Using Mobile Software for Medical Device Sales

SUPPLY CHAIN

Medical device manufacturers have a variety of systems in place within the manufacturing process to ensure that the right products and quantities are shipped to the right locations.

But they also need to track a product after it has reached its destination, particularly if that product is transferred from location to location before it is finally used. And once the product is implanted or consumed, they need to have systems that can obtain usage confirmation and also manage stock replenishment.

To achieve these goals, manufacturers are increasingly adopting mobile software to manage these processes and close the supply-chain loop. Mobile applications that enhance regulatory compliance and improve efficiency are being applied to critical supply-chain and sales functions, including consigned inventory management, ordering, surgical case tracking, and product kit scheduling.

This article explores the regulatory and business challenges that medical device manufacturers face, how software and mobile devices have evolved to meet their needs, and how manufacturers are using these systems.

Handling Urgent Phone Calls

I was scheduled to meet recently with two vice presidents from an orthopedics company. They asked to delay the meeting for a half-hour while they worked with customer service to search for a specific medical device that a hospital needed for a surgery the next day. The hospital did not have the product in its inventory, and the surgeon involved threatened to give the business to a competitor if the product was not located and delivered in time for the surgery.

Have you or members of your team been involved in a situation like this? It isn't an isolated incident. In fact, it is surprisingly common in the medical device business. Many sales reps spend hours trying to find and deliver products after receiving that dreaded 5 p.m. phone call that something is not in stock for a key surgeon's case at 7 a.m. the next day—300 miles away. A sales rep's job is tough enough without having to search for products.

In the medical device world, inventory management comes down to two things: ensuring physicians have the products they need, and being able to locate specific products in the field to comply with FDA regulations. While these may seem like relatively simple tasks, they are in fact rather complex, considering how frequently some medical products are moved from one location to another.

Regulatory and Business Challenges

The ability to track products after they have left the warehouse is important to any manufacturer. But it is particularly crucial in the medical device industry because inadequate product visibility and traceability can place manufacturers at risk for noncompliance with FDA regulations and can potentially endanger lives. Furthermore, the value of medical devices presents the possibility that poor tracking could result in significant revenue losses from uninvoiced or lost product.

Under the FDA regulations 21 CFR 820, Quality System Regulation, and 21 CFR 821.25, Device Tracking System Requirements, manufacturers must establish adequate quality systems to ensure patient safety and, when required, to be able to find specific types of devices when serious problems arise.¹

For example, the agency may require tracking for certain Class II or Class III devices

Under the latest modification to its “Medical Device Tracking; Guidance for Industry and FDA Staff,” FDA is now required to specifically issue an order for manufacturers to track a device or group of devices.¹ To date, FDA has issued orders for a number of devices, including temporomandibular joint (TMJ) prostheses, implantable pacemakers, automatic implantable cardioverter defibrillators, implantable infusion pumps, and silicone-gel-filled breast implants. (A complete list is available at www.fda.gov/cdrh/comp/guidance/169.html.)

The guidance reiterated that when tracking is required, manufacturers must develop and employ methods that enable them to rapidly provide FDA with specific information, as follows:

Tracking methods must provide certain critical information about the location of a tracked device within a short time frame. Manufacturers will have three days to provide critical information about devices that have not yet been distributed to a patient and 10 working days for devices that have been distributed to patients.

Although most medical device manufacturers have extensive systems to track products during the manufacturing process, many companies still face significant challenges managing products once items leave the shipping dock. Medical device companies that manufacture high-cost, expiration-dated implants often have large amounts of inventory in the field, in the form of loaner product, trunk stock, and consignment items. This is especially true in the orthopedic, cardiovascular, ophthalmic, and aesthetic sectors where products are moved from place to place between sales representatives, within facilities, and between facilities. Such transfers can hamper a device manufacturer's ability to locate products in a critical situation or when they are needed to meet customer demand.

Beyond compliance and patient safety issues, lack of inventory management in the field presents a number of business challenges to manufacturers. A large part of a typical sales rep's day is taken up by administrative tasks. In fact, one study of sales personnel, conducted by a national marketing company, reported that approximately 27% of the average sales rep's day is “swallowed up” by company meetings, training, reporting and administrative work.³ Reps spend endless hours counting inventory, faxing or e-mailing orders, calling customer service to ensure the products were shipped, transferring products from facility to facility, and tracking down purchase orders. This doesn't allow as much time as sales management would like for sales reps to do what they do best—sell products.

