking about them, but it turns out the bureau is concerned about the risks around the rising use of Internet of Things (IoT) devices, including medical devices.

In a September 10 public service announcement, titled “Internet of Things Poses Opportunities for Cyber Crime,” the FBI outlined the ways IoT devices can put users at risk. Weak security and user ignorance about hacking risks can lead to hackers “compromising the IoT device to cause physical harm,” among other risks, the FBI notes.

Along with home appliances and office equipment, the alert singles out medtech products like wireless heart monitors and insulin dispensers, as well as fitness wearables, as IoT devices that might be targets for cyber crime.

The FBI gives a more detailed example of what a cybersecurity breach could look like for medtech patients:

“Criminals can also gain access to unprotected devices used in home health care, such as those used to collect and transmit personal monitoring data or time-dispense medicines. Once criminals have breached such devices, they have access to any personal or medical information stored on the devices and can possibly change the coding controlling the dispensing of medicines or health data collection . . .”

Users are encouraged to take a number of protective measures, including using IoT devices on separate, protected networks, purchasing such devices from makers that take cybersecurity seriously, implementing security patch updates, and knowing whether their medical device has risk factors like allowing remote operation or data transmission.

The FBI alert follows prior warnings about cybersecurity concerns related to medical devices from FDA and outside experts.

Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference , November 4–5, 2015.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie 

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Market Access and Reimbursement Opportunities in the British NHS

Michael Branagan-Harris 

With 900 more hospital admissions per day in NHS England this year over 2014, the opportunities and need for change have never been greater. The medical device and diagnostic industries have to rise to the challenge and work collaboratively with the system to play a key role in transforming care though innovation, but introducing new medical technologies and diagnostics into NHS England has always been challenging.

In 2014 the NHS was rated as the world’s best healthcare system in terms of efficiency, effective care, safe care, coordinated care, patient-centred care and cost-related problems, according to a study conducted by the Commonwealth Fund, a private US foundation. Compared to healthcare systems of other developed countries, the NHS is very efficient. In 2013, health expenditure in the UK was 8.46 per cent of GDP. This compares to 16.43 per cent in the USA, 10.98 per cent in Germany, and 10.95 per cent in France. Per capita spending for the UK was $3,235 in 2013 compared to $8,713 in the USA, $4,819 in Germany, and $4,124 in France.

“The device and diagnostic industries play a key role in delivering new products that benefit the NHS, the economy and above all, patients.”

Professor Dame Sally C. Davies Chief Medical Officer Department of Health

“Transformation on this scale needs strength of purpose, unwavering commitment, and investment to support innovation and to release the entrepreneurial energies within the NHS, to bring care closer to people’s homes and communities, and to support the empowerment of patients to better manage their own health through modern technologies.”

NHS England Chairman Sir Malcolm Grant

While the NHS manages to be less expensive than most other healthcare systems, this doesn’t seem to affect the quality of the service. In the 2014 Care Quality Commission inpatient satisfaction survey 84 per cent of 56,300 respondents rated their overall experience as 7 (11%), 8 (24%), 9 (22%) or 10 (27 %) out of 10. 95.37% of 184,711 inpatients treated by NHS trusts and foundation trusts would recommend their provider to friends or family. Average length of stay for all causes in the UK was 7.0 days in 2013. This compares to 17.2 in Japan, 9.1 in Germany, and 5.6 in France.

However, the NHS is likely to face severe funding challenges in the nearer future. As one of few countries in Europe, the kingdom’s population is projected to increase from an estimated 63.7 million in mid-2012 to 67.13 million by 2020 and 71.04 million by 2030. At the same time, the UK population is expected to continue ageing, with the average age rising from 39.7 in 2012 to 42.8 by 2037. The number of people aged 65 and over is projected to increase from 10.84m in 2012 to 17.79m by 2037. As part of this growth, the number of over-85s is estimated to more than double from 1.44 million in 2012 to 3.64 million by 2037. With the higher share of older people, age-related diseases will occur more frequently. For instance, it is estimated that there will be 4 million people with diabetes in the UK by 2025 compared to 3.2m today. In England the proportion of men classified as obese increased from 13.2% in 1993 to 26.0% in 2013 (peak of 26.2% in 2010), and from 16.4 % to 23.8 % for women over the same timescale (peak of 26.1% in 2010).

