Two Medtronic presentations at Healthpack 2010 on innovative package redesigns prompted PMP News editor Daphne Allen to ask, “What role does innovation play in today’s medical device packaging?”
For this year’s medical packaging roundtable, PMP News asked Editorial Advisory Board Members Nick Fotis and Jordan Montgomery to explain the inspiration behind innovation and whether today’s corporate culture encourages innovation. Fotis is manager, packaging engineering, for Cardinal Health’s Packaging Technology Center, and Montgomery is technical fellow for Medtronic’s CRDM Packaging Engineering Department. (Questions in bold are posed by Allen.)
Q: What role is innovation playing today in medical device packaging design and development?
Montgomery: For the ICM product, there was an opportunity to improve the part of the procedure known as implant mapping. Systems engineers involved in developing the next-generation device had a “what-if” moment: What if we could use the device itself to analyze the patient for preimplant mapping. We could put a circuit on the package and attach the package to the patient and take the reading using the packaged device. The device communicates to an external instrument through telemetry. We designed a package to do just that.
The number-one message I’d like to communicate is not how the device or the package works but rather the process in which packaging engineers worked with engineers throughout the company during device development toward an innovation solution.
Fotis: That’s not just thinking outside the box but also between the seals!
Montgomery: That was just one opportunity we had to bring innovation to packaging. It was really a partnership. There’s potential for innovation during new device development. The packaging engineer just needs to be in the loop.
Fotis: There would be more innovation in the industry if packaging engineers were interacting more with physicians or in the operating room. One example years ago from Baxter was an engineer that printed a scale/ruler on a clear plastic/Tyvek pouch. The printing itself of a ruler wasn’t so innovative but the way the packaging engineer understood how the physician uses the device led to a more innovative, useful package.
Q: So witnessing how healthcare is practiced is a good inspiration for innovation.
How hard is it to do?
Fotis: In our industry it is getting more difficult: patient privacy laws, hospitals not wanting to take risk, or difficulty compensating hospitals. Often packaging engineers end up relying on third-party groups, but there is no substitution for being in an OR. You have to spend a lot of time in ORs to uncover problems, because those problems offer the chance to innovate.
Montgomery: It is not uncommon at Medtronic for product development engineers to have a great deal of clinical experience or associate with those who do. We have a large field force, clinical specialists, technical field engineers. So packaging engineers at Medtronic have opportunities to work with those colleagues. These opportunities are available, but they are not handed out. It is something you really need to make happen. You must have the drive to learn as much as you can.
Fotis: Do physicians want to talk about packaging?
Montgomery: My experience is 50/50. Some only clearly want to talk about devices. I learn more about packaging from scrub techs and nurses and internal personnel that support implants.
Fotis: OR nurses, directors, and materials managers are more open to talk about packaging. But I still think we could get feedback from physicians for quantum leap innovation. We could then find out how the package could help in device placement. One example is an implant packaged in a poly bag; that bag was useful to the physician putting on bone cement.
Q: Do corporations support innovation?
Montgomery: Medtronic has a large focus on innovation, so it is very much part of our daily culture.
Fotis: At Cardinal the green initiatives we have going are encouraging innovation and encouraging us to get out to the field. Nurses are asking for better, green products, but we don’t always know what their recycling streams are, so we need to find out whether they would be willing to tear apart a Tyvek pouch to recycle Tyvek in one waste stream and the laminate in another stream. Or do they even recycle at all? These initiatives are driving us closer to the customer and forcing innovation.
Montgomery: Problems aren’t the only time for innovation. If we hear about a problem immediately we have to solve it. But what about products that have no reported problems but are just not optimal? If you don’t go out into the field (hospital, warehouse, or distribution center) and witness the use environment, you’d never know it wasn’t the best product. You may be able to do a better job of defining your requirements.
Q: Does the work involved in qualifying a new package material, developing a new package, and testing the new design scare companies away from innovation?
Montgomery: In a lot of cases there are risk versus value propositions that are made regarding packaging in particular, so that may make it a challenge to innovate. Sometimes there are clear opportunities. Thinking in another realm, there are a lot of areas where we need to be innovative to be competitive, such as materials and cost. A lot of companies for economic reasons are consolidating or withdrawing material offerings that medical device manufacturers use. We get a lot of buyer notification letters these days. We therefore need to do our due diligence to ensure the change won’t affect device safety or efficacy. We need to be innovative in how we approach material changes in order to do it in a timely and cost-effective manner.
