Connectivity and Internet of Things Will Transform Availability of Healthcare
by Sean Fenske
Participating in this week’s Friday 5 is Dave Jacobs. He is director of medical devices at Boston Engineering. The Friday 5 is an ongoing feature that poses five questions to a member of the medical device development industry.
Jacobs has had the opportunity to experience the full gamut of companies that make up the medical device community. He’s been responsible for product development, engineering, and operations at Fortune 100 companies through to medical device startups. He also served as the director of operations at ACT Medical, which was acquired by Accellent.
Leading the medical devices practice with Boston Engineering, a product design and development firm, Jacobs gets his hands dirty in an array of device sectors. Projects range from orthopedic tools to drug delivery systems to surgical devices.
“I guess you can say that we do the hard stuff,” says Jacobs of his team at Boston Engineering. “We specialize in highly technical projects that require a multi-discipline team and a systems engineering perspective.”
Jacobs is able to leverage his OEM experience in his role, which is now to support those companies and their projects. “Having worked in both start-up and global companies, I understand what it’s like to be in their shoes.”
1. What are some significant changes you’ve seen in the medical device development industry since your start in this market?
Jacobs: Our industry is continually reshaped by innovation, M&A activity, and regulatory changes. Recent trends include the very real need to reduce healthcare delivery costs and the move toward outcome-based reimbursement.
The most significant change in my mind is “smart” connected devices that have the ability to transform patient care worldwide. It’s important to note that the FDA is not imposing any additional scrutiny when reviewing these new interconnected devices. A year and a half ago, many people (myself included) felt that the FDA would be an obstacle to implementing wireless technologies. But in fact, the agency’s done a great job and should be congratulated for staying in front of this area and granting new clearances for these devices virtually every week.
2. What’s the most exciting aspect of the medical device industry?
Jacobs: Nearly half of the world’s seven billion people have no access to medical care. We can't build enough clinics or train enough physicians to solve that problem. So, the only way to deliver healthcare to many corners of the globe and to underserved areas in our own country is with remote diagnostics and therapies.
Connectivity, which is often referred to as the “Internet of Things” and associated wireless capabilities, are providing a new framework for improving virtually every aspect of healthcare. This includes shifting from reactive to preventative healthcare, improving care through enhanced monitoring and coordination of services, increasing patient independence, and controlling costs.
At the opposite end of the spectrum, I’m always a fan of simple, effective devices. I’ve recently worked with entrepreneurs who are addressing systemic issues with new low-tech devices. Some examples include a device that helps address the increasing number of antibiotic resistant bacteria such as MRSA; a new very simple device that allows physicians to perform hysteroscopy more cost effectively; a device that allows an old, very effective but unsafe procedure to be administered safely; and the re-purposing of pharmaceuticals, which, although a little out of my wheelhouse, is really interesting.
I see ideas for new medical devices every week, and I’m partial to the ones that are simple to use. That said, it often takes some very complex engineering to create those elegantly simple devices.
3. What keeps you up at night?
Jacobs: Many good ideas aren’t being funded. Venture capital funding in medical devices is at its lowest point since 2005. Venture capital investment in very early-stage companies is virtually non-existent. This is requiring entrepreneurs to bootstrap their companies and get funding through alternative methods such as angel investors, or grants through the likes of MassChallenge or theMIT $100K. While angel investor groups are doing larger investments, the funding, albeit small from business plan competitions, can sometimes carry these early stage ventures to a point, such as demonstrating feasibility, which allows them to attract additional investors.
I often hear that venture capital firms are not investing in medical device companies due to the increased risk and uncertainty surrounding FDA clearances. I believe that this concern is overblown and certainly doesn’t warrant the degree of pull-back in funding we’re seeing.
Typically, within 30 days of the FDA accepting a 510(k) submission for substantial review, they send a list of questions to the company. Those questions may or may not require additional testing, and in some cases, require a design or process change. However, the agency’s questions and requirements are specific and can usually be accomplished in a relatively short amount of time. An experienced team understands what's involved with the 510(k) process, has probably already anticipated many of the questions, will respond to the agency’s questions quickly to minimize any potential delay in the process, and will have anticipated and planned for this almost inevitable "extra" work.
4. What factor is having the most significant impact on the medical device sector?
Jacobs: The medical device tax is ultimately a tax on consumers and is hindering our competitiveness internationally. The U.S. exports $44 billion of medical devices annually. Over the past year, medical device exports grew less than 2% compared to more than 5% annually from 2008 to 2013. At the same time, device imports to the U.S. are increasing by almost 5% annually. That said, I am optimistic that with the help of our legislative bodies, this downward trend can be reversed and the U.S. can continue to be the world leader in medical devices.
5. Where are we headed?
Jacobs: Wearable devices will proliferate during the next few years. One example is a wearable heart monitor by start-up Infobionic that sends, stores, and analyzes patient data in the cloud. When a cardiac event is detected, the physician is notified. The physician can review the ECG and then diagnose and treat the patient quickly.
I envision house calls becoming viable again with primary care physicians. Only now, a hologram of the physician will perform my annual physical in my home or office, and will check my vitals using data transmitted from my wearable or implanted monitoring devices.
The use of remote robotic surgery will grow, electronic implantable devices will be recharged transdermally, implantable electronic chips will restore sight, and nerve stimulation devices will enable people with spinal cord injuries to walk again. Tissue engineering will allow us to print organs, which will alleviate the need for powerful antirejection drugs, and we’ll be debating the ethics and moral dilemmas associated with brain transplants.
Interested in taking part in an upcoming Friday 5? Reach out to me firstname.lastname@example.org.
To read this article on Medical Design Technology, please click here.