Next-Generation Medical Devices: Ready to Save Lives Today

Rapid advances in technology for new medical devices are outpacing evolving regulatory frameworks, creating a challenge for this sector.


https://businessfacilities.com/2015/10/next-generation-medical-devices-ready-to-save-lives-today/
Rapid advances in technology for new medical devices are outpacing evolving regulatory frameworks, creating a challenge for this sector.
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Next-Generation Medical Devices: Ready to Save Lives Today

Next-Generation Medical Devices: Ready to Save Lives Today

By the BF Staff
From the July/August 2015 Issue

A variety of trends are presenting opportunities and challenges for the medical device industry in 2015, according to an industry tracker, HealthDecisions.com.

The medical device industry faces a host of changes driven by rapid advances in science and technology, evolving regulatory frameworks in the U.S. and EU and reimbursement challenges that reduce and delay access to venture capital. There will be rapid progress in Next Generation Sequencing, indication-specific molecular diagnostics and companion diagnostics, with continued strength in immunoassays.

The group also projects robust activity in a variety of medical implants. 3D printing will present new opportunities and challenges. FDA’s new regulatory framework for LDTs and the EU’s new Medical Device Regulation will have substantial and sometimes unpredictable effects. There is increased urgency about diagnostics for infectious disease based on worldwide concern following the Ebola virus outbreak in Africa.

The role of medical devices in our lives is growing by the day in a variety of settings, including at the point-of-care, in the home, in hospitals and commercial labs. With exploding growth in identification of biomarkers, the need for new assays has probably never been greater. However, a difficult reimbursement environment is giving venture capitalists second thoughts about investing in new device development projects early, when funds are needed most.

The technology of 3D printing will play a growing role in the medical-device industry in 2015 and beyond, enabling new competitors to enter some markets while presenting an alternative manufacturing approach for new and established companies alike. New implants, many with wireless communications, will proliferate to meet the needs of an aging population, in many cases involving not only an implant but also an instrument for insertion and an external monitoring device.

HAVING IT ALL IN DEVENS, MA

After serving as the U.S. Army’s New England Headquarters for 79 years, Devens, Massachusetts has transformed into a thriving 4,400-acre mixed-use community that is home to 91 organizations. Thirty-one manufacturing, professional, scientific, and technical services businesses have chosen to locate in Devens, providing the community with a higher concentration of these industries than Massachusetts as a whole. Two of the largest medical device manufacturers in the region—Nypro and SMC Limited—are located in Devens. A business-friendly environment and a talented workforce of more than 4,000 sustain Devens as a prime destination for medical-device companies.

Devens offers ample developable commercial land for businesses to customize office buildings, manufacturing plants, and retail spaces. Earlier this year, medical device contract manufacturer SMC Limited selected Devens as the home of its new manufacturing facility. Brian Payson, Vice President and General Manager of SMC East, said, “The move to Devens will allow us to better serve our customers with an expanded manufacturing service offering and increased product development capabilities.”

Reliable, affordable utility services are essential to business success, especially manufacturers that use large amounts of energy. The Utilities Division in Devens pursues innovative programs to increase energy supply, reliability, and efficiency while limiting costs. The Utilities Division also provides pole and conduit access for telecommunications, and cable television and antennae siting for wireless communication.

The region boasts a diverse and highly skilled workforce thanks to its concentration of higher education institutions and proximity to greater Boston and Worcester. Nypro, a leader in healthcare supplies, purchased a manufacturing facility in Devens two years ago, citing the pool of talent available in the community. Of the move, General Manager John Witkowski said, “It made sense for us… We can get some really good hires.” MassDevelopment has signed an agreement with Devens Village Green LLC, a local development group, to build up to 124 units of housing in the community’s Grant Road neighborhood. These homes will help meet increasing demand for local housing given the hundreds of people who have started working in Devens in the last two years. The development is roughly two miles from the town center, an easy, stress-free commute for employees of any company that chooses to locate in Devens.

Given the dynamic nature of advanced manufacturing, employees need access to training opportunities to stay up-to-date on current industry needs. Working closely with area businesses and manufacturers, the Devens campus of Mount Wachusett Community College offers several programs, including Advanced Manufacturing Industry Readiness Training to help workers in the region prepare for successful careers in the advanced manufacturing industry. The College often coordinates with Bristol-Myers Squibb, one of the largest businesses in Devens, to develop the school’s manufacturing training programs and curriculums and prepare students for real-world positions. BMS employs about 400 workers at its Devens plant to develop the biotechnology drug Orencia to battle rheumatoid arthritis. The company invested about $750 million in the original facility and is currently building a $250 million expansion, which will add 300 R&D employees. Bristol-Myers Squibb expects to finish that construction later this year.