Medical device manufacturers are increasingly implementing integrated mobile software and device applications to automate the inventory management process. By doing so, companies can better track products regardless of where they are located—in distributor inventory, hospital operating rooms, or even sales reps' cars. In turn, their reps can do their jobs more efficiently and reallocate time spent on administrative tasks to better manage physician relationships.

Of equal or greater importance, software on small, handheld devices also offers manufacturers the ability to accurately account for the value of their inventory. Typically, the value of field or consigned inventory is significant enough to be mentioned in financial statements. Lack of controls to adequately report on inventory can be an indicator to management or investors that there are potential business and financial compliance issues.

Placing and Tracking Orders

When it comes to placing and tracking orders, most device manufacturers still rely on phone- or paper-based systems that are inefficient to manage, prone to human error, and do not provide the required level of product visibility and traceability.

In a typical scenario, a sales rep meets with a physician to discuss product needs for an upcoming surgical case. The rep handwrites the order on a paper form, faxes the form to customer service, and then spends perhaps hours on the phone with customer service to ensure the order has been placed and shipped to the customer. A sales rep from a breast implant manufacturer recently explained that he spends an hour a day, every day, calling in orders to customer service. Obviously, he said he would rather spend that time face-to-face with physicians.

Meanwhile, a busy customer service representative must take the time to decipher the sales reps' handwritten notes, or spend time talking with them on the telephone, before inputting the product information into the manufacturer's order or enterprise resource planning (ERP) system. If the sales rep has written down the wrong information or the customer service rep cannot understand it, the two parties must call or e-mail one another to resolve the problems, which increases time and work for both parties.

Advanced Bionics Corp. dealt with these issues several years ago while the company was building its sales force. The customer service team received information from sales reps in a wide variety of paper formats. The biggest challenge was that the data sent by the reps did not always conform to the company's predefined processes. Sometimes data would be missing or incomplete. It took staff significant energy and time to resolve the issues and ensure the orders were accurate.⁴

Across the industry, more and more manufacturers are using mobile computers to enter and manage product orders electronically, thereby streamlining the process. For example, in the orthopedic industry, 7 of the 10 largest companies either are in the process of implementing a mobile order and inventory application or already have a system in place.⁵ Using a mobile device, a sales rep can meet with a physician, pull up the hospital account on the device screen, enter the order using an electronic form, and capture the hospital or clinician's authorizing signature. Then, the rep's phone or mobile device can automatically forward the order to the customer service department for review before it is transmitted to the ERP system.

At Advanced Bionics, the integration of mobile data to the ERP system eliminated the need for data to be entered twice—once by the rep and then later by customer service. Today, sales reps submit their orders electronically from the field and customer service simply reviews and approves the reps' orders. Because handheld phones can automatically transmit and receive information, sales reps can track product orders in real time, update customers on the status of an order, and confirm that the products have been shipped.

If a product can't arrive on time for a case, the rep will know in advance and can take steps to resolve the issue. Instead of placing frantic phone calls to neighboring hospitals and other reps to track down the product, the rep can use the handheld device to find facilities that have that specific product and quickly arrange to have that product transferred to the customer that needs it.

Smith and Nephew Orthopedics is another company implementing mobile tools for placing and tracking orders. In a case study, the company reported increased overall productivity in the field and in the customer service department. By streamlining and automating key business processes, the company improved its relationships with customers by responding to their needs in a thorough and timely manner.⁶

Automating Inventory Management

Most manufacturers rely on paper-based processes for inventory management. Typically a sales rep visits a facility's storage area, count products, and physically write down required information, including the size, serial number, lot number, and expiration date for each product. The situation is even more complex when independent distributors play a significant role in the supply chain. For example, in orthopedics, large quantities of expensive implants are stored at distribution locations and independent distributors schedule the delivery of these products. Because products move in and out of the distribution centers quickly and there are rarely adequate tracking systems in place, manufacturers are unable to maintain an accurate and up-to-date inventory.

A U.S. manufacturer of cardiovascular products recently documented its inventory management process and the time it takes for a rep to conduct an inventory audit at each hospital. On average, it takes a sales rep 10 to 15 minutes per hospital to fill out paper forms and manually record serial numbers for approximately 25 items at each location. Since the reps do not have fax machines in their offices, they need to drive to locations where they can fax information to customer service, adding another 15 minutes to the process. This manufacturer estimated the total amount of time spent for each hospital's audit to be at least 25 to 30 minutes.