Already, the demand for health services is increasing constantly. In 2013/14 there were 64 per cent more operations completed by the NHS compared to 2003/04, with an increase from 6.712m to 11.030m. There were 15.462m total hospital admissions in 2013/14, 32 per cent more than a decade earlier (11.699m). The increase has an effect on both cost and quality of the service. At the end of April 2015, there were 3.026 million patients on the waiting list for treatment. 6.7% had been waiting for longer than 18 weeks, compared to 6.3% at the same point in 2014. NHS net expenditure (resource plus capital, minus depreciation) has increased from £64.173 billion in 2003/04 to £109.721bn in 2013/14. Planned expenditure for 2014/15 is £113.035bn and for 2015/16 is around £116.4bn. Health expenditure per capita in England has risen from £1,712 in 2008/09 to £1,912 in 2012/13. “The NHS is facing a perfect storm, caught between huge increases in demand and the prospect of a massive £30 billion deficit. Without revolutionary change the NHS as we know it will become unsustainable,” said NHS England Chairman, Sir Malcolm Grant.

Understanding NHS Health Technology Assessment - The National Institute for Health and Care Excellence (NICE) and its various programmes

NHS Facts and Figures

•    209 clinical commissioning groups who commission and fund primary and secondary care activities

•    155 acute trusts (including 100 foundation trusts)

•    56 mental health trusts (including 43 foundation  trusts)

•    34 community providers (15 NHS trusts, 3 foundation trusts and 16 social enterprises)

•    10 ambulance trusts (including 5 foundation trusts)

•    8,000 General Practitioner practices

•    853 for-profit and not-for-profit independent sector organisations, providing care to NHS patients from 7,331 locations 

The NHS Employs 1.388 M NHS staff

•    150,273 doctors,

•    377,191 qualified nursing staff,

•    155,960 qualified scientific, therapeutic and technical staff and

•    37,078 managers. 

There were 32,467 additional doctors employed in the NHS in 2014 compared to 2004. There were 18,432 more NHS nurses in 2014 compared to 2004. 

Managers and senior managers accounted for 2.67 per cent of the 1.388 million staff employed by the NHS in 2014.

Understanding this background is important for medical device companies who intend to market their products in the UK. Like many others, the British healthcare system is faced with the challenge to uphold healthcare standards with decreasing funds. Innovative technologies to treat patients more efficiently will certainly be part of the solution.

The most important organization to introduce new technologies in the UK healthcare system is the National Institute for Health and Care Excellence (NICE). There is always confusion about what NICE does, its guidance and what it means. NICE run many different programmes, looking at Medical Devices and Diagnostics in many ways from safety and efficacy, to patient, system and economic benefit.

NICE is the national guidance organization providing guidance to the health and social care system on public health interventions, care pathways and specific technologies. NICE guidance helps the UK’s National Health Service (NHS) adopt effective and cost-efficient technologies and procedures. NICE Guidance is highly influential among health authorities across the World. The organisation achieves that by thoroughly reviewing of the evidence and by incorporating advice and expertise from experts, patients and care-givers. The organisation does this nationally for local health authorities, for local government, for charities, and for anyone with a responsibility for commissioning or providing health and social care. With the exception of some Technology Appraisal (TA) guidance, there is no legal requirement for the hospitals and clinicians to comply with the recommendations NICE makes, although it is considered best clinical practice for the NHS to do so.

It became clear that NICE had not applied the same level of varied assessment in the device and diagnostic area as they did with pharmaceuticals. Until 2010 there were really only two main programmes that evaluated new medical technologies Interventional Procedures (or IP) Programme, and Technology Appraisal (or TA) Programmes. In 2010 two new programmes were introduced – Medical Technology Guidance or MTG, and Diagnostic Assessment Programme or DAP.

NICE Interventional Procedures Programme (IPG)
The 37 week long established NICE Interventional Procedures Programme looks purely at safety and efficacy of new or novel procedures. Unlike medicines, there is no licensing system in the UK for operations or other interventional procedures. This means that it can be difficult for healthcare professionals to be fully informed about the possible risks and benefits of procedures that are emerging within UK clinical practice. The guidance both encourages doctors to consider newer procedures that they may not have otherwise used, as well as protects patients by advising on the risks and benefits of their use.

The guidance means that innovative procedures that could provide significant health benefits can be incorporated into clinical practice in a responsible way. Under the Interventional Procedures programme, comparative effectiveness and health economic considerations are not relevant. It focuses on if the technique or approach is safe for the NHS to adopt and results in a number of outcomes and conditions from normal guidance, special arrangements, only in research and do not use.

