Opinion leaders are very important, but hands-on users are critical

If you are on good terms with your CEO’s secretary and the company’s building custodian, your career can flourish. Treat them disrespectfully, and your life will be miserable. The same applies in medicine. Going over heads of nurses, lab workers, and other hands-on health care staff can lead to a sharp grassroots rejection of even the best new medical products. Consulting and including them from the outset can pave the way to acceptance and success, according to Respironics product manager Paul Hodge, who will be presenting a case study in new product adoption to a forum of the Product Strategy Network on December 7.

Particularly in the world of health care, it is absolutely essential to get influential doctors, researchers, and other esteemed leaders of the medical community on board when introducing a new technology to market. Acceptance by these powerful individuals, and by the institutions they influence, is fundamental to the success of any new medication, diagnostic tool, or therapeutic device – especially when that product represents a break from the established protocol of care.

But high-level acceptance alone is not enough. Just ask product manager Paul Hodge of Respironics, who is guiding the introduction of BiliChek, the company’s novel device for optically measuring the concentration of Bilirubin in infants. Bilirubin – a waste product in the blood stream formed by the breakdown of hemoglobin and associated with the presence of jaundice – is common in newborns but, particularly at high levels, can lead to complications ranging from fever, seizures, and a high-pitched crying to mental retardation. So determining whether a baby is in danger is an important, although routine, procedure.

A jaundiced eye

Until now, the established medical standard of care for diagnosing infant jaundice has been to have a nurse pierce the baby’s skin, typically at the heel, and draw blood which is sent to a laboratory for analysis. It is a painful experience for the baby, and it is frequently painful for the baby’s parents to watch as well.

However the BiliChek works differently. It is non-invasive, using only light, and it generates instant readings of Bilirubin levels without drawing blood or involving laboratory serum tests. But establishing that procedure as a replacement standard of care means winning over more than just the luminaries of modern medicine; it also involves winning over the nurses, the phlebotomists, the laboratory technicians, and everyone else whose work, and sometimes whose income, would be affected by the change.

Top down, bottoms up

“When it’s time to try to get a purchase order, you need to make sure all the stakeholders are involved, informed, and educated about the product and its impact on their operations,” Hodge said. “If you only tried to involve physicians, it could slow the acceptance by actual users. In the case of BiliChek, the typical user is a neonatal staff nurse. If a physician unilaterally decides he wants to implement the device in the nursery, it could be an uphill battle to get the actual day-to-day users to buy into the new system if they hadn’t been consulted before the decision.”

Accordingly, when a hospital is evaluating the BiliChek system, its personnel get in-service training on the product from Respironics staff members. Even after they have purchased the device, the company provides hospital personnel with staff development, training, clinical education in jaundice, and instruction in the use of the meter. Ongoing product, technical, and sales support are also provided on a continuous basis, he said.

“Although our sales reps may already know that a neonatal nurse manager has buying authority, it still behooves them to involve laboratory personnel, biomedical engineering, and the hospital administration,” Hodge said. “You want to ensure that each individual or department that could be affected by the new technology is informed as early in the process as possible. The sooner that is accomplished, the better the likelihood of a smooth product evaluation and faster acceptance.

Lab rats

“I’ve experienced how challenging it can be when laboratory personnel aren’t integrated into the process early on,” he said. “The best thing you can do is include them from the outset, get them on board, make sure they understand your product, and make them feel a part of the evaluation process. That can streamline the process and lead to greater success.”

“If the folks from the laboratory are overlooked in the beginning, the potential for acrimony goes way up,” Hodge said. “It’s easy to understand how the lab would be unnerved by a new method of blood analysis replacing a tried and true standard of practice they controlled – especially if they weren’t appropriately consulted.”

“Our reps understand that regardless of who is leading the initiative to bring Bilichek into the hospital, the laboratory will likely be involved in validating its performance,” he pointed out. “What typically happens is a side-by-side linearity comparison of the BiliChek with some serum samples, and the lab reports how the BiliChek performed. If those comparison studies aren’t well-controlled, and the interfering variables aren’t well-understood, you can get reports back that BiliChek results are not comparing favorably. When that happens, the evaluation process drags out and we have to investigate and in many cases restart the evaluation process.”

Advisory boards

To help the company secure buy-in from nurses, lab workers, and the other health care technicians who actually use the product, Respironics has established a multi-tiered advisory system. “The user is going to have huge influence. They may not be the ultimate decision makers in the process, but you definitely have to incorporate their thoughts about the device’s utility because they’re going to be its primary users,” he said.

“In our case, in developing an advisory board, we understood the importance of including different layers of stakeholders. First there are the physicians, researchers and clinicians who have a special interest in neonatal jaundice management – typically neonatologists and pediatricians who are doing the research and who really understand the disease state. But I also have advisory boards of neonatal nurses who are really the key – probably the Number One day-to-day users of the device and care givers,” Hodge explained.

“I’m also in the process of developing an advisory board of laboratory professionals – the phlebotomists, directors of pathology, and point-of-care technology coordinators,” he said. “They are key stakeholders and it is critical for us to understand their perspective and for them to have a complete understanding of the BiliChek system and how it’s going to impact their day-to-day operations.”

Peter Longini is a Managing Editor for the Pittsburgh Product Strategy Network. He can be reached at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it