BioPro Spotlight: SAM Medical Enters Worldwide Market with FDA Class II Product
By Seamus Kennedy

Looking to enter the fully regulated FDA Class II medical device market, SAM Medical Products developed a strategy that included investing in BioPro training. The company was pleased to discover that the classes addressed an array of specific concerns they would encounter in the process. As a result, SAM Medical had the savvy to anticipate and satisfy stringent federal requirements.

SAM Medical manufactures medical devices for emergency, military and hospital care. Dr. Sam Scheinberg – the “Sam” of SAM Medical – is an orthopedic surgeon and CEO of the company. His vision of quality emergency products stems from his field experience as a Vietnam War surgeon. Last year, the company celebrated 25 years of providing innovative medical products, such as splints, hemostatic agents and dressings.

Each year since 2007, SAM Medical has placed well in annual rankings of the Inc. 5000 Fastest Growing Private Companies in America. Much of the company’s acceleration is now coming from new markets in Europe and Asia, and core to this was its executed plan to develop and manufacture FDA Class II medical devices, followed by approval from the European Commissions. Its international sales represent 30 percent of company-wide sales.

Developing Class II medical device products requires a plan

FDA Class II standards are a major leap upward from Class I, and require full understanding of FDA post-market surveillance and review. Because Class II devices involve significantly greater human risks, the FDA’s approval takes on the full operations of the company and approval is renewed every two years.

Every wording in advertisements, product labeling, manuals and company e-mails are reviewed. Thus any communication can become a concern. The continuous FDA review can lead to additional investigations. The cause can be poorly worded texts, such as not carefully separating aesthetic concerns of product appearance from product performance.

Preparation starts with BioPro Training

Pivotal to SAM Medical’s progress to produce FDA Class II medical devices has been Oregon Bio training. Jack McCutcheon, SAM Medical’s quality assurance and regulatory affairs manager, is enthusiastic: “BioPro Training has been a boon, with solid support for company progress; the payback is very high.”

As Jack notes, the training classes are organized to address the scope of FDA concerns. SAM Medical anchored its plan by taking BioPro classes in Quality Enhancement, Documentation Systems, Lean Manufacturing, Junior Engineering and Advertising.

Beginning with Managing an Effective Quality System, Planning & Time Management, and Facility Management, the foundation for the company’s plan was established. This was followed by Technical Writing Techniques, as well as Document Control, Practices & SOPs, plus Team Building, Diversity, Innovation & Change. In total, SAM Medical employees took 17 different classes, and the scope of a regulatory world was realized.

Harmonizing standards for the world

One of the benefits of this developed strategy for FDA and European Common standards is a harmonized standard that allows SAM Medical to enter other markets, most notably those in Asia and Australia, and garner approval.

SAM Medical has achieved solid recognition as an innovator of emergency medical technology. Its SAM splint was even featured in the exhibit “SAFE: Design Takes on Risk” at the Museum of Modern Art in New York City. As an Oregon company, it is poised to continue its progress in the world market.

Cross-pollination with Oregon Bio members produces profitable results

SAM Medical also champions partnering with Oregon Bio member companies for cross-pollination. That includes learning new ideas from visiting other companies, and for supportive teams such as the Internal Auditor Exchange Program (IAEP) (see BiO article). Jack affirms that such teams facilitate SAM Medical’s efforts to increase its market and fulfill on regulatory requirements.

And Oregon Bio will continue to support the company’s growth. As Dan Hill, director of member services and BioPro Workforce Training director, notes, “Oregon Bio member companies merit great teamwork. And the move upward, with markets and products, starts and continues with BioPro Training.”

Seamus Kennedy is a business communicator, who deals with effective packaging of verbal, nonverbal, written and visual communication. What we say and how we say it can add strength to even our clearest message, and Seamus helps individuals and organizations to bolster their ability to get their message across. His public speaking and presentation classes, for example, have garnered the attention of local press. skennedy@imagina.com