Based on this, NICE publishes guidance on whether or not doctors should consider specific interventional procedures to treat or diagnose their patients. This type of NICE guidance does not consider how much the procedures would cost the NHS, or whether the NHS should allocate funding for them. These decisions are made at a local NHS level and usually on a case-by-case basis. This means that if NICE has issued guidance recommending any given interventional procedure, the NHS is not obliged to provide it. To date this programme has performed over 529 assessments. 

IP guidance does not name or relate to the specific devices that may be used: it evaluates the procedure or intervention
The clinician wishing to perform the procedures completes a notification to NICE and there is very little interaction with the device manufacturer. NICE describes an interventional procedure as one that involves making a cut through the skin, using instruments to enter the body (e.g. endoscopes) or equipment, which uses energy sources (e.g. ultrasound or electromagnetic radiation) to diagnose or treat patients

This programme is currently under review and new updated processes and methods will be available in 2015. The guidance results in allocation of OPCS or procedure codes and ICD-10 diagnostic codes, which combined are then calculated and grouped into a Healthcare Resource Group (HRG) tariff or Diagnostic Related Group (DRG) IP guidance does not lead to mandatory funding. Two of the most recent IP being total prosthetic replacement of the jaw – known as “the bionic jaw” procedure (IPG500) and insertion of a double balloon catheter for induction of labour (IPG528).

A medical device manufacturer’s perspective:

As a global Market Access leader in a Medical Device company, I am pleased to see the significant progress NICE made in the last several years toward providing a modified review pathway tailored for the unique requirements of a medical device.  The Medical Technologies Evaluation Programme (MTEP) is a highly collaborative, objective review process where devices are assessed based on clinical outcomes and cost effectiveness. 

The MTEP team in Manchester is responsive, professional and genuinely interested in partnering with industry and physicians to provide the best available technologies to UK patients through the development of guidelines.  Timelines are well established and adhered to, and multiple opportunities exist for stakeholder review and input. 

I believe that NICE has reset the bar globally on ‘best in class’ partnership with the medical device industry.  It has been a true pleasure working with the team.” 

Kathy Sherwood – Head of Global Market Access - AMS Medical Inc.

About NICE Technology Appraisal (TA) Guidance
NICE’s technology appraisals assess the clinical and cost effectiveness of health technologies, such as new drugs and devices, to ensure that all NHS patients have equitable access to the most clinically- and cost-effective treatments that have significant impact on NHS or policy priorities. Regulations require clinical commissioning groups, NHS England and local authorities to comply with recommendations in a technology appraisal within 3 months of its date of publication.

During a technology appraisal, an independent Appraisal Committee examines the evidence and reaches a consensus on the effectiveness of a technology. The committee uses information from clinical trials as well as information from patients and clinical experts. The committee then makes recommendations about the use of the drug or technology in the NHS. An appraisal may contain multiple technologies and therefore a number of recommendations may be made in each appraisal. From 1 March 2000 to 30 June 2015, NICE published 344 technology appraisals (TA) in total, less than 10% of these appraisals involved a device or diagnostic.

The Newer NICE Evaluation programmes
Two brand new programmes – Medical Technology Guidance Programme (MTG) and the Diagnostic Assessment Programme (DAP) were designed specifically to help speed up the ultimate adoption of new technologies into the NHS, by setting new levels of clinical evidence requirement.

NICE medical technologies guidance (MTG) addresses specific technologies notified to NICE by manufacturers. The ‘case for adoption’ recommendations are based on the claimed advantages of introducing the specific technology compared with current management of the condition. This ‘case’ is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported, then the technology has been found to offer advantages to patients and the NHS. NICE MedTech Programme takes approximately 48 weeks to complete. The first 10 weeks stage of the process is confidential between the sponsor (Company) and NICE and this allows NICE to ensure that the device meets the criteria and the evidence matches the claims and for the NICE Medical Technologies Advisory Committee (MTAC) to engage with NHS users that support the adoption of technology. If the device or simple diagnostic is accepted then there is an announcement made on the website, and the remaining part of the programme (38 weeks) commences. The MTG programme is based around the evaluation of Medical Devices and diagnostics that are cost saving or cost neutral compared to the comparator outlined in the submission. The economics are based on cost consequence modelling.

NICE Diagnostic Assessment Programme (DAP)
Diagnostics Assessment Programme (DAP) focuses on the evaluation of innovative medical diagnostic technologies in order to ensure that the NHS is able to adopt clinically and cost effective technologies rapidly and consistently.

The Diagnostics Assessment Programme (DAP) provides specialist capacity for undertaking complex assessments of diagnostic technologies. In many cases, the meaningful assessment of diagnostic technologies requires detailed knowledge of the post-diagnosis care pathways, which results in considerable complexity. The economics can be based around Quality Adjusted Life Years (QALY) that NICE will commission to produce. The DAP takes around 60 weeks and can lead to commissioned research by NICE. 