As far as costs go, industrywide, companies are trying to take cost out of packaging while maintaining a high level of quality. This is the same for green initiatives.
Fotis: One barrier to innovation is just identifying the right questions that need to be addressed. For instance, when management asks you to reduce packaging materials by 25% or to use sustainable packaging materials, you get innovative.
Q: This sounds like the Medtronic Stylet package redesign.
Montgomery: That project sought cost reduction and also efficiency gains and green initiatives through material reduction. Innovation is just this simple. The project’s success shows that you don’t have to do something overly complicated to be innovative.
Q: Do standards support innovation?
Montgomery: Yes. Standards are our basic roadmap for ensuring the due diligence we use to prove safety and efficacy. Alignment with the standards gives us a common understanding to discuss the testing of packaging changes or innovations with regulators like FDA and others.
Fotis: Jackie Daly Johnson [of Beacon Converters] is leading an ISO task group to take TIR 22 guidance to an ISO level. The interesting part has been developing a section for healthcare providers that package and sterilize sterile medical devices. It has provided an opportunity for discussions between packaging professionals and clinicians. There is an opportunity for innovation just by listening to what clinicians say about packaging processes.
We do a lot of testing to get it to hospital docks, but packages really must hold up throughout the products’ shelf lives. We are experts at mitigating shock and vibration, but what happens when packages are crammed into plastic bins or nurses pockets?
In fact, what is the most rigorous challenge, the pressure differential experienced when traveling over mountains or by air, or that from slamming a stock closet door or a drawer?
Q: Are there practical reasons to resist innovation?
Fotis: Innovation for innovation’s sake should be resisted.
Montgomery: It comes down to value. What is driving the need for the innovation? If it doesn’t seem like a legitimate need, you need to investigate whether it is worth it.
Fotis: Material suppliers should innovate for market needs that are truly there, not just perceived.
Q: What do you need from converters to support innovation?
Fotis: It is very rare that raw materials companies call on us. There are R&D efforts going into improving plastic materials, but the industry has pushed back on converters so much that many have reduced their R&D departments and often struggle to bring us innovation.
Having a four-way discussion among raw material providers, converters, machinery providers, and medical device packagers would certainly help, and if you added a nurse practitioner to the room, we could all talk about changing processes as well as reducing costs—we could really come up with innovations.
Montgomery: It is important for packaging engineers to know what the capabilities are of raw material suppliers and what they are working on. Knowledge is the best way to determine whether the opportunity to innovate exists.
Fotis: One area of opportunity for innovation that hasn’t developed as quickly as I thought it would is new sterilization technologies. High-intensity light and sound as well as different chemical sterilants would spur tremendous innovation in packaging. The speed of innovation in other industries will affect us.
Montgomery: Regarding green initiatives, it is a necessity and our company is working on green projects, and raw material suppliers need to be thinking the same way.
Fotis: At Cardinal we are committed to true verifiable green initiatives. There are a lot of ideas that seem good on the surface but it is important to separate perception from fact. So it is important to spend the money and do the life cycle analysis. If you switch from disposable to reusable packaging for instance, you want to be sure you don’t waste more energy transporting the package or use a lot of detergents to wash it. It takes a lot of work to do it right.
There is also a tendency to jump on something novel, but you have to be sure it is really the right thing for sustainability in order to spend the money needed in R&D to develop a new material. You might just find a better way with existing materials.
It is strange that the popularity of sustainability seems to be cyclical, though. Companies like Cardinal and Medtronic are continually looking to ensure we are not wasting packaging materials and downgauging over time as well as minimizing the use of package materials. When the media focuses on it, oftentimes we have already done our jobs. A history of being environmentally responsible is as important as an individual instance.
Companies in a hurry to decrease packaging waste may run the risk of increasing total system waste because— through minimizing packaging and risking product damage—they may go past that optimal point and experience failures in the field from damaged shipments.
Q: Is innovation rewarded in the industry? Corporately?
Fotis: Innovation is rewarded in industry and corporately. The AmeriStar and WorldStar awards recognize innovation. Cardinal won the WorldStar with its hybrid package with a Tyvek vent made by a thermoform-fill-seal machine. It was recognized that just as much effort went into improving and innovating that package as goes into device development.
Montgomery: A lot of recognition happens through the AmeriStar and WorldStar awards. Submissions to these awards are judged by our peers, so people who are working on similar projects recognize packages that are different and innovative.