In this example, once customer service receives a fax, the customer service rep must manually reenter the information into the manufacturer's ERP system. While there is always a risk of losing or miskeying information, the worst-case scenario occurs when the customer service rep finds that the salesperson missed some critical information during the inventory audit. If there is no other way to verify the information, the salesperson may have to drive back to the hospital or surgery center to reinspect the inventory—a chore that could take hours and hundreds of miles of drive time.

Mobile devices and software have revolutionized inventory management for those manufacturers that have adopted the technology. With the latest generation of products, sales reps can scan product bar codes or radio-frequency identification tags by using their handheld devices. A phone-based device like a Palm Treo can automatically transmit the information to the manufacturer's customer service team where it can be reviewed, approved, and transferred to the manufacturer's ERP system. If the sales rep is in a hospital basement or some other place without a phone signal, the most sophisticated mobile systems will store the information and transmit it once reception becomes available.

Managing Trunk, Loaner, and Consignment Inventory

Managing trunk, loaner, and consigned inventory is one of the greatest challenges for many manufacturers. These product types are often moved by sales reps using their own vehicles. This is particularly true when it comes to orthopedic, cardiovascular, and other products that are expensive, are included as parts of complex kits, or have defined expiration dates.

At many companies, it is common for sales reps to move products from facility to facility to meet the changing needs of their customers. There are two ways that manufacturers typically handle this process. One way is for the sales rep to call customer service and report which products are being moved. The customer service rep then notes the transfer of products in the ERP system and places an order to ensure the products are replenished at the original facility.

An interventional cardiology company uses a more formal, but still paper-based, transfer form process. Here, the sales rep fills out the form and then drives to a place where it can be faxed to customer service. A single transfer can take the salesperson more than 20 minutes to complete. Using a mobile phone like a Palm Treo or HP iPAQ, the transaction time would be reduced from 20 minutes to as little as a minute and a half. On a handheld, the sales rep can complete the transaction using pull-down menus and a scanner to record the required information about the product and the locations. When the electronic form is complete, everything is sent wirelessly to the database at the home office.

Trunk inventory that is controlled by sales reps poses challenges for reps and frequently for sales operations and regulatory affairs. In many cases, one sales rep will realize that a specific product is needed at a facility and spend minutes, if not hours, calling other sales reps to locate an available product. The sales reps will then meet someplace to make the transfer. To accurately keep track of inventory, the movement of the product has to be recorded, and in many companies sales reps do not complete this portion of the task. As a result, companies can be exposed to significant regulatory risk for lack of compliance with FDA requirements.

A mobile device can streamline this process and also ensure FDA compliance. Through a series of screens, the first sales rep can record the receipt of the product from the second sales rep, and the second sales rep can record the distribution of the product to the first sales rep. The steps of the transaction are automatically transmitted from the reps' handheld devices to the database at the home office, where the data can be sent to the ERP system.

In the above scenarios, the manufacturer has a seamless process in place to maintain product visibility and traceability in the field and comply with FDA regulations. If there is ever a need for a product recall, the company knows exactly where the products are located and can act accordingly.

Invoicing and Replenishment

A final step in the inventory management process is for the manufacturers to confirm when their products have been used, place orders to replenish supplies, and invoice customers for the new products. When asked how much time they typically spend calling customer service to place and check on orders and submit purchase orders, sales reps report anywhere from 30 minutes to two hours a day, depending on territory size and the nature of the business.

In many parts of the industry, the most common method of managing this process is for the sales rep to call customer service to place an order for the customer. Later, the salesperson will follow up with customer service to check the status of the order and report this information back to the customer. Often, the sales rep will not have a purchase order from the customer and will need to contact the customer's purchasing or materials management department to obtain the purchase order. And after all of that, the rep still needs to place one more call to customer service to finalize the order.

For sales reps at one company, the reporting of purchase orders was so onerous they typically waited until the end of the month to place orders. On the last day of the month, this company's customer service department would receive more than double the usual order volume from the sales force, considerably more than the staff could handle in one day. As a result, at month's close, there was simply not enough time for customer service to enter all the orders into the system. This broken process delayed product delivery and payment of rep's commission. More importantly, it slowed down the company's ability to send invoices and collect revenue.

This company now uses handheld software to manage orders from the sales reps. Invoicing and replenishment processes are managed continuously throughout the month, and the customer service team is no longer inundated with orders on the last day of the month.