The programme is closely linked to NICE's Medical Technologies Evaluation Programme MTEP) and the Medical Technologies Advisory Committee (MTAC). MTAC undertakes topic selection for all medical technologies and routes appropriate diagnostics topics to the DAP.

Opportunities for research – the NHS National Institute for Health Research (NIHR)
From a Market Access perspective, there is good news for those considering entering the market here. To start with if you are an overseas company with a CE Marked product and needing to generate evidence, The National Institute for Health Research (NIHR) funded through the Department of Health is in place to improve the health and wealth of the nation through research. It is a large, multi-faceted and nationally distributed organisation. Together, NIHR people, facilities and systems represent the most integrated clinical research system in the world, driving research from bench to bedside for the benefit of patients.

Since its establishment, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research.

The National Office for Clinical research infrastructure (NOCRI) is a special department within the NIHR set up to provide direct and simplified access to experienced NIHR investigators for the Medical Device and Diagnostic industry. NOCRI provides a direct route to these experts and facilities and can support companies to set up collaborations with one or more research centres in a streamlined and efficient way.

These investigators can help companies understand the potential of their devices and diagnostics, shorten cycle times and enable earlier go or no go decisions. These introduction services are free and have helped many Device Access clients accelerate research, which has been used for evidence submissions for a health technology assessment.

How to get reimbursement in the NHS
The publically funded NHS reimbursement system does not reward clinicians financially for performing a procedure – clinicians are paid an annual salary. There are no specific product related codes that are used either. The system is the same across NHS England, so unlike other markets and countries, you do not need to negotiate with hundreds of insurance companies. The Clinical Commissioning Groups (CCG’s) pay the Hospitals for performing procedures, are CCG’s are now often referred to as ‘payers’.

The NHS reimbursement system works on the following;

  • The diagnosis of the patient and their co-morbidities by ICD code
  • The procedure or procedures performed by OPCS code
  • Length of stay and type of admission 
  • The location of the hospital known as Market forces Factor or MFF – for example London Hospitals get paid around 30% more that those in other parts of the country due to higher local costs.

Put simply, the above ICD and OPCS codes and information are put into a hospital computer system called a grouper, by the coding department and the result of these codes is a HRG (or DRG) code, which has a financial value or tariff. The Hospital claims the amount for the procedure from the CCG monthly in a payment system called SUS.

There are several other factors that make a difference to what the hospital is paid for performing the procedure that can make a significant difference to the HRG, below are some examples:

  • Emergency admissions are often paid higher
  • Specialist service top-ups – ie paediatric procedures have a significant % top up
  • There are several rewards in place to financially drive day case treatments over longer stays to reward productivity- these are called Best Practice Tariff or BPT.

Overall the NHS Reimbursement system, once called Payment by Results or PbR but now Monitor Payment system is a complex one. It really rewards activity and not necessarily results, and a very recent NHS announcement states a significant increase in the current number of HRG Tariff codes from 1285, to 2266 next year.

A CE marked medical device may be sold into the NHS without NICE approval or a specific product code. It would depend though on a number of factors:

  • Is the device a brand new type of operation? For example, are you entering the body in a new unproven way? Does the procedure involve a new type of energy or radiotherapy? If so the clinician will need to notify the NICE Interventional Procedures (IP) department to advise them, and in addition get local ethics approvals.
  • Price – is the price significantly higher than the comparator?
  • Is there enough money in the NHS HRG tariff to cover the cost of using the device or diagnostic?
  • Has the clinician been sufficiently trained in the technique?
  • Has the clinician got Hospital / local approval for using the technology?
  • Does the company have $8M public and $8M private liability insurance in place to sell to the NHS?
  • Is it financially worth the hospital doing the procedure? There are a number of perverse incentives in the system and it could be better for the hospital to continue to perform the old more expensive procedure because it makes more profit out of this activity.

The NHS probably holds the richest data of episodes of care in the World
One of the biggest benefits with NHS England is the fact that this single organisation collects information on every single episode of care. This is recorded by an organisation called the Health and Social Care Information Centre, and has been made available to a number of select commercial organisations including Device Access UK Ltd. This data can be analysed by looking at single or multiple diagnostic or ICD-10, Procedure or OPCS and Spend HRG/DRG codes.

