Much more is required of packaging for pharmaceuticals and medical devices these days. In 2016, healthcare packaging professionals managed several emerging regulatory requirements and market demands. We count down to the top trends impacting packaging decisions, as evident in seven of 2016's most popular articles on pharmaceutical and medical device packaging issues.
The in vitro diagnostics industry is expected to undergo a transformation. Learn more about the potential disruptors and what IVD companies can do to keep pace.
The results of a recent survey offer insight into the biggest problems digital health companies face.
In 2015, Portland, OR-based medical device startup Otoharmonics launched a new tinnitus therapy device. The product incorporates a custom earphone and proprietary sound algorithms that are run on an iPad app. Unlike most other digital health devices, it is a Class II therapeutic device.
“As far as we know, this was the first Class II device incorporating an iPad to make it through the FDA 510(k) process and to receive the CSA certification for a medical device for electrical safety,” Otoharmonics CEO Michael Baker said. “In addition to the therapy, this device incorporates a number of more traditional digital health features, such as patient and clinician dashboards. As a regulated medical device, it is quite interesting from a regulatory point of view, and I predict we’re going to see more and more personalized medical treatment applications in the future.”
Otoharmonics is just one of an increasing number of companies incorporating digital health concepts into medical devices. To get a deeper understanding of what these companies are actually wrestling with, Starfish Medical recently completed a digital health device industry survey with help from MD+DI, Biocom, LifeSciences Washington, Medical Alley, Interface Health, MEDEC, and LifeSciences BC. More than 140 companies—ranging in size from startups to 10,000-plus-employee multinationals—responded from across the industry. The median company size was just over 20 people.
Sure enough, regulatory issues were identified by survey respondents as one of the most cited difficulties their digital health companies face. But a number of other challenges and risks came to light in the survey, too.
We first asked respondents to group the issues they raised using free-form comments, so as to avoid leading their answers. The top 10 challenges they cited are as follows:
■ Data security.
■ Figuring out a business model.
■ Data analytics.
■ Electronic medical record (EMR) integration.
The issues raised in respondents’ text answers shed light on the nuances of these challenges. For example, adoption was named as the second most common challenge digital health companies face. Particular problems cited included “clinical workflow inertia” and “patient compliance.”
One respondent observed that “changing protocols to maximize the benefits of connected health” is a major challenge. In other words, the benefits of digital health can clearly be seen, but compliance is a challenge. Getting clinicians to change their workflow to accommodate digital health tools and getting patients to actually use digital health systems remains elusive. The same respondent noted the importance of having powerful internal champions within the clinical environment.
Figuring out how to get paid adequately for a digital health solution is a common frustration and one of the core elements with which the industry is struggling.
Several companies noted that deciding what to do with all the data generated by digital health devices can be difficult. Geof Auchinleck, CEO of remote health company Claris, mentioned in an interview that in his experience, clinicians want nothing to do with a large volume of data that they don’t understand and can’t trust the quality of, and they certainly don’t want that data in a patient record for which they will be responsible. To him, the social challenge presented by digital health is much larger than the technological one.
Determining a business model is also a new hurdle digital health pioneers must overcome. Respondents said they have struggled with “new product conception,” “user group consensus,” and “how to monetize” digital health products. Figuring out how to get paid adequately for a digital health solution is a common frustration and one of the core elements with which the whole digital health industry is struggling.
Entrepreneurial companies often do not have enough money or time to demonstrate the efficacy required to attract more capital, so it’s not a surprise that financial concerns are high on the list of digital health companies’ biggest challenges.
Digital Health Product Risks
When asked to prioritize a list of 10 potential challenges impacting their digital health programs, the surveyed companies produced the following ranking:
■ 1) Breach risk.
■ 2) Privacy.
■ 3) Regulatory.
■ 4) EMR issues.
■ 5) Partners.
■ 6) Service.
■ 7) Software/IT.
■ 8) Device capability.
■ 9) Reimbursement.
■ 10) Consent.
We compared companies in development and companies with existing products, and both showed very similar results. The single biggest risk they were concerned about was data security and the risk of hacking, followed by privacy. In the age of WikiLeaks and the Panama Papers, those are sensible concerns. We anticipate that some larger infrastructure providers will appear in time to offer digital health data management and security within standard and cost effective models.
EMR integration issues were cited as well. Some of the related comments bemoaned the diversity and complexity of integrating with many interfaces and then having to maintain them. We are familiar with challenges with the breadth of the Health Level 7 protocol.
Partner issues round out the top five most cited risks associated with developing digital health products. Most companies are not handling the full range of activities from web hosting to patient interaction to data storage themselves. Instead, they are relying on strategic partners and allowing themselves to focus on their core capabilities.
