By Lisette Miller, Mechanical Engineer
MassDevice held its second annual Big 100 Roundtable East event in Waltham, MA on July 10th. For being a relatively local affair, there was an impressive turnout of attendees ranging from engineers to marketing folk, regulatory specialists to c-suite execs. My colleague and I were looking forward to hearing discussion of burgeoning trends in the industry and the people behind them. Two major themes mentioned throughout the night resonated strongly with me, and I later shared these insights with my team at Ximedica.
When something seems medically wrong, consumers use WebMD or general search engines to find the apparent ailment or solution. This can be a good thing – information is power – but at the same time, the lay person’s lack of medical expertise might lead them to make the wrong assumptions. Either way, consumers come into their physicians’ offices asking for products and services by name. This comes as a result of seeing advertisements on television or, more likely, on the internet in relation to the ailments they are researching. Product-specific requests require health care professionals to not only keep up with current trends, but also know enough about the brand to be able to advise patients on the best course of action.
- The first applies to every industry, but especially to medical devices and health care providers – that is, the way in which technology has empowered the consumer. Instead of depending solely on health care professionals, consumers and patients are now looking to the internet for their information. Technology can better-educate the patient on his or her own time, in the comfort of their home or on a mobile device, by giving them access to valuable medical information. BUT the consequences of this “empowerment” may not be entirely positive if the patient decides to self-treat without consulting his or her doctor first. From a marketing standpoint, the consumer’s exposure to and curiosity about medical information may present a goldmine of opportunity. For a medical device design and development company like Ximedica, it’s a reminder of the evolving dynamic that will indirectly effect the use and success of the products we generate. From a marketing standpoint, the consumer’s exposure to and curiosity about medical information may present a goldmine of opportunity. For a medical device design and development company like Ximedica, it’s a reminder of the evolving dynamic that will indirectly effect the use and success of the products we generate. At its most basic level, the PPSA provides an opportunity for the life sciences industry to evaluate and reassess its spending allocations for relationships with health care providers.
- Another major topic covered at the Big 100 was the explanation of the Physician Payment Sunshine Act (PPSA), which was introduced as part of the 2010 Patient Protection and Affordable Care Act. This requires drug and device manufacturers to publicly report any payments or other transfers of value they make to physicians or teaching hospitals – creating transparency in their financial relationships (Ober.com). What kind of spending are we talking about here? Reported items include (according to DuvalFDALaw.com): Although individual states may have unique reporting requirements in addition to the PPSA, the general consensus is that compliance will require the development of accurate, somewhat standardized record-keeping procedures to be used by life sciences companies and health care professionals alike. Because the financial information will be released to the public, records need to be flawless. The transparency of this information will no doubt empower clients and consumers (not unlike the notion behind the first takeaway) and the consequences of the PPSA will resonate with everyone touching the industry. Public disclosure of information has become the new reality for everyone, but for the medical device and manufacturing industry, it can make or break reputations. Consumers and clients will become more aware than ever of formerly private information. Although the intent of this regulation is to have a positive and honest impact, its effects on the industry are far-reaching and may increase the cost of business. It is no longer merely ‘good business practice’ to comply with federal transparency regulations - it’s an investment in the future.
- Gifts, entertainment, travel expenses
- Consulting fees
- Research funding or grants
- Direct compensation provided to faculty members of educational seminars
- Collaborative research
- Ownership or investment interest held by physician in company
- Licensing fees
- Additions the Secretary of Health & Human Services (“the Secretary”) deems appropriate