Seated in north central Massachusetts, Devens also has easy access to major highways and public transportation, and is just 40 miles west of Boston Logan International Airport. Medical device companies in the community can benefit from a successful statewide medical device industry. In July, two Massachusetts biotech companies, Nanobiosym Inc. and Zaiput Flow Technologies, received a large grant from the Massachusetts Life Sciences Center to conduct experiments in outer space. Massachusetts Gov. Charlie Baker noted that “collaboration is one of our greatest strengths in Massachusetts” and leads to achievement across the industry.

Whether businesses are looking to lease office space or build specialized facilities, Devens offers real estate opportunities to fit every need. Companies moving to the community can use the Devens business website (devensbusiness.com) as a one-stop database of available area real estate. The new Red Tail Heights parcel, at 18.5 acres and fully serviced by all utilities, can accommodate buildings of up to 225,000 square feet. Overlooking the 18th hole and clubhouse of Red Tail Golf Club, the open space offers businesses an especially attractive setting for their corporate headquarters.

Devens has enjoyed notable growth in recent years. Between 2012 and 2014, Devens organizations hired more than 800 workers, and the economic activity of private and nonprofit Devens entities supported more than 4,100 Massachusetts jobs through indirect and induced spending. As more and more high-tech science and manufacturing businesses choose to put down roots in Devens, medical device companies can find a welcome home in this vibrant community.

CARLSBAD, NM: GROWTH CENTER

A growing community faces many challenges as it gets bigger. Housing supply, abundance of jobs, and infrastructure issues are common hurdles faced. Many communities might find it difficult to be well positioned enough to handle sustained growth over a long period of time. Carlsbad, New Mexico, has been the fastest growing city in the state, with a growth rate of 5.37%, for some time now. Growth is a challenge gladly accepted by businesses and the community alike.

medical-devices
The Carlsbad Medical Center has invested over $35 million in improvements, including a new Outpatient Diagnostic Center and a remodeled front entrance.

Take for example the Carlsbad Medical Center. Since 2004, CMC has invested over $35 million in improvements and expansions. This investment has been not only to keep up with current medical trends and technology, but also because the Carlsbad community has been growing quickly. The need for essential medical care has been one of the top indicators of growth in the area, and the hospital has recognized this need with several projects aimed at improving the types and quality of care available to the community.

Part of the funds have been invested in a new Outpatient Diagnostic Center, upgraded diagnostic imaging equipment, an expanded Intensive Care Unit, and an upgraded and expanded Emergency Department. A $15-million renovation project was completed in January 2011, resulting in additional operating rooms, a new inpatient laboratory, a renovated Women’s Services Unit, and a remodeled front entrance and lobby.

The hospital also recently upgraded their cardiac catheterization lab, which enables patients the ability to stay in the area instead of transferring out for interventional cardiac procedures. Another recent improvement/addition includes $75,000 for a new MRI Anesthesia Machine. This machine is the only one within 200 miles, and it enables hospital staff to sedate pediatric patients and ones who are claustrophobic.

The hospital investment is a direct indicator of the growth in the Carlsbad community. Current census numbers and estimates show the population in the Greater Carlsbad area to be above 44,000. When coupled with national water usage formulas, the number grows dramatically to over 71,500. The Carlsbad Caverns National Park and other outdoor attractions bring in an average of 500,000 visitors each year as well, making Carlsbad a natural tourist destination.

Carlsbad is facing major industrial expansions in oil and gas, potash, and the nuclear industries. This accelerated growth has led to a housing shortage and low, steady unemployment rates for the area as well. But it has also created a great deal of opportunity for new and existing businesses as well, with increased potential partners to work with and an influx of workers to the area.

With the population increasing at the rate it has shown recently, the advancements and investments made in the medical industry have gone a long way to improve the overall offering for Carlsbad residents. In the past, patients would often need to travel to surrounding larger markets such as Roswell, Lubbock, and even El Paso. The goal of the hospital was to keep patients in the market by providing more services that were previously unavailable. It has made a difference, and has given people the peace of mind in knowing they can receive the care they need without having to leave town.

As Carlsbad continues to grow, with more projected new businesses and expansions planned for the next several months, more jobs will be created. This, in turn, will necessitate the need for more people to fill the jobs, which then leads to a demand for housing, infrastructure, retail, dining establishments, and more. Having looked ahead at what to expect in terms of this growth, the Carlsbad Medical Center, along with other companies such Xcel Energy, is looking to stay ahead of the demands the growing community brings. Gauging what kinds of needs can be a risky scenario, but ultimately, with the tools provided and information at hand, companies coming into the Carlsbad market can make solid plans aimed at handling the growth. Elected officials and community leaders are hard at work to make the community exceptionally business friendly, and look forward to the future with anticipation and excitement.