Reimbursement was also among the top 10 risks presented by digital health products. In many cases, there is no reimbursement available, so different financial models must be found for digital health products to truly succeed.
Digital health devices and services have the potential to solve many of today’s healthcare problems, engaging and benefitting patients, caregivers, and payers alike. As such, the challenges this exciting field faces are worth understanding for all medical device professionals.
Wearable health technologies are in heavy demand but these three considerations must be incorporated when developing connected medical devices.
U.S. hospital systems, as those in China, are going through a challenging period and, just as species must adapt to environmental changes, hospitals are evolving to survive. Already tight margins are getting tighter as reimbursement levels fall and patient mix shifts
Medtech companies are chafing under unprecedented pricing pressures from hospitals. A recent survey report from L.E.K. Consulting that annually polls hospital CEOs should serve as a wake-up call to the medtech industry to look for innovative ways to partner with hospitals instead of having purely a transactional relationship.
Here’s why the glory days aren’t coming back.
Hospital reimbursement levels are falling and the mix of patients is shifting to Medicare and Medicaid, according to the report. As a result, hospitals are taking four steps to improve profitability without sacrificing patient care and quality - they are consolidating; integrating with alternate care facilities and buying up primary care practices; assuming more risk through accountability; and centralizing and coordinating their supply chains.
Most apparent from these steps are the immediate threats to the traditional medtech modus operandi. The threats are:
- Nearly 90% of survey respondents that comprised 150 hospital CEOs and other senior decision makers report that reducing costs is among their top five most pressing needs.
- A director of materials management at one Massachusetts hospital said: “The purchasing process has become much more complicated and restrictive. All supplies and new technology that are proposed for use have to go through a value/cost analysis committee. The days of the clinician getting to use a product because of sheer preference are behind us.”
- To cut costs, hospital administrators plan to increase rationalization of suppliers going forward, particularly in invasive and large medical devices.
Yet, for those medtech companies looking to reinvent their business models to take advantage of the shift in healthcare, there is fertile ground ready to be plowed.
- Despite cost constraints, about 60% of hospital C-suite executives would be interested in buying additional services from medtech companies, particularly in clinical IT and analytics, operations management and efficiency, and education, training, and compliance.
- They want to see medtech firms prove that their solutions can improve the quality of patient care, lower hospitals’ overall costs, or increase the efficiency of their clinical staffs.
- A CEO of one California hospital said, “If a MedTech can come in and show cost-benefit, that is highly, highly important for us. We want to see that the product is beneficial to patients and helps reduce utilization.
Given the move to the accountable care organizations, any medtech firm that can demonstrate that its products and services leads to improved clinical outcomes and reduces hospitalization rates would be highly coveted, the report implies. Here is what a director of materials management of a New Hampshire hospital told L.E.K. Consulting in its annual survey”
What I would like to see, but is not yet in place is a guarantee, particularly if a MedTech can claim we will use less of a product or reduce length of stay. If a company tells me there is more savings, if they work with us, that is going to capture some attention.
But therein lies the rub. So far, medtech companies haven’t had to prove that their products indeed improve patient’s lives beyond the broad efficacy box they have to check when getting products cleared through the FDA.
The real opportunity however is linked to this very practice of attaching price of a product to clinical or some other agreed-upon value.
How to get there? The report has a not-so-easy answer.
“..., before MedTechs can offer performance guarantees or outcome-based pricing, most will first need to up their game in understanding the incremental economic value that their products and solutions deliver in the first place.”
They may have saved the U.S. government tens of millions of dollars. But medical device company whistleblowers still have to treat the rewards they receive from the government as ordinary income that is taxable, a U.S. Tax Court judgeruled this week.
Judge Diane Kroupa ruled Monday that former Kyphon Inc. reimbursement manager Craig Patrick needs to pay the federal government an extra $811,597 in income taxes for 2008 and 2009 because he should have treated his $6.8 million “qui tam” reward from the government as regular income, versus capital gains.
In 2008 and 2009, the capital gains tax rate was 15%, while the top income tax bracket was 35%.
At the Mobile World Congress 2014, Sensirion AG is presenting its latest humidity and temperature sensorSHTW1, which opens up new possibilities in the wearable and mobile market with its chip-scale packaging technology. This global innovation combines minimal size with maximum performance to define the latest generation of humidity and temperature sensors, enabling unprecedented opportunities.Sensirion creates space for new ideas – there is no limit to the range of possible uses of the tiny SHTW1.
The long journey that recently culminated in the development of a silicon-based microfluidic probe posed considerable challenges for researchers at IBM Research - Zürich. “There were many technical challenges,” says IBM scientist Govind Kaigala, who was part of the team that developed the device, which is designed to assist in disease detection and drug discovery via tissue staining technology. “How do you know how far the probe is from the tissue section?