Tips for Implementing Mobile Applications

If your company is contemplating the use of mobile software solutions to manage inventory, order, and sales processes, consider all of the tasks that sales reps must complete each day. Companies can improve the rate of adoption and maximize the value of investments by providing tools that enable reps to manage all of their tasks. Reps would prefer one device to manage everything from sending e-mail to scheduling surgeries and managing inventory. If they can use one device to do many tasks, they will be much more likely to use the device for purposes that benefit the company. With an improved electronic process, reps can work more efficiently, better serve their customers, and dedicate more time to increasing sales.

There are several practical steps a company should consider to successfully implement and promote the adoption of any mobile software system.

Assemble a Project Team. Because mobile tools influence many areas of a business, it is important to assemble a project team with contributors from all related areas of the company, including sales, operations, supply chain, IT, and finance. By having these groups take part in the planning process, including defining the requirements, the implemented solution has a greater chance of bringing value to the entire business.

Get Management Commitment. Management-level commitment from the business side of a firm is critical for successful adoption. Sales reps may initially worry that new technology will add time and effort to their already busy day. To ensure adoption, management must be able to clearly articulate the benefits, while making it clear that use of the new tools is a requirement rather than a suggestion.

Tap End-Users. Get end-users and their managers involved early in documenting the business processes that you intend to automate and identify the requirements for the end-users and other constituent groups. Users will resist implementation of a system that does not meet their needs, so it is crucial for management to understand their needs early in the project rather than learn that needs have not been addressed after implementation is complete.

Standardize the Application. To maximize the benefit to a corporation, standardize the application. By standardizing an enterprise application that integrates with the back-office systems (ERP, CRM, etc.), data gathered in the field will be collected and transmitted to existing systems that are accessible by internal staff members. Staff can then analyze data without having to learn new systems. There is little value in making a field force more efficient if staff at the home office will have to deal with spreadsheets and nonstandard data.

Assess Device Tasks. Consider all the tasks field personnel need to accomplish with a mobile device. Do they place orders? Get e-mail? Scan bar codes? Select a limited number of device models that can meet the defined requirements. Limiting devices to one or two specific models helps simplify support and training.

Choose a Pilot Group. Identify a small pilot group for the initial rollout. Work with that group for a few months to test the system and identify any issues that should be addressed before rollout to the entire team.

Train. Use face-to-face training in small groups. Training offered as part of a national sales meeting agenda is usually unsuccessful. There are too many distractions at large meetings, and retention of the training material is typically low.

Consider Additional Services. When preparing devices to be deployed, consider how additional services should be managed. Remember that software may need to be loaded along with territory-specific data. Once devices are in the field, keep in mind that there may be issues with the hardware or software from time to time. Because field reps do not want to spend time troubleshooting, look for vendors that can supply overnight replacement services to eliminate the burden on the IT staff.

Conclusion

The future of medical devices hinges on manufacturers' ability to become more mobile. Handheld devices have improved dramatically. Devices now have greater memory, faster processor speed, and wireless data transmission capabilities. Reps should be able to communicate effectively no matter the situation.

By knowing exactly where products are in the field—whether in hospitals, in distributor warehouses, or in sales reps' vehicles—manufacturers can improve their compliance with FDA regulations, effectively manage recalls if necessary, and enhance patient safety.

Many manufacturers have already realized how mobile software can increase sales, improve compliance, and give them an edge over competitors. In every sector of the medical device industry, leading companies are implementing mobile software. The question for medical device sales and supply chain executives is not, “Will we implement mobile tools?” but rather, “How soon can we do so?”

Mark Lagunowich is director of sales for GHX Mobile Solutions (Louisville, CO). He can be reached at [email protected].

References

1. Code of Federal Regulations, 21 CFR 820 and 21 CFR 821.25.

2. “Guidance for Industry—Medical Device Tracking; Guidance for Industry and FDA Staff” [online] (Rockville, MD: FDA, CDRH November 2, 2007 [cited 4 February 2008]); available from Internet: www.fda.gov/cdrh/comp/guidance/169.html.

3. “Break the Paperwork Shackles and Let Your Salespeople Sell,” in Real Business Network [online] June 20, 2007 [cited 4 February 2008]; available from Internet: www.realbusiness.co.za/Article.aspx?articleID=3982&typeID=14.

4. “Advanced Bionics Case Study” [online] (Louisville, CO: GHX Mobile Solutions [cited 4 February 2008]); available from Internet: www.ghx.com/Default.aspx?tabid=419.

5. Interviews held by GHX Mobile Solutions from January to November 2007.

6. “Smith & Nephew Orthopaedics Case Study,” [online] (Louisville. CO, GHX Mobile Solutions [cited 4 February 2008]); available from Internet: www.ghx.com/Default.aspx?tabid=417.

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