FRANKLIN, MA: THE CENTRAL SOLUTION FOR BUSINESS

Franklin is located within 30 miles of New England’s three largest cities of Boston, Worcester and Providence, RI, TF Green airport, and Logan International Airport. The Town also is within close proximity of over 100 colleges and universities including some of the most respected in the nation. Gillette Stadium, home of the New England Patriots is only eight miles away.

Franklin is conveniently located along and between multiple interstates and regional highways. The Town has two exits and on-ramps onto I-495, which connects with I-95, I-90 (Mass Pike) and I-290. State Route 140 bisects the Town and many additional regional highways are easily accessible including U.S. Route 1 and 1A and State Highways 16, 109, 115, 121, and 126. This is coupled with two MBTA commuter rail train stations that provide access to Boston. Franklin’s rail lines can also provide access for the transporting of cargo, as the lines are owned by CSX Transportation.

Benjamin Franklin’s quote “Industry Need Not Wish” is still the Town of Franklin’s motto. This is not simply a saying, but is demonstrated by action. Franklin was awarded a “Platinum BioReady Community” ranking by MassBio, in recognition of its work streamlining permitting of life sciences facilities. Franklin’s bio-tech ready areas are within Economic Opportunity Areas, which allow for Tax Incremental Financing. The Town convenes technical review meetings that bring together all pertinent departments to provide an overview of the local permitting process at the start of a proposed project. Franklin is also noted for its low, stable, single real estate tax rate of $14.84 compared to Boston’s rate of $29.52, Worcester’s rate of $31.73 and the state average of $17.13.

Mark Hamilton, President of Hamilton Storage said “We made a great decision by choosing to relocate our company to Franklin, MA. We are an innovative life science technology company and the Town was both supportive and attractive for business of this type. Furthermore, the location benefits our employees with convenience and amenities.” Bill Miller, General Manager of Tegra Medial said, “Franklin provides great support and has a tremendous infrastructure that really helps businesses grow.” Other businesses that call Franklin home because of the pro-business environment are EMC, Thermo Fisher Scientific Inc., Zepto Metrix, Entegris, Owens & Minor, Echo Therapeutics, Jaco Inc., Fisher Bio Storage, Liko North America and many more.

Franklin’s master planned business and industrial parks of Forge Park and Franklin Industrial Park as well as Grove Street Business Corridor are within 1 mile of I-495. These areas house a substantial number and variety of businesses representing many industrial sectors including data storage, software development, fiber optics, measurement devices, bio-storage, nanotechnology, medical devices and biotechnology. All of these areas have buildings available for rent or purchase.

Franklin offers an educated workforce with a wide variety of skills. Approximately 43% of the residents over 25 years old have a bachelor’s degree and 14% have a masters or professional degree. The area has a high concentration of two-year and four –year colleges with over 40 institutions that offer master’s degrees in science and technology. The Tri-County Regional Vocational High School offers 17 career programs including metal fabrication, engineering technology, and electrical wiring technology.

Gregory Chiklis, PhD., President of ZeptoMetrix and Franklin Resident said “Being a company in a Town like this has huge advantages for ZeptoMetrix. When you bring a candidate in and you drive them around they say “Wow, this is a wonderful community.’ Look at the schools, the Town buildings, senior center and all the resources that are available. For a community like ours, it’s outstanding. When we went to grow and expand our business in our third build-out, the Town was right there with us. They were helping with the permitting and designs. It is a business friendly town, which makes it fantastic for other businesses to come here.”

Franklin is judged as a family community because it has what parents want most: affordable homes, good jobs, top rated schools, open space and community events. The Town has been recognized by Bloomberg Businessweek as One of the Best Places to Raise Kids, CNN Money as One of the Top Ten Places to Live & Launch, and Family Circle as One of the Best Places to Raise a Family.

The Town completed construction on the new Franklin High School in 2014 at a cost of over $100 million dollars. The school contains a media center with a fully functioning television and radio station, state of the art computer labs, and 13 science labs. The students can take courses in forensics, physiology, robotics green engineering, meteorology, anatomy and alternative energy.

The Town has an abundance of civic, sports, religious and youth activities for residence of all ages and abilities. The Town has 14 recreational fields and offers live performances at the recently completed Black Box Performing Arts Center. Franklin’s history includes the first public library in America and the birthplace of Horace Mann, who is considered the father of public education.

Franklin is the complete package offering what businesses and families want. If you are looking for a great location to start, expand, or relocate your business, please contact Bryan W. Taberner, AICP, Director of Planning and Community Development at (508) 520-4907 or [email protected]

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