Xtract Solutions Extracts Immediate Benefits from BioPro Training
By Seamus Kennedy

Hand-making Allergy Medication Belabors Doctors and Staff

Portland doctor James W. Baker observed that unlike many medications made at hospital labs, allergen extracts are prepared in the doctor’s office. Amid day-to-day office operations, medical staff hand-make each injection medication from an array of bottles over lab tables.

Allergy immunotherapy preparation is slow and labor-intensive, and has a potential concern for accuracy. Moreover, mixing methods have not changed in decades, despite a huge increase in allergy patients. In fact, according to the National Institute of Health, allergies are skyrocketing, with more than 54% of all Americans now being allergy sensitive. Dr. Baker saw an immediate need for medical devices to assist. Thus, Xtract Solutions was born.

Syringe Keys and the Allergen Mixing Assistant to the rescue

Dr. Baker’s son, also James Baker, is Xtract’s president. He, along with Greg Fry, director of marketing, are ready to help allergists reduce cost and waste, which will allow more time to focus on patient care.

The company’s first set of products, the Syringe Keys, offer quick, consistently accurate syringe measurements. Its second product, the Allergen Mixing Assistant, is a more ambitious device which both maintains laboratory conditions and adds quick organization to the mixing process. The Assistant will be launched this month.

Training for a future market

While blazing a new product trail, James and Greg recognized that further support would be needed, particularly in a market that may prove to be resistant to change. They invested in BioPro for additional expertise in developing their company. The classes, to their delight, were taught by industry experts and addressed the immediate issues they are facing.

Immediate benefits of BioPro training

By sheer coincidence, James’s first BioPro class: “Preparing for Regulatory Inspections,” which covers regulatory audits and inspections, came to help faster than expected. While working on a project outside of Xtract Solutions, James experienced an FDA audit only one week later. He felt that his BioPro training made the process more understandable, greatly reduced fear, and strengthened his communications with the auditor.

An Xtract Solutions colleague, Luke Barratt, also gained from two other classes: “Design Controls” and “Engineers’ Bootcamp.” The first class teaches how to effectively integrate regulatory standards into the engineering of medical devices. Bootcamp is a thorough two-day investigation into building consensus, to matrixed management, to completion of a successful project.

Both James and Greg enrolled in “Labeling, Advertising & Promotion” to find out how product and service promotions are affected by the auditing process. They learned about the close relationship between regulations and all product promotions and literature, which includes user manuals. James sees that this training was “valuable to have prior to our product launch.”

They both went on to take “Complaints, MDR and Adverse Event Reporting.” In this class, they learned how to identify customer complaints, and what the required steps are to reporting them. Greg remarked that this class “distilled legal language into questions you should be asking each other in your company.”

The New Approach

Xtract Solutions is now confidently prepared to enter its market and its leaders rely on BioPro for training. James also recommends BioPro to gain knowledge and skills required for today’s regulatory environment. He looks forward to taking further training.

Dan Hill, BioPro Workforce Training Director, is pleased to offer an extensive new list of training classes. Dan notes that BioPro is ready to support the training needs of our industry.

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