Company Background:
For the past 30 years Jeffrey Allard, PhD has been involved in the IVD (In Vitro Diagnostics) industry working for large companies and as a consultant. In 2015 he decided to form his own company, and with his son Paul Allard, they started Lakeside Life Science out of Jeffrey’s house in New Durham, NH.
Since 2015 Lakeside Life Science has grown to 11 employees now working out of a 3,000 square foot facility in Belmont, NH.
Lakeside Life Science is an industry leader and full-service clinical research organization that offers integrated services during every stage of diagnostics product development. They provide the scientific and clinical expertise to help their clients complete the journey through the seasons of product development of laboratory tests from concept to FDA clearance and commercialization.
Lakeside has designed and implemented the protocols to support more than 100 Analytical and Clinical Validation Studies. These studies have led to successful implementation of Laboratory Developed Tests (LDTs) and 54 successful FDA submissions.
Situation:
“We were a small company looking to grow but at that time our growth was primarily from word of mouth,” said Gabriela Cook-DiDomenico, Senior Vice President of Quality and Regulatory Affairs for Lakeside Life Science. They realized growth meant having to compete with other IVD companies and most of them had some kind of certification. “We needed a way to show potential clients that we have processes in place and could compete at the highest level.”
They decided that getting ISO 9001:2015 certified would open doors for getting new customers. That ISO 9001:2015 certification would allow these customers to feel confident that Lakeside Life Science had the proper processes and procedures in place.
Solution:
A colleague who had worked with NH MEP recommended to Gabriela she reach out to their President, Zenagui Brahim. He assigned an NH MEP Project Manager, and along with DeNovo, LLC their 3rd party partner and trainer, they developed an on-site ISO 9001:2015 certification training program for Lakeside Life Science.
ISO 9001:2015 training for Lakeside Life Science would formalize its processes, create ways to effectively manage its people and resources, and be better able to meet customer requirements. Top management would be provided support in designing and implementing a QMS (Quality Management System) tailored to meet the needs of the company’s operations and customers.
The ISO 9001:2015 training and coaching would span their service offerings in areas such as diagnostic research services, clinical trials, product development, analytical validation, and FDA submissions. This training and coaching would take place over 6 months.
Results:
“Now that we are ISO 9001:2015 certified our customers know we can do the job and do it right. Things are well documented, things are on time. Having the right processes in place builds confidence in the relationships we have with our customers and they are happy because of that,” said Cook-DiDomenico. “I also think our employees are more confident in understanding our processes because we have them documented and in place and they train on them regularly.”
The following results for Lakeside Life Science can be credited to having gone through NH MEP’s ISO 9001:2015 certification training:
- $1,100,000 in new sales over the last 12 months
- Retained sales of $203,000 over the last 12 months that otherwise would have been lost
- Added 2 new jobs over the last 12 months
- Retained 8 jobs over the last 12 months
- Increased investment of $12,000 in new products or processes over the last 12 months
- Increased investment of $125,000 in plant or equipment over the last 12 months
- Increased investment of $50,000 in information systems and software over the last 12 months
- Increased investment of $10,000 in workforce practices or employee skills over the last 12 months
“NHMEP, its support staff, project management and Subject Matter Experts were very helpful in helping us achieve ISO 9001:2015 certification in less than 6 months. It has made a very noticeable difference in the services we provide to our customers, including how we present our service offerings, execute our agreements, and provide the final product to our clients. I can’t thank NHMEP enough in helping us achieve this goal.”