In December 2014, Device Access was granted a licence to access over 1/2 billion anonymised patient records and 3 years historic procedure activity data and can supply MedTech and diagnostic companies (subject to strict data reuse agreement and eligibility) bespoke information to examine the current NHS patient pathway and see precisely where their MedTech or diagnostic device could be best used with for example the most appropriate cohort of patients, and help improve NHS patient, hospital and NHS system outcomes. This by NHS England Hospital data includes outpatient, inpatient, critical care and maternity episodes, by diagnosis, treatment, length of stay and spend, and can be updated and refreshed monthly to help analyse NHS activity trends over time.

Michael Branagan-Harris, CEO of Device Access UKincorporated Device Access UK Ltd in 2010, which is now UK’s leading NHS MedTech Market Access consultancy.From assistance in getting the right clinicians and centres on board to generate research through clinical studies,  right through to assessment though NICE, and onto reimbursement and commercialisation,  Device Access has assisted over 120 start up and multinational companies navigate their way into the UK’s National Health Service (NHS).

9 Antique Medical Devices to Make You Happy It's 2016

1. Leech CaseIf you’re going to stick leeches on patients, it’s good to have a snazzy-looking carrying case for them. This case is one of countless antique medical devices and other artifacts from medical history that can be discovered at The Mütter Museum of the College of Physicians of Philadelphia. (Halloween is an especially popular time to visit the museum.)The use of leeches for bloodletting goes back thousands of years in many civilizations. It was only until the late 19th century that medical practitioners realized that bloodletting was harmful and could hasten patient deaths. However, a substance called hirudin that leeches excrete has been investigated for its useful anticoagulant properties, Mütter Museum director Robert Hicks, PhD, explains in the video below as he holds his pet leech Hunter.Continue >>

9 Antique Medical Devices to Make You Happy It's 2016

Updated August 4, 2016

It’s easy to take modern medicine as we know it for granted. But it has actually only been around for several decades.

Here are nine reminders of just how old-fashioned medicine was before then.

Continue >>

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

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

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[Image modified from medical devices on display in the Gröditz museum.]

Want to Win the Minnesota Medtech Week Innovation Prize?

We are hosting a contest to acknowledge the most innovative new products, services, and technologies developed by Minnesota Medtech Week exhibitors.

Chris Newmarker and Brian Buntz

UBM Canon is looking to identify the most innovative exhibitors at Minnesota Medtech Week, and give them the attention they deserve. The Minnesota Medtech Week Innovation Prize is a contest that will acknowledge the most innovative products, services, and technologies developed in recent years by exhibitors at the conference, held November 4-5 in Minneapolis.

Finalists in the contest will be honored at the show as well as on UBM Canon's industry-leading Qmed and MD+DI websites and newsletters. Finalists will also get included in an Innovation Prize tour at Minnesota Medtech Week that will attract more attendees to check out their technology at the event.

The winner will also be announced during the show and will be promoted in editorial coverage as well.

To enter, please complete the form found here by 5 p.m. Pacific time on Wednesday, October 14, 2015. 

Winning the Minnesota Medtech Week Innovation Prize pays benefits going forward: The company named the most innovative in the contest will receive a 22-inch-by-28-inch sign to display at Minnesota Medtech Week and future shows.

This is a chance to showcase the best your company has to offer in the design and manufacturing of medical devices, and get public recognition for it.

Here are the steps in the contest:

  • UBM Canon's editorial team will review each submission and designate 10 entrants as semi-finalists.
  • The editorial team will then ask our online audience to help select five finalists, which will be highlighted during an Innovation Prize Tour at Minnesota Medtech Week.
  • During the tour, a group of attendees will stop by the booth at a designated time to learn more about your firm's technology. After the tour is completed, the attendees will cast votes for the technology they think is the most innovative. In the event of a tie, our editorial team will help select a winner.

Eligibility and Requirements for Participation

The official rules are explained in detail on this page although here is a summary. Interested companies should:

  • Be a 2015 Minnesota Medtech Week exhibitor.
  • Have company operations in the United States or Canada.
  • Showcase an innovation developed between 2014 and the present relevant to the medical device industry.
  • Answer the required questions at the link provided in no more than 100 words each. Make sure to adequately state your case as to why your product, service, or technology is truly innovative, and to include an image (ideally less than 1 MB in size) and, if available, a video showing how the product works. (Note that the media you submit could be used in a future news story.)
  • Be willing to have their technology featured in a Innovation Tour at Minnesota Medtech Week, where a group of attendees stops by the booth to learn more about the relevant technology.

To enter, please complete the form found here by 5 p.m. Pacific time on Wednesday, October 14, 2015.